Basis and Purpose:		The purpose of the addition of Rule 5.00.55 is to detail requirements for reinstating expired registrations of in-state prescription drug outlets and non-resident prescription drug outlets.
Statement of Authority:	The Board is granted authority to promulgate these rules pursuant to CRS sections 12-22-108, 12-22-110, 12-22-120(2) and (3), and 24-4-103.
5.00.55	REINSTATEMENT OF AN IN-STATE OR NON-RESIDENT PRESCRIPTION DRUG OUTLET REGISTRATION.
	A.	IN-STATE PRESCRIPTION DRUG OUTLET.  IF A REGISTRATION HAS EXPIRED, A FACILITY SEEKING TO REINSTATE SUCH REGISTRATION SHALL SUBMIT THE FOLLOWING:
(1)	THE CURRENT REINSTATEMENT APPLICATION WITH THE REQUIRED FEE;
(2)	IF THE OWNER OF THE IN-STATE PRESCRIPTION DRUG OUTLET IS A CORPORATION, SUBMIT EITHER A COPY OF THE ARTICLES OF INCORPORATION AS THEY WERE FILED WITH THE COLORADO SECRETARY OF STATE OR A CERTIFICATE OF GOOD STANDING ISSUED BY THE COLORADO SECRETARY OF STATE;
(3)	A LETTER STATING WHETHER THE CORPORATION IS PUBLIC OR PRIVATE AS FOLLOWS:
	(A)	IF THE CORPORATION IS A PUBLIC CORPORATION, SUBMIT A LIST OF 	ALL STOCKHOLDERS OWNING FIVE PERCENT OR MORE OF THE 	STOCK; OR
	(B)	IF THE CORPORATION IS A PRIVATE CORPORATION, SUBMIT A LIST OF 	ALL STOCKHOLDERS;
(4)	AN ACCURATE DRAWN-TO-SCALE FLOOR PLAN OF THE PRESCRIPTION DRUG OUTLET’S COMPOUNDING / DISPENSING AREA DETAILING ALL COUNTERS, BAYS, SINKS, REFRIGERATORS AND, IF APPLICABLE, STERILE AND NON-STERILE COMPOUNDING HOODS; 
(5)	A COMPLETED, DATED AND SIGNED MINIMUM EQUIPMENT SELF-INSPECTION FORM AS PROVIDED WITH THE REINSTATEMENT APPLICATION; AND
(6)	A STATEMENT, SIGNED BY THE PHARMACIST MANAGER, STATING WHETHER OR NOT GREATER THAN TEN PERCENT OF THE BUSINESS IS OWNED BY A PERSON OR PERSONS AUTHORIZED BY LAW TO PRESCRIBE DRUGS.
	B. 	NON-RESIDENT PRESCRIPTION DRUG OUTLET.  IF A REGISTRATION HAS EXPIRED, A FACILITY SEEKING TO REINSTATE SUCH REGISTRATION SHALL SUBMIT THE FOLLOWING:
	 	(1)	THE CURRENT REINSTATEMENT APPLICATION WITH THE REQUIRED FEE;
(2)	A VERIFICATION OF THE CURRENT PHARMACY LICENSE OR REGISTRATION ISSUED BY THE RESIDENT STATE BOARD OF PHARMACY;
(3)	IF THE REGISTRATION HAS EXPIRED FOR MORE THAN TWO YEARS, A COPY OF A REPORT DETAILING AN INSPECTION OF THE NON-RESIDENT PRESCRIPTION DRUG OUTLET BY ITS RESIDENT STATE BOARD OF PHARMACY DATED WITHIN 2 YEARS OF SUBMISSION OF THE REINSTATEMENT APPLICATION.

Basis and Purpose:		The purpose of the addition to Rule 14.00.40 is to detail the requirements to reinstate expired registrations of “Other Outlets” (as defined in §12-22-102(23)).
Statement of Authority:	The Board is granted authority to promulgate these rules pursuant to CRS sections 12-22-108, 12-22-110, 12-22-120(2) and (3), and 24-4-103.
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.
	G.	REINSTATEMENT OF REGISTRATION.  IF AN OTHER OUTLET REGISTRATION HAS 	EXPIRED, A REGISTRANT WISHING TO REINSTATE SUCH REGISTRATION SHALL 	SUBMIT THE FOLLOWING:
(1)	THE CURRENT REINSTATEMENT APPLICATION WITH THE REQUIRED FEE; AND
(2)	TWO COMPLETE AND DUPLICATE COPIES OF WRITTEN PROTOCOLS, ON FORMS PROVIDED BY THE BOARD, WHICH ARE SIGNED AND DATED BY THE INDIVIDUAL WHO IS THE CONSULTANT PHARMACIST AT THE TIME THE REINSTATEMENT APPLICATION IS SUBMITTED TO THE BOARD. 

Basis and Purpose:		The amendment to Rule 15.01.17 makes the term “wholesaler” consistent with the references throughout the rest of the rule.  Rule 15.01.18 adds requirements for reinstatement of expired registrations.  The amendment to Rule 15.02.11 defines “common carriers” and requires wholesalers to contract only with common carriers that meet the required standards.  The amendment to Rule 15.05.13 clarifies that wholesalers must report any losses of drugs during delivery by common carriers.  In addition, the amendment clarifies that the time to report such losses is thirty calendar days.  The amendment to Rule 15.08.19 (f) changes the retention period for information concerning unsalable drugs to three years in order to render the wholesaler rules consistent with record-keeping requirements in the wholesaler statute at CRS section 12-22-805(5).  The amendment to Rule 15.09.11(d) extends the date by which wholesalers shall be required to implement the necessary technology for electronic pedigrees to January 1, 2017.  The additions and amendments to Rule 15.09.15 add requirements to what information must be detailed on records of receipt of drugs in order to facilitate inspections performed pursuant to 12-22-110(1)(a).  The amendment to Rule 15.09.19 requires prescription drugs to be distributed to the licensee or registrant authorized to possess them in accordance with CRS 12-22-804(2)    The amendment to Rule 15.09.20(g) changes the retention period in order to render the wholesaler rules consistent with record keeping requirements in the wholesaler statute at CRS section 12-22-805(5)  The amendment to Rule 15.09.20(h) adds a requirement to the information contained in records of distribution of drugs in order to facilitate inspections performed pursuant to 12-22-110(1)(a).  The additions of Rules 15.09.23 and 15.09.24 require wholesalers to have a system to report losses of prescription drugs and maintain detailed records of such losses.  The amendments and additions to Rule 15.10.10 detail changes to the written policies and procedures already required for wholesalers, in accordance with the changes to Rule 15 as set forth above.
