STATE OF COLORADO

Department of Regulatory Agencies
D. Rico Munn, Executive Director

Division of Registrations
Rosemary McCool, Director

STATE BOARD OF PHARMACY
Wendy L. Anderson, Program Director
1560 Broadway, Suite 1300
Denver, Colorado  80202
Phone (303) 894-7800
Fax (303) 894-7692
TTY: Dial 711 for Relay Colorado
www.dora.state.co.us/pharmacy

	

Bill Ritter, Jr.
Governor	

NOTICE OF RULE MAKING HEARING

Pursuant to Colorado Revised Statutes, Title 12, Article 22 and Title 24, Article 4, CRS (2008), you are hereby advised that the Colorado State Pharmacy Board will hold a public rule making hearing on Thursday, October 16, 2008, at 9:30 a.m., at the Denver Post Building, 1560 Broadway, Conference Room 1550, Denver, Colorado 80202, for consideration of the following:

Hearing Regarding Modification, Amendment, Revision or Adoption of certain sections of the following rules:
1.00.00  (3 CCR, 719-1)
2.00.00 	 (3 CCR, 719-1)
3.00.00   (3 CCR, 719-1)
5.00.00   (3 CCR, 719-1)
7.00.00	  (3 CCR, 719-1)
11.00.00  (3 CCR, 719-1)
12.00.00  (3 CCR, 719-1)
14.00.00  (3 CCR, 719-1)

The portions of 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 September 25, 2008.  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 __________________, 2008

COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, October 16, 2008
Proposed Changes with Statement of Basis, Purpose, and Authority

Basis and Purpose:		The purpose of the amendment to Rule 1.00.24 is to clarify that all prescription drugs and controlled substances must be obtained from a Board registered entity.
Statement of Authority:	The Board is granted authority to promulgate these rules pursuant to CRS sections 12-22-101, 12-22-108, 12-22-110, 12-22-112 and 24-4-103.

1.00.24	A prescription drug outlet shall ensure that all PRESCRIPTION drugs AND CONTROLLED SUBSTANCES 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).

COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, October 16, 2008
Proposed Changes with Statement of Basis, Purpose, and Authority

Basis and Purpose:		The purpose of the amendments to Rules 2.01.10, 3.00.50(b), 11.04.20, 11.04.30 and the addition of Rule 3.00.51 is to change how the initial interpretations and final evaluations of orders are conducted and recorded to allow pharmacists and outlets more flexibility in determining the most suitable method for their business.
Statement of Authority:	The Board is granted authority to promulgate these rules pursuant to CRS sections 12-22-101, 12-22-108, 12-22-110, 12-22-112, and 24-4-103.

2.01.10 Information to Appear on Each Order.  The following information must appear on each written or oral order except as provided for chart orders for hospitalized patients (hospital chart orders):
A.  	The date the order was compounded and dispensed; and
B. 	In the case of a prescription or chart order for a resident of a long term care facility (LTCF chart order), the assigned serial number.
C.  	The quantity dispensed if differs from the quantity ordered.
D..  	In the case of a controlled substance order, the patient address, prescriber address, and prescriber’s DEA registration.

3.00.50	Initial Interpretation and Final Evaluation. 
a.	Initial interpretation means the review of an order accompanied by order entry.  The pharmacist(s) conducting the initial interpretation shall be held accountable for the accuracy of the electronic order entry/manual transcription and for drug regimen review.
b.	Final evaluation means the review of the final prescription to ensure that the ordered medication is properly prepared and placed in a suitable container with appropriate labeling.  THE PHARMACIST(S) CONDUCTING THE FINAL EVALUATION SHALL BE HELD ACCOUNTABLE FOR ASSURING THAT THE IDENTITY OF THE DRUG THAT APPEARS ON THE PRESCRIPTION LABEL CORRESPONDS WITH IDENTITY OF DRUG CONTAINED THEREIN.  WHEN REFILLS ARE DISPENSED, THE PHARMACIST CONDUCTING THE FINAL EVALUATION SHALL BE HELD ACCOUNTABLE FOR THE APPROPRIATE DISPENSING OF REFILLS INCLUDING ALL DRUG UTILIZATION REVIEWS AS THEY PERTAIN TO REFILL DISPENSING.
c. 	Drug regimen review includes but is not limited to the evaluation of order(s) and patient records(s) for:
1)	Known allergies;
2)	Rational therapy and contraindications;
3)	Reasonable dose, duration of use, and route of administration considering age, gender, and other patient factors;
4)	Reasonable directions for use;
5)	Potential or actual adverse drug reactions;
6)	Drug-drug interactions;
7)	Drug-food interactions;
8)	Drug-disease contraindications;
9)	Therapeutic duplication;
10)	Proper utilization (including over- or under-utilization) and optimum therapeutic outcomes; and
11)	Abuse/misuse.
d.	A pharmacist shall conduct an initial interpretation of each new order and a pharmacist shall conduct the final evaluation of each order dispensed.  When refills are dispensed, the pharmacist making the final evaluation shall be held accountable for the appropriate dispensing of refills.   The pharmacist manager shall be held accountable for the maintenance of all appropriate records.   
e.	The original prescription or LTCF order shall bear the identity of the pharmacist making the initial interpretation, by either license number, initials, name or secure electronic identifier.  The pharmacist making the initial interpretation on a hospital chart order shall be identified as required by regulation 2.01.20(c). 	  The pharmacist making the final evaluation shall be identified by either license number, initials, name, or secure electronic identifier on a uniformly maintained, readily retrievable document.  The order or a uniformly maintained, readily retrievable document shall bear the license number, initials, name, or secure electronic identifier of any additional pharmacists involved in the dispensing of the order.  The pharmacist conducting the initial interpretation and final evaluation may be the same person.
f.	In the case where the computer software utilized is not password protected, the initial interpretation and final evaluation shall be maintained in a handwritten format bearing the license number, initials, or name of the responsible pharmacist.  In addition, the identification of any other pharmacists involved in the dispensing shall be maintained in the same handwritten format.

3.00.51		RECORDS OF INITIAL INTERPRETATION AND FINAL EVALUATION.

A.	RECORDS DETAILING BOTH THE INITIAL INTERPRETATION AND FINAL EVALUATION 	SHALL BE RETAINED AT THE PRESCRIPTION DRUG OUTLET FOR EACH 	PRESCRIPTION DISPENSED AND FOR AT LEAST TWO YEARS FROM THE DATE OF ANY 	TRANSACTION PERTAINING TO THE ORDER.  THESE RECORDS SHALL INCLUDE AT 	LEAST THE FOLLOWING: 

	1,	THE LICENSE NUMBER, INITIALS, NAME, OR SECURE ELECTRONIC IDENTIFIER OF THE PHARMACIST CONDUCTING THE INITIAL INTERPRETATION FOR EACH NEW ORDER;
 	2.	THE LICENSE NUMBER, INITIALS, NAME, OR SECURE ELECTRONIC IDENTIFIER OF THE PHARMACIST CONDUCTING THE FINAL EVALUATION FOR EACH NEW AND REFILL PRESCRIPTION; AND
	3.	THE SPECIFIC DATE IN WHICH EACH INITIAL INTERPRETATION AND FINAL EVALUATION OCCURRED.  IN THE EVENT THE INITIAL INTERPRETATION AND FINAL EVALUATION FOR A NEW ORDER ARE CONDUCTED ON SEPARATE DATES, BOTH DATES SHALL BE RECORDED TO STATE SPECIFICALLY WHEN BOTH OCCURRED.  

