1.00.00  RULES OF PROFESSIONAL CONDUCT.

1.00.11  A pharmacist shall at all times conduct his/her profession in conformity with all federal and state drug laws, rules and regulations; and shall uphold the legal standards of the current official compendia.

1.00.12  A pharmacist shall not be a party or accessory to nor engage in any fraudulent or deceitful practice or transaction in pharmacy, nor knowingly participate in any practice which detrimentally affects the patient, nor discredit his/her profession.

1.00.13  A pharmacist shall not enter into any agreement or arrangement with anyone for the compounding of secret formula or coded orders, except for investigational drugs.

1.00.15  A pharmacist shall not, directly or indirectly, be employed as a pharmacist to dispense drugs by a person authorized to prescribe drugs.  For the purpose of this regulation, the term person shall include any person or persons, partnership or business entity in which the person or persons authorized to prescribe drugs has an ownership interest individually or jointly greater than 10 percent.

1.00.16  Confidentiality.

a.  A pharmacist shall not exhibit, discuss, or reveal the contents of any order or prescription, the therapeutic effect thereof, the nature, extent, or degree of illness suffered by any patient or any medical information furnished by the practitioner with any person other than the patient or his authorized representative, the practitioner or another licensed practitioner then caring for the patient, another pharmacist or intern serving the patient, or a person duly authorized by law or by the patient to receive such information.

b.  A pharmacist may disclose patient information to unlicensed assistants, authorized law enforcement personnel, another pharmacist acquiring and maintaining the records, third party entities responsible for payment and any other parties allowed by federal privacy regulations.

c.  The pharmacist shall exercise his professional judgment in the release of patient information to a patient or his authorized agent.

1.00.17  A pharmacist or prescription drug outlet shall not pay or offer to pay or infer that payment might be made of any sum of money or other thing of value to a practitioner, health care facility, nursing care or assisted living facility, or any other health care provider or entity as consideration for any referral to, or promotion of, a prescription drug outlet.

1.00.18  Patient Counseling.

a.  When the patient seeks advice, or when, in the pharmacist's professional judgment, the best interest of the patient will be served, the pharmacist shall offer to advise the patient regarding the prescription.

b.  An employer, employer's agent, employee, pharmacist or prescription drug outlet shall not interfere with the professional judgment of the pharmacist to advise the patient regarding a prescription.

1.00.21  Violation of Board Orders or Negotiated Stipulations or Diversion Program Contracts.  It shall be considered unprofessional conduct for a Colorado-licensed pharmacist or intern to violate a lawful Board order or negotiated stipulation issued in result of a formal complaint against the licensee or to violate a peer health assistance diversion program contract entered into pursuant to Rules 18.02.11 and 18.02.18.

1.00.22  A pharmacist has a professional responsibility to report to the Board in a timely manner any pattern of misconduct in the practice of pharmacy which constitutes a danger to the health, safety, or welfare of a patient or the public.

1.00.23  Severability Clause.  If any word, clause, sentence, paragraph, or section of these Rules of Professional Conduct shall for any reason be adjudged by any court of competent jurisdiction to be unconstitutional or otherwise invalid, such judgment shall not affect, repeal, or invalidate the remainder thereof, but shall be confined in its operation to the word, clause, sentence, paragraph, section thereof so found to be unconstitutional or otherwise invalid.

1.00.24	A prescription drug outlet shall ensure that all drugs dispensed or active ingredients used in compounded preparations are procured from another entity or person registered by the Colorado State Board of Pharmacy.  Any drug designated as an Investigational New Drug from the Federal Food and Drug Administration is exempt from this requirement provided the research requirements for the receipt of the product are followed and it meets the requirements of CRS 12-22-128(2).

3.00.00  DISPENSING.  

3.00.10  Limitations.  Except as provided in CRS 12-22-122(2), no order shall be dispensed or refilled after one year from the date of issue by the practitioner.

3.00.20  Medical Need.  No licensee or registrant shall compound, dispense, deliver or distribute any drug to any person in such quantity or in any situation where the licensee or registrant knows or reasonably should know said drug has no recognized medical utility or application.  Violation of this rule shall constitute prima facie proof of violation of CRS 12-22-125.

The pharmacist may not dispense a prescription drug or a controlled substance to a practitioner based on an order that does not list a specific patient.  A prescription order for “office use” is not a valid order.
3.00.21  A pharmacist shall make every reasonable effort to ensure that any order, regardless of the means of transmission, has been issued for a legitimate medical purpose by an authorized practitioner.  A pharmacist shall not dispense a prescription drug if the pharmacist knows or should have known that the order for such drug was issued on the basis of an internet-based questionnaire, an internet-based consultation, or a telephonic consultation, all without a valid preexisting patient-practitioner relationship.

3.00.30  Labeling.  When a prescription drug is dispensed pursuant to an order, the name of the drug that appears on the container label shall correspond with the identity of the drug contained therein unless otherwise requested by the practitioner.

3.00.40  Expiration Dating.  No drug or device shall be dispensed which will be outdated prior to utilization by the consumer, based on the practitioner's directions for use.  

3.00.50  Final Evaluation. Each time a prescription drug or device is dispensed in a prescription drug outlet, a pharmacist shall make the final evaluation of the transaction.  At the time of such final evaluation, the pharmacist shall take whatever action is necessary to ensure that the initial interpretation, container, label, and prescription drug or device dispensed, as well as all records relating to the transaction are complete, accurate, and appropriate.

a.  The record or records of each dispensing transaction shall bear the identity of the pharmacist making the final evaluation, and this pharmacist shall be held responsible and accountable for each dispensing transaction which bears this pharmacist’s identity.

b.  In the event that the pharmacist making the final evaluation did not make the initial interpretation and does not have access to the order, then the pharmacist making the initial interpretation must be identified in the transaction record as responsible for that initial interpretation.

3.00.60  When a substitution is made on a prescription order, a patient shall be given oral and written notice of this fact at the time such substitution initially occurs, except as provided in CRS 12-22-124.  On subsequent refilling of a prescription order, such oral and written notices shall not be required unless, in the professional judgment of the pharmacist, the best interest of the patient will be served by giving such notices.

3.00.70  Responsibility for Unlicensed Assistants.  A pharmacist:

a.  Shall be responsible for unlicensed assistants and shall at all times strictly comply with CRS 12-22-119(5).

3.00.80  Return or Exchange of Drugs for Dispensing or Donation.  No prescription drug outlet shall accept drugs for return or exchange for redispensing or donation after such drugs have been dispensed except in the following situations:

a.  An outlet that complies with Regulations 3.00.81 through 3.00.85 may accept drugs for return and redispensing.  Such prescription drug outlet shall have return drug protocols approved by the Board.

b.  A hospital prescription drug outlet may accept drugs for redispensing or reissue from all areas of the hospital, provided that the integrity of the product and package are maintained and the following requirements are met:

(1)  An appropriate, uniformly maintained and readily retrievable record shall be maintained which indicates at least the total number of doses of the drug which were actually administered.  This record may be combined with the record permitted by regulation 2.01.20(c); or

(2)  If the drug was distributed as floor stock in the facility, an appropriate, uniformly maintained and readily retrievable record of such return shall be made.  This record shall state the following:

(a)  The name of the drug;

(b)  The strength of the drug;

(c)  The dosage form of the drug if appropriate;

(d)  The quantity of the drug;

(e)  The location within the facility to which the drug was originally distributed; and

(f)  The date of the return. 

c.  A drug shall only be returned to the prescription drug outlet from which originally dispensed.

d.  Any medication returned for redispensing or donation from an inpatient hospice, nursing care facility, or assisted living residence that is licensed pursuant to section CRS 25-3-101 shall bear an expiration date that is at least six months after the date the drug was returned.

e.  In an inpatient hospice, nursing care facility, or assisted living residence that is licensed pursuant to section 25-3-101, C.R.S., a patient, resident, or the patient’s or resident’s next of kin may return unused medication to the prescription drug outlet which had originally dispensed the medication.  The prescription drug outlet may redispense the medication to another patient of the same facility from which it was returned or it may donate the medication to a non-profit entity that has the legal authority to possess the medication.  Such donation and redispensing shall comply with all requirements of regulations 3.00.80 through 3.00.85.  For the purposes of this regulation, a non-profit entity that has legal authority to possess the medication is defined as a registered other outlet which is non-profit, or a registered prescription drug outlet which is non-profit.

3.00.81  For the purposes of this regulation:

a.  "Unit dose package" means a package which contains one pharmaceutical unit.

b.  "Unit of issue package" means a package which provides multiple units of doses but separated in a medication card or other specifically designed container.

c.  "Unit dose dispensing system" means a drug distribution system which is in a prescription drug outlet or hospital other outlet and uses unit dose packages or unit of issue packages that enable distribution of packaged doses in a manner that preserves the identity of the drug until the time of administration.

d.  "Traditional dispensing system" means a drug package system in which individual doses are not packaged in unit dose packages or unit of issue packages.

e.  "Single dose package" means a package which contains a quantity of a drug intended for administration as a single dose.

f.  "Customized patient medication package" means a package which contains two or more drugs.

g.  	“Automated cassette ” is a container that is filled with a drug.  This container may count the drug and may package the drug into a container suitable for dispensing, and may affix a label to the container.  These cassettes may be used to dispense drugs in a traditional dispensing system or may be used to package unit-dose medication, or drugs in a unit of issue packaging system.  An automated cassette shall not be used for schedule II controlled substances.

h.  “Package” means to prepare a drug in a container other than the original container.  The packaging might include a unit dose dispensing system, single dose, automated cassette, or a container suitable for a traditional system.  Unless otherwise specified, this includes preparing a drug in advance of the immediate need for dispensing (prior to the receipt of an order), or pursuant to an existing order. 

3.00.82  No prescription drug outlet shall accept a returned drug product for redispensing or donation unless and until the pharmacist manager of the prescription drug outlet has submitted to the Board a set of protocols detailing procedures for such restocking, redispensing, and donation, and has received the written approval of such protocols from the Board.  Any change to such approved protocols shall be submitted to the Board in writing for approval prior to implementation.  Such protocols shall clearly set forth at least the following:

a.  Methods of ensuring that deterioration and/or contamination of the product will not occur during delivery to the location, storage at the location, and return to the prescription drug outlet from which dispensed;

b.  Methods of packaging with a description of the container system(s), labeling and records to be kept, including examples and/or samples as appropriate.

c.  Records of receipt of returned drugs shall include at least the following:

(1)  Date of return to the pharmacy;

(2)  Date dispensed;

(3)  Prescription number;

(4)  Drug name and strength;

(5)  Quantity returned; and

(6)  Expiration date of drug.

d.  Records of donation to non-profit entities with authority to possess drugs shall include at least the following:

(1)  Name and address of non-profit entity;

(2)  Name and strength of drug;

(3)  The dosage form, if appropriate;

(4)  The quantity of drug;

(5)  The name of the manufacturer or the NDC number of the drug if labeled only with its generic name;

(6)  The date of distribution; 

(7)  The name and address of the distributing pharmacy; and

(8)  Expiration date of drug.

3.00.83  The following shall not under any circumstances be returned to the prescription drug outlet for redispensing or donation:

a.  Any drug declared to be a controlled substance under any state or federal law or regulation except as provided in 3.00.80(b).

b.  Any drug dispensed in a traditional dispensing system, as defined in 3.00.81(d).

c.  Any drugs dispensed in a customized patient medication package.

d.  Any drug not labeled in accordance with 3.01.20 and 3.01.21.

3.00.84  The following are the responsibility of the pharmacist manager of the prescription drug outlet:

a.  To ensure that conditions of delivery to, storage at the location, and during the return from the location, are such as to prevent deterioration and/or contamination by any means that would affect the efficacy and/or toxicity of the product.

b.  To ensure that:

(1)  Control of the drug being returned is known to the pharmacist to have been the responsibility of a person trained and knowledgeable in the storage and administration of drugs, and the drug has not come into the physical possession of the person for whom it was prescribed.

(2)  It can be readily determined that entry or attempted entry to the unit dose or unit of issue package has not been made.

(3)  The drug labeling or packaging has not been altered or defaced so that identity of the drug and such other information as may be required pursuant to Regulation 3.01.00 is retrievable.

3.00.85  When drugs are returned for redispensing, the following shall apply:

a.  Drug products in manufacturer's unit dose or unit of issue packages may be redispensed as often as necessary, provided that the integrity of the product and package are maintained.

b.  Drug products which have been packaged into unit dose or unit of issue packages in the prescription drug outlet may be redispensed one time only, except as provided for in 3.00.80(b), provided that the integrity of the product and the package are maintained.

c.  Drug products which have been packaged into unit of issue packages in the prescription drug outlet may be redispensed one time only and then only in the package in which originally dispensed, except as provided in (e) below.  Partially-used unit of issue packages may not be emptied and the drugs removed and packaged, nor may additional units of medication be added to partially-used unit of issue packages.

d.  Drug products which have been packaged into single dose packages in the prescription drug outlet may be redispensed one time only and then only in the package in which originally dispensed, except as provided in (e) below.  Single dose packages may not be emptied and the drugs removed and packaged.

e.  Drug products which have been packaged into unit of issue packages or single dose packages may be removed from such packages and packaged for dispensing in a traditional dispensing system.

3.00.86  Prescriptions Dispensed but Not Delivered. When a drug has been dispensed pursuant to a prescription or LTCF chart order but has not been delivered to the ultimate consumer, the drug may be returned to stock for subsequent redispensing provided that:

a.  It is stored in the container in which it was dispensed, with the original prescription label intact;

b.  A separate written record or a separate record printable upon request is maintained for prescriptions returned to stock.  such record shall indicate only prescriptions returned to stock and shall list at minimum the following:
	
	(1)	Prescription number;
	(2)	Drug name and strength;
	(3)	Quantity returned to stock;
	(4)	Date of return; and
	(5)	If centrally filled, the location where filled.

c.  The expiration date of the drug shall not be more than one year from the date it was dispensed. Unless it was dispensed in the manufacturer’s original container and bears the manufacturer’s original label and expiration date; and

d.  The drug remains under the same ownership from which it was originally dispensed or is dispensed from a pharmacy in which the pharmacy has a contractual affiliation for central fill processing;

e.  If the drug was delivered to another prescription drug outlet for delivery to the ultimate consumer, the following apply:

(1)  The lot number and manufacturer’s expiration date must be placed on the label of the drug container by the original dispensing prescription drug outlet; or

(2)  The original dispensing prescription drug outlet can access and provide the expiration date and lot number upon request.

(3)	No controlled substance prescriptions may be returned to stock.

3.01.00  Packaging.

3.01.10  a. In a prescription drug outlet packaging shall only be done by a pharmacist, or by an intern or an unlicensed assistant under the supervision of a pharmacist.  In an other outlet, packaging may be done by a person not licensed as a pharmacist pursuant to protocols approved by the Board.

b.  Such packaged drugs shall only be dispensed or distributed from the premises where packaged.  Such drugs shall only be distributed to a location which is under the same ownership as, or is contractually affiliated with, the premises where packaged. 

c. Any container used for packaging shall meet compendia requirements.

3.01.20  Each packaged container, whether for use in a unit dose distribution system or a traditional dispensing system, shall be labeled in accordance with this regulation.  Any packaged unit dose, single dose or unit of issue container for which return for restocking and redispensing, pursuant to 3.00.80, is anticipated, shall be labeled in accordance with this regulation.  Additionally, any packaged container from which subsequent dispensing may occur, shall be labeled in accordance with this regulation.  Such labeling shall include at least the following:

a.	If a suitable internal record is maintained in the prescription drug outlet or other outlet, the requirements of (e), (f), (g), and (h) of this rule may be omitted from the labeling and maintained in such record.  An internal lot number shall be assigned and shall appear in the labeling.  In a prescription drug outlet the record shall be signed by the pharmacist responsible for each lot packaged.  In an other outlet the record shall be signed by the person specified in the Board approved protocol.  The record shall be retained for two years from the date of packaging unless otherwise required by law or regulation.

b. Name and strength of the medication, and, in the case of a single dose package, the total number of individual tablets or capsules per dose;

c.  A suitable expiration date, which shall be not later than the expiration date on the manufacturer’s container, or one year from the date the drug is packaged, whichever is less;

d.  The identity of the manufacturer or distributor;

e.  The manufacturer's or distributor's lot number;

f. 	The manufacturer’s or distributor’s expiration date;;

g.	The date the product was packaged;

h.	The identity of the pharmacist responsible for packaging in a prescription drug outlet, or, in the case of an other outlet, the identity of the non-pharmacist permitted to do so pursuant to protocols approved by the Board;

3.01.21  If the unit dose package or unit of issue package is obtained from the manufacturer or distributor and complies with applicable federal requirements, such package may be dispensed without additional labeling as required in 3.01.20 above.

3.01.22	Filling of automated cassettes.

	a.	If a multi-source drug, the outlet may not use drugs in the same cassette from multiple manufacturers or distributors;

	b.	Schedule II controlled substances may not be packaged into automated cassettes.	

c.	Automated cassettes, without electronic maintenance or records, shall be labeled with the following:

1.	If a suitable internal record is maintained in the prescription drug outlet or other outlet, the requirements of (4), (5), (6), (7), and (8) of this rule may be omitted from the labeling and maintained in such record.  An internal lot number shall be assigned and shall appear in the labeling.  In a prescription drug outlet the record shall be signed by the pharmacist responsible for each lot packaged.  In an other outlet the record shall be signed by the person specified in the board approved protocol.  The record shall be retained for two years from the date of packaging, unless otherwise required by law or regulation.

2.  Name and strength of the medication;

3.  A suitable expiration date, which shall be not later than the expiration date on the manufacturer’s container, or one year from the date the drug is packaged, whichever is sooner;

4.  The identity of the manufacturer or distributor; 

5.  The manufacturer's or distributor's lot number(s); 

6.	The manufacturer’s or distributor’s expiration date; 

7.	The date the product was packaged;

8.	The identity of the pharmacist responsible for packaging in a prescription drug outlet, or, in the case of an other outlet, the identity of the non-pharmacist permitted to do so pursuant to protocols approved by the board;

9.	All records detailing item 1-8 above, shall be retained at the pharmacy for at least two years.

d.   In the event that the automation associated with the cassettes deactivates the cassette when the suitable expiration date is reached, and the outlet either prints packaging printouts on a daily basis or is capable of electronically maintaining the packaging information, the cassette need only be labeled with the name and strength of the drug.

e.  In the event of a product recall, the pharmacist manager shall reasonably ensure that all recalled drug has been removed from the cassette.