Statement of Authority:	The Board is granted general authority to promulgate these rules pursuant to CRS sections 12-22-108, 12-22-110, 12-22-805, and 24-4-103.   More specific statutory authority is as follows:
Amendments to Rule 15.01.18 = CRS sections 12-22-118 and 12-22-120(2) and (3).
Amendments to Rule 15.08.19(f) = CRS section 12-22-805(5).
Amendments to Rule 15.09.19 = CRS section 12-22-804(2).
Amendments to Rule 15.09.20(g) = CRS section 12-22-805(5).

15.00.00  WHOLESALERS.
15.01.00  	Wholesale Drugs Distributor Registration Requirement.
	a.	A wholesaler means any person engaged in the wholesale distribution of prescription drugs, including, but not limited to repackagers, own-label distributors, private-label distributors, jobbers, brokers, warehouses, including manufacturers’ and distributors’ warehouses; manufacturers’ exclusive distributors; authorized distributors of record; drug wholesalers or distributors; independent wholesale drug traders; specialty wholesaler distributors; pharmacy buying cooperative warehouses; retail pharmacies that conduct wholesale distribution; and chain pharmacy warehouses that conduct wholesale distribution.
	b.	Every wholesaler must be registered with the Colorado State Board of Pharmacy if it resides in Colorado and distributes drugs or is located in another state or territory of the United States and ships prescription drugs into Colorado.
15.01.10  	Requirements for Licensure.
15.01.11  	Minimum required information for registration.
	a.  	The following minimum information shall be required from each wholesaler as part of the registration:
	(1)  	The name, full business address, and telephone number of the applicant;
	(2)  	All trade or business names used by the applicant;
	(3)  	Addresses, telephone numbers, and the names of contact persons for all facilities used by the applicant for the storage, handling and distribution or prescription drugs;
	(4)  	The type of ownership or operation (i.e., partnership, corporation, sole proprietorship, limited liability company, or government entity); and
	(5)  	The name(s) of the owner and operator of the applicant including:
		(a)  	If a person, the name of the person;
	(b)	If a partnership, the name of each partner, the name of the partnership, and the federal employer identification number (FEIN);
	(c)  	If a corporation, the name and title of each corporate officer and director, the name of the parent company,  the corporate names, the federal employer identification number of the business, and the name of the state of incorporation; and
	(d)  	Name of the business entity.  If a sole proprietorship, the full name of the sole proprietor, and the name and federal employer identification number of the business entity.
	(e)  	If a government entity, identify the name of director and the name of the governmental agency he/she represents.
	(6) 	If a limited liability company, the name and title of each member, federal employer identification number (FEIN) of the business, and name of parent company, if any. 
	(7)	A list of the licenses and permits issued to the applicant by any other state that authorizes the applicant to purchase or possess prescription drugs.
	(8)	The name of the applicant’s designated representative, who must meet the following requirements:
			(a)	Be at least twenty-one years of age;
(b)	Have at least three years of full-time employment history with a pharmacy or a wholesaler in a capacity related to the dispensing and distribution of and the recordkeeping related to prescription drugs;
(c)	Be employed by the applicant in a full-time managerial position;
(d)	Be actively involved in and aware of the actual daily operation of the wholesaler;
(e)	Be physically present at the facility of the applicant during regular business hours, except when the absence of the designated representative is authorized, including, but not limited to, sick leave and vacation leave;
(f)	Serve in the capacity of a designated representative for only one applicant or wholesaler at a time, except where more than one licensed wholesaler is co-located in the same facility and the wholesalers are members of an affiliated group as defined by section 1504 of the federal “Internal Revenue code of 1986.”
(g)	Not have any convictions under federal, state, or local law relating to wholesale or retail prescription drug distribution or controlled substances;
(h)	Not have an felony convictions pursuant to federal, state, or local law; and
			(i)	Undergo a background check as required by CRS 12-22-803.
	(9)	Wholesalers that distribute animal drugs exclusively are exempt from the requirements of 15.01.11(a)(8).
	b.  	Changes in any information in section 15.01.11 shall be submitted to the Colorado Board of Pharmacy within fourteen calendar days thereof.
	c.	Any registered wholesale drug distributor that is accredited by a board approved accreditation body shall inform the board, in writing, within 72 hours if its accreditation is:
	(1)	Expired;
	(2)	Suspended;
	(3)	Revoked; or
	(4)	Withdrawn.
15.01.12  	Minimum Qualifications.
	a.  	The Colorado Board of Pharmacy shall consider, at a minimum, the following factors in reviewing the qualifications of persons of businesses described in 15.01.11 above who engage in the wholesale distribution of prescription drugs within the state:
	(1)  	Any conviction of the applicant under any federal, state, or local laws relating to drug samples, wholesale or retail drug distribution, or distribution of controlled substances;
	(2)  	Any criminal or civil convictions of the applicant under federal or state laws;
	(3)  	The applicant's past experience in the manufacture or distribution of prescription drugs, including controlled substances;
	(4)  	The furnishing by the applicant of false or fraudulent material in any application made in connection with drug manufacturing or distribution;
	(5)  	Disciplinary proceedings by any federal, state, or local government of any registration currently or previously held by the applicant for the manufacture, distribution or dispensing of any drugs, including controlled substances;
	(6)  	Compliance with registration requirements under a previously granted registration, if any;
	(7)  	Compliance with requirements to maintain and/or make available to the Colorado Board of Pharmacy or other governmental agency those records required under this section; and
	(8)  	Any other factors or qualifications the Colorado Board of Pharmacy considers relevant to and consistent with the public health and safety.
	b.  	The Colorado Board of Pharmacy shall have the right to deny a registration to an applicant if it determines that the granting of such a registration would not be in the public interest.
	c.	All applicants shall be inspected within the previous two years prior to registration.  If the applicant is located in Colorado, inspectors from the Colorado state board of pharmacy shall conduct the inspection.  If the wholesaler is located outside of Colorado, the board of pharmacy of the state in which the wholesaler resides shall conduct an inspection of the facility or the out of state wholesaler may be inspected by a board-approved accreditation body.  
	d.	The Board may suspend, revoke, refuse to renew, or otherwise discipline the registration of any wholesale drug distributor if its Board approved accreditation has been suspended, revoked, or withdrawn.  
15.01.13  	A wholesaler must be located at a commercial location.  It may not be located in a personal dwelling or residence.