B.	EACH OUTLET SHALL MAINTAIN, IN WRITTEN FORMAT, A NOTICE DETAILING HOW INITIAL INTERPRETATIONS AND FINAL EVALUATIONS ARE DOCUMENTED IN THE OUTLET.  SUCH NOTICE SHALL INCLUDE AND COMPLY WITH THE FOLLOWING:
	1.	THE MANNER IN WHICH INITIAL INTERPRETATIONS ARE RECORDED AND MAINTAINED IN THE OUTLET FOR ALL NEW ORDERS.
	2.	THE MANNER IN WHICH FINAL EVALUATIONS ARE RECORDED IN THE OUTLET FOR ALL NEW AND REFILL PRESCRIPTIONS. 
	3.	A STATEMENT THAT ALL PHARMACY PERSONNEL INVOLVED IN THE DISPENSING OF PRESCRIPTIONS HAVE THE ABILITY TO PRINT, UPON REQUEST, A RECORD DETAILING THE INITIAL INTERPRETATION FOR EACH NEW PRESCRIPTION DISPENSED AND FINAL EVALUATION FOR EACH NEW AND REFILL PRESCRIPTION DISPENSED.
	4.	SUCH WRITTEN NOTICE SHALL BE SIGNED AND DATED BY THE PHARMACIST MANAGER.  IN THE EVENT THE PHARMACIST MANAGER CHANGES, THE INCOMING PHARMACIST MANAGER SHALL REVIEW, SIGN AND DATE THE NOTICE WITHIN 72 HOURS OF ASSUMING THE DUTIES OF PHARMACIST MANAGER.  IN THE EVENT THERE IS A LAPSE BETWEEN THE TIME ONE PHARMACIST MANAGER CEASES THE DUTY AND ANOTHER ASSUMES THE DUTY, THE PREVIOUS METHOD OF RECORDING INTIAL INTERPRETATIONS AND FINAL EVALUATIONS SHALL REMAIN IN EFFECT.
	5.	IF THERE ARE ANY CHANGES TO THE OUTLET’S METHOD OF DOCUMENTING INITIAL INTERPRETATIONS AND FINAL EVALUATIONS, A NEW WRITTEN NOTICE DETAILING THE REQUIREMENTS OF SECTIONS 1., 2., 3. AND 4 ABOVE SHALL BE EXECUTED.  THIS NOTICE SHALL DETAIL THE EFFECTIVE DATE OF CHANGE.
	6.	THE OUTLET SHALL POST THESE NOTICES ON A WALL DIRECTLY NEXT TO THE OUTLET’S MOST CURRENT BOARD REGISTRATION.
	7.	THESE NOTICES SHALL BE RETAINED AT THE OUTLET FOR A PERIOD OF THREE YEARS FROM THE DATE LAST UTILIZED.
	8.	IN THE EVENT SUCH NOTICES ARE NOT POSTED, THE PHARMACIST MANAGER SHALL BE HELD ACCOUNTABLE FOR THE FAILURE TO POST THE REQUIRED NOTICE AND ANY DISPENSING ERRORS.  IN THE EVENT SUCH NOTICES ARE NOT POSTED DURING THE PERIOD OF TIME BETWEEN ONE PHARMACIST MANAGER LEAVING THE POSITION AND ANOTHER ASSUMING THE POSITION, THE OUTLET SHALL BE HELD ACCOUNTABLE FOR THE FAILURE TO POST THE REQUIRED NOTICE AND ANY DISPENSING ERRORS.

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 name and strength of the drug dispensed;
(9)  	The quantity of the drug dispensed;
(10) 	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 name and strength of the drug dispensed;
(9)  	The quantity of the drug dispensed;
(10)  	In the case of a refill, the total number of refills dispensed to date;
(11)  	Whether the prescription order is a new or refill transaction;
(12)  	In the case of a controlled substance, a means of visually identifying orders for such substances and differentiating them from non-controlled substances.

COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, October 16, 2008
Proposed Changes with Statement of Basis, Purpose, and Authority

Basis and Purpose:		Rules 3.02.00 through 3.02.50 are being deleted because they have been recodified in Rule 21.00.00  
Statement of Authority:	The Board is granted authority to promulgate these rules pursuant to CRS sections 12-22-101, 12-22-108, 12-22-110, and 24-4-103.

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.

COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, October 16, 2008
Proposed Changes with Statement of Basis, Purpose, and Authority

Basis and Purpose:		The purpose of the changes to Rule 5.00.00, Outlets, is to clarify which requirements are applicable to in-state prescription drug outlets versus non resident prescription drug outlets, and to delete unnecessary language regarding facility requirements for the compounding of sterile products.  These requirements are now detailed in Rule 21.00.00, Compounding.
Statement of Authority:	The Board is granted authority to promulgate these rules pursuant to CRS sections 12-22-101, 12-22-108, 12-22-110, 12-22-112, and 24-4-103.

5.00.00  OUTLETS.
5.00.01	DEFINITIONS.  THE FOLLOWING WORDS AND TERMS SHALL HAVE THE FOLLOWING MEANINGS, UNLESS THE CONTEXT CLEARLY INDICATES OTHERWISE.
	A.	COMPOUNDING / DISPENSING AREA:	MEANS ANY AREA IN A PRESCRIPTION 	DRUG OUTLET WHERE “COMPOUNDING / DISPENSING” IS PERFORMED.
	B.	IN-STATE PRESCRIPTION DRUG OUTLET:	MEANS ANY PRESCRIPTION DRUG OUTLET LOCATED WITHIN COLORADO THAT IS REGISTERED PURSUANT TO CRS TITLE 12, 	ARTICLE 22, WHERE PRESCRIPTIONS ARE COMPOUNDED AND DISPENSED.
	C.	NON-RESIDENT PRESCRIPTION DRUG OUTLET:	MEANS ANY PHARMACY OUTLET 	LOCATED OUTSIDE THIS STATE THAT IS REGISTERED PURSUANT TO CRS TITLE 12, 	ARTICLE 22, WHICH SHIPS, MAILS, OR DELIVERS, IN ANY MANNER, DRUGS OR 	DEVICES INTO THIS STATE PURSUANT TO A PRESCRIPTION ORDER.  

5.00.10  Registration.  The applicant for registration shall obtain the appropriate form as approved by the Board to register an outlet.  In the case of an application for a new IN-STATE OR NON-RESIDENT prescription drug outlet, for a transfer of ownership of a AN IN-STATE OR NON-RESIDENT prescription drug outlet, or for the relocation of AN IN-STATE OR NON-RESIDENT prescription drug outlet, the applicant shall submit such additional documentation as the Board may require.
5.00.20  Applications.  The Board, or its agent, may require any applicant or PHARMACIST manager of an outlet to meet with the Board, or its agent, before the Board takes action on any registration.
5.00.30  No two registered IN-STATE OR NON-RESIDENT PRESCRIPTION DRUG outlets may occupy the same physical space.  If there are two (or more) registrants co-located within the same building or at the same address, each must have its own area, separated by floor to ceiling walls, and separate entrances.
5.00.40	Transfer of Ownership.  Application to transfer registration of AN IN-STATE OR NON-RESIDENT prescription drug outlet shall be submitted to the Board as provided in CRS 12-22-119, IMMEDIATELY upon THE transfer of ownership.  A Transfer of ownership shall be deemed to have occurred:
a.  	In the event the IN-STATE OR NON-RESIDENT prescription drug 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.
b.  	In the event the IN-STATE OR NON-RESIDENT prescription drug outlet is owned by a partnership, upon sale or transfer of 20 percent or more of any ownership interest.
c.  	In the event the IN-STATE OR NON-RESIDENT prescription drug outlet is owned by a limited liability company (LLC), upon sale or transfer of 20 percent or more of the membership interests.
	d.  	Upon incorporation of an existing IN-STATE OR NON-RESIDENT prescription 	drug outlet.
5.00.50	relocation.  In the event of a relocation of aN IN-STATE OR non-resident prescription drug outlet, the outlet shall submit an application provided by board along with the prescribed fee AT LEAST 30 DAYS prior to the EFFECTIVE DATE OF relocation.
5.00.60	Discontinuance.
a.  	Discontinuance shall mean the permanent cessation of the practice of pharmacy in any IN STATE OR NON-RESIDENT prescription drug outlet.  for in-state prescription drug outlets, Discontinuance shall also be deemed to have occurred if the compounding/dispensing area is not open for business the minimum hours specified in 5.01.40(a).
B.  	Upon the discontinuance of the practice of pharmacy in any in-state or NON-RESIDENT prescription drug outlet it shall be the responsibility of the last pharmacist manager of record to remove the prescriptions 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.  Such relocation of records shall be made within 72 hours after discontinuance of the practice of pharmacy occurs.  If the last pharmacist manager of record fails to relocate the records as required herein, the Board may direct the removal of the records to a suitable location.  The last pharmacist manager of record shall make a reasonable effort to inform patrons of the prescription drug outlet of the location of the records.
C.  	The Board on request shall provide the owner of any prescription 	drug outlet an 	instruction sheet applicable to the transaction 	prior to discontinuing business, or 	conducting bankruptcy 	proceedings, or transferring or selling the prescription drug 	inventory.