3.01.23	Maintenance of automated cassette records.

A prescription drug outlet may utilize a computer (automated data processing system) for storage and retrieval of information regarding packaging in automated cassettes.  The following requirements shall be met:

a. 	All information required by regulation 3.01.22 (c) (1-8) shall be entered into the system at the time of the transaction.

b.  Every 24 hours the system must produce a hard-copy document that, for the purposes of these regulations, shall be known as the “packaging printout”.  It shall consist of a single, uniform, complete document.  The packaging printout shall list, separately, each packaging transaction for the previous 24 hours and shall contain all information required by this regulation. Packaging printouts shall be retained in a chronological manner.  If the printouts are bound, the sheets shall be separated into individual pages that are then placed in the same order as printed and bound uniformly.  If the pages are bound in any other manner so that they are not uniform in placement or appearance, they shall be deemed not readily retrievable and available.

3.01.24  Electronic Maintenance of Packaging Records.

A prescription drug outlet which utilizes a computer (automated data processing system) for storage and retrieval of information regarding packaging transactions need not print the packaging printout required by regulation 3.01.23 if the prescription drug outlet and the computer system utilized are capable of complying with the following requirements:

a.  The prescription drug outlet must be able to provide on-line retrieval of all information required by this regulation for all packaging transactions during the two years preceding the request.

b.  The prescription drug outlet must ensure a daily (i.e., every twenty-four hours) back up is performed for use in restoring required information in case of a system failure.

c.  The prescription drug outlet must:

(1)  Have and maintain a complete on-line transaction file that is printable on the inspector’s request,  

or

(2)  Have a “lock-out” feature that prevents editing of packaging information.

d. The Board or its inspectors must be able to inspect and review the packaging transactions of the prescription drug outlet.  Therefore, immediately upon the oral or written request of the Board or its inspectors, the prescription drug outlet shall either:

(1)  Print a report of all packaging transactions for such period of time as the Board or its inspector(s) may specify.  The system must be capable of retrieving and printing such a report within a limited time not to exceed two hours.  Additionally within 72 hours, the system must be capable of retrieving and printing the information sorted according to the variables which include, but are not limited to, date packaged; drug name, strength and dosage form; lot number,  manufacturer/distributor; or expiration date.

(2)  Provide a computer terminal and monitor for the sole use of the Board or its inspector(s) to inspect and review packaging transactions, and, if necessary, provide a person to assist the Board or its inspector(s) for a period of time not to exceed two hours in operating the system.  If the prescription drug outlet elects to comply with this subparagraph (d), the system must also be capable of printing the same reports described in subparagraph (1).

(3)  It is the responsibility of the prescription drug outlet manager to ensure that all prescription drug outlet staff are aware of the requirements of subparagraphs (1) and (2).  Any failure or refusal by the prescription drug outlet manager and/or a staff pharmacist to comply with a request by the Board or its inspector(s) will be deemed to be a willful violation of these regulations.

e.  Whether the prescription drug outlet elects to comply with regulation 3.01.24(d), the system and any reports printed on request shall contain, as a minimum, the following information for each transaction:

1.  Name and strength of the medication;

2. A suitable expiration date, which shall be not later than the expiration date on the manufacturer’s container, or one year from the date the drug is packaged;

3.  The identity of the manufacturer or distributor; 

4. The manufacturer's or distributor's lot number(s); 

5.	The manufacturer’s or distributor’s expiration date; 

6.	The date the product was packaged;

7.	The identity of the pharmacist responsible for packaging in a prescription drug outlet, or, in the case of an other outlet, the identity of the non-pharmacist permitted to do so pursuant to protocols approved by the board;

3.01.25	Maintenance and cleaning of automated cassettes

a.	The outlet must maintain, on-site and available for inspection, the manufacturer’s guidelines for maintenance and cleaning of the cassettes.

b.	The maintenance and cleaning schedule recommended by the manufacturer shall be adhered to and records of performed maintenance shall be available for inspection for a period of at least two years.

c.	If the outlet changes the drug used in a cassette, the cassette must be thoroughly cleaned per manufacturer’s recommendations prior to using the cassette for a different drug.

3.01.26	Responsibility for unit-dose medications packaged with automated cassettes is the responsibility of the pharmacist responsible for loading the cassette.

3.01.27	The pharmacist responsible for the final evaluation of any prescriptions dispensed using drugs packaged in automated cassettes shall be held accountable for the accuracy of the product.

3.02.00  Compounding.

The purpose of this regulation is to provide information to pharmacists to enhance the pharmacist’s ability to compound preparations that are of acceptable strength, quality and purity.

If the pharmacist compounds a preparation according to the manufacturer’s labeling instructions, then further documentation is not required.  All other compounded preparations require further documentation.

3.02.10	Limitations.  

a.  No preparation shall be compounded in advance in such quantity as may exceed a 90 day supply or is necessary to accurately compound the preparation.  A 90 day supply shall be determined by the average number of dosage units dispensed or distributed of said preparation during the previous 6 month period.

b.  No expired components may be used in compounding.  No component may be used which will expire prior to the beyond-use date of the final compounded product.

3.02.20  Formulation Record.  For each compounded preparation, a uniform, readily retrievable formulation record shall be maintained, documenting:

a.  The name, strength, and dosage form of the preparation compounded;

b.  All ingredients and their quantities;

c.  The equipment used to prepare the preparation, when appropriate, and mixing instructions;

d.  The formulation assigned expiration date;

e.  The container used in dispensing;

f.  The storage requirements;

g.  Procedures for quality control.

3.02.30  Compounding Record.  For each compounded preparation, a record shall be maintained on the original order, or on a separate, uniform, readily retrievable record documenting:

a.  The name and strength of the compounded preparation;

b.  The formulation record reference for the preparation;

c.  The sources and lot numbers of each ingredient;

d.  The manufacturer’s expiration date of each ingredient when applicable;

e.  The total number of dosage units compounded;

f.  The name of the person who prepared the preparation;

g.  The name of the pharmacist who approved the preparation;

h.  The date of preparation;

i.  The assigned internal identification number if applicable;

j.  The assigned expiration date which, in the absence of stability information that is applicable to a specific drug and preparation,

(1)  For nonaqueous and solid formulations

(a)  Where the manufactured drug product is the source of the active ingredient, shall not exceed 25% of the time remaining until the product’s expiration date or 6 months, whichever is earlier;

(b)  Where a USP-NF substance is the source of active ingredient, shall not be greater than 6 months;

(2)  For water-containing formulations prepared from ingredients in solid form, shall not be greater than 14 days when stored at cold temperatures;

(3)  For all other formulations, shall not be greater than the intended duration of therapy or 30 days, whichever is earlier;

k.  The prescription number, if appropriate;

l.  The results of quality control procedures.

3.02.40  Labeling of Dispensed Compounded Prescriptions.

a.  Labeling shall comply with CRS 12-22-123.  In addition, the label shall contain the beyond-use expiration date of the product.

3.02.50  Casual Sales/distribution of Compounded Products.

a.  A pharmacy may only distribute a compounded product to a practitioner authorized by law to prescribe the drug.  

b.  The pharmacy must retain the following information on a current basis for each practitioner to whom it distributes compounded products:

1.  Verification of practitioner’s license from the jurisdiction in which licensed;

2.  Verification of practitioner’s current DEA registration, if controlled substances are distributed to the practitioner;

3.  If the products are distributed to practitioners located outside of Colorado, the pharmacy shall verify that the practitioners legally authorized to prescribe the drug in the jurisdiction in which the practitioner is licensed;

4.  If the products are distributed outside of the United States, the pharmacy shall maintain written documentation of the above in English; and

5.  Controlled substances may not be distributed outside of the United States unless the pharmacy has obtained registration with DEA as an exporter.

c.  Labeling of compounded products which are distributed shall contain at least the following:

1.  Name and address of the outlet;

2.  Name and strength of the drug(s);

3.  Total quantity in package;

4.  Quantity of active ingredient in each dosage unit;

5.  Beyond-use date;

6.  Batch (lot) number;

7.  Specific route of administration;

8.  Storage directions;

9.  “RX only”;

10.  “This product was compounded by the pharmacy”.

d.  Records of distribution shall comply with regulation 11.07.20.

3.03.00  Customized Patient Medication Packages (Med Paks).

3.03.10  When a unit dose, single dose, unit of issue or customized patient medication package is dispensed pursuant to an order, the prescription shall comply with all requirements of CRS 12-22-123(2).  Container requirements of a prescription for the purpose of unit dose systems may be broadened to include trays, bins, carts and locked cabinets or drawers.  Additionally, a customized patient medication package shall comply with all the following requirements:

a.  Labeling

The patient med pak shall bear a label stating

(1)  The name of the patient;

(2)  A serial number for the patient med pak itself and a separate identifying serial number for each of the prescription orders for each of the drug products contained therein;

(3)  The name, strength, and total quantity of each drug product contained therein;

(4)  The directions for use and cautionary statements, if any, contained in the prescription order for each drug product therein;

(5)  Any storage instructions or cautionary statements;

(6)  The name of the prescriber of each drug product therein;

(7)  The date of preparation of the patient med pak, the expiration date which may not exceed 60 days from the date of preparation;

(8)  The name, address, and telephone number of the dispenser.

b.  Record Keeping.

(1)  Patient name and address;

(2)  The serial number of the prescription order for each drug in product contained therein;

(3)  Descriptive information sufficient to allow subsequent preparation of an identical patient med pak;

(4)  Date of preparation of the patient med pak and the expiration date assigned;

(5)  Any special labeling instructions;

(6)  The identity of the pharmacist who prepared the patient med pak.

c.  Packaging

(1)  Each container shall meet or exceed United States Pharmacopoeia standards.

(2)  Each container shall be either not reclosable or so designed as to show evidence of having been opened.

3.03.20  It shall not be considered redispensing for a prescription drug outlet to modify a customized medication package which it has previously dispensed if the following criteria are met:

a.  The med pak is modified for the same patient for which it was originally dispensed.

b.  The med pak is returned to the prescription drug outlet from which it was originally dispensed.

c.  Only discontinued medication may be removed from the med pak.  Additional medications may not be added.

d.  The medications removed from the med pak are destroyed.  They may not be redispensed.

d.  The med pak is assigned a new serial number.

e.  The labeling of the med pak is modified to comply with 3.03.10(a).  The expiration date affixed to the label prior to modification must be retained.

f.  Records are maintained for the modified med pak which comply with regulation 3.03.10(b).

3.04.00  Colorado Cancer Drug Repository Program.

3.04.10  A prescription drug outlet may accept donations of non-controlled cancer drugs and medical devices from cancer patients or the cancer patient’s family, provided the drugs or devices meet the following requirements:

a.  The drug is in the original, unopened, sealed, and tamper-evident unit-dose packaging, or if in a single unit dose package, the single unit dose package is unopened;

b.  The drug is not expired;

c.  The drug is not adulterated or misbranded as determined by the pharmacist; 

d.  The drug does not require refrigeration, freezing, or other special temperature requirements beyond controlled room temperature; and

e.  The drug does not require patient registration with the drug manufacturer prior to dispensing.

3.04.20  The drugs and devices shall be stored in the compounding/dispensing area under manufacturer’s recommended storage conditions.  The drugs and devices shall be stored separately from the other drug stock.

3.04.30  Dispensing/distribution of repository drugs/devices.

3.04.31  The prescription drug outlet may distribute the donated drugs or devices to the following:

a.  A medical clinic, which is defined as a community health clinic required to be licensed or certified by the Colorado Department of Public Heath and Environment.  Such clinic must be registered with the board as an other outlet; or

b.  A registered prescription drug outlet.

3.04.32  The prescription drug outlet may dispense the drugs to eligible patients based on a valid order from a practitioner.  An eligible patient is defined as an uninsured or underinsured cancer patient who meets the eligibility criteria established in rule by the State Board of Health.  The pharmacy may only charge a handling fee for such dispensing.  This fee shall be determined by the State Board of Health.

3.04.40  Recordkeeping.

3.04.41  The prescription drug outlet shall retain separate records detailing the receipt and distribution/dispensing of repository drugs and devices.

3.04.42  Records of receipt shall include at least the following:

a.  Name and address of person donating the drug or device;

b.  Drug name and strength;

c.  Manufacturer of drug or device;

d.  Manufacturer’s lot number;

e.  Drug expiration date;

f.  Date received; and

g.  Quantity received.

3.04.43  Records or distribution shall include at least the following:

a.  Name and address of medical clinic or prescription drug outlet;

b.  Drug or device name;

c.  Drug strength;

d.  Dosage form, if appropriate;

e.  Quantity distributed;

f.  Identity of manufacturer of drug or device;

g.  Manufacturer’s lot number;

h.  Drug expiration date; 

i.  Date of distribution; and

j.  Name and address of distributing pharmacy.

3.04.44  Records of dispensing shall include at least the following;

a.  Patient name;

b.  Prescription number;

c.  Drug or device name and drug strength;

d.  Quantity dispensed;

e.  Practitioner’s name;

f.  Date dispensed;

g.  Identity of drug or device manufacturer; and

h.  Drug or device lot number.

4.00.00  LICENSING.

4.00.10  Interns.  An intern must practice in conformity with the laws, rules, and regulations of the state in which he/she interns.

a.  The intern must obtain one thousand five hundred (1,500) hours of internship.

(1)  These hours may be obtained by participation in a rotation program conducted by an accredited school or college of pharmacy; and/or internship hours may be independently obtained by a licensed intern enrolled in, in good standing with, or having graduated from an approved school of pharmacy or holding a valid Foreign Pharmacy Graduate Equivalency Committee certificate.

(2)  Up to thirty (30) percent of the required hours may be obtained with a drug manufacturer under the supervision of such manufacturer or with a school or college of pharmacy in drug or drug related research activities as provided in CRS 12-22-111(1)(b)(i).

b.  An intern who fails to surrender his/her intern license upon the request of the Board, shall be deemed to be in violation of this regulation.  Although he/she may be granted the experience time submitted, administrative action may be instituted to suspend or revoke his/her license to practice as an intern, or to deny his/her license to practice as a pharmacist.

c.  A license to practice as an intern may be granted only to a person who has submitted satisfactory evidence that he/she has graduated from, is enrolled in, is in attendance at, or is in good standing with an accredited school or college of pharmacy, or has submitted to the Board a certificate issued by the Foreign Pharmacy Graduate Examination Commission.

d.  A person on suspension from a school or college of pharmacy does not meet the definition of an intern and is not entitled to exercise the privileges of the intern license.

e.  A person who is in good standing with the school or college of pharmacy, but is not attending, may be licensed as an intern.

4.00.20  Preceptors.  A preceptor is a pharmacist or other authorized person training an intern in compliance with the pharmacy laws, rules and regulations of a state.

a.  A pharmacist preceptor shall have been licensed and in the practice of pharmacy for at least two consecutive years immediately prior to his/her application for preceptor approval.

b.  Other than Letters of Admonition, during the five years preceding such application, the preceptor shall not have been found guilty nor been disciplined by a court or Board for violation of any law or rule. 

c.  A preceptor who meets the requirements of these rules and who has been approved by the Board or approved by an accredited school or college of pharmacy within a clinical rotation shall be employed at each location where an intern is engaged in the practice of pharmacy for credit towards satisfaction of the intern requirements.

d.  A pharmacist shall oversee the practice of pharmacy of an intern and shall be responsible for the actions of such intern that pertain to the practice of pharmacy as defined.

e.  A preceptor of record shall be responsible for the overall training program of not more than two interns at the same work time.

f.  More than one pharmacist or other authorized person may be approved by the Board as a preceptor at any location.

4.01.00  License Transfer.  An applicant for license transfer must transfer a license, which was issued by another state which is current and in good standing.

a.  The applicant for license transfer shall use the Board designated clearinghouse for license transfer.  The applicant must submit the application for license transfer on forms approved by the Board, along with such other documents, fees and requirements as designated by the Board.

b.  The applicant for license transfer must have passed a Board examination with a score meeting the Colorado standards at the time of original licensure.

c.  Limitations.  An applicant for license transfer must pass a Board approved jurisprudence examination, which, for the purpose of this regulation, shall be the practical examination.  The passing point shall be set at 75 to reflect minimum competence.

d.  Applicants for license transfer must have been licensed for at least one year or have served an Internship meeting the Colorado requirements at the time of original licensure.

e.  No temporary license to practice pharmacy in the State of Colorado shall be granted.

4.02.00  Licensure by Examination.  The examinations for licensure as a pharmacist shall consist of an academic examination and a jurisprudence examination, each approved by the Board.

a.  For licensure by examination the academic examination shall be fairly designed to test the applicant’s knowledge of pharmacy and other related subjects.  The passing point shall be set at 75 to reflect minimum competence.

b.  The candidate for licensure by examination must pass a Board approved jurisprudence examination, which, for the purpose of this regulation, shall be the practical examination.  The passing point shall be set at 75 to reflect minimum competence.

c.  If an applicant for licensure by examination passes only one of the required examinations, the applicant shall be required to repeat the failed examination.  If, after 24 months, the applicant has not passed both required examinations, he shall be required to also repeat the previously passed examination.

d.  Score Transfer applicants must complete their licensure within one year from the date the score transfers are received by the Colorado State Board of Pharmacy.

e.  If a candidate for licensure fails to appear for a scheduled examination, the fee shall be forfeited.  If the candidate later desires to take the examination, he/she shall reapply and pay the current fee.

f.  Practice in lieu of internship.  One year of practice of pharmacy as a licensed pharmacist in another state may be accepted by the Board in lieu of a Colorado internship, if the candidate is seeking licensure by examination and has completed this year of practice prior to taking the examination.

g.  Examination results.  Results of the examination for licensure by examination shall be released whether the candidate is eligible for licensure or not.  The Board's staff may release licenses to all candidates when all requirements have been met, and the Board shall act on such released licenses at the next scheduled meeting.

h.  Intern hours obtained over five years past graduation from a school or college of pharmacy shall not be valid for the purposes of obtaining a license by examination or score transfer.