15.01.14  	Change of name, location, or ownership, or designated representative.
	a.	Any change in the name or location of the wholesaler shall be reported to the board on an application provided by the board prior to such change.
	b.  	Any change in ownership shall be reported on an application provided by the Board within fifteen calendar days of the change and the new owner(s) shall apply for a new registration from the Board and pay the appropriate fee.  A change of ownership shall be deemed to have occurred:
	(1)  	In the event the owner is a corporation, upon sale or transfer of 20 percent or more of the shares of the corporation to a single individual or entity;
	(2)  	In the event the outlet is owned by a partnership, upon sale or transfer of 20 percent or more of any ownership interest.
	(3)  	In the event the outlet is owned by a limited liability company (LLC), upon sale or transfer of 20 percent or more of the membership interests.
	(4)  	Upon incorporation of an existing wholesaler.
	c.	Any change in the designated representative of a wholesaler shall be reported to the board on a form supplied by the board within 14 calendar days of such change.  The incoming designated representative must undergo the required background check.
15.01.17  	When a wholesaler changes location, the outlet shall submit an application on a form provided by the Board prior to outlet relocation.
15.01.18	REINSTATEMENT OF AN EXPIRED IN-STATE OR OUT-OF-STATE PRESCRIPTION 	DRUG WHOLESALER REGISTRATION.
	A.	IN-STATE PRESCRIPTION DRUG WHOLESALER.  IF A REGISTRATION HAS EXPIRED, A 	REGISTRANT WISHING TO REINSTATE SUCH REGISTRATION SHALL SUBMIT THE 	FOLLOWING:
(1)	THE CURRENT REINSTATEMENT APPLICATION WITH THE REQUIRED FEE;
(2)	A NEWLY COMPLETED DESIGNATED REPRESENTATIVE AFFIDAVIT, ON A FORM PROVIDED BY THE BOARD, THAT IS SIGNED AND DATED BY THE DESIGNATED REPRESENTATIVE; AND
(3)	IF A DIFFERENT DESIGNATED REPRESENTATIVE HAS BEEN ESTABLISHED FOR THE APPLICANT SINCE THE EXPIRATION OF THE REGISTRATION, THE APPLICANT SHALL SUBMIT THE NEW DESIGNATED REPRESENTATIVE’S FINGERPRINTS TO THE COLORADO BUREAU OF INVESTIGATION FOR BOTH A STATE AND FEDERAL BACKGROUND CHECK AT THE TIME OF SUBMISSION OF THE REINSTATEMENT APPLICATION, UNLESS OTHERWISE STATUTORILY EXEMPT OR PREVIOUSLY WAIVED BY THE BOARD.   
	B. 	OUT-OF-STATE PRESCRIPTION DRUG WHOLESALER.  IF A REGISTRATION HAS 	EXPIRED, A REGISTRANT WISHING TO REINSTATE SUCH REGISTRATION SHALL 	SUBMIT THE FOLLOWING:
(1)	THE CURRENT REINSTATEMENT APPLICATION WITH THE REQUIRED FEE;
(2)	THE APPLICANT SHALL SUBMIT THE DESIGNATED REPRESENTATIVE’S FINGERPRINTS TO THE COLORADO BUREAU OF INVESTIGATION FOR BOTH A STATE AND FEDERAL BACKGROUND CHECK AT THE TIME OF SUBMISSION OF THE REINSTATEMENT APPLICATION, UNLESS OTHERWISE STATUTORILY EXEMPT OR PREVIOUSLY WAIVED BY THE BOARD.   
		(3)	A VERIFICATION OF THE CURRENT PRESCRIPTION DRUG 	WHOLESALER 	LICENSE OR REGISTRATION ISSUED BY THE RESIDENT STATE BOARD OF 	PHARMACY;
		(4)	A NEWLY COMPLETED DESIGNATED REPRESENTATIVE AFFIDAVIT, ON A 	FORM PROVIDED BY THE BOARD, THAT IS SIGNED AND DATED BY THE 	DESIGNATED REPRESENTATIVE; AND
(5)	IF THE REGISTRATION HAS EXPIRED/LAPSED FOR OVER 2 YEARS, A REGISTRANT SHALL SUBMIT ONE OF THE FOLLOWING:
	(A)	A COPY OF A REPORT DETAILING AN INSPECTION OF THE OUT-OF-	STATE PRESCRIPTION DRUG WHOLESALER BY ITS RESIDENT STATE 	BOARD OF PHARMACY DATED WITHIN 2 YEARS OF SUBMISSION OF 	THE REINSTATEMENT APPLICATION; OR
 	(B)	A CURRENT COPY OF THE WHOLESLAER’S ACCREDITATION BY A 	BOARD-APPROVED ACCREDITATION BODY; OR 
	(C)	PROOF OF THE WHOLESALER’S CURRENT REGISTRATION WITH THE 	FEDERAL FOOD AND 	DRUG ADMINISTRATION (FDA).
15.02.00  	Personnel.
15.02.10  	Designated Representative. A single person shall be designated by name and title who has complete and overall responsibility for the operation of the facility in compliance with all applicable laws, rules and regulations pertaining to drugs and devices.  This person's name, social security number, and title shall be reported to the Board in writing.  
15.02.11  	Wholesalers shall certify that all staff, employees, personnel, AND COMMON CARRIERS have suitable education or experience for the position such staff and employees hold and the job functions they are assigned.  The wholesaler shall affirm that such staff AND COMMON CARRIERS, HAVE disclosed any past criminal convictions or violations of state and federal law.  FOR THE PURPOSES OF THIS REGULATION, “COMMON CARRIER” MEANS ANY PERSON OR ENTITY WHO UNDERTAKES, WHETHER DIRECTLY OR BY ANY OTHER ARRANGEMENT, TO TRANSPORT PROPERTY INCLUDING PRESCRIPTION DRUGS AND CONTROLLED SUBSTANCES FOR COMPENSATION.

15.02.12  	The Designated Representative shall have overall responsibility for the operation and compliance of the facility and shall have a minimum of three years verifiable full-time experience in a pharmacy or wholesaler.
15.03.00  	Sanitation.
15.03.10  	Adequate sanitary and plumbing facilities shall be installed.  These facilities shall be maintained in good repair and shall be regularly cleaned.
15.03.11  	All areas of the facility shall be regularly and routinely cleaned.  The walls, ceilings, windows and floors of the premises shall be clean and maintained in good repair and order.
15.03.12  	The premises shall be free from noxious odors.
15.03.13  	There shall be adequate pest control.
15.03.14  	All personnel shall keep themselves and their attire as clean as possible.  Facilities for storage of additional clothing and changing shall be provided as necessary and appropriate.