5.00.70	CHANGE IN Pharmacist manager.
a.	aN IN-STATE AND non-resident prescription drug outlet shall be under 	the direct charge of a pharmacist manager.  a proprietor who is not a 	pharmacist 	shall comply with this requirement and shall provide a 	manager who is a pharmacist.
	b.	the registration of any IN-STATE AND non-resident prescription drug 	outlet shall become void if the pharmacist manager in whose name the 	registration was issued ceases to be engaged as the manager, and the 	owner shall close the outlet unless such owner has employed a 	pharmacist 	manager and, within fourteen days after termination of 	the former 	manager’s employment, has made application to transfer 	the registration to the new pharmacist manager and has paid the 	transfer fee therefor.
5.00.80	DISCLOSURE.  ANY BOARD REGISTERED NON-RESIDENT PRESCRIPTION DRUG OUTLET SHALL DISCLOSE TO THE BOARD, IN WRITING, THE LOCATION, NAMES, AND TITLES OF ALL PRINCIPAL ENTITY OFFICERS AND ALL PHARMACISTS WHO ARE DISPENSING DRUGS TO RESIDENTS OF THIS STATE ON AN ANNUAL BASIS AND WITHIN THIRTY DAYS AFTER ANY CHANGE OF OFFICE, OFFICER OR PHARMACIST. 
5.01.00  Prescription Drug Outlet OUTLETS (IN-STATE).
5.01.10  Controlled Substance Inventory.
a.  	Upon the change of pharmacist manager of a prescription drug outlet, an inventory of all controlled substances shall be taken within seventy-two hours, by the new pharmacist manager or the new pharmacist manager’s designee.  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.
b.  	Upon the transfer of ownership of a prescription drug outlet, an inventory of all controlled substances shall be taken by the pharmacist manager or the pharmacist manager’s designee.  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.
5.01.20 COMPOUNDING/DISPENSING AREA (IN-STATE)
5.01.21 In the event a transfer of ownership of a prescription drug outlet occurs, and the principal compounding/dispensing area or any satellite compounding/dispensing area does not meet the physical requirements of this regulation, the transfer of the registration may be approved, provided that compliance with such requirements shall be accomplished within six months of the approval of the transfer of the registration or by the next prescription drug outlet registration renewal date, whichever time is greater.
5.01.31 Within every prescription drug outlet as defined in CRS 12-22-102(30.2), there shall be one area designated as the principal compounding/dispensing area. In addition to the principal compounding/dispensing area there may be one or more satellite compounding/dispensing areas (“satellites”) which are located in the same building as the principal compounding/dispensing area.  The principal compounding/dispensing area and any satellite shall comply with the following conditions:
a.  	The principal compounding/dispensing area shall not be less than 225 continuous square feet, except that prescription drug outlets registered by the Board prior to the effective date of this regulation that do not meet this space requirement are hereby exempted from such requirement.  However, any new prescription drug outlet shall comply with this requirement prior to the granting of the initial registration.  Any existing prescription drug outlet which is being remodeled or is being moved from one location to another, whether or not there is a change of address, shall submit documentation required by the Board prior to remodeling or relocation.  Satellite compounding/dispensing areas at the same location must not be less than 100 continuous square feet and must be approved by the Board prior to use for compounding/dispensing.
b.  	All compounding/dispensing areas shall be well-lighted and well-ventilated with clean and sanitary surroundings devoted primarily to compounding/dispensing.  These areas shall provide necessary protection for drugs, chemicals and devices from deterioration due to light, heat or evaporation and shall be arranged to protect all prescription drugs and devices from pilferage or other unauthorized removal.  No areas shall be subject to any condition likely to lead to errors.
c.  	There shall be a minimum of 12 continuous square feet of compounding/dispensing area, and a minimum of 6 continuous square feet of compounding/dispensing area for each person engaged in compounding/dispensing as defined. These counters and surfaces shall be kept free and clear at all times for the purpose of compounding/dispensing.  Any computer workstation or other equipment for the preparation of prescription labels and/or storage and retrieval of records shall be in addition to the minimum free compounding/dispensing area.
(1) 	The free floor space behind all compounding/dispensing counters or work surfaces shall be not less than 30 inches in width;
(2)  	The free floor space between shelf sections shall be not less than 24 inches;
(3)  	There shall be sufficient shelf, drawer and/or cabinet space for proper storage of prescription drugs and devices.
d.  	In the principal compounding/dispensing area there shall be a sink, equipped with running hot and cold water, which is attached to an approved drain, waste and vent system, or to a portable enclosed tank which is emptied as frequently as necessary. Each satellite area shall also be so equipped if appropriate to the compounding/dispensing activities which are or will be performed therein.
e.  	The following minimum professional and technical equipment shall at all times be located within at least one of the compounding/dispensing areas:
(1)  	Pharmaceutical graduates capable of accurately measuring volumes from 1 ml to at least 250 ml.
(2)  	Spatula.
(3)  	Ointment slab or ointment pads.
(4)  	Glassine papers for weighing and compounding.
(5)  	Suitable containers for various dosage forms.
(6)  	Prescription balance meeting minimum compendia sensitivity.
(7)  	Weights:  appropriate metric.
(8)  	Refrigeration meeting the compendia requirements and with an accurate thermometer in the refrigerator.
(9)  	Any other such equipment as may be necessary for the safe compounding and dispensing of drug products.
f.  	There shall be a professional reference library available in the prescription drug outlet or electronically.  If an electronic library is provided, workstations must be provided in a compounding/dispensing area and must be readily available for use by staff, interns and Board personnel.  This library shall contain current copies of the following references which shall be maintained and readily available for use by staff and inspection by the Board:
(1) 	All parts of CRS Title 12, Article 22; the Pharmaceuticals and Pharmacists Act.
(2)  	CRS Title 18, Article 18, the Uniform Controlled Substances Act of 1992;
(3)  	The current rules and regulations of the Board of Pharmacy;
(4)  	The current edition of 21 Code of Federal Regulations (“CFR”) Part 1300 to End containing Drug Enforcement Administration rules relating to controlled substances;
(5)	IF COMPOUNDING STERILE PRODUCTS, GUIDE TO PARENTERAL ADMIXTURES OR HANDBOOK ON INJECTABLE DRUGS OR OTHER COMPARABLE REFERENCES AS DETERMINED BY THE PHARMACIST MANAGER;
(6)	IF COMPOUNDING CYTOTOXIC PRODUCTS, TECHNICAL MANUAL SECTION VI:  CHAPTER 2, CONTROLLING OCCUPATIONAL EXPOSURE TO HAZARDOUS DRUGS OR ASHP TECHNICAL ASSISTANCE BULLETIN ON HANDLING CYTOTOXIC AND HAZARDOUS DRUGS; AND
(7)  	Any other references that the pharmacist manager of the prescription drug outlet may deem necessary.
g.  	If telephone prescription orders are accepted while the compounding/dispensing area is closed, a voice recording device shall be provided to receive them, and they shall be played back by the pharmacist or intern.
h.  	Written prescription orders and refill requests for prescription orders may be delivered to the prescription drug outlet while the compounding/dispensing areas are closed, provided a slot or drop box is provided for the prescription order or prescription order refill requests.
i.  	All prescription drug outlets shall maintain an adequate inventory of prescription drugs and shall offer adequate pharmaceutical service to the public they normally serve.  Adequate service shall include the compounding of prescriptions generally used whether composed of a single or many ingredients.
j.  	Every prescription drug outlet shall display in the principal compounding/dispensing area the report of the most recent inspection conducted by the Board or a photocopy of the most recent self-inspection performed by the pharmacist manager using the form provided by the Board, whichever is more recent, and have readily available documents sent or provided by the Board to clarify or assist in the legal operation of the prescription drug outlet.
k.  	No person other than a pharmacist or intern employed by the prescription drug outlet shall be permitted in the compounding/dispensing area without the consent of the pharmacist in charge of the compounding/dispensing area.
5.01.33 The use of any tobacco product in any compounding/dispensing area is hereby prohibited.  However, this regulation shall not apply to the compounding, dispensing or use of a drug which has been derived from a tobacco product and which is being used as an adjunct to a smoking cessation program.
5.01.34 Delivery and Temporary Storage of Prescriptions.  Upon the request of a patient or an agent of the patient and with the approval of the pharmacist on duty a prescription may be delivered or temporarily stored outside the confines of a compounding/dispensing area.  The pharmacist manager of the prescription drug outlet shall determine or approve procedures for the storage and security of, the access to, the confidentiality of, and the counseling regarding, prescriptions, including record keeping.
5.01.40  Minimum Hours of Operation.
a.  	The principal compounding/dispensing area of a prescription drug outlet shall be open for normal business a minimum of two designated days per week (Monday through Sunday) and at least four continuous hours on each such designated day.
b.  	In the event that the principal compounding/dispensing area is open less than 32 hours per week, the pharmacist manager shall submit to the Board a written statement of the designated days and hours when the principal compounding/dispensing area will be open for business, and this statement shall be submitted at least 30 days prior to the date on which the hours of operation will be less than 32 hours per week.
5.01.50 Security.  In every prescription drug outlet, all compounding/dispensing areas shall comply with this regulation.
a.  	When any compounding/dispensing area of a prescription drug outlet is occupied by any employee, a pharmacist must be physically present on the premises.
b. 	In the event a pharmacist is on the premises but absent from a compounding/dispensing area, it is the responsibility of the pharmacist to ensure the proper safeguard of all drugs.
c.  	If a compounding/dispensing area is continually attended by a pharmacist when other people are in the building, the compounding/dispensing area need not be enclosed.  However, if other people are in the building when there is not a pharmacist present, every compounding/dispensing area must be enclosed by a barrier as specified in paragraph (d) below.
d.  	Prescription drug outlet constituting part of a large establishment may be closed while the balance of the establishment is open for business, provided every compounding/dispensing area is enclosed with a secure floor-to-ceiling physical barrier, which shall be a divider or secure total enclosure, in which any openings shall not be large enough to permit removal of items from the compounding/dispensing area.  The barrier must be of weight and strength sufficient to prevent it from being readily lifted, removed, penetrated or bent.
e.  	All entrances to every compounding/dispensing area shall be secured from unauthorized entry when the pharmacist leaves the building.  No one other than a pharmacist shall be permitted to enter any compounding /dispensing area except in extreme emergencies, which shall be defined as a threat to property, public disaster or other catastrophe whereby the public is better served by overlooking the security restrictions of drugs and devices.  If any compounding/dispensing area is opened in the absence of a pharmacist or left unsecured from unauthorized entry when the pharmacist leaves the building, the pharmacist manager shall notify the Board of Pharmacy in writing within ten days of the discovery of the occurrence.  This written notice shall state:
(1) 	The name of the person authorizing the opening of the compounding/dispensing area if known, or the name of the pharmacist responsible for securing the compounding/dispensing area from unauthorized entry;
(2)  	The name of the person opening the compounding/dispensing area if known; and
(3) 	A description of the situation requiring opening of the compounding/dispensing area including the date and time of the opening.
f.  	While the compounding/dispensing area is closed and the rest of the establishment is open, a person on duty in the establishment shall be able to contact a pharmacist in case of emergency.
g.  	The hours of business of the compounding/dispensing area shall be submitted to the Board in writing.
h.  	No prescription drug outlet shall avail itself of the privileges of this regulation until the barrier system and other requirements have been acknowledged, subject to final approval by the Board.
i.  	This paragraph applies only to the compounding/dispensing areas of a hospital which operates a prescription drug outlet pursuant to a certificate of compliance; or which operates a registered prescription drug outlet on the premises of the hospital for the primary purpose of providing pharmaceutical services to the hospital’s in-patients; or permits a registered prescription drug outlet to be operated on the premises of the hospital by another business entity for the primary purpose of providing pharmaceutical service to the hospital’s in-patients.
(1)  	In an emergency situation and when a pharmacist is not on the premises of the hospital and administration of a drug to, or use of a device by or on, an in-patient is necessary pursuant to a chart order, and such drug or device is only available from a locked compounding/dispensing area, an authorized registered nurse may enter a locked compounding/dispensing area to obtain the drug or device.  In the case of a drug, only pre-labeled packages, such as unit dose or unit-of-use packages, or a pre-labeled container, may be removed from the compounding/dispensing area.
 (2)  	The following information regarding the removal of such drug or device shall be consistently recorded and maintained in a retrievable document:  date; time; name, strength and dosage form of drug, and/or name, and size, if applicable, of device; total quantity of drug or device removed; name and location of patient for whose use the drug or device is necessary; name of the practitioner ordering the drug or device; and the initials or signature of the nurse obtaining the drug or device.  This document shall be available for inspection by the Board for a period of 2 years.  Additionally, the original, duplicate or electronic or mechanical facsimile of the chart order shall be left with the above document by the nurse at the time of obtaining the drug or device.

