STATE OF COLORADO

State PHARMACY Board	Department of Regulatory Agencies
Wendy L. Anderson, Program Director	Tambor Williams
	Executive Director
1560 Broadway, Suite 1300	
Denver, Colorado 80202-5146		Division of Registrations
Phone (303) 894-7800		Rosemary McCool
Fax (303) 894-7764		Director
TTY:Dial 711 for Relay Colorado				
www.dora.state.co.us/pharmacy	
	Bill Owens
	Governor

NOTICE OF RULE MAKING HEARING

Pursuant to Colorado Revised Statutes, Title 12, Article 22 and Title 24, Article 4, CRS (2006), you are hereby advised that the Colorado State Pharmacy Board will hold a public rule making hearing on Thursday, January 18, 2007, at 9:30 a.m., at the Denver Post Building, 1560 Broadway, Suite 1380 Conference Room, Denver, Colorado 80202, for consideration of the following:

Hearing Regarding Modification, Amendment, Revision or Adoption of:
Rules 1.00.24, 3.00.70, 3.00.81, 3.00.82(b), 3.00.85, 3.00.86, 3.01.00, 4.00.10, 4.00.20, 4.05.00, 7.00.30, 11.02.00, 14.00.10, 14.00.80, 15.00.00, 16.00.10, 18.02.23, 18.02.24, 18.02.25, and 18.02.27  (3 CCR, 719-1)

The proposed rules under consideration are attached to this notice and fully incorporated herein.

The Board encourages interested parties to submit written comments to the letterhead address regarding any of the above-listed rulemaking matters no later than December 21, 2006.  In addition, at the time and place designated in this notice, the Board of Pharmacy will afford interested parties an opportunity to submit written information, data, views or arguments.  The Board also will afford interested parties an opportunity to make brief oral presentations unless the Board in its discretion determines that such oral presentations are unnecessary.  All submissions will be considered.  The rules under consideration may be changed or modified after public comment and hearing.

BY ORDER OF THE COLORADO STATE BOARD OF PHARMACY

_______________________________________
Wendy Anderson, Program Director

Dated this ___________ day of __________________, 2006

COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, January 18, 2007

Proposed Changes with Statement of Basis, Purpose, and Authority

Basis and Purpose:		This rule is being added to clarify that prescription drug outlets may only procure drugs from other Board registered invididuals or entities

Statement of Authority:	The Board is granted authority to promulgate rules pursuant to CRS sections 12-22-108 and 110 and 24-4-103(2006)

1.00.00  RULES OF PROFESSIONAL CONDUCT.

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.

COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, January 18, 2007

Proposed Changes with Statement of Basis, Purpose, and Authority

Basis and Purpose:		This rule is being amended due to statutory changes.

Statement of Authority:	The Board is granted authority to promulgate rules pursuant to CRS sections 12-22-108 and 110 and 24-4-103(2006)

3.00.00  DISPENSING.  

3.00.70  Responsibility for Unlicensed Assistants.  A pharmacist:

a.  Shall not at any time supervise the work of more than two unlicensed assistants to assist in the practice of pharmacy as defined in CRS 12-22-102(26)(b).  (Refer to Rule 4.00.26 regarding interns.)

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

COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, January 18, 2007

Proposed Changes with Statement of Basis, Purpose, and Authority

Basis and Purpose:		These rules are being amended or added to regulate the use of automated cassettes in the practice of pharmacy.

Statement of Authority:	The Board is granted authority to promulgate rules pursuant to CRS sections 12-22-108 and 110 and 24-4-103(2006)

3.00.00  DISPENSING.  

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.

g.  "Prepackage" means to prepare a drug in a container in advance of actual, immediate need for dispensing, prior to the receipt of an order.  Such packaging may be in a unit dose, single dose or unit of issue package for use in a unit dose dispensing system, or in a container suitable for a traditional dispensing system, or in a customized patient medication package.

h.  "Repackage" means to prepare a unit dose, single dose, unit of issue, customized patient medication package or traditional dispensing system package for dispensing pursuant to an existing order.