15.04.00  Storage.
15.04.10  	All drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs, or with requirements in the current edition of an official compendium such as the USP/NF.
	a.  	If no storage requirements are established for a drug, the drug may be held at “controlled” room temperature, as defined in an official compendium such as USP/NF, to help ensure that its identity, strength, quality, and purity are not adversely affected.
	b.  	Appropriate manual, electromechanical, or electronic temperature and humidity equipment, and/or logs shall be utilized to document proper storage of drugs.  Refrigerator and freezer units shall be monitored each business day.  If done manually, the temperature shall be recorded each business day.  All electromechanical or electronic temperature equipment utilized shall alert the outlet if the temperature falls out of the acceptable range.
	c.  	Packaging of the drugs should be in accordance with an official compendium such as USP/NF and identify any compromise in the integrity of the drugs due to tampering or adverse storage conditions.
	d.  	Controlled substance drugs should be isolated from non-controlled substance drugs and stored in a secure area in accordance with DEA security requirements and standards.
	e.  	All areas of the outlet shall be well lighted and ventilated.
15.04.11  	There shall be adequate storage space.  Products that are not stored on shelving or under special conditions, such as refrigeration, shall not be stored directly on the floor.
15.04.12  	Drugs and devices shall be placed under proper storage conditions as soon as possible after receipt.
15.04.13  	The wholesaler shall be responsible that proper storage requirements are met for all drugs during shipment to a purchaser or other person entitled to receive such products.
15.05.00  	Security.
15.05.10  	a.  All facilities used for wholesale drug distribution shall be secure from    unauthorized entry:
	(1)  	Access from outside the premises shall be kept to a minimum and be well-controlled;
	(2)  	The outside perimeter of the premises shall be well-lighted; and
	(3)  	Entry into areas where drugs are held shall be limited to authorized personnel.
	b.  	All facilities shall be equipped with an alarm system to detect unauthorized entry.  Such alarm systems shall be both external and centrally monitored with a dedicated line and systems back up.  The systems and the back up shall be regularly inspected and tested.
	c.  	All facilities shall be equipped with a security system that will provide suitable protection against theft and diversion.  When appropriate, the security system shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.
	d.  	All facilities shall be equipped with inventory management and control systems that detect, protect against, and document any instances of theft, diversion, or counterfeiting.
	e.  	All facilities shall be equipped with security systems to protect the integrity and confidentiality of data and documents and make such data and documents readily available to the Board and other state and federal law enforcement officials.
15.05.11  	One person shall be designated by name or title, in writing, to have ultimate responsibility for security of all keys or other methods of entry into the facility itself and into all limited access areas within the facility.  There shall be a list that identifies all persons who are authorized to have access to controlled substances.  This information shall be made available to the Board upon request.
15.05.12  	Storage areas shall be constructed in such a manner as to reduce the possibility of illegal entry.  The wholesaler shall take adequate precautions to ensure the security of controlled substances during shipment to a purchaser or other person entitled to receive and possess controlled substances.
15.05.13  	Any theft, suspicious loss, or recurring loss of prescription drugs or any loss of controlled substances, INCLUDING DURING DELIVERY BY COMMON CARRIERS, shall be reported to the Board within thirty CALENDAR days of the loss, along with a description of the loss, cause of the loss and any other appropriate information.  Any loss of controlled substances shall also be reported to the appropriate law enforcement agency.  
15.05.14  	Any computer system used by the wholesaler shall be protected from unauthorized use.
15.06.00  	Drug receipt, handling, and shipment.
15.06.10  	Drugs and devices shall be placed under proper storage conditions as soon as possible after receipt.
15.06.11  	The wholesaler shall be responsible that proper storage requirements are met for all drugs during shipment to a purchaser or other person entitled to receive such products.
15.06.12  	Upon receipt, each shipping container shall be visually examined for identity and to determine if it may contain contaminated, contraband, counterfeit, suspected of being counterfeit or damaged drugs or drugs that are otherwise unfit for distribution.  This examination shall be adequate to reveal container damage that would suggest possible contamination, adulteration, misbranding, counterfeiting, suspected of being counterfeit, or other damage to the contents.
15.06.13  	The drugs found to be unacceptable under section 15.06.12 shall be quarantined from the rest of stock until the examination and determination that the drugs are not outdated, damaged, deteriorated, misbranded, counterfeited, or adulterated and determined to be fit for human use.
15.06.14  	Each outgoing shipment shall be carefully inspected for identity of the drugs and to ensure that the drugs for shipment have not been damaged in storage or held under improper conditions.
15.06.15  	Upon receipt, a wholesale distributor must review records for the acquisition of drugs for accuracy and completeness, noting the wholesale distributors involved.
15.06.16  	The recordkeeping requirement in 15.09.00 shall be followed for all incoming and outgoing drugs and devices.
15.07.00   	Returned drugs.
15.07.10  	A drug which has been returned to the wholesaler shall be segregated from other stock until it can be determined if the item is salable and suitable for placement into inventory or if it is unsalable.
15.07.11  	Any drug or device returned to a manufacturer or wholesale distributor shall be kept under proper conditions for storage, handling, transport, shipment, and documentation showing that proper conditions were maintained prior to its return is provided to the manufacturer or wholesale distributor to which the drugs are returned.
15.07.12  	If the conditions under which a drug or device has been returned cast doubt on the drug’s or device’s safety, identity, strength, quality, or purity, then the drug or device shall be destroyed, or returned to the supplier, unless examination, testing or other investigation proves that the drug or device meets appropriate standards of safety, identity, strength, quality, and purity. 
15.07.13  	Any returned drug which is deemed unsalable shall be handled in accordance with the procedures delineated in regulation 15.08.00.
15.08.00  	Unsalable drugs (outdated, damaged, adulterated, misbranded, counterfeit, or suspected of being counterfeit).
15.08.10  	Counterfeit drugs are those in which the container, shipping container, seal, or labeling, without authorization, bears the trademark, trade name, or other identifying mark, imprint, device, or any likeness thereof, of a manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by such other manufacturer, processor, packer, or distributor.
15.08.11  	A drug or device shall be deemed to be adulterated if:
	a.  	It consists in whole or in part of any filthy, putrid, or decomposed substance; or
	b.  	It has been produced, prepared, packed, or held under unsanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or
	c.  	If the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that the drug or device meets the requirements of this part as to safety and has the identity and strength, and meets the quality and purity characteristics which it purports or is represented to possess; or
	d.  	If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or
	e.  	If it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of the federal food, drug and cosmetic act.