4.03.00  Reinstatement of Pharmacist License.  A person seeking to reinstate his/her license as a pharmacist shall be required to pay the appropriate fee and prove 24 hours continuing education in the 24-month period preceding the application date.  If the person’s pharmacist license has been lapsed for over two years, such person shall be required to take and pass the approved examinations as specified below prior to the granting of such reinstatement:

a.  If the person has not practiced pharmacy as defined in CRS 12-22-102(26)(a) and (b), for at least 400 hours during the year prior to seeking such reinstatement, he/she shall be required to take and pass both the current practice and jurisprudence examinations, each Board approved, to be eligible for reinstatement.  The passing point shall be set at 75 to reflect minimum competence.

b.  If the person has been practicing pharmacy as defined in CRS 12-22-102(26) for at least 400 hours during the year prior to seeking reinstatement, he/she shall only be required to take and pass the jurisprudence examination.  The passing point shall be set at 75 to reflect minimum competence.

4.04.00  Reactivation of Pharmacist License.  A person seeking to reactivate his license when his license is inactive shall be required to file an application and demonstrate that he has met the twenty-four hour approved continuing education requirement.  Should the person’s license have been inactive for a period longer than two years from the date of filing of the application for reactivation, he must also take and pass the current practice examination and the jurisprudence examination prior to reactivation.  The passing point shall be set at 75 to reflect minimum competence.

4.05.00  License Changes.

a.  Name change.  The Board records shall reflect a name change that has been appropriately reported.  When a licensee’s name changes, a duplicate license will not be required in the new name.  If the licensee wishes a copy of the license with the new name, the licensee shall pay the requisite fee.

b.  Change of employment or address.  All pharmacists and interns shall notify the Board in writing within 30 days of any change of location of employment or change of address.

c.  Change of manager.  A pharmacist shall immediately notify the Board in writing of the date he ceases to be the pharmacist manager of a prescription drug outlet.

4.06.00  Identification of Licensee.  A pharmacist shall at all times while on duty wear a badge which is visible to the patient and which shall state at least the title Pharmacist and license number.  Interns shall wear a badge labeled intern pharmacist.

7.00.00  PHARMACY MANAGER RESPONSIBILITIES.

7.00.10  Reporting Violations. The pharmacist manager of a prescription drug outlet shall report the following violations of the Drugs and Druggists Act:

a.  Diversion of substances from the pharmacy.

b.  Security breaches within the pharmacy or pharmacy area of the establishment.

c.  The unaccountable loss of medications from the pharmacy, whether by theft or unknown means.

d.  Any pharmacist working in the pharmacy who is impaired due to the use of alcohol or drugs, or a pharmacist with a mental or physical impairment which affects his ability to perform his job competently.

e.  Significant errors related to the practice of pharmacy such as those that result in serious personal injury or death of a patient.

7.00.20  Administrative Reporting Responsibilities:

a.  A pharmacist manager shall immediately notify the Board in writing of the date he ceases to be the pharmacist manager of a prescription drug outlet.

b.  Upon the change of pharmacist manager of a prescription drug outlet, the new pharmacist manager or the new pharmacist manager’s designee shall take an inventory of all controlled substances within seventy-two hours.  The inventory shall be taken either as of the opening or as of the close of business activity on the inventory date and such time and date taken shall be entered on the inventory record.

c.  Upon the transfer of ownership of a prescription drug outlet, the pharmacist manager or the pharmacist manager’s designee shall take an inventory of all controlled substances.  The inventory shall be taken either as of the opening or as of the close of business activity on the inventory date and such time and date taken shall be entered on the inventory record.

d.  The pharmacist manager shall determine or approve procedures for prescriptions delivered or temporarily stored outside the confines of a compounding/dispensing area at the request of a patient or an agent of the patient.  This procedure shall include the storage of, security of, the access to, the confidentiality of, and the counseling regarding, prescriptions and necessary record keeping.

e.  Upon the discontinuance of the practice of pharmacy in any prescription drug outlet it shall be the responsibility of the last pharmacist manager of record to remove the prescription and/or chart orders to another prescription drug outlet where patrons and/or practitioners are afforded reasonable access to a pharmacist’s interpretation of such orders.

f.  The daily printout shall contain all information as required by regulation except that the identity of the pharmacist who makes the final evaluation may appear either on the daily printout or on another separate, uniformly maintained and readily retrievable record.  The pharmacist manager shall determine which of the two methods for identifying the responsible pharmacist is more appropriate for the outlet, and only that method for recording such information shall be used.  This applies to both prescription order and chart order dispensing.

g.  It is the responsibility of the pharmacist manager to ensure that all prescription drug outlet staff are aware that they must be able to print a report of all prescription order or chart order transactions for such period of time as the Board or its inspector(s) may specify, or to provide a computer terminal and monitor for the sole use of the Board or its inspector(s) to inspect and review dispensing transactions, and, if necessary, provide a person to assist the Board or its inspector(s) for a period of time not to exceed two hours in operating the system.  (If the prescription drug outlet elects to comply with the latter requirement of providing equipment and/or personnel, the system must also be capable of printing the reports previously described.)  Any failure or refusal by the pharmacist manager and/or a staff pharmacist to comply with a request by the Board or its inspector(s) will be deemed to be a willful violation of these regulations.

h.  It is the responsibility of the pharmacist manager to maintain records as required by Regulation 11.00.00.

7.00.30  Compliance of Outlet:

a.  The manager of a prescription drug outlet is responsible for the operation of the outlet in compliance with all state and federal laws, rules, and regulations.

b.  The manager shall be responsible for posting the following information for each pharmacy technician working in the compounding/dispensing area :

1.  Certificate indicating the technician is certified by a nationally recognized certification Board, or

2.  Diploma indicating the technician has graduated from an accredited pharmacy technician training program, or

3.  Documentation that the pharmacy technician has completed five hundred hours of experiential training at the pharmacy.  This documentation must be certified by the pharmacist manager of the prescription drug outlet; or

4.  Documentation that the pharmacy technician does not have certification from a nationally recognized certification Board, has not graduated from an accredited pharmacy technician training program, and has not completed 500 hours of experiential training at the pharmacy.

	c.	The pharmacist manager is responsible for ensuring that all prescription drugs dispensed or active ingredients used in compounded preparations in the prescription drug outlet are procured from an entity or person registered by the Colorado State Board of Pharmacy.  Any drug designated as an Investigational New Drug from the Federal Food and Drug Administration is exempt from this requirement provided the research requirements for the receipt of the product are followed and it meets the requirements of CRS 12-22-128(2).

11.00.00  RECORDS AND RECORDKEEPING. 

11.01.00  Records in General.  All outlets registered and/or licensed by the Board shall maintain such records and inventories of prescription drugs as may be required by these regulations or any other state or federal law or regulation pertaining to such drugs. Such records shall be maintained on a current basis and shall be complete and accurate for all drugs which the outlet manufactures, receives, dispenses, distributes or otherwise disposes of in any other manner.  Records and inventories of controlled substances shall be deemed to be “complete” only if each individual record and inventory contains all required information regarding each specific transaction, and if the set of records and inventories contains all information and documents requires to be kept by state and federal laws, rules, and regulations.  A record or inventory shall be deemed to be “accurate” only if it is a complete, true and factual statement regarding or reflecting each specific transaction.  A set of records or inventories shall be deemed to be “accurate” only if they are complete, and when considered as a whole, they demonstrate that the controlled substances and/or the records and inventories pertaining thereto have been handled in compliance with all applicable laws or regulations and that all such controlled substances are properly accounted for.

All such records shall be retained for a period of at least two years after the date of any transaction relating to such record or inventory by any process providing an exact duplicate of the original order in a reproducible quality acceptable to the Board.  Records shall be retained in a format that cannot be altered.

Records on an automated data processing system or subsequent storage of such records must be immediately retrievable (via monitor display or hard copy printout).  Upon written Board approval, outlets capable of meeting the above standards may not be required to retain the original prescription order or LTCF chart order for non-controlled drugs.

11.02.00  Retrievability of Records.  For the purposes of these regulations, records and inventories shall be deemed “readily retrievable” if they meet the following requirements:

For all Registered Prescription Drug Outlets:

a.  The following records shall be maintained on the premises of the prescription drug outlet at all times, unless written authorization for off-site storage has been approved by the board, and shall be made available for inspection by the Board or its inspectors immediately upon request:

(1)  All DEA-222 forms executed during the two years preceding the request;

(2)  All inventories of controlled substances required to be taken during the two years preceding the request;

(3)  All prescription orders or LTCF chart orders dispensed during the two years preceding the request;

(4)  All records of dispensing, receipts (invoices for drugs received and credited) of controlled substances, distribution, loss, surrender or disposal in manner of prescription drugs and controlled substances during the two years preceding the request;

(5)  All lists as required by regulations 11.08.00 and 11.09.00.

b.  The following records shall be made available within 48 hours or two business days, whichever is longer, on request by the Board or its inspectors:

(1)  All unexecuted DEA-222 forms.

(2)  Specific records requested by the inspector if the inspector determines the records are not maintained in a readily retrievable manner.

(3)  Records of receipt of non-controlled prescription drugs.

11.03.00  Inventories of Controlled Substances.  Any inventory of controlled substances shall comply with the following:

a.  If the outlet is registered with the Drug Enforcement Administration as a “hospital/clinic”, the inventory shall include all drugs located throughout the facility, excluding any drug which has been dispensed pursuant to a lawful chart order but which has not yet been administered to the patient.

b.  Each inventory shall contain a complete and accurate records of all controlled substances (including outdated controlled substances) on hand on the date the inventory is taken.  The inventory shall be maintained in written, typewritten or printed form at the prescription drug outlet.  Schedule II drugs shall be separated from schedule III, IV, and V drugs.  Controlled substances shall be deemed to be “on hand” if they are in the possession of or under the control of the registrant.  However, the inventory shall exclude any drug that has been dispensed pursuant to a lawful prescription order but which has not yet been delivered.

c.  The inventory shall be taken either as of opening of business or as of the close of business on the inventory date and it shall be recorded on the inventory.  In the event the prescription drug outlet is open 24 hours per day, the inventory shall specify the time the inventory was conducted.

d.  After the initial inventory is taken, the prescription drug outlet shall take new inventory of all stocks of controlled substances on hand at least every two years.

e.  On the effective date of a law or rule on which a previously non-scheduled drug is added to any schedule of controlled substances, every prescription drug outlet that possesses that drug shall take an inventory of all stocks of the drug on hand.  Thereafter, that drug shall be included in each inventory made by the prescription drug outlet.

f.  The following information shall be recorded on the inventory.

(1)  The name of the drug;

(2)  Each finished form of the drug (strength and dosage form);

(3)  The number of units or volume of each finished form.

(4)  All outdated controlled substances.

g.  In determining the number of units of each finished form of a controlled substance in a commercial container which has been opened, the prescription drug outlet shall do as follows:

(1)  If the drug is a schedule II drug, an exact count of the contents shall be made.

(2)  If the substance is listed in schedule III, IV, or V, and estimated count of the measure of the contents may be made, unless the container holds more than 1,000 tablets or capsules, in which case an exact count of the contents must be made.

h.  All controlled substance inventories shall be retained at the prescription drug outlet for at least two years from the date of such inventory.

11.04.00  Records pertaining to prescription orders and chart orders for long-term care facility patients (LTCF chart orders).

11.04.10  A hard copy of every prescription order shall be readily retrievable and available for inspection for a period of two years from the date of any transaction relating to such prescription order unless the prescription drug outlet has received written Board approval to not retain the original prescription order for non-controlled drugs.  Prescription orders will be deemed to be readily retrievable and available if they are filed according to the numerical sequence of the serial numbers assigned pursuant to 2.01.10.  In addition to being filed in numerical sequence, three different prescription files shall be maintained:  one file shall consist only of schedule II controlled substance prescription orders; the second file shall consist only of schedule III, IV and V controlled substance prescription orders; and the third file shall consist of all non-controlled substance prescription orders.  Filing of prescription orders in any manner other than by numerical sequence will result in such prescription orders being deemed not readily retrievable and available.

A hard copy of every chart order shall be readily retrievable and available for inspection for a period of two years from the date of any transaction relating to such order.  The LTCF chart orders will be deemed to be readily retrievable and available if they are filed according to the date of dispensing.  Chart orders for schedule III, IV, and V controlled substances shall be readily identifiable from non-controlled chart orders.  Schedule II orders shall be retained separately from all other orders.

If a prescription drug outlet utilizes both prescription orders and chart orders, assigning serial numbers to both with the same computer system, the orders must be filed sequentially by serial number.

11.04.20  Computer Use With Prescription Order or LTCF Chart Order Transactions.

A prescription drug outlet may utilize a computer (automated data processing system) for storage and retrieval of information regarding prescription and LTCF chart order transactions.  The following requirements shall be met:

a.  All new and refill prescription and LTCF chart order transactions shall be entered into the system at the time of the transaction, except as provided in regulation 11.04.20(i).

b.  Every 24 hours, except as provided in regulation 11.04.30, the system must produce a hard-copy document which, for the purposes of these regulations, shall be known as the “daily printout”.  It shall consist of a single, uniform, complete document, except as otherwise permitted in this regulation.  The daily printout shall list, separately, each prescription or LTCF chart order transaction for the previous 24 hours and shall contain all information required by this regulation.  Daily printouts shall be retained in a chronological manner.  If the printouts are bound, the sheets shall be separated into individual pages which are then placed in the same order as printed and bound uniformly.  If the pages are bound in any other manner so that they are not uniform in placement or appearance, they shall be deemed not readily retrievable and available.

c.  The daily printout shall contain all of the following information for each prescription or LTCF chart order transaction and shall differentiate between new and refill transactions.  As an alternative, new and refill transactions may be separated into two separate uniform and complete documents which contain the following:

(1)  The serial number;

(2)  The name of the patient;

(3)  The name of the practitioner:

(4)  For each controlled substance dispenses, the practitioner’s Drug Enforcement Administration registration number;

(5)  The date of issue by the practitioner, the date dispensed shall be presumed to be the date of issue.

(6)  The total number of refills authorized;

(7)  Date dispensed;

(8)  The initials of the pharmacist making the final evaluation;

(9)  The name and strength of the drug dispensed;

(10)  The quantity of the drug dispensed;

(11)  In the case of a refill, the total number of refills dispensed to date.

d.  Records of prescription or LTCF chart order transactions involving controlled substances shall be identifiable from those involving non-controlled substances.  Alternatively a separate complete printout listing only controlled substance transactions may be produced.

e.  The daily printout shall be available for inspection by the Board within 72 hours from the most recent date recorded on the printout.

f.  Prescription or LTCF chart order refill transactions must be uniformly recorded on the original prescription or LTCF chart order or on the daily printout.  In the event of a discrepancy between the entry on the order and the entry on the daily printout, the information recorded on the daily printout shall be deemed to be correct.

g.  Documentation of the fact that the refill information entered into the automated data processing system each time a pharmacist refills an original prescription or LTCF chart order for a schedule III, IV, or V controlled substance is correct must be provided by the pharmacist who makes the final evaluation.  This documentation may be retained in the following manner:

(1)  If such a system provides a hard-copy printout of each day’s controlled substance prescription or LTCF chart order refill data, the controlled substance refill information shall be verified, dated, and signed by the pharmacist making the final evaluation.  The pharmacist shall verify that the date indicated is correct and then sign this document in the same manner as he/she would sign a check or legal document.  This document shall be maintained in a separate file at the prescription drug outlet for a period of two years from the dispensing date.  The printout of the day’s controlled substance prescription or LTCF chart order refills must be generated by the prescription drug outlet within 72 hours of the date on which the refill was dispensed.  It must be verified and signed by each pharmacist who is involved in dispensing controlled substance refills.

or

(2)  The prescription drug outlet shall maintain a bound log book, or separate file, in which each pharmacist involved in dispensing controlled substance order refills shall sign attesting to the fact that the refill information entered into the computer that day has been reviewed by him/her and is correct as shown.  Such a book or file must be maintained at the prescription drug outlet for a period of two years after the date of dispensing the appropriately authorized refill.

h.  The daily printout shall contain all information as required by this regulation except that the identity of the pharmacist who makes the final evaluation may appear either on the daily printout or on another separate, uniformly maintained and readily retrievable record.  The outlet manager shall determine which of the two methods for identifying the responsible pharmacist is more appropriate for the outlet, and only that method for recording such information shall be used.

i.  Because of the potential for a system malfunction or failure, the prescription drug outlet must have a manual procedure for recording all dispensing transactions during the system failure or malfunction.  All recoverable transaction data and all manually recorded transaction data shall be entered or restored into the system within a reasonable period of time not to exceed seven days following the restoration or operation of the system.

j.  Any automated data processing system used by an outlet shall maintain the confidentiality of records in accordance with applicable laws, rules and regulations.

11.04.30  Electronic Maintenance of Prescription or LTCF Chart Order Records.

A prescription drug outlet which utilizes a computer (automated data processing system) for storage and retrieval of information regarding prescription or LTCF chart order transactions need not print the daily printout required by regulation 11.04.20 if the prescription drug outlet and the computer system utilized are capable of complying with the following requirements:

a.  The prescription drug outlet must be able to provide on-line retrieval of all information required by this regulation for all prescription order transactions during the two years preceding the request.

b.  The prescription drug outlet must ensure a daily (i.e., every twenty-four hours) back up is performed for use in restoring required information in case of a system failure.

c.  The prescription drug outlet must:

(1)  Have and maintain a complete on-line transaction file that is printable on the inspector’s request,  

or

(2)  Have a “lock-out” feature that prevents editing of dispensing information.

d.  The Board or its inspectors must be able to inspect and review the prescription order transactions of the prescription drug outlet.  Therefore, immediately upon the oral or written request of the Board or its inspectors, the prescription drug outlet shall either:

(1)  Print a report of all prescription or LTCF chart order transactions for such period of time as the Board of its inspector(s) may specify.  The system must be capable of retrieving and printing such a report within a limited time not to exceed two hours.  Additionally within 72 hours, the system must be capable of retrieving and printing the information sorted according to the variables which include, but are not limited to, date dispensed; drug name, strength and dosage form; patient name, and practitioner name; or

(2)  Provide a computer terminal and monitor for the sole use of the Board or its inspector(s) to inspect and review dispensing transactions, and, if necessary, provide a person to assist the Board or its inspector(s) for a period of time not to exceed two hours in operating the system.  If the prescription drug outlet elects to comply with this subparagraph (d), the system must also be capable of printing the same reports described in subparagraph (1).