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

 (6)  The date of distribution; 

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

(8)  Expiration date of drug.

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 prepackaged or repackaged 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 prepackaged or repackaged 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 repackaged PACKAGED, nor may additional units of medication be added to partially-used unit of issue packages.

d.  Drug products which have been prepackaged or repackaged 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 repackaged PACKAGED.

e.  Drug products which have been prepackaged or repackaged PACKAGED into unit of issue packages or single dose packages may be removed from such packages and repackaged, but not prepackaged, 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 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 indicating a return to stock and the date of such return 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:

(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  Prepackaging and Repackaging. PACKAGING.

3.01.10  a. In a prescription drug outlet prepackaging and repackaging 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, prepackaging and repackaging 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 prepackaged or repackaged 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 prepackaged or repackaged PACKAGED.

c.  Any container used for prepackaging or repackaging PACKAGING shall meet compendia requirements.

3.01.20  Each prepackaged 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 repackaged 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 repackaged 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) 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 prepackaged or repackaged 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 prepackaging or repackaging PACKAGING, unless otherwise required by law or regulation.

Ba.  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.b.  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 prepackaged or repackaged PACKAGED, WHICHEVER IS LESS;

D.c.  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.eThe date the product was prepackaged or repackaged PACKAGED;

H.f	The identity of the pharmacist responsible for PACKAGING prepackaging or repackaging 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;

g	If a suitable internal record is maintained in the prescription drug outlet or other outlet, the requirements of (c), (d), (e), (F) and (f)  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 prepackaged or repackaged.  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 prepackaging or repackaging, unless otherwise required by law or regulation.

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) 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 PREPACKAGING 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.

 COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, January 18, 2007

Proposed Changes with Statement of Basis, Purpose, and Authority

Basis and Purpose:		These rules are being amended to change the requirements for intern hours, reporting of hours, and reporting intern license changes.

Statement of Authority:	The Board is granted authority to promulgate rules pursuant to CRS sections 12-22-108 and 110 and 24-4-103(2006)

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 A maximum of one thousand one hundred (1,100) hours may be obtained by participation in a rotation program conducted by an accredited school or college of pharmacy; other 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, within 30 days after becoming employed or changing location of employment, of preceptor or of residence, shall inform the Board, in writing, of the change.  Not more than 40 hours per seven (7) consecutive days will be credited toward the internship requirement as stated.  The intern will submit all information to the Board when due and as requested.  The intern will submit a Work Record and all accompanying evaluations and appropriate pages from the Colorado Intern Manual within 21 days of the termination of the preceptor/intern relationship.

B.c.  An intern who fails to report his/her experience or location of employment or residence as required above, or who is no longer eligible to be licensed as an intern under Regulation 4.00.10(d) and 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.d.  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.e.  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. f.  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. and who has been notified in writing by the Board that he/she is deemed qualified to train an intern.

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 MEET 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 directly supervise 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.  A pharmacist shall have up to 10 days after accepting an intern to apply to the Board for approval as a preceptor.

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

h.  To obtain credit hours, the hours must be obtained by the intern in compliance with a state's internship program.  Every intern and every preceptor shall complete the Colorado Intern Training Manual and shall be held jointly responsible for the timely filing of reports and documents.

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.	
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.

 COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, January 18, 2007

Proposed Changes with Statement of Basis, Purpose, and Authority

Basis and Purpose:		This rule is being added to further clarify the responsibility of a pharmacist manager.

Statement of Authority:	The Board is granted authority to promulgate rules pursuant to CRS sections 12-22-108 and 110 and 24-4-103(2006)

7.00.00  PHARMACY MANAGER RESPONSIBILITIES.

7.00.30  Compliance of Outlet:

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.

COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, January 18, 2007

Proposed Changes with Statement of Basis, Purpose, and Authority

Basis and Purpose:		This rule is being added to allow the off-site storage of records by prescription drug outlets which meet certain criteria.