	(1)  	It is a color additive, the intended use of which is for purposes of coloring only, and is unsafe within the meaning of the federal food, drug, and cosmetic act;
	(2)  	If it purports to be or is represented as a drug, the name of which is recognized in an official   compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in the compendium.  Such determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in the compendium, or in the absence of or inadequacy of these tests or methods of assay, those prescribed under the authority of the federal food, drug, and cosmetic act.  No drug defined in an official compendium shall be deemed to be adulterated under this paragraph because it differs from the standard of strength, quality, or purity therefore set forth in the compendium, if its difference in strength, quality, or purity from that standard is plainly stated on its label.  Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States it shall be subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the Homeopathic Pharmacopoeia of the United States and not those of the United States Pharmacopoeia;
	(3)  	If it is not subject to paragraph (2) and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess;
	(4)  	If it is a drug and any substance has been (a) mixed or packed therewith so as to reduce its quality or strength; or (b) substituted wholly or partially into it.
15.08.12  	A drug or device shall be deemed to be misbranded if the label is false or misleading in any particular; or the label does not bear the name and address of the manufacturer, packer, or distributor, and does not have an accurate statement of the quantities of the active ingredients in case of a drug; or if the label does not show an accurate monograph for legend drugs.
15.08.13  	Any unsalable drug shall be segregated in a specific area away from salable stock.
15.08.14  	Any drug or device whose immediate or sealed outer or secondary containers or labeling is adulterated, misbranded, counterfeited, or suspect of being counterfeit shall be quarantined and physically separated from other drugs or devices until it is returned to either the manufacturer or wholesale distributor from which it was acquired or destroyed.  When the immediate or sealed outer or secondary containers or labeling of any drug or device is adulterated, misbranded, counterfeited, or suspect of being counterfeit, notice of the adulteration, misbranding, counterfeiting, or suspected counterfeiting shall be provided to the Board, FDA, and manufacturer and wholesale distributor from which it was acquired within three (3) business days.
15.08.15  	Any drug or device that has been opened or used, but is not adulterated, misbranded, counterfeited, or suspect of being counterfeit, shall be identified as such, and shall be quarantined and physically separated from other drugs or devices until they are returned to the manufacturer or wholesale distributor from which acquired or destroyed.
15.08.16  	Contraband, counterfeit, or suspected to be counterfeit drugs and devices, other evidence of criminal activity, and accompanying documentation shall be retained and not destroyed until its disposition is authorized by the Board and FDA.
15.08.17  	The shipping container, immediate or sealed outer or secondary container or labeling, and accompanying documentation, suspected of or determined to be counterfeit or fraudulent shall not be destroyed until its disposition is authorized by the Board and FDA.
15.08.18  	An unsalable controlled substance shall be disposed of in compliance with the requirements of the drug enforcement administration and appropriate records shall be kept. 
15.08.19 	 In the case of a drug or a device which is unsalable, records shall be kept which contain the following:
	a.  	The name of the drug;
	b.  	The strength of the drug;
	c.  	The dosage form if appropriate;
	d.  	The quantity of the drug;
	e.  	The name and/or NDC number of the labeler of the drug if labeled only with its generic name;
	f.  	If just an NDC number is used the wholesaler or manufacturer shall maintain a current, complete printed or typed list, which shows both the symbol and code and its complete definition.  This list shall be readily retrievable for examination by the Board for at least THREE years;
	g.  	Method of disposition of item;
	h.  	Date of disposition; and
	i.  	Method of destruction, if applicable; and
	j.  	Signature of individual destroying, if applicable, and signature of individual witnessing destruction.
15.09.00  Recordkeeping.
15.09.10  	All records of receipt, distribution or other disposal of prescription drugs and/or controlled substances shall be available to the Board on request for inspection, copying, verifying or other proper use.  If authorization has been granted to maintain certain records centrally at another location, these records shall be made available within two business days (48 hours maximum.)  Records kept at an inspection site or other site than can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period.  If recap records are available, the Board may, at its option, utilize them, but the original records must also be produced if requested and shall be considered the document of record in any case.
15.09.11  	Records in general.  All wholesalers registered by the Board shall maintain such records and inventories of prescription drugs as may be required by these regulations or any other state or federal law or regulation pertaining to such drugs. Such records shall be maintained on a current basis and shall be complete and accurate for all drugs which the outlet manufactures, receives, distributes or otherwise disposes of in any other manner.  Records, including pedigrees,  and inventories of controlled substances shall be deemed to be “complete” only if each individual record and inventory contains all required information regarding each specific transaction, and if the set of records and inventories contains all information and documents required to be kept by state and federal laws, rules, and regulations.  A record or inventory shall be deemed to be “accurate” only if it is a complete, true and factual statement regarding or reflecting each specific transaction.  A set of records or inventories shall be deemed to be “accurate” only if they are complete, and when considered as a whole, they demonstrate that the controlled substances and/or the records and inventories pertaining thereto have been handled in compliance with all applicable laws or regulations and that all such controlled substances are properly accounted for.
	a.	All such records, including pedigrees, shall be retained for a period of at least three years after the date of any transaction relating to such record or inventory by any process providing an exact duplicate of the original order in a reproducible quality acceptable to the Board.  Records shall be retained in a format that cannot be altered.
	b.	A wholesaler in the possession of a pedigree (a document or electronic file containing information that records each distribution of any given prescription drug that leaves the normal distribution channel) for a prescription drug shall verify that each transaction on the pedigree has occurred prior to distributing the prescription drug.
	c.	The pedigree shall include all necessary identifying information concerning each sale in the chain of distribution of the product from the manufacturer or first authorized distributor of record through the acquisition and sale by a wholesaler until final sale to a pharmacy or other person dispensing or administering the prescription drug.  When a wholesaler distributes a product to another wholesaler, both the distributing and receiving wholesaler shall maintain a copy of the pedigree. The pedigree shall include at least the following:
	(1)	The name, address, telephone number, and, if available, the e-mail address of each owner of the prescription drug and each wholesaler of the drug;
	(2)	The name and address of each location from which the prescription drug was shipped, if different from that of the owner;
	(3)	The transaction dates;
	(4)	Certification that each recipient has authenticated the pedigree;
	(5)	The name of the prescription drug;
	(6)	The dosage form and strength of the prescription drug;
	(7)	The size and number of containers;
	(8)	The lot number of the prescription drug; and
	(9)	The name of the manufacturer of the finished dosage form.
	d.	Effective January 1, 2017, all wholesalers shall be required to use electronic pedigrees.
Records on an automated data processing system or subsequent storage of such records must be immediately retrievable (via monitor display or hard copy printout).  