(3)  It is the responsibility of the prescription drug outlet manager to ensure that all prescription drug outlet staff are aware of the requirements of subparagraphs (1) and (2).  Any failure or refusal by the prescription drug outlet manager and/or a staff pharmacist to comply with a request by the Board or its inspector(s) will be deemed to be a willful violation of these regulations.

e.  Whether the prescription drug outlet elects to comply with regulation 11.04.30 (d), the system and any reports printed on request shall contain, as a minimum, the following information for each transaction:

(1)  The prescription order serial number;

(2)  The name of the patient;

(3)  The name of the practitioner;

(4)  For each controlled substance dispensed, the practitioner’s Drug Enforcement Administration registration number;

(5)  The date of issue by the practitioner; if the date is omitted by the practitioner, the date dispensed shall be presumed to be the date of issue;

(6)  The total number of refills authorized;

(7)  Date dispensed;

(8)  The initials or other means of identification of the pharmacist making the final evaluation;

(9)  The name and strength of the drug dispensed;

(10)  The quantity of the drug dispensed;

(11)  In the case of a refill, the total number of refills dispensed to date;

(12)  Whether the prescription order is a new or refill transaction;

(13)  In the case of a controlled substance, a means of visually identifying orders for such substances and differentiating them from non-controlled substances.

11.05.00  Records Pertaining to Hospital Chart Orders.

11.05.10  A chart order or the other appropriate, uniformly maintained records permitted by regulation 2.01.20 (c) shall be readily retrievable and available for inspection for a period of two years from the date of any transaction relating to such order or record.  However, if the records permitted by regulation 2.01.20 (c) and 11.05.20 are retained and are complete, the prescription drug outlet copy of a chart order need not be retained.  Prescription drug outlet copies of chart orders or the other appropriate, uniformly maintained records permitted by 2.01.20 (c) and 11.05.20 will be deemed to be readily retrievable and available if they are filed:

a.  In chronological order according to the date of discharge of the patient; or

b.  Alphabetically by patient surname by month of discharge; or

c.  By date of dispensing transaction.

Filing of chart order/dispensing transaction record in any other manner will result in such orders or records being deemed not readily retrievable and available.

11.05.20  Records Pertaining to Chart Orders Shall Contain the Following Information:

a.  The identity of the pharmacist making the initial interpretation;

b.  The identity of the pharmacist making the final evaluation each time a drug is dispensed, if different from the pharmacist making the initial interpretation;

c.  The quantity dispensed and

d.  The date of dispensing;

e.  Any record of a controlled substance dispensed pursuant to a chart order for and individual patient shall be visually identifiable from records of non controlled substances.

11.05.21  It is permissible to store different types of chart order dispensing records separately.  For the purpose of this regulation, different types of chart order dispensing records include fill lists, records of compounded injectable products, records of the initial dispensing of a chart order, and the records of redispensing of chart orders.  If the prescription drug outlet chooses to maintain different types of dispensing records separately, they must be maintained as required by regulation 11.05.10.

11.05.30  Computer Use with Hospital Chart Order Transactions.  A prescription drug outlet may utilize a computer (automated data processing system) for storage and retrieval of information regarding chart order transactions if the following requirements are met:

a.  All new chart orders shall be entered into the system, except as provided in regulation 11.05.30 (e).  For the purpose of this regulation, “dispensing transaction” is defined as delivery of a drug or device pursuant to a chart order.

b.  All records produced by this computer system must comply with regulation 11.05.20.  These records shall be printed a minimum of every 24 hours unless the prescription drug outlet complies with regulation 11.05.40.  This documentation shall be retained for at least two years from the date of dispensing.  This documentation shall be retained in a chronological manner.  If printouts are bound, the sheets shall be separated into individual pages, which are then placed in the same order as printed and bound uniformly.  If the pages are bound in any other manner so that they are not uniform in placement or appearance, they shall be deemed not readily retrievable.  This documentation shall be available for inspection by the Board or its inspectors within 72 hours from the most recent date recorded on the documentation.

c.  Any computer system utilized shall have the capability of producing a single-document printout, which shows for any controlled substance a complete history of all dispensing transactions during the previous two years for each patient admission.  This printout shall be available within 72 hours of a request by the Board.

d.  Because of the potential for a system malfunction or failure, the prescription drug outlet must have a manual procedure for recording all dispensing transactions during the system failure or malfunction.  All recoverable transaction data and all manually entered transaction data shall be entered or restored into the system within a reasonable period of time not to exceed seven days following the restoration of operation of the system.

e.  Any automated data processing system used by an outlet shall maintain the confidentiality of records in accordance with applicable laws, rules and regulations.

11.05.40  Electronic Maintenance of Hospital Chart Order Records.  A prescription drug outlet which utilizes a computer (automated data processing system) for storage and retrieval of information regarding chart order transactions need not print the records of chart order dispensing required by regulation 11.05.20, if the prescription drug outlet and the computer system utilized are capable of complying with the following requirements.

a.  The prescription drug outlet must be able to provide on-line retrieval of all information required by this regulation for all chart order transactions during the two years preceding the request.

b.  The prescription drug outlet must ensure a daily (i.e., every twenty-four hours) back up is performed for use in restoring required information in case of a system failure.

c.  The prescription drug outlet must:

(1)  Have and maintain a complete on-line transaction file that is printable on the inspector’s request, 

or

(2)  Have a “lock-out” feature that prevents editing of dispensing information.

d.  The Board or its inspectors must be able to inspect and review the chart order transactions of the prescription drug outlet.  Therefore, immediately upon the oral or written request of the Board or it inspectors, the prescription drug outlet shall either:

(1)  Print a report of all chart order transactions for such period of time as the Board or its inspector(s) may specify.  The system must be capable of retrieving and printing such a report within a limited time not to exceed two hours.  Additionally, within 72 hours, the system must be capable of retrieving and printing the information sorted according to variables which include, but are not limited to, date dispensed; drug name, strength and dosage form; patient name; or

(2)  Provide a computer terminal and monitor for the sole use of the Board or its inspector(s) to inspect and review dispensing transactions, and, if necessary, provide a person to assist the Board or its inspector(s) for a period of time not to exceed two hours in operating the system.  If the prescription drug outlet elects to comply with this subparagraph (b), the system must also be capable of printing the same reports described in subparagraph (1)

(3)  It is the responsibility of the prescription drug outlet manager to ensure (1) and (2).  Any failure or refusal by the prescription drug outlet manager and/or a staff pharmacist to comply with a request by the Board or its inspector(s) will that all prescription drug outlet staff are aware of the requirements of subparagraphs be deemed to be a willful violation of these regulations.

e.  Whether the prescription drug outlet elects to comply with regulation 11.05.40 (d) (1) or (2), the system and any reports printed on request shall contain, as a minimum, the following information for each transaction:

(1)  The name and/or other identifying factor of the patient;

(2)  The identity of the pharmacist making the initial interpretation;

(3)  The quantity dispensed;

(4)  The date of dispensing;

(5)  Any record of a controlled substance dispensed pursuant to a chart order for an individual patient shall be distinguishable from records of non-controlled substances.  Alternatively, a separate complete printout listing on controlled substance transactions may be produced.

f.  The daily printout shall contain all information as required by this regulation except that the identity of the pharmacist who makes the final evaluation may appear either on the daily printout or on another separate, uniformly maintained and readily retrievable record.  The outlet manager shall determine which of the two methods for identifying the responsible pharmacist is more appropriate for the outlet, and only that method for recording such information shall be used.

11.06.00  Receipts

11.06.10  Records of receipts of prescription drugs and controlled substances shall contain the following information for each such substance received:

a.  Name of the drug;

b.  Strength of the drug;

c.  Dosage form if appropriate;

d.  Quantity received;

e.  Date received if a controlled substance;

f.  Name of the labeler of the drug if it is labeled only with its generic name;

g.  Name of the distributor;

h.  DEA number of distributor if a controlled substance;

i.  The DEA form 222 or a copy of the DEA form 222 and the corresponding invoice shall be attached to each other.

11.06.20  All records of receipt (including credit invoices) of prescription drugs and controlled substances shall be maintained for a period of time not less than two years from the date the drugs were received.  Records of receipt (including credit invoices) of non-controlled prescription drugs need not be maintained on the premises provided that they shall be made available within 48 hours or two business days, whichever is longer, on request by the Board or its inspectors.

11.06.30  All records of receipt of schedule II controlled substances shall be maintained separately from all other records.

11.06.40  Records of receipt of schedule III, IV, and V controlled substances may be maintained with other records of receipt.  However, the record shall be readily identifiable from the records of receipt of non-controlled drugs.

11.07.00  Distribution

11.07.10  Records of distribution of controlled substances and prescription drugs within hospitals.  Records of distribution of controlled substances and prescription drugs shall comply with the following:

a.  In a hospital which operates a registered prescription drug outlet, a controlled substance or prescription drug may be distributed for floor stock to appropriate areas of the facility.  A record of any such distribution shall be made and retained for a period of time not less than two years and shall include the following information:

(1)  The location receiving the drug;

(2)  The name of the drug;

(3)  The strength of the drug;

(4)  The quantity of the drug;

(5)  The dosage form if appropriate;

(6)  The date the drug was supplied;

(7)  The identity of the person in the prescription drug outlet who issued the drug;

(8)  The identity of the person who placed the drug into floor stock.

b.  These records of distribution may be retained electronically provided the following requirements are met:

(1)  The prescription drug outlet must ensure a daily (i.e., every twenty-four hours) back up is performed for use in restoring required information in case of a system failure.

(2)  The prescription drug outlet must:

(a)  Have and maintain a complete on-line distribution file that is printable on the inspector’s request,

or

(b)  Have a “lock-out” feature that prevents editing of distribution information.

(3)  The Board and its inspectors must be able to inspect and review the distribution transactions of the prescription drug outlet.  Therefore, immediately upon the oral or written request of the Board or its inspectors, the prescription drug outlet shall either:

(a)  Print a report of all distribution transactions for such period of time as the Board or its inspector(s) may specify.  The system must be capable of retrieving and printing such a report within a limited time not to exceed two hours.  Additionally, the system must be capable of retrieving and printing the information sorted according to variables which include, but are not limited to, date distributed, drug name, strength and dosage form, or

(b)  Provide a computer terminal and monitor for the sole use of the Board or its inspector(s) to inspect and review distribution transactions, and, if necessary, provide a person to assist the Board or its inspector(s) for a period of time not to exceed two hours in operating the system.  If the prescription drug outlet elects to comply with this subparagraph (2), the system must also be capable of printing the same reports described in subparagraph (1)

(c)  It is the responsibility of the prescription drug outlet manager to ensure that all prescription drug outlet staff are aware of the requirements of subparagraphs (1) and (2).  Any failure or refusal by the prescription drug outlet manager and/or a staff pharmacist to comply with a request by the Board or its inspector(s) will be deemed to be a willful violation of these regulations.

(4)  If the prescription drug outlet chooses to maintain records of distribution electronically, any reports printed upon request shall contain, as a minimum, the following information for each transaction:

(a)  The location receiving the drug;

(b)  The name of the drug;

(c)  The strength of the drug;

(d)  The quantity of the drug;

(e)  The dosage form if appropriate;

(f)  The date the drug was supplied;

(g)  The identity of the person in the prescription drug outlet who issued the drug;

(h)  The identity of the person who placed the drug into floor stock.

11.07.20  Records of Distribution/Casual Sale of Controlled Substances and Prescription Drugs.  A prescription drug outlet which distributes prescription drugs and/or controlled substances shall record the following:

a.  The name of the drug;

b.  The strength of the drug;

c.  The dosage form if appropriate;

d.  The quantity of the drug;

e.  The name of the manufacturer or the NDC number of the drug if labeled only with its generic name.  In the case of a compounded product, the name of the pharmacy shall be recorded;

f.  If a compounded product, the batch or lot number;

g.  The date of distribution;

h.  The name and address of the distributing outlet;

i.  The name and address of the receiver;

j.  If a controlled substance is distributed, the record shall also indicate the Drug Enforcement registration number of the distributing outlet and the receiver.

k.  A schedule II controlled substance shall only be distributed pursuant to receipt of a properly executed DEA-222 form.

11.07.21  These records of distribution and casual sale required by 11.07.20 shall be retained for a period of time not less than two years from the date of the distribution.

11.07.22  Records of distribution and casual sale required by regulation 11.07.20 may be maintained electronically if the following requirements are met:

a.  The prescription drug outlet must ensure a daily (i.e., every twenty-four hours) back up is performed for use in restoring required information in case of a system failure.

b.  Have and maintain a complete on-line distribution and casual sale file that is printable on the inspector’s request, or

c.  Have a “lock-out” feature that prevents editing of distribution and casual sale information.

d.  The Board or its inspectors must be able to inspect and review the distribution transactions of the prescription drug outlet.  Therefore, immediately upon the oral or written request of the Board or its inspectors, the prescription drug outlet shall either:

(1)  Print a report of all distribution and casual sale transactions for a period of time as the Board or its inspector(s) may specify.  The system must be capable of retrieving and printing such a report within a limited time not to exceed two hours.  Additionally, the system must be capable of retrieving and printing the information sorted according to variables which include, but are not limited to; date of distribution, drug name, strength and dosage form, and licensee receiving the distribution;

or

(2)  Provide a computer terminal and monitor for the sole use of the Board or its inspector(s) to inspect and review distribution transactions, and, if necessary, provide a person to assist the Board or its inspector(s) for a period of time not to exceed two hours in operating the system.  If the prescription drug outlet elects to comply with this subparagraph (2), the system must also be capable of printing the same reports described in subparagraph (1).

(3)  It is the responsibility of the prescription drug outlet manager to ensure that all prescription drug outlet staff are aware of the requirements of subparagraphs (1) and (2).  Any failure or refusal by the prescription drug outlet manager and/or a staff pharmacist to comply with a request by the Board or its inspector(s) will be deemed to be a willful violation of these regulations.

e.  If the prescription drug outlet chooses to maintain records of casual sales and distribution electronically, any reports printed upon request shall contain, as a minimum, the following information for each transaction:

(1)  The name of the drug;

(2)  The strength of the drug;

(3)  The dosage form if appropriate;

(4)  The quantity of the drug;

(5)  The manufacturer name and/or NDC number of the drug if labeled only with its generic name;

(6)  The date of distribution;

(7)  The name and address of the distributing outlet;

(8)  The name and address of the receiver;

(9)  If a controlled substance is distributed, the record shall also indicate the Drug Enforcement registration number of the distributing outlet and the receiver.

11.08.00  List of Employees.  Each prescription drug outlet shall keep and maintain on a current basis a list of every licensed pharmacist and intern who has practiced pharmacy in that outlet at any time during the previous two years, including all part-time or relief personnel.  This list shall show, for each such person, the following information:

a.  The printed name of the person;

b.  The person’s license number;

c.  A sample of his/her initials and signature and any other identifying mark as affixed to any record required by law or regulation; and

d.  The date upon which such person began practicing pharmacy in the prescription drug outlet.

11.09.00  Symbols and Codes.  Symbols and codes may be used to identify any manufacturer, distributor or repackager.  If such symbols and codes appear in the records of a prescription drug outlet, the prescription drug outlet shall keep a current, complete printed or typed list, which shows both the symbol and code and its complete definition.  This list shall be readily retrievable and available for examination by the Board for at least two years.

14.00.00  OTHER OUTLETS.

14.00.10  General Criteria.  Unless otherwise exempted, the general criteria, which shall be met by other outlets herein enumerated, which are seeking to be registered by the Board pursuant to CRS 12-22-120(1)(e), are stated below.

a.  For the purpose of this section, the consultant pharmacist is the pharmacist responsible for the other outlet registration and the overall operation pertaining to drug receipt and distribution.
	
b.	All prescription drugs utilized by the outlet shall be obtained from an entity or individual registered with the Colorado State Board of Pharmacy or a state or local health agency.

14.00.20  Protocols.  Written protocols shall be developed by the consultant pharmacist and submitted to the Board for approval.  These protocols shall be submitted on form(s) provided by the Board and shall establish:

a.  A system of recordkeeping to document the procurement, administration, compounding, dispensing, and/or distribution, including the return to the original source, of all prescription drugs and devices, including recalled items.

b.  A system to ensure that no drug or device shall be dispensed which will be outdated prior to utilization by the consumer, based on the practitioner’s directions for use.

c.  A system by which drugs are dispensed complying with the labeling, drug identification and container requirements imposed by law.

d.  The duties of the consulting pharmacist.

14.00.30  Revisions to other outlet protocols.  Revisions to other outlet protocols shall be submitted as a complete set in duplicate for approval by the Board.  Prior to becoming effective, the protocol changes must be approved by the Board or its designee.

14.00.40  Application Procedure.

a.  Original application.  Original application for registration as an other outlet shall be made on a form provided by the Board.  This application shall be accompanied by the appropriate fee and two copies of the protocols.

b.  Other outlet relocation.

(1)  When an other outlet changes location, the outlet shall submit an application on a form provided by the Board prior to outlet relocation.

(2)  The consultant pharmacist for the other outlet shall submit two copies of revised protocols to the Board within 30 days of relocation.

c.  Change of ownerships of other outlet.  Application to transfer registration of an other outlet shall be submitted on a form provided by the Board.  This application shall be accompanied by the appropriate fee and two copies of protocols.  Transfer of ownership shall be deemed to have occurred:

(1)  In the event the other outlet is owned by a corporation, upon sale or transfer of 20 percent or more of the shares of said corporation to a single individual or entity.

(2)  In the event the other outlet is owned by a partnership, upon sale or transfer of 20 percent or more of any ownership interest.

(3)  In the event the other outlet is owned by a limited liability company (LLC), upon sale or transfer of 20 percent or more of the membership interests.

(4)  Upon incorporation of an existing other outlet.

d.  Change of name of other outlet.  Changes in the name of an other outlet shall be submitted to the Board on a form provided by the Board.  Two copies of protocols shall be submitted to the Board within 30 days of the other outlet changing its name.

e.  Change of consultant pharmacist.