Statement of Authority:	The Board is granted authority to promulgate rules pursuant to CRS sections 12-22-108 and 110 and 24-4-103(2006)

11.00.00  RECORDS AND RECORDKEEPING. 

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.

COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, January 18, 2007

Proposed Changes with Statement of Basis, Purpose, and Authority

Basis and Purpose:		These rules are being amended or added to clarify that other outlet may only obtain drugs from individuals or entities registered with the Board.
 
Statement of Authority:	The Board is granted authority to promulgate rules pursuant to CRS sections 12-22-108 and 110 and 24-4-103(2006)

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.

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 BY THE COLORADO STATE BOARD OF PHARMACY.

COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, January 18, 2007

Proposed Changes with Statement of Basis, Purpose, and Authority

Basis and Purpose:		These rules are being amended or added to implement the CRS 12-22-800
 
Statement of Authority:	The Board is granted authority to promulgate rules pursuant to CRS sections 12-22-108 and 110 and 24-4-103(2006)

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 OF THE UNITED STATES AND SHIPS PRESCRIPTION DRUGS INTO COLORADO.

Every wholesaler, distributor (wholesale distributor) located in Colorado who engages in wholesale distributions of prescription drugs or controlled substances must be registered in accordance with this part before engaging in wholesale distributions of such drugs.

15.01.10  Requirements for licensure.

15.01.11  Minimum required information for registration.

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

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

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

(3)  Addresses, telephone numbers, and the names of contact persons for all facilities used by the APPLICANT registrant 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 registrant including:

(a)  If a person, the name and social security number of the person;

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

(c)  If a corporation, the name, social security number, 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 and social security number 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, social security number, 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.

b.  Changes in any information in section 15.01.11 shall be submitted to the Colorado Board of Pharmacy within FOURTEEN CALENDAR ten 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 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.  VERIFIED-ACCREDITED WHOLESALER DISTRIBUTORS  IS THE ACCREDITATION BODY APPROVED BY THE BOARD.

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.

15.01.15  Any change in the name of the business shall be reported to the Board in writing on an application provided by the Board within fifteen days of such change.

	A.	ANY 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.
	
15.01.16 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:

a.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;

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

c.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.

d.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.  Any change in name or title of the person having such responsibility shall be reported to the Board in writing within fifteen days of such change unless extended by the Board.

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 person designated DESIGNATED REPRESENTATIVE SHALL HAVE as having overall responsibility for the operation and compliance of the facility AND shall have a minimum of THREE two 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 15.08.00 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 outlets 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 requires 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 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.

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 PRESCRIPTON 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.

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 two THREE  years preceding the request;

(2)  All inventories of controlled substances required to be taken during the two 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 two 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 two  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 CALENDAR 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 two 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 AFFIRMATIVLEY 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 repackaged 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.

COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, January 18, 2007

Proposed Changes with Statement of Basis, Purpose, and Authority

Basis and Purpose:		This rule is being added to clarify that limited licenses may only obtain drugs from individuals or entities registered with the Board.

Statement of Authority:	The Board is granted authority to promulgate rules pursuant to CRS sections 12-22-108 and 110 and 24-4-103(2006)

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 ENTIITY REGISTERED BY THE COLORADO STATE BOARD OF PHARMACY.

COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, January 18, 2007

Proposed Changes with Statement of Basis, Purpose and Authority

Basis and Purpose		 These rules are being amended to implement statutory changes in the pharmacy practice act.

Statement of Authority:	The Board is granted authority to promulgate rules pursuant to CRS sections 12-22-108 and 110 and 24-4-103.

18.00.00  PHARMACY PEER HEALTH ASSISTANCE DIVERSION PROGRAM.

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)(a)(I) and/or (II) 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(2)(a)(I) and/or (II) 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(2)(a)(I) and/or (II) 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.

18.02.27  If the REC receives information from a PHAO, that if proven would constitute a violation of CRS 12-22-125(2)(a)(I) and/or (II) 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.