(3)  	Any unused portion of a drug or device so removed shall be returned to the 	compounding/dispensing area when a pharmacist is again on the premises.  	Additional quantities of the drug or device shall be supplied by a pharmacist and 	properly recorded as required by law and regulation.

COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, October 16, 2008
Proposed Changes with Statement of Basis, Purpose, and Authority

Basis and Purpose:		The purpose of the amendments to Rules 7.00.00, 7.00.10, 7.00.20, and 7.00.30 are to clarify pharmacist manager responsibilities, including the reporting of violations, the documentation of initial interpretations and final evaluations of orders, the maintenance of compounding policy and procedure manuals, and clarifying the requirement for obtaining prescription drugs and controlled substances only by individuals or entities registered by the Board.
Statement of Authority:	The Board is granted authority to promulgate these rules pursuant to CRS sections 12-22-101, 12-22-108, 12-22-110, and 24-4-103.

7.00.00  PHARMACIST MANAGER RESPONSIBILITIES.
7.00.10	Reporting Violations. The pharmacist manager of a prescription drug outlet shall report TO THE BOARD, IN WRITING, WITHIN THE TIMELINES SET FORTH IN THE RELEVANT RULES AND STATUTES, the following violations of the PHARMACEUTICALS AND PHARMACISTS 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.  IN SUCH INSTANCE THE REPORT SHALL BE SUBMITTED TO THE BOARD IMMEDIATELY UPON DISCOVERY.
e.  	Significant errors related to the practice of pharmacy, INCLUDING THOSE RELATED TO COMPOUNDING, such as those that result in serious personal injury or death of a patient.  IN SUCH INSTANCE THE REPORT SHALL BE SUBMITTED TO THE BOARD IMMEDIATELY UPON DISCOVERY.
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.  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.
I.	IT IS THE RESPONSIBILITY OF THE PHARMACIST MANAGER TO MAINTAIN RECORDS OF INITIAL INTERPRETATION AND FINAL EVALUATION AS REQUIRED BY REGULATION 3.00.51(A) AND (B).
J.	IT IS THE RESPONSIBILITY OF THE PHARMACIST MANAGER TO MAINTAIN AND TO ASSURE THE OUTLET’S COMPLIANCE WITH A POLICY AND PROCEDURE MANUAL, WHERE APPLICABLE, ENCOMPASSING ALL ASPECTS OF NON-STERILE AND STERILE COMPOUNDING AS REQUIRED BY REGULATIONS 21.10.10 AND 21.20.30, RESPECTIVELY.  THE ANNUAL REVIEW OF SUCH MANUAL OR MANUALS SHALL BE SIGNED AND DATED BY THE PHARMACIST MANAGER.  IN THE EVENT THE PHARMACIST MANAGER CHANGES, THE NEW MANAGER SHALL REVIEW, SIGN, AND DATE THE MANUAL WITHIN 30 DAYS OF BECOMING THE PHARMACIST MANAGER.    
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 AND CONTROLLED SUBSTANCES are procured BY THE OUTLET 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).

COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, October 16, 2008
Proposed Changes with Statement of Basis, Purpose, and Authority

Basis and Purpose:		The purpose of the amendments to Rules 3.01.20 and 11.07.20 is to clarify the labeling of packaged products when the product is packaged and distributed by a prescription drug outlet owned and operated by a hospital that is accredited by the Joint Commission on Accreditation  of Healthcare Organizations or a successor organization or by a pharmacy that is operated by a health maintenance organization.  These changes are in response to 2007 House Bill 1289. 
Statement of Authority:	The Board is granted authority to promulgate these rules pursuant to CRS sections 12-22-101, 12-22-108, 12-22-110, and 24-4-103.

3.01.00  Packaging.
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 (d), (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 another 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.
I.	THE NAME AND ADDRESS OF THE PACKAGING PHARMACY IF THE DRUG IS DISTRIBUTED BY A PRESCRIPTION DRUG OUTLET OWNED AND OPERATED BY A HOSPITAL THAT IS ACCREDITED BY THE JOINT COMMISSION OF ACCREDITATION OF HEALTHCARE ORGANIZATIONS OR A SUCCESSOR ORGANIZATION OR BY A PRESCRIPTION DRUG OUTLET OPERATED BY A HEALTH MAINTENANCE ORGANIZATION AS DEFINED IN SECTION 10-16-102, C.R.S.  SUCH DRUGS MAY ONLY BE DISTRIBUTED TO PRESCRIPTION DRUG OUTLETS UNDER COMMON OWNERSHIP.

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.
L.	THE INTERNAL LOT NUMBER ASSIGNED IF THE DRUG IS PACKAGED AND DISTRIBUTED BY A PRESCRIPTION DRUG OUTLET OWNED AND OPERATED BY A HOSPITAL THAT IS ACCREDITED BY THE JOINT COMMISSION OF ACCREDITATION OF HEALTHCARE ORGANIZATIONS OR A SUCCESSOR ORGANIZATION OR BY A PRESCRIPTION DRUG OUTLET OPERATED BY A HEALTH MAINTENANCE ORGANIZATION AS DEFINED IN SECTION 10-16-102, C.R.S.  SUCH DRUGS MAY ONLY BE DISTRIBUTED TO PRESCRIPTION DRUG OUTLETS UNDER COMMON OWNERSHIP.

COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, October 16, 2008
Proposed Changes with Statement of Basis, Purpose, and Authority

Basis and Purpose:		The purpose of the amendments to Rule 12 is to clarify which pharmacists are nuclear pharmacists, the registration and minimum equipment requirements for nuclear pharmacies, the security requirements for nuclear pharmacies, and recordkeeping for nuclear pharmacies.
Statement of Authority:	The Board is granted authority to promulgate these rules pursuant to CRS sections 12-22-101, 12-22-102(21), 12-22-108, 12-22-110, 12-22-112, and 24-4-103.

12.00.00  NUCLEAR PHARMACY.
12.00.10 		Authorized handling.  It is unlawful to receive, possess or transfer radiopharmaceuticals, except in accordance with CRS 12-22-108.  It is also unlawful for any person to provide radiopharmaceutical services unless he or she is a nuclear pharmacist acting in accordance with CRS Title 12, Article 22, and the regulations of the State Board of Pharmacy and regulations of the Colorado Department of Health, with the exception of an authorized practitioner for administration to his patients.  No person may receive, acquire, possess, use, transfer or dispose of any radioactive material except in accordance with the conditions of any radioactive material license required by the Colorado Department of Health pursuant to CRS 25-11-101 et seq.  The requirements of this regulation are in addition to, and not in substitution for, other applicable provisions of regulations of the State Board of Pharmacy and the State Radiation Control Agency.
12.00.20  Definitions.
12.00.21 	A "nuclear prescription drug outlet" means a prescription drug outlet which deals with the preparation and delivery of radioactive material as defined in CRS 25-11-101.
12.00.22	"Nuclear pharmacist" means a pharmacist who HOLDS AN ACTIVE PHARMACIST LICENSE WITH THE BOARD AND HAS MET THE STANDARDS OF TRAINING AND EXPERIENCE FOR “AUTHORIZED USER STATUS” IN HANDLING RADIOACTIVE MATERIALS IN ACCORDANCE WITH EITHER THE STATE RADIATION CONTROL AGENCY OR THE U.S. NUCLEAR REGULATORY COMMISSION. 
12.00.23  	"Radiopharmaceutical service" shall mean, but shall not be limited to, the compounding, dispensing, labeling and delivery of radiopharmaceuticals; the participation in radiopharmaceutical selection and radiopharmaceutical utilization reviews; the proper and safe storage and distribution of radiopharmaceuticals; the maintenance of radiopharmaceutical quality assurance; the responsibility for advising, where necessary or where regulated, of therapeutic values, hazards, and use of radiopharmaceuticals, and the offering or performing of those acts, services, operations or transactions necessary in the conduct, operation, management and control of radiopharmaceuticals.
12.00.24  	A "radiopharmaceutical" is any substance defined as a drug in Section 201(g)(1) of the Federal Food, Drug and Cosmetic Act which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or protons and includes any such drug which is intended to be made radioactive.  This definition includes non-radioactive reagent kits and nuclide generators which are intended to be used in the preparation of any such substance but does not include drugs such as carbon-containing compounds or potassium-containing salts which contain trace quantities of naturally occurring radionuclides.
12.00.25  	"Radiopharmaceutical quality assurance" means, but is not limited to, the performance of appropriate chemical, biological and physical tests on radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history and the keeping of proper records.
12.00.26  	"Internal test assessment" means, but is not limited to, conducting those tests of quality assurance necessary to ensure the integrity of the test.
12.00.27  	"Authentication of product history" means, but is not limited to, identifying the purchasing source, the ultimate fate, and intermediate handling of any component of a radiopharmaceutical.
12.00.28  	"Authorized practitioner" means a practitioner authorized by law to possess, use and administer radiopharmaceuticals, acting within the scope of such authority.
12.00.30  	Requirements For Nuclear Prescription Drug Outlets.  A nuclear prescription drug outlet shall only be managed by a nuclear pharmacist.  All personnel performing tasks in the preparation and distribution of radiopharmaceuticals shall be under the direct supervision of a nuclear pharmacist.  A nuclear pharmacist shall be in attendance at all times that the nuclear prescription drug outlet is open for business and shall be responsible for all operations of the registered area.
12.00.31  	ALL nuclear prescription drug outletS shall have adequate space, commensurate with the scope of services required and provided.  The nuclear prescription drug outlet area shall be separate from the areas for non-radioactive drugs and shall provide a radioactive storage and product decay area separate from and exclusive of the radioactive laboratory, compounding, dispensing, quality assurance and administrative area.  PRIOR TO REGISTRATION, A NUCLEAR PRESCRIPTION DRUG OUTLET THAT WISHES TO COMPOUND BOTH RADIOPHARMACEUTICALS AND NON-RADIOPHARMACEUTICALS NOT DIRECTLY PERTAINING TO NUCLEAR STUDIES SHALL MEET THE SPACE REQUIREMENTS SET FORTH IN REGULATION 5.01.31.  IF A NUCLEAR PRESCRIPTION DRUG OUTLET WISHES TO COMPOUND ONLY RADIOPHARMACEUTICALS, IT SHALL NOT BE REQUIRED TO MEET THE SPACE REQUIREMENTS SET FORTH IN REGULATION 5.01.31.  ALL NUCLEAR PRESCRIPTION DRUG OUTLETS SHALL SUBMIT DETAILING DRAWING-TO-SCALE FLOOR PLANS TO THE BOARD THAT HAVE BEEN APPROVED BY THE STATE RADIATION CONTROL AGENCY BEFORE APPROVAL OF THE REGISTRATION.
12.00.32  	NUCLEAR PRESCRIPTION DRUG OUTLETS THAT COMPOUND BOTH RADIOPHARMACEUTICALS AND NON-RADIOPHARMACEUTICALS NOT DIRECTLY PERTAINING TO NUCLEAR STUDIES SHALL MAINTAIN A PROFESSIONAL LIBRARY IN COMPLIANCE WITH REGULATION 5.01.31(F), REGULATION 12.00.32(A) THROUGH (D), AND IF APPLICABLE, REGULATION 5.01.32(A)(3).  A NUCLEAR PRESCRIPTION DRUG OUTLET THAT COMPOUNDS ONLY RADIOPHARMACEUTICALS SHALL MAINTAIN AND HAVE AVAILABLE IN THE OUTLET OR ELECTRONICALLY A PROFESSIONAL LIBRARY IN COMPLIANCE WITH REGULATION 12.00.32(A) THROUGH (D) AND SHALL BE EXEMPT FROM THE REQUIREMENTS OF REGULATION 5.01.31(F) AND 5.01.32(A)(3).  IF AN ELECTRONIC LIBRARY IS PROVIDED, WORKSTATIONS MUST BE PROVIDED AND MUST BE READILY AVAILABLE FOR USE BY STAFF AND BOARD PERSONNEL.  THIS LIBRARY SHALL CONTAIN CURRENT COPIES OF THE FOLLOWING REFERENCES WHICH SHALL BE MAINTAINED AND READILY AVAILABLE FOR USE BY STAFF AND INSPECTION BY THE BOARD:
		A.	ALL PARTS OF CRS TITLE 12, ARTICLE 22;
		B.	THE CURRENT RULES AND REGULATIONS OF THE BOARD OF PHARMACY;
		C.	THE CURRENT RULES AND REGULATIONS OF THE STATE RADIATION CONTROL AGENCY AND U.S. NUCLEAR COMMISSION; AND
		D.	ANY OTHER REFERENCES THAT THE PHARMACIST MANAGER OF THE NUCLEAR PRESCRIPION DRUG OUTLET DEEMS NECESSARY.
12.00.33  	A nuclear prescription drug outlet shall comply with all applicable laws and regulations of federal and state agencies, including those laws and regulations governing non-radioactive drugs.
12.00.34  	A nuclear prescription drug outlet shall have adequate equipment commensurate with the scope of radiopharmaceutical services to be provided.  
12.00.35	NUCLEAR PRESCRIPTION DRUG OUTLETS WHICH COMPOUND AND DISPENSE ONLY RADIOPHARMACEUTICALS SHALL BE EXEMPT FROM THE SECURITY REQUIREMENTS OF REGULATION 5.01.50 PROVIDED THE FOLLOWING CONDITIONS ARE MET:
	A.	ONLY INDIVIDUALS IDENTIFIED AS HAVING “AUTHORIZED USER” STATUS BY THE STATE RADIATION CONTROL AGENCY OR THE U.S. NUCLEAR REGULATORY COMMISSION MAY ENTER THE COMPOUNDING/DISPENSING AREA IN THE ABSENCE OF A PHARMACIST AND ONLY FOR THE PURPOSE OF EQUIPMENT MAINTENANCE.
	B.	THE NUCLEAR PRESCRIPTION DRUG OUTLET MAINTAINS A WRITTEN RECORD DOCUMENTING SUCH ENTRY DETAILING THE FOLLOWING INFORMATION:
		1)	DATE AND TIME OF ENTRY;