(1)  A new application shall be submitted to the Board within 30 days after the former consultant pharmacist ceases to be the consultant pharmacist.

(2)  If an application is not submitted within 30 days, the other outlet registration shall become void and the Board shall be informed in writing by the person responsible for the overall operation of the other outlet of the disposition of all drug stock possessed by the other outlet.

(3)  The other outlet registration shall be issued in the name of the consultant pharmacist.  At such time as the consultant pharmacist ceases to be engaged in said position, he/she shall immediately upon knowledge thereof, notify the Board in writing.  The person responsible for the overall operation of the other outlet shall immediately notify the Board in writing when the consultant pharmacist ceases to function as such.  

(4)  A pharmacist assuming the duties as a consultant pharmacist for an other outlet shall notify the Board in writing within seven days of assuming said position.

(5)  A pharmacist assuming duties as a consultant pharmacist for an other outlet shall review the current protocols and document the review within 30 days of assuming said position.  Documentation shall include the date of review and the consultant pharmacist’s signature.  Said documentation shall be retained with the consultant pharmacist’s record of inspection or the current Board approved protocols.

14.00.50  Board request that protocols be submitted.  When the Board requests that protocols be submitted, the consultant pharmacist shall comply within 30 days of said request.

14.00.60  Registration posting.  Every other outlet shall display in the primary drug storage area, or other readily accessible area, all licenses and registrations applicable to the possession and distribution of prescription drugs and controlled substances.  Furthermore, every other outlet shall display in the primary drug storage area, or other readily accessible area, the report of the last inspection conducted by the Board and have readily available Board approved protocols, consultant pharmacist reports of inspections and any other documents sent by the Board to clarify or assist in the legal operation of the other outlet.

14.00.70  Other required registrations.  The other outlet shall obtain such state and/or federal registrations as may be required.

14.00.80  Consultant pharmacist.

a.  A consultant pharmacist shall either:

(1)  Initially interpret all prescription orders dispensed from the other outlet, or

(2)  Provide written protocols for dispensing by unlicensed persons.

b.  A consultant pharmacist shall be available for professional consultation.

c.  A consultant pharmacist shall annually review the protocols for compliance with this regulation 14.00.00.  The review shall be documented in writing, signed, and dated by the consultant pharmacist.

d.  A consultant pharmacist shall visit the other outlet a minimum of one time each quarter to ensure compliance with the protocols and all applicable laws, rules, and regulations.  The consultant pharmacist shall develop a form to document the visit and the results thereof.  Such form shall be dated and signed by the consultant pharmacist and shall be maintained and available for inspection at the other outlet by the Board for a period of two years.

e.  The consultant pharmacist shall be responsible for the accuracy of records pertaining to drug stock returned to the original supplier, the manufacturer, or via a reverse distributor.  The record of any returned drug stock shall indicate, as a minimum, the name and address of the original supplier, manufacturer or reverse distributor, the date of return, and the name, strength, and quantity of the drug returned.  This record shall be signed by the consultant pharmacist, and shall be maintained on the premises for a minimum of two years.

f.  The consultant pharmacist for a licensed hospital other outlet shall be notified of any casual sale or loan of a drug made by the licensed hospital other outlet to a practitioner authorized by law to prescribe the same prior to the transaction.  The consultant pharmacist for a licensed hospital other outlet shall be notified within 72 hours of any casual sale or loan of a drug to a registered other outlet, a prescription drug outlet, or a mobile emergency care unit.

g.  The consultant pharmacist is responsible for ensuring all prescription drugs obtained by the other outlet are procured from an individual or entity registered b the Colorado State Board of pharmacy or a state or local health agency.

14.00.90  Institutions operating other outlets for limited public welfare purposes pursuant to Board-approved protocols.

a.  Jails which operate registered other outlets.  A jail which obtains prescription drugs solely on the basis of individual prescription orders which have been compounded in and dispensed from a registered prescription drug outlet shall be exempt from registration.

b.  County health departments.

c.  Community and rural health clinics.

d.  Colleges, universities and schools (grades kindergarten through twelve) which operate a school-based clinic for students and faculty of that school.  Schools must submit any contractual affiliations to the Board prior to registration.

e.  Hospitals which do not operate a registered prescription drug outlet.  For such institutions, dispensing shall be limited as provided in CRS 12-22-121(11).

f.  Family planning clinics.

14.01.00  Interim designated consultant pharmacist.  In the event the consultant pharmacist in whose name the other outlet registration is issued is unable to perform the duties of a consultant pharmacist, the consultant pharmacist shall designate an individual pharmacist to assume the consultant pharmacist’s duties for no more than 90 consecutive days.  The consultant pharmacist in whose name the other outlet registration is issued shall notify the Board in writing within ten days of designating an individual pharmacist to assume said consultant pharmacist’s duties.  Said written notification shall include, as a minimum, the name and license number of the individual pharmacist, the beginning and ending dates for which said individual pharmacist assumes the consultant pharmacist’s duties, and the reason for which said individual pharmacist is designated to assume the consultant pharmacist’s duties.  In the event the consultant pharmacist in whose name the other outlet registration is issued is unable to perform the duties of a consultant pharmacist for a period exceeding 90 days, an application identifying a new consultant pharmacist shall be submitted to the Board no later than 30 days following the end of the original 90 day period.

14.02.00  Records and recordkeeping in other outlets.

14.02.10  Records in general.  All other outlets registered and/or licensed by the Board shall maintain such records and inventories of prescription drugs as may be required by these regulations or any other state or federal law or regulation pertaining to such drugs.  Such records shall be maintained on a current basis and shall be complete and accurate for all drugs which the outlet manufactures, receives, dispenses, distributes or otherwise disposes of in any other manner.  Records and inventories of controlled substances shall be deemed to be "complete" only if each individual record and inventory contains all required information regarding each specific transaction, and if the set of records and inventories contains all information and documents required to be kept by state and federal laws, rules, and regulations.  A record or inventory shall be deemed to be "accurate" only if it is a complete, true and factual statement regarding or reflecting each specific transaction.  A set of records or inventories shall be deemed to be "accurate" only if they are complete, and, when considered as a whole, they demonstrate that the controlled substances and/or the records and inventories pertaining thereto have been handled in compliance with all applicable laws or regulations and that all such controlled substances are properly accounted for.

14.02.20  Retrievability of records.  For the purposes of these regulations, records and inventories shall be deemed "readily retrievable" if they meet the following requirements:

a.  For all other outlets:

(1)  The following records shall be maintained on the premises of the other outlet at all times and shall be made available for inspection by the Board or its inspectors immediately upon request.

(a)  All DEA-222 forms executed during the two years preceding the request;

(b)  All inventories of controlled substances required to be taken during the two years preceding the request;

(c)  All records of dispensing, receipt (invoices for drugs received and drugs credited), distribution, loss, surrender or disposal in any other manner of prescription drugs and controlled substances during the two years preceding the request;

(2)  The following records shall be made available within 48 hours or two business days, whichever is longer, on request by the Board or its inspectors:

(a)  All unexecuted DEA-222 forms.

b.  In the case of a request by the inspector for specific records:

(1)  Records shall be maintained in such a manner as to permit the inspector to retrieve specific records immediately.

(2)  If the inspector determines the records are not maintained in the manner specified in (1) above, the inspector may give the consultant pharmacist or outlet staff a list of the items to be retrieved.  The requested records shall be made available to the inspector within 48 hours of the request.

14.02.30  Inventories of controlled substances.  Any inventory of controlled substances shall comply with the following:

a.  If the outlet is registered with the Drug Enforcement Administration as a "hospital/clinic", the inventory shall include all drugs located throughout the facility, excluding any drug which has been dispensed pursuant to a lawful chart order but which has not yet been administered to the patient.

b.  Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken.  The inventory shall be maintained in written, typewritten or printed form at the other outlet.  Schedule II drugs shall be separated from schedule III, IV, and V drugs.  Controlled substances shall be deemed to be “on hand” if they are in the possession of or under the control of the outlet.  However, the inventory shall exclude any drug that has been dispensed pursuant to a lawful order but which has not yet been delivered.

c.  The inventory shall be taken either as of opening of business or as of the close of business on the inventory date and this shall be recorded on the inventory.  In the event the other outlet is open 24-hours per day, the inventory shall specify the time the inventory was conducted.

d.  After the initial inventory is taken, the other outlet shall take a new inventory of all stocks of controlled substances on hand at least every two years.  

e.  On the effective date of a law or rule on which a previously non-scheduled drug is added to any schedule of controlled substances, every other outlet that possesses that drug shall take an inventory of all stocks of the drug on hand.  Thereafter, that drug shall be included in each inventory made by the other outlet.

f.  The following information shall be recorded on the inventory.

(1)  The name of the drug;

(2)  Each finished form of the drug (strength and dosage form);

(3)  The number of units or volume of each finished form;

(4)  All outdated controlled substances.

g.  In determining the number of units of each finished form of a controlled substance in a commercial container which has been opened, the other outlet shall do as follows:

(1)  If the drug is a schedule II drug, an exact count of the contents shall be made.

(2)  If the substance is listed in schedule III, IV, or V, an estimated count of the measure of the contents may be made, unless the container holds more than 1000 tablets or capsules, in which case an exact count of the contents must be made.

h.  All controlled substance inventories shall be retained at the other outlet for at least two years from the date of such inventory.

14.03.00  Dispensing records.

a.  At minimum, dispensing records must include the following information for every transaction:

(1)  Unique serial number;

(2)  Patient name;

(3)  Prescriber;

(4)  Date dispensed;

(5)  Name and strength of drug dispensed;

(6)  Quantity dispensed;

(7)  Whether the transaction is a new or refill transaction;

(8)  If refill transaction, the date of the initial order;

(9)  Number of refills authorized;

(10)  Number of refills dispensed to date;

(11)  Identification of individual responsible for dispensing;

(12)  If a controlled substance, the DEA registration number of the prescriber;

Records must be current and show all dispensing transactions, new and refill.

14.03.10  Computer use for dispensing transactions.  An other outlet may utilize a computer (automated data processing system) for storage and retrieval of information regarding dispensing transactions.  The following requirements shall be met:

a.  All new and refill transactions shall be entered into the system at the time of the transaction, except as provided in regulation 14.03.10(i).

b.  Every 24 hours, except as provided in regulation 14.03.20, the system must produce a hard-copy document which, for the purposes of these regulations, shall be known as the "daily printout".  It shall consist of a single, uniform, complete document, except as otherwise permitted by this regulation.  The daily printout shall list, separately, each prescription order transaction for the previous 24 hours and shall contain all information required by this regulation.  Daily printouts shall be retained in a chronological manner.  If the printouts are bound, the sheets shall be separated into individual pages which are then placed in the same order as printed and bound uniformly.  If the pages are bound in any other manner so that they are not uniform in placement or appearance, they shall be deemed not readily retrievable and available.

c.  The daily printout shall contain all of the following information for each dispensing transaction and shall differentiate between new and refill transactions.  As an alternative, new and refill transactions may be separated into two separate uniform and complete documents which contain the following:

(1)  The serial number;

(2)  The name of the patient;

(3)  The name of the practitioner;

(4)  For each controlled substance dispensed, the practitioner's Drug Enforcement Administration registration number;

(5)  The date of issue by the practitioner.  If the date is omitted by the practitioner, the date dispensed shall be presumed to be the date of issue;

(6)  The total number of refills authorized;

(7)  The date dispensed;

(8)  The initials of the individual making the final evaluation;

(9)  The name and strength of the drug dispensed;

(10)  The quantity of the drug dispensed;

(11)  In the case of a refill, the total number of refills dispensed to date.

d.  Records of dispensing transactions involving controlled substances shall be identifiable from those involving non-controlled substances.  Alternatively, a separate complete printout listing only controlled substance transactions may be produced.

e.  The daily printout shall be available for inspection by the Board within 72 hours from the most recent date recorded on the printout.

f.  Documentation of the fact that the refill information entered into the automated data processing system each time a person refills an original prescription order for a schedule III, IV, or V controlled substance is correct must be provided by the individual who makes the final evaluation.  This documentation may be retained in the following manner:

(1)  If such a system provides a hard-copy printout of each day’s controlled substance prescription order refill data, the controlled substance refill information shall be verified, dated, and signed by the person making the final evaluation.  This individual shall verify that the date indicated is correct and then sign this document in the same manner as he/she should sign a check or legal document.  This document shall be maintained in a separate file at the other outlet for a period of two years from the dispensing date.  The printout of the day’s controlled substance dispensing transaction must be generated by the other outlet within 72 hours of the date on which the refill was dispensed.  It must be verified and signed by each person who is involved in dispensing controlled substance refills.

or

(2)  The other outlet shall maintain a bound log book, or separate file, in which each person involved in dispensing controlled substance refills shall sign attesting to the fact that the refill information entered into the computer that day has been reviewed by him/her and is correct as shown.  Such a book or file must be maintained at the other outlet for a period of two years after the date of dispensing the appropriately authorized refill.

g.  The daily printout shall contain all information as required by this regulation except that the identity of the person who makes the final evaluation may appear either on the daily printout or on another separate, uniformly maintained and readily retrievable record.  The consultant pharmacist shall determine which of the two methods for identifying the responsible person is more appropriate for the outlet, and only that method for recording such information shall be used.

h.  Because of the potential for a system malfunction or failure, the other outlet must have a manual procedure for recording all dispensing transactions during the system failure or malfunction.  All recoverable transaction data and all manually recorded transaction data shall be entered or restored into the system within a reasonable period of time not to exceed seven days following the restoration of operation of the system. 

i.   Any automated data processing system used by an outlet shall maintain the confidentiality of records in accordance with applicable laws, rules and regulations.

14.03.20  Electronic maintenance of dispensing records.  An other outlet which utilizes a computer (automated data processing system) for storage and retrieval of information regarding dispensing transactions need not print the daily printout required by regulation 14.03.10 if the other outlet and the computer system utilized are capable of complying with the following requirements:

a.  The other outlet must be able to provide on-line retrieval of all information required by this regulation for all dispensing transactions during the two years preceding the request. 

b.  The other outlet must ensure a daily (i.e., every twenty-four hours) back up is performed for use in restoring required information in case of a system failure.

c.  The other outlet must

(1)  Have and maintain a complete on-line transaction file that is printable on the inspector’s request,

or

(2)  Have a “lock-out” feature that prevents editing of dispensing information.

d.  The Board or its inspectors must be able to inspect and review the dispensing transactions of the other outlet.  Therefore, immediately upon the oral or written request of the Board or its inspectors, the other outlet shall either:

(1)  Print a report of all dispensing transactions for such period of time as the Board or its inspector(s) may specify.  The system must be capable of retrieving and printing such a report within a limited time not to exceed two hours.  Additionally, the system must be capable of retrieving and printing the information sorted according to variables which include, but are not limited to, date dispensed; drug name, strength and dosage form; patient name, and practitioner name;

or

(2)  Provide a computer terminal and monitor for the sole use of the Board or its inspector(s) to inspect and review dispensing transactions, and, if necessary, provide a person to assist the Board or its inspector(s) for a period of time not to exceed two hours in operating the system.  If the other outlet elects to comply with this subparagraph (d), the system must also be capable of printing the same reports described in subparagraph (1).

(3)  It is the responsibility of the consultant pharmacist to ensure that all outlet staff are aware of the requirements of subparagraphs (1) and (2).  Any failure or refusal by the consultant pharmacist and/or outlet staff to comply with a request by the Board or its inspector(s) will be deemed to be a willful violation of these regulations.

e.  Whether the other outlet elects to comply with regulation 14.03.20(d), the system and any reports printed on request shall contain, as a minimum, the following information for each transaction:

(1)  The prescription order serial number;

(2)  The name of the patient;

(3)  The name of the practitioner;

(4)  For each controlled substance dispensed, the practitioner’s Drug Enforcement Administration registration number;

(5)  The date of issue by the practitioner; if the date is omitted by the practitioner, the date dispensed shall be presumed to be the date of issue;

(6)  The total number of refills authorized;

(7)  Date dispensed;

(8)  The initials or other means of identification of the individual dispensing the order;

(9)  The name and strength of the drug dispensed;

(10)  The quantity of the drug dispensed;

(11)  In the case of a refill, the total number of refills dispensed to date;

(12)  Whether the prescription order is a new or refill transaction;

(13)  In the case of a controlled substance, a means of visually identifying orders for such substances and differentiating them from non-controlled substances.

14.04.00  Receipts.

14.04.10  Records of receipts of prescription drugs and controlled substances shall contain the following information for each such substance received:

a.  Name of the drug;

b.  Strength of the drug;

c.  Dosage form if appropriate;

d.  Quantity received;

e.  Date received if a controlled substance;

f.  Name of the labeler of the drug if it is labeled only with its generic name;

g.  Name of the distributor;

h.  DEA number of distributor if a controlled substance.

i.  The DEA form 222 or a copy of the DEA form 222 and the corresponding invoice shall be attached to each other.

14.04.20  All records of receipt of prescription drugs and controlled substances shall be maintained at the other outlet for a period of time not less than two years from the date the drugs were received.

14.04.30  All credit invoices of prescription drugs and controlled substances shall be maintained at the other outlet for a period of time not less than two years from the date of the invoice.

14.04.40  All records of receipt of schedule II controlled substances shall be maintained separately from all other records.

14.04.50  Records of receipt of schedule III, IV, and V controlled substances may be maintained with other records of receipt.  However, the record shall be readily identifiable from the records of receipt of non-controlled drugs.

14.05.00  Distribution.

14.05.10  Records of distribution of controlled substances and prescription drugs within hospital other outlets.  Records of distribution of controlled substances and prescription drugs shall comply with the following:

a.  In a hospital which operates a registered hospital other outlet, a controlled substance or prescription drug may be distributed for floor stock to appropriate areas of the facility.  A record of any such distribution shall be made and retained for a period of time not less than two years and shall include the following information:

(1)  The location receiving the drug;

(2)  The name of the drug;

(3)  The strength of the drug;

(4)  The quantity of the drug;

(5)  The dosage form if appropriate;

(6)  The date the drug was supplied;

(7)  The identity of the person in the prescription drug outlet who issued the drug;

(8)  The identity of the person who received the drug into floor stock.

b.  These records of distribution may be retained electronically provided the following requirements are met:

(1)  The other outlet must ensure a daily (i.e., every twenty-four hours) back up is performed for use in restoring required information in case of a system failure.