15.09.12  	Retrievability of records.  For the purposes of these regulations, records and inventories shall be deemed “readily retrievable” if they meet the following requirements:
	a.  	The following records shall be maintained on the premises of the registrant at all times and shall be made available for inspection by the Board or its inspectors immediately upon request:
	(1)  	All DEA-222 forms executed during the three years preceding the request;
	(2)  	All inventories of controlled substances required to be taken during the three years preceding the request;
	(3)  	All records of receipt (invoices for drugs received and credited) of controlled substances, distribution, loss, surrender or disposal in manner of prescription drugs and controlled substances during the three years preceding the request;
	(4)  	List(s) of symbols and codes, if applicable.  Symbols and codes may be used to identify any manufacturer, distributor, or repackager.  If such symbols and codes appear in the records of the registrant, the registrant shall keep a current, complete printed or typed list, which shows both the symbol and code and its complete definition.  This list shall be readily retrievable and available for examination by the Board for at least three years.
	b.  	The following records shall be made available within 48 hours or two business days, whichever is longer, on request by the Board or its inspectors:
	(1)  	All unexecuted DEA-222 forms.
	(2)  	Specific records requested by the inspector if the inspector determines the records are not maintained in a readily retrievable manner.
	(3)  	Records of receipt of non-controlled prescription drugs.
	c.	Pedigrees shall be made available to the board or its inspectors within five business days of request.
15.09.13  	Inventories of controlled substances.  Any inventory of controlled substances shall comply with the following:
	a.  	Each inventory shall contain a complete and accurate record of all controlled substances (including outdated controlled substances, returns from customers, and items ordered but not yet invoiced) on hand on the date the inventory is taken.  The inventory shall be maintained in written, typewritten or printed form at the outlet.  Schedule II drugs shall be separated from schedule III, IV, and V drugs.  Controlled substances shall be deemed to be “on hand” if they are in the possession of or under the control of the registrant.
	b.  	The inventory shall be taken either as of opening of business or as of the close of business on the inventory date and it shall be recorded on the inventory.  In the event the prescription drug outlet is open 24 hours per day, the inventory shall specify the time the inventory was conducted.
	c.  	After the initial inventory is taken, the outlet shall take new inventory of all stocks of controlled substances on hand at least every two years.
	d.  	On the effective date of a law or rule on which a previously non-scheduled drug is added to any schedule of controlled substances, every prescription drug outlet that possesses that drug shall take an inventory of all stocks of the drug on hand.  Thereafter, that drug shall be included in each inventory made by the outlet.
	e.  	The following information shall be recorded on the inventory:
	(1)  	The name of the drug;
	(2)  	Each finished form of the drug (strength and dosage form);
	(3)  	The number of units or volume of each finished form; and
	(4)  	The number of commercial containers of each finished form.

	g.  	All controlled substance inventories shall be retained at the prescription drug outlet for at least three years from the date of such inventory.
15.09.14  	Receipts.
	a.	In-state prescription drug wholesalers shall only receive prescription drugs and controlled substances from an entity that is registered by the Colorado State Board of Pharmacy. This section shall not apply to intracompany or reverse distribution transactions. 
15.09.15  	Records of receipt of prescription drugs and controlled substances shall contain the following information for each such substance received:
	a.  	Name of the drug;
	b.  	Strength of the drug;
	c.  	Dosage form if appropriate;
	d.  	Quantity received;
	e.  	Date received if a controlled substance;
	f.  	Name of the labeler of the drug if it is labeled only with its generic name;
	G.	NAME OF THE RECEIVER;
	H.	ADDRESS OF THE RECEIVER;
	I.	NAME OF THE DISTRIBUTOR, AND ITS COLORADO STATE BOARD OF 	PHARMACY 	REGISTRATION NUMBER, THAT PHYSICALLY DISTRIBUTED 	THE DRUG DIRECTLY TO THE RECEIVER;
	J.	ADDRESS OF THE DISTRIBUTOR WHERE THE DRUG WAS DIRECTLY 	DISTRIBUTED FROM;
	K.	DEA REGISTRATION NUMBER OF THE DISTRIBUTOR IF A CONTROLLED 	SUBSTANCE;
	L.	DEA REGISTRATION NUMBER OF THE RECEIVER IF A CONTROLLED 	SUBSTANCE;
	M.	THE DEA FORM 222 OR AN ELECTRONIC ORDER FORM SHALL BE COMPLETED 	FOR EACH SCHEDULE II CONTROLLED SUBSTANCE RECEIVED.	
15.09.16  	All records of receipt (including credit invoices) of prescription drugs and controlled substances shall be maintained for a period of time not less than two years from the date the drugs were received.  Records of receipt (including credit invoices) of non-controlled prescription drugs need not be maintained on the premises provided that they shall be made available within 48 hours or two business days, whichever is longer, on request by the Board or its inspectors.
15.09.17  	All records of receipt of schedule II controlled substances shall be maintained separately from all other records.
15.09.18  	Records of receipt of schedule III, IV, and V controlled substances may be maintained with other records of receipt.  However, the record shall be readily identifiable from the records of receipt of non-controlled drugs.
15.09.19  	Distribution.
	a.  	A manufacturer or wholesaler as defined in regulation 15.01.00 shall furnish prescription drugs only to a person or entity licensed by the appropriate regulatory board.  Before furnishing prescription drugs to a person not known to the wholesaler, the wholesaler shall affirmatively verify that the person or entity is legally authorized to receive the prescription drugs by contacting the appropriate regulatory board.
	b.	Prescription drugs furnished by a manufacturer or wholesaler shall be delivered only to THE LICENSEE OR REGISTRANT AUTHORIZED BY LAW TO POSSESS THEM.  The manufacturer or wholesaler may furnish prescription drugs to an authorized person or agent of the person listed on the license if the identity and authorization of the recipient is properly established and the method of receipt is employed only to meet the immediate needs of a particular patient of the authorized person or agent.
	c.	Prescription drugs may be furnished to a hospital pharmacy receiving area provided that a pharmacist or authorized receiving agent signs, at the time of delivery, a receipt showing the type and quantity of the prescription drug received.  Any discrepancy between the receipt and the type and quantity of the prescription drug actually received shall be reported to the delivering manufacturer or wholesaler by the next business day after the delivery to the pharmacy receiving area.
15.09.20  	Records of distribution of controlled substances and prescription drugs.  An outlet which distributes prescription drugs and/or controlled substances shall record the following:
	a.  	The name of the drug;
	b.  	The strength of the drug;
	c.  	The dosage form if appropriate;
	d.  	The quantity of the drug;
	e.  	The name of the manufacturer or the NDC number of the drug if labeled only with its generic name;
	f.  	The date of distribution;
	g.  	If just an NDC number is used the wholesaler or manufacturer shall maintain a current, complete printed or typed list, which shows both the symbol and code and its complete definition.  This list shall be readily retrievable for examination by the Board for at least THREE years;
	h.  	The name, address AND COLORADO STATE BOARD OF PHARMACY 	REGISTRATION NUMBER of the distributing wholesaler;
	i.  	The name and address of the receiver;
	j.  	If a controlled substance is distributed, the record shall also indicate the drug enforcement registration number of the distributing outlet and the receiver; and
	k.  	A schedule II controlled substance shall only be distributed pursuant to receipt of a properly executed DEA-222 form or an electronic order.