		2)	AUTHORIZED USERS NAME;
		3)	REASON FOR ENTRY; AND
		4)	SIGNATURE OF PHARMACIST MANAGER.
	SUCH RECORD SHALL BE MAINTAINED ON THE PREMISES AND AVAILABLE FOR INSPECTION FOR AT LEAST TWO YEARS FROM THE DATE OF ENTRY.
12.00.40  	General Requirements For Nuclear Pharmacists.  A nuclear pharmacist shall:
	A.	BE A PHARMACIST LICENSED TO PRACTICE IN COLORADO;

B.	MEET THE STANDARDS OF TRAINING AND EXPERIENCE FOR “AUTHORIZED USER STATUS” IN HANDLING OF RADIOACTIVE MATERIALS IN ACCORDANCE WITH EITHER THE STATE RADIATION CONTROL AGENCY OR THE U.S. NUCLEAR REGULATORY COMMISSION; AND

C.	BE SPECIFICALLY IDENTIFIED, BY NAME, AS AN “AUTHORIZED NUCLEAR PHARMACIST” ON EITHER A 	RADIOACTIVE 	MATERIALS LICENSE ISSUED BY THE COLORADO DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT OR ON A U.S. NUCLEAR REGULATORY COMMISSION MASTER LICENSE.  

12.00.45 	NUCLEAR PRESCRIPTION DRUG OUTLETS SHALL POST, IN A CONSPICUOUS AREA OF THE COMPOUNDING / DISPENSING AREA OF THE OUTLET, AND SHALL HAVE READILY AVAILABLE FOR INSPECTION, THE FOLLOW:
	A.	THE ORIGINAL COPY OF THE CURRENT REGISTRATION WITH THE PHARMACY BOARD;
	B.	THE ORIGINAL COPY, OR A REFERENCE TO ITS SPECIFIC LOCATION IN THE OUTLET, OF THE MOST CURRENT RADIOACTIVE MATERIALS LICENSE ISSUED BY THE COLORADO DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT;
	C.   	A COPY, OR A REFERENCE TO ITS SPECIFIC LOCATION IN THE OUTLET, OF THE MOST CURRENT U.S. NUCLEAR REGULATORY COMMISSION MASTER LICENSE WHICH DETAILS A LISTING OF ITS AUTHORIZED NUCLEAR PHARMACISTS IF THE CURRENT RADIOACTIVE LICENSE ISSUED BY THE COLORADO DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT REFERENCES THE OUTLET’S U.S. NUCLEAR REGULATORY COMMISSION MASTER LICENSE RATHER THAN DETAILING A LISTING 	OF THE OUTLET’S AUTHORIZED NUCLEAR PHARMACISTS ITSELF; AND
	D.  	THE OUTLET’S CURRENT LIST OF EMPLOYEES THAT COMPLIES WITH REGULATION 11.08.00.
12.00.64	NUCLEAR COMPOUNDING.
IF A NUCLEAR PHARMACIST COMPOUNDS A PREPARATION ACCORDING TO THE MANUFACTURER’S LABELING INSTRUCTIONS, THEN FURTHER DOCUMENTATION IS NOT REQUIRED. ALL OTHER COMPOUNDED PREPARATIONS REQUIRE FURTHER DOCUMENTATION. 

A.  	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.

	B.	THE COMPOUNDING OF STERILE RADIOPHARMACEUTICALS SHALL COMPLY WITH REGULATION 21.00.00, INCLUDING ALL RECORDKEEPING REQUIREMENTS.