(2)  The other outlet must:

(a)  Have and maintain a complete on-line distribution file that is printable on the inspector’s request,

or

(b)  Have a “lock-out” feature that prevents editing of distribution information.

(3)  The Board or its inspectors must be able to inspect and review the distribution transactions of the other outlet.  Therefore, immediately upon the oral or written request of the Board or its inspectors, the prescription drug outlet shall either:

(a)  Print a report of all distribution transactions for such period of time as the Board or its inspector(s) may specify.  The system must be capable of retrieving and printing such a report within a limited time not to exceed two hours.  Additionally, the system must be capable of retrieving and printing the information sorted according to variables which include, but are not limited to, date distributed, drug name, strength and dosage form;

or

(b)  Provide a computer terminal and monitor for the sole use of the Board or its inspector(s) to inspect and review distribution transactions, and, if necessary, provide a person to assist the Board or its inspector(s) for a period of time not to exceed two hours in operating the system.  If the other outlet elects to comply with this subparagraph (2), the system must also be capable of printing the same reports described in subparagraph (1).

(c)  It is the responsibility of the consultant pharmacist to ensure that all other outlet staff are aware of the requirements of subparagraphs (1) and (2).  Any failure or refusal by the consultant pharmacist and/or outlet staff to comply with a request by the Board or its inspector(s) will be deemed to be a willful violation of these regulations.

(4)  If the other outlet chooses to maintain records of distribution electronically, any reports printed upon request shall contain, as a minimum, the following information for each transaction:

(a)  The location receiving the drug;

(b)  The name of the drug;

(c)  The strength of the drug;

(d)  The quantity of the drug;

(e)  The dosage form if appropriate;

(f)  The date the drug was supplied;

(g)  The identity of the person in the prescription drug outlet who issued the drug;

(h)  The identity of the person who received the drug into floor stock.

14.05.11  A county health department registered as an other outlet may distribute prescription drugs to another registered other outlet owned or operated by that county health department.  The drug shall be distributed in the original sealed container in which it was received from the wholesaler.

14.05.20  Records of distribution (casual sales) of controlled substances and prescription drugs. A hospital or county health department other outlet which distributes prescription drugs and/or controlled substances shall record the following:

a.  The name of the drug;

b.  The strength of the drug;

c.  The dosage form if appropriate;

d.  The quantity of the drug;

e.  The manufacturer name or NDC number of the labeler of the drug if labeled only with its generic name;

f.  The date of distribution;

g.  The name, and address of the distributing outlet;

h.  The name, and address of the receiving practitioner or registered outlet.

i.  If a controlled substance is distributed, the record shall also indicate the Drug Enforcement registration number of the distributing outlet and the receiving practitioner or registered outlet.

j.  A schedule II controlled substance shall only be distributed pursuant to receipt of a properly executed DEA-222 form.

14.05.21  These records of distribution (casual sales) required by 14.05.20 shall be retained for a period of time not less than two years from the date of the distribution.

14.05.22  Records of distribution (casual sales) required by regulation 14.04.20 may be maintained electronically if the following requirements are met:

a.  The other outlet must ensure a daily (i.e., every twenty-four hours) back up is performed for use in restoring required information in case of a system failure.

b.  Have and maintain a complete on-line distribution file that is printable on the inspector’s request,

or

c.  Have a “lock-out” feature that prevents editing of distribution information.

d.  The Board or its inspectors must be able to inspect and review the distribution transactions of the other outlet.  Therefore, immediately upon the oral or written request of the Board or its inspectors, the other outlet shall either:

(1)  Print a report of all distribution transactions for such period of time as the Board or its inspector(s) may specify.  The system must be capable of retrieving and printing such a report within a limited time not to exceed two hours.  Additionally, the system must be capable of retrieving and printing the information sorted according to variables which include, but are not limited to, date of distribution; drug name, strength and dosage form; and licensee receiving the distribution;

or

(2)  Provide a computer terminal and monitor for the sole use of the Board or its inspector(s) to inspect and review distribution transactions, and, if necessary, provide a person to assist the Board or its inspector(s) for a period of time not to exceed two hours in operating the system.  If the other outlet elects to comply with this subparagraph (2), the system must also be capable of printing the same reports described in subparagraph (1).

(3)  It is the responsibility of the consultant pharmacist to ensure that all outlet staff are aware of the requirements of subparagraphs (1) and (2).  Any failure or refusal by the consultant pharmacist and/or outlet staff to comply with a request by the Board or its inspector(s) will be deemed to be a willful violation of these regulations.

e.  If the other outlet chooses to maintain records of distribution electronically, any reports printed upon request shall contain, as a minimum, the following information for each transaction:

(1)  The name of the drug;

(2)  The strength of the drug;

(3)  The dosage form if appropriate;

(4)  The quantity of the drug;

(5)  The manufacturer name or NDC number of the labeler of the drug if labeled only with its generic name;

(6)  The date of distribution;

(7)  The name, and address of the distributing outlet;

(8)  The name, and address of the receiving practitioner or registered outlet;

(9)  If a controlled substance is distributed, the record shall also indicate the Drug Enforcement registration number of the distributing outlet and the receiving practitioner or registered outlet.

14.05.24  Advertising.

a.  Only one address shall appear on a prescription label and that shall be the address of the other outlet from which the prescription was dispensed.

b.  An other outlet shall only use, operate or advertise under the name that appears on the current registration issued by the Board of Pharmacy.

c.  An other outlet may not advertise, either orally or in writing, that it is a prescription drug outlet (pharmacy).

15.00.00  WHOLESALERS.

15.01.00  Wholesale drugs distributor registration requirement.

	a.	A wholesaler means any person engaged in the wholesale distribution of prescription drugs, including, but not limited to repackagers, own-label distributors, private-label distributors, jobbers, brokers, warehouses, including manufacturers’ and distributors’ warehouses; manufacturers’ exclusive distributors; authorized distributors of record; drug wholesalers or distributors; independent wholesale drug traders; specialty wholesaler distributors; pharmacy buying cooperative warehouses; retail pharmacies that conduct wholesale distribution; and chain pharmacy warehouses that conduct wholesale distribution.

	b.	Every wholesaler must be registered with the Colorado State Board of Pharmacy if it resides in Colorado and distributes drugs or is located in another state or territory of the United States and ships prescription drugs into Colorado.

15.01.10  Requirements for licensure.

15.01.11  Minimum required information for registration.

a.  The following minimum information shall be required from each wholesaler as part of the registration:

(1)  The name, full business address, and telephone number of the applicant;

(2)  All trade or business names used by the applicant;

(3)  Addresses, telephone numbers, and the names of contact persons for all facilities used by the applicant for the storage, handling and distribution or prescription drugs;

(4)  The type of ownership or operation (i.e., partnership, corporation, sole proprietorship, limited liability company, or government entity); and

(5)  The name(s) of the owner and operator of the applicant including:

(a)  If a person, the name of the person;

(b)  If a partnership, the name of each partner, the name of the partnership, and the federal employer identification number (FEIN);

(c)  If a corporation, the name and title of each corporate officer and director, the name of the parent company,  the corporate names, the federal employer identification number of the business, and the name of the state of incorporation; and

(d)  Name of the business entity.  If a sole proprietorship, the full name of the sole proprietor, and the name and federal employer identification number of the business entity.

(e)  If a government entity, identify the name of director and the name of the governmental agency he/she represents.

(6) If a limited liability company, the name and title of each member, federal employer identification number (FEIN) of the business, and name of parent company, if any. 

(7)	A list of the licenses and permits issued to the applicant by any other state that authorizes the applicant to purchase or possess prescription drugs.

(8)	The name of the applicant’s designated representative, who must meet the following requirements:
	(a)	Be at least twenty-one years of age;
(b)	Have at least three years of full-time employment history with a pharmacy or a wholesaler in a capacity related to the dispensing and distribution of and the recordkeeping related to prescription drugs;
	(c)	Be employed by the applicant in a full-time managerial position;
(d)	Be actively involved in and aware of the actual daily operation of the wholesaler;
(e)	Be physically present at the facility of the applicant during regular business hours, except when the absence of the designated representative is authorized, including, but not limited to, sick leave and vacation leave;
(f)	Serve in the capacity of a designated representative for only one applicant or wholesaler at a time, except where more than one licensed wholesaler is co-located in the same facility and the wholesalers are members of an affiliated group as defined by section 1504 of the federal “Internal Revenue code of 1986.”
(g)	Not have any convictions under federal, state, or local law relating to wholesale or retail prescription drug distribution or controlled substances;
	(h)	Not have an felony convictions pursuant to federal, state, or local law; and
	(i)	Undergo a background check as required by CRS 12-22-803.

(9)	Wholesalers that distribute animal drugs exclusively are exmpt from the requirements of 15.01.11(a)(8).

b.  Changes in any information in section 15.01.11 shall be submitted to the Colorado Board of Pharmacy within fourteen calendar days thereof.

15.01.12  Minimum Qualifications.

a.  The Colorado Board of Pharmacy shall consider, at a minimum, the following factors in reviewing the qualifications of persons of businesses described in 15.01.11 above who engage in the wholesale distribution of prescription drugs within the state:

(1)  Any conviction of the applicant under any federal, state, or local laws relating to drug samples, wholesale or retail drug distribution, or distribution of controlled substances;

(2)  Any criminal or civil convictions of the applicant under federal or state laws;

(3)  The applicant's past experience in the manufacture or distribution of prescription drugs, including controlled substances;

(4)  The furnishing by the applicant of false or fraudulent material in any application made in connection with drug manufacturing or distribution;

(5)  Disciplinary proceedings by any federal, state, or local government of any registration currently or previously held by the applicant for the manufacture, distribution or dispensing of any drugs, including controlled substances;

(6)  Compliance with registration requirements under a previously granted registration, if any;

(7)  Compliance with requirements to maintain and/or make available to the Colorado Board of Pharmacy or other governmental agency those records required under this section; and

(8)  Any other factors or qualifications the Colorado Board of Pharmacy considers relevant to and consistent with the public health and safety.

b.  The Colorado Board of Pharmacy shall have the right to deny a registration to an applicant if it determines that the granting of such a registration would not be in the public interest.

c.	All applicants shall be inspected within the previous two years prior to registration.  If the applicant is located in Colorado, inspectors from the Colorado state board of pharmacy shall conduct the inspection.  If the wholesaler is located outside of Colorado, the board of pharmacy of the state in which the wholesaler resides shall conduct an inspection of the facility or the out of state wholesaler may be inspected by a board-approved accreditation body.  

15.01.13  A wholesaler must be located at a commercial location.  It may not be located in a personal dwelling or residence.

15.01.14  Change of name, location, or ownership, or designated representative.

	a.	aAny change in the name or location of the wholesaler shall be reported to the board on an application provided by the board prior to such change.
	
b.  Any change in ownership shall be reported on an application provided by the Board within fifteen calendar days of the change and the new owner(s) shall apply for a new registration from the Board and pay the appropriate fee.  A change of ownership shall be deemed to have occurred:

1.  In the event the owner is a corporation, upon sale or transfer of 20 percent or more of the shares of the corporation to a single individual or entity;

2.  In the event the outlet is owned by a partnership, upon sale or transfer of 20 percent or more of any ownership interest.

.3.  In the event the outlet is owned by a limited liability company (LLC), upon sale or transfer of 20 percent or more of the membership interests.

4.  Upon incorporation of an existing wholesaler.

c.	Any change in the designated representative of a wholesaler shall be reported to the board on a form supplied by the board within 14 calendar days of such change.  The incoming designated representative must undergo the required background check.

15.01.17  When a wholesale outlet changes location, the outlet shall submit an application on a form provided by the Board prior to outlet relocation.

15.02.00  Personnel.

	15.02.10  Designated Representative. A single person shall be designated by name and title who has complete and overall responsibility for the operation of the facility in compliance with all applicable laws, rules and regulations pertaining to drugs and devices.  This person's name, social security number, and title shall be reported to the Board in writing.  

15.02.11  Wholesalers shall certify that all staff, employees, and personnel have suitable education or experience for the position such staff and employees hold and the job functions they are assigned.  The wholesaler shall affirm that such staff have disclosed any past criminal convictions or violations of state and federal law.

15.02.12  The Designated Representative shall have overall responsibility for the operation and compliance of the facility and shall have a minimum of three years verifiable full-time experience in a pharmacy or wholesaler.

15.03.00  Sanitation.

15.03.10  Adequate sanitary and plumbing facilities shall be installed.  These facilities shall be maintained in good repair and shall be regularly cleaned.

15.03.11  All areas of the facility shall be regularly and routinely cleaned.  The walls, ceilings, windows and floors of the premises shall be clean and maintained in good repair and order.

15.03.12  The premises shall be free from noxious odors.

15.03.13  There shall be adequate pest control.

15.03.14  All personnel shall keep themselves and their attire as clean as possible.  Facilities for storage of additional clothing and changing shall be provided as necessary and appropriate.

15.04.00  Storage.

15.04.10  All drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs, or with requirements in the current edition of an official compendium such as the USP/NF.

a.  If no storage requirements are established for a drug, the drug may be held at “controlled” room temperature, as defined in an official compendium such as USP/NF, to help ensure that its identity, strength, quality, and purity are not adversely affected.

b.  Appropriate manual, electromechanical, or electronic temperature and humidity equipment, and/or logs shall be utilized to document proper storage of drugs.  Refrigerator and freezer units shall be monitored each business day.  If done manually, the temperature shall be recorded each business day.  All electromechanical or electronic temperature equipment utilized shall alert the outlet if the temperature falls out of the acceptable range.

c.  Packaging of the drugs should be in accordance with an official compendium such as USP/NF and identify any compromise in the integrity of the drugs due to tampering or adverse storage conditions.

d.  Controlled substance drugs should be isolated from non-controlled substance drugs and stored in a secure area in accordance with DEA security requirements and standards.

e.  All areas of the outlet shall be well lighted and ventilated.

15.04.11  There shall be adequate storage space.  Products that are not stored on shelving or under special conditions, such as refrigeration, shall not be stored directly on the floor.

15.04.12  Drugs and devices shall be placed under proper storage conditions as soon as possible after receipt.

15.04.13  The wholesaler shall be responsible that proper storage requirements are met for all drugs during shipment to a purchaser or other person entitled to receive such products.

15.05.00  Security.

15.05.10  a.  All facilities used for wholesale drug distribution shall be secure from    unauthorized entry:

(1)  Access from outside the premises shall be kept to a minimum and be well-controlled;

(2)  The outside perimeter of the premises shall be well-lighted; and

(3)  Entry into areas where drugs are held shall be limited to authorized personnel.

b.  All facilities shall be equipped with an alarm system to detect unauthorized entry.  Such alarm systems shall be both external and centrally monitored with a dedicated line and systems back up.  The systems and the back up shall be regularly inspected and tested.

c.  All facilities shall be equipped with a security system that will provide suitable protection against theft and diversion.  When appropriate, the security system shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.

d.  All facilities shall be equipped with inventory management and control systems that detect, protect against, and document any instances of theft, diversion, or counterfeiting.

e.  All facilities shall be equipped with security systems to protect the integrity and confidentiality of data and documents and make such data and documents readily available to the Board and other state and federal law enforcement officials.

15.05.11  One person shall be designated by name or title, in writing, to have ultimate responsibility for security of all keys or other methods of entry into the facility itself and into all limited access areas within the facility.  There shall be a list that identifies all persons who are authorized to have access to controlled substances.  This information shall be made available to the Board upon request.

15.05.12  Storage areas shall be constructed in such a manner as to reduce the possibility of illegal entry.  The wholesaler shall take adequate precautions to ensure the security of controlled substances during shipment to a purchaser or other person entitled to receive and possess controlled substances.

15.05.13  Any theft, suspicious loss, or recurring loss of prescription drugs or any loss of controlled substances shall be reported to the Board within thirty CALENDAR days of the loss, along with a description of the loss, cause of the loss and any other appropriate information.  Any loss of controlled substances shall also be reported to the appropriate law enforcement agency.

15.05.14  Any computer system used by the wholesaler shall be protected from unauthorized use.

15.06.00  Drug receipt, handling, and shipment.

15.06.10  Drugs and devices shall be placed under proper storage conditions as soon as possible after receipt.

15.06.11  The wholesaler shall be responsible that proper storage requirements are met for all drugs during shipment to a purchaser or other person entitled to receive such products.

15.06.12  Upon receipt, each shipping container shall be visually examined for identity and to determine if it may contain contaminated, contraband, counterfeit, suspected of being counterfeit or damaged drugs or drugs that are otherwise unfit for distribution.  This examination shall be adequate to reveal container damage that would suggest possible contamination, adulteration, misbranding, counterfeiting, suspected of being counterfeit, or other damage to the contents.

15.06.13  The drugs found to be unacceptable under section 15.06.12 shall be quarantined from the rest of stock until the examination and determination that the drugs are not outdated, damaged, deteriorated, misbranded, counterfeited, or adulterated and determined to be fit for human use.

15.06.14  Each outgoing shipment shall be carefully inspected for identity of the drugs and to ensure that the drugs for shipment have not been damaged in storage or held under improper conditions.

15.06.15  Upon receipt, a wholesale distributor must review records for the acquisition of drugs for accuracy and completeness, noting the wholesale distributors involved.

15.06.16  The recordkeeping requirement in 15.09.00 shall be followed for all incoming and outgoing drugs and devices.

15.07.00   Returned drugs.

15.07.10  A drug which has been returned to the wholesaler shall be segregated from other stock until it can be determined if the item is salable and suitable for placement into inventory or if it is unsalable.

15.07.11  Any drug or device returned to a manufacturer or wholesale distributor shall be kept under proper conditions for storage, handling, transport, shipment, and documentation showing that proper conditions were maintained prior to its return is provided to the manufacturer or wholesale distributor to which the drugs are returned.

15.07.12  If the conditions under which a drug or device has been returned cast doubt on the drug’s or device’s safety, identity, strength, quality, or purity, then the drug or device shall be destroyed, or returned to the supplier, unless examination, testing or other investigation proves that the drug or device meets appropriate standards of safety, identity, strength, quality, and purity. 