15.09.21  	These records of distribution shall be retained for a period of time not less than two years from the date of the distribution.
15.09.22  	Records of distribution may be maintained electronically if the following requirements are met:
	a.  	The wholesaler must ensure a daily (i.e., every twenty-four hours) back up is performed for use in restoring required information in case of a system failure.
	b.  	Have and maintain a complete on-line distribution file that is printable on the inspector’s request, or
	c.  	Have a “lock-out” feature that prevents editing of distribution information.
	d.  	The Board or its inspectors must be able to inspect and review the distribution transactions of the wholesaler.  Therefore, immediately upon the oral or written request of the Board or its inspectors, the outlet shall either:
	(1)  	Print a report of all distribution transactions for a period of time as the Board or its inspector(s) may specify.  The system must be capable of retrieving and printing such a report within a limited time not to exceed two hours.  Additionally, the system must be capable of retrieving and printing the information sorted according to variables which include, but are not limited to; date of distribution, drug name, strength and dosage form, and registrants receiving the distribution;
		or
	(2)  	Provide a computer terminal and monitor for the sole use of the Board or its inspector(s) to inspect and review distribution transactions, and, if necessary, provide a person to assist the Board or its inspector(s) for a period of time not to exceed two hours in operating the system.  If the outlet elects to comply with this subparagraph (2), the system must also be capable of printing the same reports described in subparagraph (1)
	(3) 	 It is the responsibility of the manager to ensure that all wholesale staff is aware of the requirements of subparagraphs (1) and (2).  Any failure or refusal by the outlet manager and/or staff to comply with a request by the Board or its inspector(s) will be deemed to be a willful violation of these regulations.
	e.  	If the outlet chooses to maintain records of distribution electronically, any reports printed upon request shall contain, as a minimum, the following information for each transaction:
	(1)  	The name of the drug;
	(2)  	The strength of the drug;
	(3)  	The dosage form if appropriate;
	(4)  	The quantity of the drug;
	(5)  	The manufacturer name and/or NDC number of the drug if labeled only with its generic name;
	(6)  	The date of distribution;
	(7)  	The name and address of the distributing outlet;
	(8)  	The name and address of the receiver; and
	(9)  	When a controlled substance is distributed, the record shall also indicate the drug enforcement registration number of the distributing outlet and the receiver.
15.09.23	WHOLESALERS SHALL MAINTAIN A SYSTEM FOR THE MANDATORY REPORTING OF ANY THEFT, SUSPECTED THEFT, DIVERSION OR OTHER LOSS OF ANY PRESCRIPTION DRUG OR CONTROLLED SUBSTANCE TO THE BOARD OR AS REQUIRED BY THE DRUG ENFORCEMENT ADMINISTRATION OR OTHER STATE AND/OR FEDERAL AGENCIES FOR PRESCRIPTION DRUGS AND CONTROLLED SUBSTANCES.
15.09.24	RECORDS DETAILING LOSSES OF PRESCRIPTION DRUGS AND CONTROLLED SUBSTANCES (INCLUDING LOSSES OCCURRING DURING DELIVERY BY COMMON CARRIERS) SHALL BE MAINTAINED ON THE PREMISES OF THE REGISTRANT AND SHALL BE MADE READILY AVAILABLE FOR INSPECTION BY THE BOARD OR ITS INSPECTORS IMMEDIATELY UPON REQUEST.
15.10.00  	Policies and procedures.
15.10.10  	Wholesale drug distributors shall establish, maintain and adhere to written policies and procedures, which shall be followed for the receipt, security, storage, inventory, and distribution of prescription drugs, including controlled substances, and including policies and procedure for identifying, recording, and reporting destruction, losses or thefts, and for correcting all errors and inaccuracies in inventories.  Wholesale drug distributors shall include the following in their written policies and procedures:
	a.  	A procedure whereby the oldest approved stock of a prescription drug product is distributed first.  The procedure may permit deviation from this requirement, if such deviation is temporary and is itself, an approved deviation procedure.
	b.  	The registrant shall have a procedure to assure that any outdated stock, or any stock with an expiration date that does not allow sufficient time for dispensing by the prescription drug outlet shall be segregated from other stock and shall be returned to the manufacturer or otherwise destroyed, and documented.
	c.  	A procedure to be followed for handling recalls and withdrawals of prescription drugs.  Such procedure shall be adequate to deal with recalls and withdrawals due to:
	(1)  	Any legal action initiated at the request of the food and drug administration or other government agency with jurisdiction:
	(2)  	Voluntary action by the manufacturer to remove defective or potentially defective drugs from the market:
	or
	(3)  	Any action undertaken to promote public health and safety by the replacing of existing merchandise with an improved product or new package design.
	d.  	A procedure to ensure that wholesale drug distributors prepare for, protect against, and handle any crisis that affects security of operation of any facility in the event of strike, fire, flood, or other natural disaster, or other situations of local, state, or national emergency.
	e.  	A procedure to ensure that any outdated, misbranded, counterfeit, adulterated or unsalaable prescription drugs shall be segregated from other drugs and either returned to the manufacturer or destroyed.  This procedure shall provide for written documentation which shall be maintained for 3 2 years after dispositions of the outdated drugs.
	f.  	Policies and procedures to cover the examination of materials to include the visual inspection of shipping containers for prescription drugs unfit for distribution, prescription drugs which have been damaged in storage or held under improper conditions.
	g.  	Procedures which assure employees possess the necessary education or experience for the position they hold and the job functions they are assigned.
	H.	PROCEDURES WHICH ASSURE THAT ALL PRESCRIPTION DRUGS AND CONTROLLED SUBSTANCES ARE ONLY RECEIVED FROM ENTITIES THAT ARE REGISTERED BY THE COLORADO STATE BOARD OF PHARMACY.  THIS SECTION SHALL NOT APPLY TO INTRACOMPANY OR REVERSE DISTRIBUTION TRANSACTIONS.
	I.  	A procedure to ensure that drugs are distributed only to individuals or entities with authorization to possess them.
	J.	A procedure to ensure that drugs are only distributed to THE LICENSEE OR REGISTRANT AUTHORIZED BY LAW TO POSSESS THEM.  In the event the license does not show the address, a written confirmation from the regulatory board licensing or registering the individual or entity shall be obtained.