12.00.70  DISPENSING.  
	A.	A RADIOPHARMACEUTICAL SHALL ONLY BE DISPENSED PURSUANT TO A VALID, PATIENT-SPECIFIC PRESCRIPTION ORDER THAT IS ISSUED BY AN AUTHORIZED 	PRACTITIONER.
	B.	A NUCLEAR PRESCRIPTION DRUG OUTLET SHALL ONLY DISPENSE RADIOPHARMACEUTICALS WHICH COMPLY WITH ACCEPTABLE STANDARDS OF RADIOPHARMACEUTICAL ASSURANCE.
	C.	IN ADDITION TO ANY LABELING REQUIREMENT OF THE BOARD FOR NON RADIOPHARMACEUTICALS, THE IMMEDIATE OUTER CONTAINER OF THE RADIOPHARMACEUTICAL TO BE DISPENSED SHALL ALSO BE LABELED WITH: 
		(1) 	THE STANDARD RADIATION SYMBOL; 
		(2) 	THE WORDS "CAUTION – RADIOACTIVE MATERIAL"; 
		(3) 	THE NAME OF THE RADIOPHARMACEUTICAL;
 		(3) 	THE AMOUNT OF RADIOACTIVE MATERIALS CONTAINED, IN MILLICURIES OR MICROCURIES; 
		(4) 	IF A LIQUID, THE VOLUME IN MILLILITERS; 
		(5) 	THE REQUESTED CALIBRATION TIME FOR THE AMOUNT OF RADIOACTIVITY CONTAINED; AND 
		(6) 	EXPIRATION DATA, IF APPLICABLE.
D.	THE IMMEDIATE INNER CONTAINER SHALL BE LABELED WITH:  
		(1) 	THE STANDARD RADIATION SYMBOL; 
		(2) 	THE WORDS "CAUTION – RADIOACTIVE MATERIAL";
		(3) 	THE ASSIGNED SERIAL NUMBER OF THE CORRESPONDING PRESCRIPTION ORDER; AND 
		(4) 	THE NAME OF THE RADIOPHARMACEUTICAL.
	E.	THE AMOUNT OF RADIOACTIVITY SHALL BE DETERMINED BY RADIOMETRIC 	METHODS FOR EACH INDIVIDUAL PREPARATION IMMEDIATELY PRIOR TO 	DISPENSING.
12.00.71	RECORDS OF DISPENSING.
	A.	IN ADDITION TO ANY REQUIREMENT OF THE BOARD FOR NON-RADIOPHARMACEUTICAL PRESCRIPTION ORDERS, THE PRESCRIPTION ORDER SHALL INCLUDE THE FOLLOWING:
		 (1)  	ADDRESS OF THE AUTHORIZED PRACTITIONER AND/OR THE ADDRESS WHERE THE PRESCRIPTION IS TO BE ADMINISTERED;
 		(2) 	THE NAME OF RADIOPHARMACEUTICAL; 
		(3) 	THE AMOUNT OF RADIOACTIVE MATERIALS CONTAINED, IN MILLICURIES OR MICROCURIES; AND 
		(4) 	CALIBRATION TIME FOR THE AMOUNT OF RADIOACTIVITY CONTAINED.
FOR THE PURPOSES OF THIS REGULATION, THE PRESCRIPTION DRUG OUTLETS MAY RECORD THE ADDRESS ON THE ORDER OR MAINTAIN IT IN A READILY RETRIEVABLE FORMAT.
	B.	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 ORDER.  IF A NUCLEAR PRESCRIPTION DRUG OUTLET DISPENSES ONLY RADIOPHARMACEUTICALS, PRESCRIPTION 	ORDERS WILL BE DEEMED TO BE READILY RETRIEVABLE AND AVAILABLE IF THEY 	ARE FILED ACCORDING TO THE DATE OF DISPENSING.  IF A NUCLEAR PRESCRIPTION 	DRUG OUTLET DISPENSES BOTH RADIOPHARMACEUTICALS AND NON-RADIOPHARMACEUTICALS NOT DIRECTLY PERTAINING TO NUCLEAR STUDIES, ALL 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 REGULATION 2.01.10.
12.00.72  DISTRIBUTION. 
	A.	A NUCLEAR PRESCRIPTION DRUG OUTLET MAY DISTRIBUTE 	A COMPOUNDED RADIOPHARMACEUTICAL	TO A PRACTITIONER AUTHORIZED BY LAW TO PRESCRIBE THE DRUG FOR THE PURPOSES OF ADMINISTRATION.  SUCH 	DISTRIBUTIONS SHALL BE LIMITED TO UP TO 10 PERCENT OF THE TOTAL NUMBER 	OF DRUG DOSAGE UNITS DISPENSED AND DISTRIBUTED ON AN ANNUAL BASIS BY 	SUCH OUTLET.
	B.	A NUCLEAR PRESCRIPTION DRUG OUTLET MAY REDISTRIBUTE NDA APPROVED RADIOPHARACEUTICALS IF THE OUTLET DOES NOT PROCESS THE RADIOPHARMACEUTICALS IN ANY MANNER OR VIOLATE THE PRODUCT PACKAGING.
	C.	THE IMMEDIATE OUTER CONTAINER OF THE RADIOPHARMACEUTICAL TO BE DISTRIBUTED SHALL BE LABELED WITH:  
		(1) 	THE STANDARD RADIATION SYMBOL; 
		(2) 	THE WORDS "CAUTION – RADIOACTIVE MATERIAL";
		 (3) 	“RX ONLY”; 
		(4) 	THE NAME OF 	RADIOPHARMACEUTICAL; 
		(5) 	THE AMOUNT OF RADIOACTIVE MATERIALS CONTAINED, IN MILLICURIES OR MICROCURIES; 
		(6) 	IF A LIQUID, THE VOLUME IN 	MILLILITERS; 
		(7)	THE REQUESTED CALIBRATION TIME FOR THE AMOUNT OF					RADIOACTIVITY CONTAINED; 
		(8)	 EXPIRATION DATA, IF APPLICABLE; 
		(9)	 THE ASSIGNED BATCH (LOT) NUMBER;
		(10) 	SPECIFIC ROUTE OF ADMINISTRATION; 
		(11) 	STORAGE DIRECTIONS; AND
		(12)	THE NAME AND ADDRESS OF THE  PRESCRIPTION DRUG OUTLET.
	D.	THE IMMEDIATE INNER CONTAINER SHALL BE LABELED WITH:  
		(1)	 THE STANDARD RADIATION SYMBOL; 
		(2) 	THE WORDS "CAUTION – RADIOACTIVE MATERIAL";
		(3) 	THE ASSIGNED BATCH (LOT) NUMBER; AND 
		(4) 	THE NAME OF THE RADIOPHARMACEUTICAL.
12.00.73	RECORDS OF DISTRIBUTION.
	A.	A NUCLEAR PRESCRIPTION DRUG OUTLET SHALL MAINTAIN RECORDS OF 	ACQUISITION AND DISTRIBUTION OF ALL RADIOPHARMACEUTICALS IN 	ACCORDANCE WITH CRS TITLE 12, and AND CRS TITLE 25.
	B.	A NUCLEAR PRESCRIPTION DRUG OUTLET MUST RETAIN VERIFICATION OF EACH PRACTITIONER’S LICENSE FROM THE JURISDICTION IN WHICH LICENSED ON A CURRENT BASIS FOR EACH PRACTITIONER TO WHOM IT DISTRIBUTES COMPOUNDED RADIOPHARMACEUTICALS.
	C.	A NUCLEAR PRESCRIPTION DRUG OUTLET THAT DISTRIBUTES 	RADIOPHARMACEUTICALS SHALL RECORD THE FOLLOWING:
		(1)	THE NAME OF THE RADIOPHARMACEUTICAL;
		(2)	THE AMOUNT OF RADIOACTIVE MATERIALS CONTAINED, IN MILLICURIES OR MICROCURIES;
		(3)	IF A LIQUID, THE VOLUME IN MILLILITERS;
		(4)	THE REQUESTED CALIBRATION TIME FOR THE AMOUNT OF RADIOACTIVITY CONTAINED;
		(5)	THE DATE OF DISTRIBUTION;
		(6)	THE NAME AND ADDRESS OF THE AUTHORIZED PRACTITIONER AND THE ADDRESS WHERE THE PREPARATION IS TO BE ADMINISTERED; AND
		(7)	THE NAME AND ADDRESS OF THE DISTRIBUTING OUTLET.
	D.	RECORDS OF DISTRIBUTION SHALL BE RETAINED AT THE OUTLET FOR A PERIOD OF NOT LESS THAN TWO YEARS FROM THE DATE OF DISTRIBUTION.

COLORADO STATE BOARD OF PHARMACY
Rulemaking Hearing, October 16, 2008
Proposed Changes with Statement of Basis, Purpose, and Authority