15.07.13  Any returned drug which is deemed unsalable shall be handled in accordance with the procedures delineated in regulation 15.08.00.

15.08.00  Unsalable drugs (outdated, damaged, adulterated, misbranded, counterfeit, or suspected of being counterfeit).

15.08.10  Counterfeit drugs are those in which the container, shipping container, seal, or labeling, without authorization, bears the trademark, trade name, or other identifying mark, imprint, device, or any likeness thereof, of a manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by such other manufacturer, processor, packer, or distributor.

15.08.11  A drug or device shall be deemed to be adulterated if:

a.  It consists in whole or in part of any filthy, putrid, or decomposed substance; or

b.  It has been produced, prepared, packed, or held under unsanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or

c.  If the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that the drug or device meets the requirements of this part as to safety and has the identity and strength, and meets the quality and purity characteristics which it purports or is represented to possess; or

d.  If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

e.  If it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of the federal food, drug and cosmetic act.

(1)  It is a color additive, the intended use of which is for purposes of coloring only, and is unsafe within the meaning of the federal food, drug, and cosmetic act;

(2)  If it purports to be or is represented as a drug, the name of which is recognized in an official   compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in the compendium.  Such determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in the compendium, or in the absence of or inadequacy of these tests or methods of assay, those prescribed under the authority of the federal food, drug, and cosmetic act.  No drug defined in an official compendium shall be deemed to be adulterated under this paragraph because it differs from the standard of strength, quality, or purity therefore set forth in the compendium, if its difference in strength, quality, or purity from that standard is plainly stated on its label.  Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States it shall be subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the Homeopathic Pharmacopoeia of the United States and not those of the United States Pharmacopoeia;

(3)  If it is not subject to paragraph (2) and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess;

(4)  If it is a drug and any substance has been (a) mixed or packed therewith so as to reduce its quality or strength; or (b) substituted wholly or partially into it.

15.08.12  A drug or device shall be deemed to be misbranded if the label is false or misleading in any particular; or the label does not bear the name and address of the manufacturer, packer, or distributor, and does not have an accurate statement of the quantities of the active ingredients in case of a drug; or if the label does not show an accurate monograph for legend drugs.

15.08.13  Any unsalable drug shall be segregated in a specific area away from salable stock.

15.08.14  Any drug or device whose immediate or sealed outer or secondary containers or labeling is adulterated, misbranded, counterfeited, or suspect of being counterfeit shall be quarantined and physically separated from other drugs or devices until it is returned to either the manufacturer or wholesale distributor from which it was acquired or destroyed.  When the immediate or sealed outer or secondary containers or labeling of any drug or device is adulterated, misbranded, counterfeited, or suspect of being counterfeit, notice of the adulteration, misbranding, counterfeiting, or suspected counterfeiting shall be provided to the Board, FDA, and manufacturer and wholesale distributor from which it was acquired within three (3) business days.

15.08.15  Any drug or device that has been opened or used, but is not adulterated, misbranded, counterfeited, or suspect of being counterfeit, shall be identified as such, and shall be quarantined and physically separated from other drugs or devices until they are returned to the manufacturer or wholesale distributor from which acquired or destroyed.

15.08.16  Contraband, counterfeit, or suspected to be counterfeit drugs and devices, other evidence of criminal activity, and accompanying documentation shall be retained and not destroyed until its disposition is authorized by the Board and FDA.

15.08.17  The shipping container, immediate or sealed outer or secondary container or labeling, and accompanying documentation, suspected of or determined to be counterfeit or fraudulent shall not be destroyed until its disposition is authorized by the Board and FDA.

15.08.18  An unsalable controlled substance shall be disposed of in compliance with the requirements of the drug enforcement administration and appropriate records shall be kept. 

15.08.19  In the case of a drug or a device which is unsalable, records shall be kept which contain the following:

a.  The name of the drug;

b.  The strength of the drug;

c.  The dosage form if appropriate;

d.  The quantity of the drug;

e.  The name and/or NDC number of the labeler of the drug if labeled only with its generic name;

f.  If just an NDC number is used the wholesaler or manufacturer shall maintain a current, complete printed or typed list, which shows both the symbol and code and its complete definition.  This list shall be readily retrievable for examination by the Board for at least two THREE years;

g.  Method of disposition of item;

h.  Date of disposition; and

i.  Method of destruction, if applicable; and

j.  Signature of individual destroying, if applicable, and signature of individual witnessing destruction.

15.09.00  Recordkeeping.

15.09.10  All records of receipt, distribution or other disposal of prescription drugs and/or controlled substances shall be available to the Board on request for inspection, copying, verifying or other proper use.  If authorization has been granted to maintain certain records centrally at another location, these records shall be made available within two business days (48 hours maximum.)  Records kept at an inspection site or other site than can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period.  If recap records are available, the Board may, at its option, utilize them, but the original records must also be produced if requested and shall be considered the document of record in any case.

15.09.11  Records in general.  All wholesalers registered by the Board shall maintain such records and inventories of prescription drugs as may be required by these regulations or any other state or federal law or regulation pertaining to such drugs. Such records shall be maintained on a current basis and shall be complete and accurate for all drugs which the outlet manufactures, receives, distributes or otherwise disposes of in any other manner.  Records, including pedigrees,  and inventories of controlled substances shall be deemed to be “complete” only if each individual record and inventory contains all required information regarding each specific transaction, and if the set of records and inventories contains all information and documents required to be kept by state and federal laws, rules, and regulations.  A record or inventory shall be deemed to be “accurate” only if it is a complete, true and factual statement regarding or reflecting each specific transaction.  A set of records or inventories shall be deemed to be “accurate” only if they are complete, and when considered as a whole, they demonstrate that the controlled substances and/or the records and inventories pertaining thereto have been handled in compliance with all applicable laws or regulations and that all such controlled substances are properly accounted for.

a.	All such records, including pedigrees, shall be retained for a period of at least three years after the date of any transaction relating to such record or inventory by any process providing an exact duplicate of the original order in a reproducible quality acceptable to the Board.  Records shall be retained in a format that cannot be altered.

b.	A wholesaler in the possession of a pedigree (a document or electronic file containing information that records each distribution of any given prescription drug that leaves the normal distribution channel) for a prescription drug shall verify that each transaction on the pedigree has occurred prior to distributing the prescription drug.

c.	The pedigree shall include all necessary identifying information concerning each sale in the chain of distribution of the product from the manufacturer through the acquisition and sale by a wholesaler until final sale to a pharmacy or other person dispensing or administering the prescription drug.  the pedigree shall include at least the following:

(1)	The name, address, telephone number, and, if available, the e-mail address of each owner of the prescription drug and each wholesaler of the drug;
(2)	The name and address of each location from which the prescription drug was shipped, if different from that of the owner;
	(3)	The transaction dates;
	(4)	Certification that each recipient has authenticated the pedigree;
	(5)	The name of the prescription drug;
	(6)	The dosage form and strength of the prescription drug;
	(7)	The size and number of containers;
	(8)	The lot number of the prescription drug; and
	(9)	The name of the manufacturer of the finished dosage form.

d.	Effective January 1, 2010, all wholesalers shall be required to use electronic pedigrees.

Records on an automated data processing system or subsequent storage of such records must be immediately retrievable (via monitor display or hard copy printout).  

15.09.12  Retrievability of records.  For the purposes of these regulations, records and inventories shall be deemed “readily retrievable” if they meet the following requirements:

a.  The following records shall be maintained on the premises of the registrant at all times and shall be made available for inspection by the Board or its inspectors immediately upon request:

(1)  All DEA-222 forms executed during the three years preceding the request;

(2)  All inventories of controlled substances required to be taken during the three years preceding the request;

(3)  All records of receipt (invoices for drugs received and credited) of controlled substances, distribution, loss, surrender or disposal in manner of prescription drugs and controlled substances during the three years preceding the request;

(4)  List(s) of symbols and codes, if applicable.  Symbols and codes may be used to identify any manufacturer, distributor, or repackager.  If such symbols and codes appear in the records of the registrant, the registrant shall keep a current, complete printed or typed list, which shows both the symbol and code and its complete definition.  This list shall be readily retrievable and available for examination by the Board for at least three years.

b.  The following records shall be made available within 48 hours or two business days, whichever is longer, on request by the Board or its inspectors:

(1)  All unexecuted DEA-222 forms.

(2)  Specific records requested by the inspector if the inspector determines the records are not maintained in a readily retrievable manner.

(3)  Records of receipt of non-controlled prescription drugs.

c.	Pedigrees shall be made available to the board or its inspectors within five  business days of request.

15.09.13  Inventories of controlled substances.  Any inventory of controlled substances shall comply with the following:

a.  Each inventory shall contain a complete and accurate record of all controlled substances (including outdated controlled substances, returns from customers, and items ordered but not yet invoiced) on hand on the date the inventory is taken.  The inventory shall be maintained in written, typewritten or printed form at the outlet.  Schedule II drugs shall be separated from schedule III, IV, and V drugs.  Controlled substances shall be deemed to be “on hand” if they are in the possession of or under the control of the registrant.

b.  The inventory shall be taken either as of opening of business or as of the close of business on the inventory date and it shall be recorded on the inventory.  In the event the prescription drug outlet is open 24 hours per day, the inventory shall specify the time the inventory was conducted.

c.  After the initial inventory is taken, the outlet shall take new inventory of all stocks of controlled substances on hand at least every two years.

d.  On the effective date of a law or rule on which a previously non-scheduled drug is added to any schedule of controlled substances, every prescription drug outlet that possesses that drug shall take an inventory of all stocks of the drug on hand.  Thereafter, that drug shall be included in each inventory made by the outlet.

e.  The following information shall be recorded on the inventory:

(1)  The name of the drug;

(2)  Each finished form of the drug (strength and dosage form);

(3)  The number of units or volume of each finished form; and

(4)  The number of commercial containers of each finished form.

g.  All controlled substance inventories shall be retained at the prescription drug outlet for at least three years from the date of such inventory.

15.09.14  Receipts.

15.09.15  Records of receipt of prescription drugs and controlled substances shall contain the following information for each such substance received:

a.  Name of the drug;

b.  Strength of the drug;

c.  Dosage form if appropriate;

d.  Quantity received;

e.  Date received if a controlled substance;

f.  Name of the labeler of the drug if it is labeled only with its generic name;

g.  Name of the distributor;

h.  DEA number of distributor if a controlled substance; and

i.  The DEA form 222 or an electronic order shall be completed for each schedule II controlled substance received.

15.09.16  All records of receipt (including credit invoices) of prescription drugs and controlled substances shall be maintained for a period of time not less than two years from the date the drugs were received.  Records of receipt (including credit invoices) of non-controlled prescription drugs need not be maintained on the premises provided that they shall be made available within 48 hours or two business days, whichever is longer, on request by the Board or its inspectors.

15.09.17  All records of receipt of schedule II controlled substances shall be maintained separately from all other records.

15.09.18  Records of receipt of schedule III, IV, and V controlled substances may be maintained with other records of receipt.  However, the record shall be readily identifiable from the records of receipt of non-controlled drugs.

15.09.19  Distribution.

	a.  A manufacturer or wholesaler as defined in regulation 15.01.00 shall furnish prescription drugs only to a person or entity licensed by the appropriate regulatory board.  Before furnishing prescription drugs to a person not known to the wholesaler, the wholesaler shall affirmatively verify that the person or entity is legally authorized to receive the prescription drugs by contacting the appropriate regulatory board.

	b.	Prescription drugs furnished by a manufacturer or wholesaler shall be delivered only to the premises listed on the license.  The manufacturer or wholesaler may furnish prescription drugs to an authorized person or agent of the person listed on the license if the identity and authorization of the recipient is properly established and the method of receipt is employed only to meet the immediate needs of a particular patient of the authorized person or agent.

	c.	Prescription drugs may be furnished to a hospital pharmacy receiving area provided that a pharmacist or authorized receiving agent signs, at the time of delivery, a receipt showing the type and quantity of the prescription drug received.  Any discrepancy between the receipt and the type and quantity of the prescription drug actually received shall be reported to the delivering manufacturer or wholesaler by the next business day after the delivery to the pharmacy receiving area.

15.09.20  Records of distribution of controlled substances and prescription drugs.  An outlet which distributes prescription drugs and/or controlled substances shall record the following:

a.  The name of the drug;

b.  The strength of the drug;

c.  The dosage form if appropriate;

d.  The quantity of the drug;

e.  The name of the manufacturer or the NDC number of the drug if labeled only with its generic name;

f.  The date of distribution;

g.  If just an NDC number is used the wholesaler or manufacturer shall maintain a current, complete printed or typed list, which shows both the symbol and code and its complete definition.  This list shall be readily retrievable for examination by the Board for at least two THREE years;

h.  The name and address of the distributing wholesaler;

i.  The name and address of the receiver;

j.  If a controlled substance is distributed, the record shall also indicate the drug
enforcement registration number of the distributing outlet and the receiver; and

k.  A schedule II controlled substance shall only be distributed pursuant to receipt of a properly executed DEA-222 form or an electronic order.

15.09.21  These records of distribution shall be retained for a period of time not less than two years from the date of the distribution.

15.09.22  Records of distribution may be maintained electronically if the following requirements are met:

a.  The wholesaler must ensure a daily (i.e., every twenty-four hours) back up is performed for use in restoring required information in case of a system failure.

b.  Have and maintain a complete on-line distribution file that is printable on the inspector’s request, or

c.  Have a “lock-out” feature that prevents editing of distribution information.

d.  The Board or its inspectors must be able to inspect and review the distribution transactions of the wholesaler.  Therefore, immediately upon the oral or written request of the Board or its inspectors, the outlet shall either:

(1)  Print a report of all distribution transactions for a period of time as the Board or its inspector(s) may specify.  The system must be capable of retrieving and printing such a report within a limited time not to exceed two hours.  Additionally, the system must be capable of retrieving and printing the information sorted according to variables which include, but are not limited to; date of distribution, drug name, strength and dosage form, and registrants receiving the distribution;

or

(2)  Provide a computer terminal and monitor for the sole use of the Board or its inspector(s) to inspect and review distribution transactions, and, if necessary, provide a person to assist the Board or its inspector(s) for a period of time not to exceed two hours in operating the system.  If the outlet elects to comply with this subparagraph (2), the system must also be capable of printing the same reports described in subparagraph (1)

(3)  It is the responsibility of the manager to ensure that all wholesale staff are aware of the requirements of subparagraphs (1) and (2).  Any failure or refusal by the outlet manager and/or staff to comply with a request by the Board or its inspector(s) will be deemed to be a willful violation of these regulations.

e.  If the outlet chooses to maintain records of distribution electronically, any reports printed upon request shall contain, as a minimum, the following information for each transaction:

(1)  The name of the drug;

(2)  The strength of the drug;

(3)  The dosage form if appropriate;

(4)  The quantity of the drug;

(5)  The manufacturer name and/or NDC number of the drug if labeled only with its generic name;

(6)  The date of distribution;

(7)  The name and address of the distributing outlet;

(8)  The name and address of the receiver; and

(9)  When a controlled substance is distributed, the record shall also indicate the drug enforcement registration number of the distributing outlet and the receiver.

15.10.00  Policies and procedures.

15.10.10  Wholesale drug distributors shall establish, maintain and adhere to written policies and procedures, which shall be followed for the receipt, security, storage, inventory, and distribution of prescription drugs, including controlled substances, and including policies and procedure for identifying, recording, and reporting destruction, losses or thefts, and for correcting all errors and inaccuracies in inventories.  Wholesale drug distributors shall include the following in their written policies and procedures:

a.  A procedure whereby the oldest approved stock of a prescription drug product is distributed first.  The procedure may permit deviation from this requirement, if such deviation is temporary and is itself, an approved deviation procedure.

b.  The registrant shall have a procedure to assure that any outdated stock, or any stock with an expiration date that does not allow sufficient time for dispensing by the prescription drug outlet shall be segregated from other stock and shall be returned to the manufacturer or otherwise destroyed, and documented.

c.  A procedure to be followed for handling recalls and withdrawals of prescription drugs.  Such procedure shall be adequate to deal with recalls and withdrawals due to:

(1)  Any legal action initiated at the request of the food and drug administration or other government agency with jurisdiction:

(2)  Voluntary action by the manufacturer to remove defective or potentially defective drugs from the market:
or

(3)  Any action undertaken to promote public health and safety by the replacing of existing merchandise with an improved product or new package design.

d.  A procedure to ensure that wholesale drug distributors prepare for, protect against, and handle any crisis that affects security of operation of any facility in the event of strike, fire, flood, or other natural disaster, or other situations of local, state, or national emergency.

e.  A procedure to ensure that any outdated, misbranded, counterfeit, adulterated or unsaleable prescription drugs shall be segregated from other drugs and either returned to the manufacturer or destroyed.  This procedure shall provide for written documentation which shall be maintained for 3 2 years after dispositions of the outdated drugs.

f.  Policies and procedures to cover the examination of materials to include the visual inspection of shipping containers for prescription drugs unfit for distribution, prescription drugs which have been damaged in storage or held under improper conditions.

g.  Procedures which assure employees possess the necessary education or experience for the position they hold and the job functions they are assigned.

h.  A procedure to ensure that drugs are distributed only to individuals or entities with authorization to possess them.

i.	A procedure to ensure that drugs are only distributed to the premises listed on the license or registration.  In the event the license does not show the address, a written confirmation from the regulatory board licensing or registering the individual or entity shall be obtained.

j.	 A procedure to ensure verification of all transactions on a pedigree prior to distribution of the drug.

k.	A procedure to ensure a pedigree is furnished when distribution occurs outside of the normal distribution channel.

l.	A procedure to ensure that staff have disclosed any past criminal convictions or violations of state and federal law.

15.10.11  The policies and procedures shall contain a provision for review at least annually, at which time they shall be up-dated as necessary.  A record documenting this review shall be kept with the policies and procedures and shall indicate the date of completion of the review and the signature of the responsible person as defined in regulation 15.02.10.

15.10.12  These policies and procedures and the documentation of the annual review shall be available to the Board on request for review or other proper use.

15.10.13  Additional requirements for wholesalers which distribute veterinary drugs directly to a person responsible for control of an animal.