Basis and Purpose:		The purpose of the amendments to Rules 14.00.10, 14.00.40, 14.00.80, and the addition of Rules 14.06.00 and 14.07.00 is to change the inspection requirements for certain types of other outlets that dispense large quantities of prescriptions, detail when other outlets must become prescription drug outlets due to the large quantities dispensed or the size of the facility, and to provide a provision for county health departments, in the event of an emergency, to collect and redistribute medication.
Statement of Authority:	The Board is granted authority to promulgate these rules pursuant to CRS sections 12-22-101, 12-22-108, 12-22-110, 12-22-112, 12-22-120, and 24-4-103.
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. Eff04/01/2007
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. Eff04/01/2007
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. Eff04/01/2007
C.	FOR THE PURPOSES OF THIS REGULATION, “DISPENSING UNIT” MEANS A CONTAINER OR CONTAINERS OF A DRUG, EITHER PACKAGED PURSUANT TO REGULATION _3.01.00_ OR THE MANUFACTURER’S ORIGINAL CONTAINER(S), CONTAINING A QUANTITY SUITABLE FOR THE PRESCRIBED TREATMENT OR CONDITION.	
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.
F.	CHANGE OF REGISTRATION.
(1)	ANY OTHER OUTLET LOCATED IN A COMMUNITY HEALTH CLINIC, RURAL HEALTH CLINIC, COLLEGE, OR UNIVERSITY WHICH DISPENSES MORE THAN 25000 DISPENSING UNITS IN A CALENDAR YEAR SHALL REGISTER WITH THE BOARD AS A PRESCRIPTION DRUG OUTLET.
(2)	ANY OTHER OUTLET LOCATED IN A HOSPITAL WHICH HAS GREATER THAN 25 BEDS AS STATED ON ITS LICENSE WITH THE COLORADO DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT SHALL REGISTER AS A PRESCRIPTION DRUG OUTLET.
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. Eff04/01/2007
a.	A consultant pharmacist shall either: Eff04/01/2007
(1)	Initially interpret all prescription orders dispensed from the other outlet, or Eff04/01/2007
(2)	Provide written protocols for dispensing by unlicensed persons. Eff04/01/2007
b.	A consultant pharmacist shall be available for professional consultation. Eff04/01/2007
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.  THE CONSULTANT PHARMACIST SHALL RECORD ON THE PROTOCOLS AT LEAST ANNUALLY THE NUMBER OF DISPENSNG UNITS DISPENSED IN A CALENDAR YEAR FOR THE FOLLOWING FACILITY TYPES:  COMMUNITY CLINICS, RURAL HEALTH CLINICS, COLLEGES, AND UNIVERSITIES.  A CALENDAR YEAR IS CONSIDERED TO RUN FROM JANUARY 1 THROUGH DECEMBER 31.
d.	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 INSPECT AND DOCUMENT THE INSPECTION IN WRITING AS DETAILED IN 14.00.80(D) THE FOLLOWING OTHER OUTLETS AT THE FOLLOWING FREQUENCIES:
 (1)	QUARTERLY INSPECTIONS AND VISITS SHALL BE CONDUCTED FOR THE FOLLOWING:
(A)	JAILS;
(B)	COUNTY HEALTH DEPARTMENTS;
(C)	SCHOOLS, GRADE KINDERGARTEN THROUGH TWELVE;
(D)	HOSPITALS; AND
(E)	FAMILY PLANNING CLINICS.
(2)	COMMUNITY CLINICS, RURAL HEALTH CLINICS, COLLEGES, AND UNIVERSITIES SHALL BE INSPECTED AND VISITED AS FOLLOWS:
(A)	MONTHLY IF 2500 OR LESS DISPENSING UNITS ARE DISPENSED IN A CALENDAR YEAR.  A CALENDAR YEAR IS CONSIDERED TO RUN FROM JANUARY 1 THROUGH DECEMBER 31.;
(B)	EVERY OTHER WEEK IF MORE THAN 2500 BUT LESS THAN 7501 DISPENSING UNITS ARE DISPENSED IN A CALENDAR YEAR;   A CALENDAR YEAR IS CONSIDERED TO RUN FROM JANUARY 1 THROUGH DECEMBER 31.
	(C)	EACH WEEK IF 7501 DISPENSING UNITS BUT LESS THAN 12501 DISPENSING UNITS ARE DISPENSED IN A CALENDAR YEAR.  A CALENDAR YEAR IS CONSIDERED TO RUN FROM JANUARY 1 THROUGH DECEMBER 31.
	(D)	TWICE EACH WEEK IF 12501 DISPENSING UNITS BUT LESS THAN 25001 DISPENSING UNITS ARE DISPENSED IN A CALENDAR YEAR.  A CALENDAR YEAR IS CONSIDERED TO RUN FROM JANUARY 1 THROUGH DECEMBER 31.
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. Eff04/01/2007
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. Eff04/01/2007
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. Eff04/01/2007
H.	THE CONSULTANT PHARMACIST SHALL BE RESPONSIBLE FOR ENSURING ANY SIGNIFICANT ERRORS RELATED TO THE PRACTICE OF PHARMACY, SUCH AS THOSE THAT RESULT IN SIGNIFICANT HARM TO A PATIENT OR THE DEATH OF A PATIENT,  ARE REPORTED TO THE BOARD.
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: Eff07/30/2007
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). Eff07/30/2007
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. Eff07/30/2007
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: Eff07/30/2007
(1) 	The serial number; Eff07/30/2007
(2) 	The name of the patient; Eff07/30/2007
(3) 	The name of the practitioner; Eff07/30/2007
(4) 	For each controlled substance dispensed, the practitioner's Drug Enforcement Administration registration number; Eff07/30/2007
(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; Eff07/30/2007
(6) 	The total number of refills authorized; Eff07/30/2007
(7) 	The date dispensed; Eff07/30/2007
(8) 	The initials, name, or secure electronic identifier of the individual making the final evaluation; Eff07/30/2007
(9) 	The name and strength of the drug dispensed; Eff07/30/2007
(10) 	The quantity of the drug dispensed; Eff07/30/2007
(11)	 In the case of a refill, the total number of refills dispensed to date. Eff07/30/2007
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. Eff07/30/2007
e. 	The daily printout shall be available for inspection by the Board within 72 hours from the most recent date recorded on the printout. Eff07/30/2007
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: Eff07/30/2007
(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. Eff07/30/2007
or Eff07/30/2007
(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. Eff07/30/2007
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. Eff07/30/2007
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. Eff07/30/2007
i. 	Any automated data processing system used by an outlet shall maintain the confidentiality of records in accordance with applicable laws, rules and regulations. Eff07/30/2007
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 thetwoyears 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).
14.06.00	PETITION FOR A REDUCED VISITATION/INSPECTION SCHEDULE.
A.	THE CONSULTANT PHARMACIST OF AN OTHER OUTLET MAY PETITION THE BOARD FOR A REDUCED VISITATION/INSPECTION SCHEDULE BY SUBMITTING A WRITTEN REQUEST TO THE BOARD DETAILING THE PROCEDURES OR TECHNOLOGY THE OTHER OUTLET HAS IN PLACE WHICH ELIMINATE THE NEED FOR THE REQUIRED FREQUENCY OF VISITATION/INSPECTION.  THE BOARD WILL REVIEW THESE REQUESTS IN THE ORDINARY COURSE OF BUSINESS.  NO OTHER OUTLET MAY CHANGE ITS VISITATION/INSPECTION SCHEDULE WITHOUT RECEIVING WRITTEN NOTIFICATION FROM THE BOARD APPROVING THE OUTLET’S ALTERNATIVE VISITATION/INSPECTION SCHEDULE.  SUCH WRITTEN NOTIFICATION SHALL BE MAINTAINED IN THE OTHER OUTLET POSTED NEXT TO THE OTHER OUTLET REGISTRATION.

14.07.00	EMERGENCY REDISTRIBUTION OF PRESCRIPTION DRUGS
A.	IN THE EVENT OF A SHORTAGE OF MEDICATION OR STATE OR NATIONAL EMERGENCY AS DICTATED BY EITHER THE CENTER FOR DISEASE CONTROL AND PREVENTION (CDC) OR THE COLORADO DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT (CDPHE), AN OTHER OUTLET LOCATED IN A COUNTY HEALTH DEPARTMENT OR PUBLIC HEALTH AGENCY AS DEFINED IN CRS 25-1-502 MAY OBTAIN MEDICATIONS FROM FACILITIES, PHYSICIANS, AND OTHER ENTITIES IN POSSESSION OF THE DRUGS, AND REDISTRIBUTE THE MEDICATION AS DIRECTED BY THE CDC OR CDPHE.  THE OTHER OUTLET SHALL NOT BE REQUIRED TO BECOME LICENSED AS A WHOLESALER TO CONDUCT DISTRIBUTION OF DRUGS FOR THE LIMITED PURPOSE SET FORTH IN THIS RULE.  THE OTHER OULET SHALL MAINTAIN WRITTEN RECORDS OF THE DISTRIBUTIONS DETAILING 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.	LOT NUMBER OF THE DRUG;
F.	EXPIRATION DATE OF THE DRUG;
G.	The name of the manufacturer or the NDC number of the drug if labeled only with its generic name.   
h..  	The date of distribution;
I. 	 The name and address of the distributing outlet;
J..  	The name and address of the receiver;
K.	 If a controlled substance is distributed, the record shall also indicate the Drug Enforcement ADMINISTRATION registration number of the distributing outlet and the receiver.
l.  	A schedule II controlled substance shall only be distributed pursuant to receipt of a properly executed DEA-222 form.