15.10.14  A wholesaler may sell or deliver to a person responsible for the control of an animal a drug intended for veterinary use provided the following conditions are met:

a.  A licensed veterinarian has issued, prior to such sale or delivery, a written prescription order for the drug in the course of an existing, valid veterinarian-client-patient relationship;

b.  The original order must be retained on the premises of the registrant for two years from the date of the last transaction affecting the order;

c.  The drugs, prior to distribution, may not be packaged or dispensed by the registrant;

d.  The drugs, once distributed, may not be returned to the registrant for resale or redistribution;

e.  The prescription order issued by the veterinarian becomes void after one year if for a non-controlled drug or a schedule II controlled substance, unless the veterinarian specifies a shorter expiration date.  The registrant may not distribute larger quantities than the order authorizes.

f.  If a schedule III, IV, or V controlled substance, the prescription order becomes void after six months from date of issue, unless the veterinarian specifies a shorter expiration date.  The registrant may not distribute larger quantities than the order authorizes.

g.  The original order must be retained on the premises of the registrant filed by client name.  The invoices for each distribution authorized by the order must be attached to the order.

h.  A drug distribution log must be retained on the premises of the registrant.  It shall include the following information:

(1)  Date sold/delivered;

(2)  Client and patient name;

(3)  Veterinarian name;

(4)  Veterinarian’s DEA registration if a controlled substance;

(5)  Drug sold/delivered;

(6)  Quantity drug;

(7)  Date of issue of order;

(8)  Expiration of order; and

(9)  Invoice number.

16.00.00  LIMITED LICENSE.

16.00.10  General Criteria.  The Board may issue a limited license to a humane society which is duly registered with the Secretary of State and has been in existence and in business for at least five years in this state as a nonprofit corporation or an animal control agency which is operated by a unit of government for purposes of being authorized to purchase, possess, and administer sodium pentobarbital or sodium pentobarbital in combination with other prescription drugs which are medically recognized for euthanasia, to euthanize injured, sick, homeless, or unwanted pets and animals.  Such facilities may also purchase, possess, and administer drugs commonly used for the chemical capture of animals for control purposes or to sedate or immobilize pet animals immediately prior to euthanasia.

a.  All drugs utilized by the limited license registrant shall be obtained from an individual or entity registered by the Colorado State Board of Pharmacy.

16.00.20  Application Procedure.

a.  Original Application.

Original application for registration as a limited license shall be made on a form provided by the Board.

b.  Limited License Relocation

When a limited license changes location, the facility shall submit an application on a form provided by the Board prior to relocation.

c.  Change of Name of Limited License.

Changes in the name of a limited license shall be submitted to the Board on a form provided by the Board.

16.00.30  Security.  Limited access to controlled substances shall be maintained.  Drugs shall be stored in locked cabinets or a safe bolted to the floor.  Drugs shall be stored at the address registered with the Drug Enforcement Administration.

16.00.40  Training.  Staff shall receive adequate training to properly administer all drugs referenced in this section.

16.00.50  Records in General.  All outlets registered and/or licensed by the Board shall maintain such records and inventories of prescription drugs as may be required by these regulations or any other state or federal law or regulation pertaining to such drugs.  Such records shall be maintained on a current basis and shall be complete and accurate for all drugs which the outlet manufactures, receives, dispenses, distributes or otherwise disposes of in any other manner.  Records and inventories of controlled substances shall be deemed to be “complete” only if each individual record and inventory contains all required information regarding each specific transaction, and if the set of records and inventories contains all information and documents required to be kept by state and federal laws, rules, and regulations.  A record or inventory shall be deemed to be “accurate” only if it is a complete, true and factual statement regarding or reflecting each specific transaction.  A set of records or inventories shall be deemed to be “accurate” only if they are complete, and, when considered as a whole, they demonstrate that the controlled substances and/or the records and inventories pertaining thereto have been handled in compliance with all applicable laws or regulations and that all such controlled substances are properly accounted for.

16.00.60  Retrievability of records.  For the purposes of these regulations, records and inventories shall be deemed “readily retrievable” if they meet the following requirements:

a.  For all limited licenses:

(1)  The following records shall be maintained on the premises of the limited license at all times and shall be made available for inspection by the Board or its inspectors immediately upon request:

(a)  All official DEA 222 forms executed during the two years preceding the request;

(b)  All inventories of controlled substances required to be taken during the two years preceding the request;

(c)  All records of administration, receipt (invoices for drugs received and drugs credited), distribution, loss, surrender or disposal in any other manner of prescription drugs and controlled substances during the two years preceding the request;

(2)  The following records shall be made available within 48 hours or two business days, whichever is longer, on request by the Board or its inspectors:

(a)  All unexecuted DEA 222 forms.
b.  In the case of a request by the inspector for specific records:

(1)  Records shall be maintained in such a manner as to permit the inspector to retrieve specific records immediately.

(2)  If the inspector determines the records are not maintained in the manner specified in (1) above, the inspector may give the facility a list of the items to be retrieved.  The requested records shall be made available to the inspector within 48 hours of the request.

16.00.70  Inventories of controlled substances.  Any inventory of controlled substances shall comply with the following:

a.  Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken.  The inventory shall be maintained in written, typewritten or printed form at the other outlet.  Schedule II drugs shall be separated from schedule III, IV, and V drugs.  Controlled substances shall be deemed to be “on hand” if they are in the possession of or under the control of the outlet.

b.  The inventory shall be taken either as of opening of business or as of the close of business on the inventory date and this shall be recorded on the inventory.

c.  After the initial inventory is taken, the facility shall take a new inventory of all stocks of controlled substances on hand at least every two years.

d.  The following information shall be recorded on the inventory.

(1)  The name of the drug;

(2)  Each finished form of the drug (strength and dosage form);

(3)  The number of units or volume of each finished form;

(4)  All outdated controlled substances.

e.  In determining the number of units of each finished form of a controlled substance in a commercial container which has been opened, the other outlet shall do as follows:

(1)  If the drug is a schedule II drug, an exact count of the contents shall be made.

(2) If the substance is listed in schedule III, IV, or V, an estimated count of the measure of the contents may be made, unless the container holds more than 1000 tablets or capsules, in which case an exact count of the contents must be made.

f.  All controlled substance inventories shall be retained at the facility for at least two years from the date of such inventory.

16.00.80  Records of use.  Records of use of sodium pentobarbital, sodium pentobarbital in combination with other prescription drugs, or drugs used for the purposes of chemical capture or immobilization of animals shall contain the following information:

a.  Animal number, if available, or general description.

b.  Animal weight, if available, or estimate.

c.  Amount of drug administered, and method if drug was administered for the purposes of chemical capture or control.

d.  Identification of individual administering drug.

e.	Amount of drug wasted (if applicable).

f.  Date administered.

Records of use shall be maintained for a period of at least two years from the date of administration.

16.01.00  Receipts.

16.01.10  Records of receipts of prescription drugs and controlled substances shall contain the following information for each such substance received:

a.  Name of the drug;

b.  Strength of the drug;

c.  Dosage form if appropriate;

d.  Quantity received;

e.  Date received if a controlled substance;

f.  Name of the labeler of the drug if it is labeled only with its generic name;

g.  Name of the distributor;

h.  DEA number of distributor if a controlled substance;

i.  The DEA form 222 or a copy of the DEA form 222 and the corresponding invoice shall be attached to each other.

16.01.20  All records of receipt of prescription drugs and controlled substances shall be maintained at the facility for a period of time not less than two years from the date the drugs were received.

16.01.30  All credit invoices of prescription drugs and controlled substances shall be maintained at the facility for a period of time not less than two years from the date of the invoice.

16.01.40  All records of receipt of schedule II controlled substances shall be maintained separately from all other records.

16.01.50  All records of receipt of schedule III, IV, and V controlled substances may be maintained with other records of receipt.  However, the record shall be readily identifiable from the records of receipt of non-controlled drugs.

16.02.00  Chemical capture and sedation of animals for euthanasia or immobilization.

16.02.01.  Outlets are authorized to purchase, possess and administer drugs commonly used for the chemical capture of animals for control purposes or to sedate or immobilize pet animals prior to euthanasia.   The drugs acceptable for this use are:

a.  Acepromazine.

b.  Ketamine.

c.  Xylazine.

d.  Tiletamine and Zolazepam.

e.   Sodium Pentobarbital.

16.02.02.  Outlets must maintain records of the receipt, distribution, loss surrender and/or disposal of these drugs in the manner specified in rules 16.00.50 – 16.01.50.

16.02.03.  Outlets must demonstrate that staff are trained and capable of using the drugs as intended.  Staff must demonstrate training as follows:

a.  Certification of successful completion of the chemical immobilization workshop provided by the Law Enforcement Training Institute of the University of Missouri at Columbia, Missouri; or

b.  Certification of successful completion of the Chemical Immobilization Workshop (the level I or III workshop) provided by the National Animal Control Association; or

c.  Certification of successful completion of other training programs that provide at least 6 hours of didactic classroom instruction which covers animal behavior, drug delivery equipment, drug delivery, drugs for immobilization, calculating drug dosages, dosage guidelines, post immobilization procedures, emergencies, records, and laws and safety.  In addition, the course must provide a minimum of two hours of field training on the use of instruments used for chemical immobilization.  Credentials of instructors at these courses must demonstrate their knowledge, experience and expertise in the field of chemical immobilization of animals; and

d.  In the case of euthanasia training, the consultant or staff veterinarian must certify that staff has received thorough and adequate training on the proper administration of the medications that comply with the dosage and routes guidelines of the American Veterinary Medical Association.  Furthermore, the veterinarian must certify that he/she has provided direct supervision of staff administration of such drugs for at least 3 hours prior to staff administration without supervision.

18.00.00  PHARMACY PEER HEALTH ASSISTANCE DIVERSION PROGRAM.

18.01.10  Peer Health Assistance Organizations (PHAO).

18.01.11  Eligibility for Awards.

In addition to the provisions of CRS 12-22-603(3)(c)(l) through (VII) a PHAO shall provide for licensees experiencing impaired practice as defined in CRS 12-22-602(2) the following:

a.  An initial assessment and interview of licensees who apply to participate in the diversion program.

b.  An initial evaluation report for the Rehabilitation Evaluation Committee within 10 working days of a licensee being referred by the REC.

c.  Monitoring of the compliance of all licensees with recovery/treatment plan as  established between the PHAO and the licensee.

d.  Except as provided above, quarterly written reports to the REC for each licensee in the program.

e.  Report(s) within 72 hours to the REC regarding any licensee's failure to comply with the contractual/recovery plan.

f.  Phone contacts and provide a written notice to the REC within 24 hours or the next working day when any licensee is unsafe to practice with reasonable skill and safety.

g.  A current network of treatment programs and support groups for referral of licensees.

h.  Other duties as set forth in the contract with the Board of Pharmacy ("Board").

18.01.12  Compliance Reports.  Each PHAO and/or licensee shall provide to the REC compliance reports on the licensee in the diversion program on a quarterly basis. Compliance reports may include summaries of, but shall not be limited to:

a.  Records of attendance at all prescribed therapeutic activities including, but not limited to, counseling sessions and group meetings.

b.  Records of attendance and performance from the licensee's supervisor/employer.

c.  Records of monitored Antabuse or other relevant prescribed medications/agents.

d.  Reports by treatment provider(s).

e.  Evaluations and assessments.

f.  Self-status reports.

g.  Reports as required by the licensee's recovery/treatment plan or licensee's contract with the REC.

18.01.13  Demographic Reports.  Each PHAO shall provide to the REC on an annual basis demographic data including but not limited to:

a.  Number of pharmacists and interns who are participants in the programs and who receive services from the PHAO.

b.  Age and gender of the licensees who are in the program.

c.  Practice setting.

d.  Number of licensees who are in compliance with their treatment/recovery plan.

e.  Number of licensees who are terminated from PHAO services for non-compliance.

f.  Number of successful discharges.

18.01.14  Financial Reports.  Each peer health assistance organization shall provide to the Board quarterly financial reports explaining how the funds were expended so as to comply with CRS 12-22-604(3).

18.01.15  Confidentiality.

18.01.16  Any compliance report submitted by a PHAO to the REC regarding a licensee in the diversion program shall be reported by case number, except as outlined below.

18.01.17  Reports provided to the REC by the PHAO will be maintained in the Board offices in the custody of the Program Administrator.

18.01.18  Whenever any licensee fails to comply with his/her PHAO treatment/recovery plan such failure will be reported by the PHAO to the REC, which may report such non-compliance to the Board.

18.01.19  When a failure to comply with the PHAO treatment/recovery plan has been reported to the Board, the individual's REC records and reports will no longer be confidential from the Board under this program.  Such reports and records shall be subject to the provisions of CRS 24-72-203 and CRS 24-4-104.

18.01.20  If a participant successfully completes the program, the participant's records in the possession of the REC shall be maintained for three years and then destroyed.  Notice of intent to destroy a licensee's diversion program records shall be sent to the licensee's last known address 30 days prior to destruction.

18.02.10  Participants.

18.02.11  Eligibility.  To be eligible for participation in the diversion program, a licensee shall:

a.  Be a pharmacist or intern licensed by this state.

b.  Have a psychiatric, psychological or emotional problem or abuse alcohol and/or drugs in a manner which may affect the licensee's ability to practice with reasonable skill and safety.

c.  Voluntarily request admission into the program.

d.  Agree to undergo reasonable evaluation and examination necessary for the determination of need and ability to participate in the program.

e.   Bear the cost of the program.

f.  Cooperate by providing such evaluation and treatment information, disclosure authorizations and releases of liability as may be requested by the REC and/or PHAO.

g.  Sign a written agreement with the PHAO to comply with all elements of the diversion program including a recovery plan.

h.  Sign a written agreement with the REC to comply with all elements of the diversion program.

18.02.12  Admission Procedures.

18.02.13  Each licensee requesting admission into the diversion program shall submit an application to the REC.

18.02.14  Licensees may self-report to the REC.

18.02.15  Each licensee requesting admission into the diversion program shall be available for an interview with selected members of the REC, upon such request by the committee.

18.02.16  Each licensee admitted will be assigned a case number by the PHAO for purpose of confidential identification during the licensee's participation in the program.

18.02.17  The licensee shall have his/her contract with the REC signed by an authorized representative of the REC.  The contract is to be kept in the confidential files of the REC with a copy to the PHAO and the licensee.

18.02.18  The term of any contract between the licensee and the REC shall be determined by the REC unless superseded by Board order.  The term of the contract may be extended and/or retroactive credit may be given at the discretion of the REC.

18.02.19  The licensee shall have a contract with the PHAO, signed by an authorized representative of the PHAO and others as necessary.  The contract shall be kept in the PHAO confidential files with copies provided to authorized parties as needed.

18.02.20  The REC shall make recommendations to the Board for admission or denial of admission into the program, as well as continuation of practice and/or restriction of practice, as appropriate to the licensee, throughout the licensee's participation in the program.

18.02.21  The Board shall specify to the REC, in writing, any grounds for denial of a licensee's admission into the program.

18.02.22  Should the licensee request to practice while participating in the diversion program, such request shall be evaluated by the REC with input from the PHAO, and a recommendation made to the Board.

18.02.23  The Board may permit the continuation of practice, the removal from practice, or may place restrictions on the practice of the licensee as specified in CRS 12-22-125.2 as condition(s) of admission into the program.

18.02.24  If the Board receives a written complaint, that if proven would constitute a violation of CRS 12-22-125 or CRS 12-22-126, the licensee shall be notified and given 20 days from the date of the notice to respond to the Board.

18.02.25  If the Board has reasonable cause to believe that a licensee is in violation of CRS 12-22-125 and/or CRS 12-22-126, the Board may refer a licensee to the REC by formal motion for admission into the program.

18.02.26  If the PHAO reports to the REC that a licensee is unable to practice with reasonable skill and safety, such information and the case number of the licensee shall be disclosed to the Board within twenty-four hours or the next working day.

18.02.27  If the REC receives information from a PHAO, that if proven would constitute a violation of CRS 12-22-125 and/or CRS 12-22-126,  the licensee named shall be advised by the REC to seek admission into the program within 20 days from the date of the notice.  The licensee will notify the REC of his/her actions.

18.02.28  If no response is received by the REC from the licensee within 20 days from the date of the notice, or the licensee refuses to apply for admission into the program, the REC shall notify the Board and the Board shall proceed with formal disciplinary action.

18.02.29  Successful Discharge from the Diversion Program.

a.  A licensee shall be considered to have completed the program when he/she has met the following conditions:

(1)  Has been in compliance with all of the terms of the contract with the REC and has completed the contractual treatment program.

(2)  Shall be available for an interview with two designated members of the REC upon request and reasonable notice.

b.  A licensee is considered to have completed the program if he/she transfers his/her license to another state and submits to the jurisdiction of that state's Board of Pharmacy for a diversion program or for discipline, and the other state notifies the Colorado Board of Pharmacy of its action.

18.02.30  Termination of a Licensee from the Diversion Program.

A licensee may be terminated from his/her contract with the REC for any of the following reasons:

a.  Failure to comply with his/her treatment plan or any terms of the contract with the REC.

b.  The licensee has become unsafe to practice with reasonable skill and safety.

c.  Transfer to another state and failure to submit to that state's Board of Pharmacy for discipline or admission to a diversion program.

18.03.10  Rehabilitation Evaluation Committee.

18.03.11  Responsibilities.  The committee shall be responsible for:

a.  Entering into a contract with those licensees who are admitted into the program.

b.  Informing each licensee admitted into the program of his/her rights and responsibilities under the program and the possible consequences of non-compliance.

c.  Evaluation and recommendation to the Board regarding continuation of a contract between the Board and each PHAO receiving awards from the diversion fund.

d.  Reporting to the Board.

e.  Corresponding with the licensee regarding Board or REC actions.

f.  Reviewing the reports submitted by the PHAO.

g.  Notifying the licensee, the Board and the PHAO of the termination of any licensee from the program.

h.  Destruction of all confidential material maintained by the REC three years after the licensee's successful completion of the program.

18.03.12  Administration.

18.03.13  The committee shall elect a chairperson and a vice-chairperson.

18.03.14  The Board shall provide adequate clerical support to maintain files, correspondence, and the routine business of the REC.