	K.	 A procedure to ensure verification of all transactions on a pedigree prior to distribution of the drug.
	L.	A procedure to ensure a pedigree is furnished when distribution occurs outside of the normal distribution channel.
	M.	A procedure to ensure that EMPLOYEES OF COMMON CARRIERS HAVE disclosed any past criminal convictions or violations of state and federal law.
	N.	A PROCEDURE FOR VERIFYING SECURITY PROVISIONS OF COMMON CARRIERS.
	O.	A PROCEDURE TO REPORT AND/OR RECORD LOSS OF PRESCRIPTION DRUGS AND/OR CONTROLLED SUBSTANCES BY COMMON CARRIERS TO THE BOARD AND AS REQUIRED BY THE DRUG ENFORCEMENT ADMINISTRATION OR OTHER STATE AND/OR FEDERAL AGENCIES FOR PRESCRIPTION DRUGS AND CONTROLLED SUBSTANCES.
15.10.11  	The policies and procedures shall contain a provision for review at least annually, at which time they shall be up-dated as necessary.  A record documenting this review shall be kept with the policies and procedures and shall indicate the date of completion of the review and the signature of the responsible person as defined in regulation 15.02.10.
15.10.12  	These policies and procedures and the documentation of the annual review shall be available to the Board on request for review or other proper use.
15.10.13  	Additional requirements for wholesalers which distribute veterinary drugs directly to a person responsible for control of an animal.
15.10.14  	A wholesaler may sell or deliver to a person responsible for the control of an animal a drug intended for veterinary use provided the following conditions are met:
	a.  	A licensed veterinarian has issued, prior to such sale or delivery, a written prescription order for the drug in the course of an existing, valid veterinarian-client-patient relationship;
	b.  	The original order must be retained on the premises of the registrant for two years from the date of the last transaction affecting the order;
	c.  	The drugs, prior to distribution, may not be packaged or dispensed by the registrant;
	d.  	The drugs, once distributed, may not be returned to the registrant for resale or redistribution;
	e.  	The prescription order issued by the veterinarian becomes void after one year if for a non-controlled drug or a schedule II controlled substance, unless the veterinarian specifies a shorter expiration date.  The registrant may not distribute larger quantities than the order authorizes.
	f.  	If a schedule III, IV, or V controlled substance, the prescription order becomes void after six months from date of issue, unless the veterinarian specifies a shorter expiration date.  The registrant may not distribute larger quantities than the order authorizes.
	g.  	The original order must be retained on the premises of the registrant filed by client name.  The invoices for each distribution authorized by the order must be attached to the order.
	h.  	A drug distribution log must be retained on the premises of the registrant.  It shall include the following information:
	(1)  	Date sold/delivered;
	(2)  	Client and patient name;
	(3)  	Veterinarian name;
	(4)  	Veterinarian’s DEA registration if a controlled substance;
	(5)  	Drug sold/delivered;
	(6)  	Quantity drug;
	(7)  	Date of issue of order;
	(8)  	Expiration of order; and
	(9) 	Invoice number.

Basis and Purpose:		The purpose of the addition of Rule 16.00.20 is to detail the requirements for reinstating a Limited License registration.
Statement of Authority:	The Board is granted authority to promulgate these rules pursuant to CRS sections 12-22-108, 12-22-110, 12-22-304, and 24-4-103.

16.00.20  	Application Procedure.
	a.  	Original Application.
		Original application for registration as a limited license shall be made on a form 	provided by the Board.
	b.  	Limited License Relocation
		When a limited license changes location, the facility shall submit an application 	on a form provided by the Board prior to relocation.
	c.  	Change of Name of Limited License.
Changes in the name of a limited license shall be submitted to the Board on a form provided by the Board.
D.	REINSTATEMENT OF LIMITED LICENSE.
		IF A REGISTRATION HAS EXPIRED, A REGISTRANT WISHING TO REINSTATE 	SUCH REGISTRATION SHALL SUBMIT THE FOLLOWING:
	(1)	THE REINSTATEMENT APPLICATION THAT IS CURRENT AT THE TIME SUBMITTED WITH THE REQUIRED FEE; AND
	(2)	A COPY OF THE APPLICANT’S CURRENT REGISTRATION WITH THE 	DRUG ENFORCEMENT ADMINISTRATION (DEA).

Basis and Purpose:		The purpose of the amendment to Rule 19.01.10(b)(1) is to update the educational requirements necessary for pharmacists and pharmacy interns to administer immunizations.  The amendment to Rule 19.01.30 changes the educational requirements in the written policies and procedures which are already required.
Statement of Authority:	The Board is granted authority to promulgate these rules pursuant to CRS sections 12-22-102(26)(a), 12-22-108, 12-22-110, 12-22-111, and 24-4-103.

19.00.00  	ADMINISTRATION.
19.01.00 	Immunizations.
19.01.10  	Qualifications.
	a.  	A pharmacist, or pharmacy intern under the supervision of a pharmacist certified in immunization, may administer vaccines per authorization of a physician.  A copy of the authorization will be maintained at the prescription drug outlet.  Routine childhood immunizations, as defined by the Colorado State Board of Health, shall comply with CDC guidelines.
	b.  	Licensees may administer vaccines to a person only if:

	(1)  	THE PHARMACIST OR PHARMACY INTERN HAS COMPLETED A PHARMACY-BASED IMMUNIZATION DELIVERY COURSE ACCREDITED BY THE ACCREDITATION COUNCIL FOR PHARMACY EDUCATION (“ACPE”) FOR AT LEAST 12 HOURS OF DIDACTIC TRAINING AND AT LEAST 8 HOURS OF LIVE HANDS-ON TRAINING.  PROOF OF COMPLETION OF THIS TRAINING SHALL BE POSTED AT THE PHARMACIST’S OR PHARMACY INTERN’S MAIN PRACTICE LOCATION(S).

	(2)  	The pharmacist or pharmacy intern holds a current basic cardiopulmonary resuscitation (CPR) certification issued by the American Heart Association or the American Red Cross or a basic cardiac life support certification.  Proof of certification shall be available at pharmacist’s main practice location.
	(3)  	The vaccines are administered in accordance with CDC guidelines.
	(4)  	The prescription drug outlet shall have a current version available, either in hard copy or electronically available, of the CDC reference “Epidemiology and Prevention of Vaccine-Preventable Diseases”.
19.01.20  	A trained pharmacist may delegate the administration of vaccines only to a trained pharmacy intern.
19.01.30  	Policies and Procedures
	a.  	Prior to administering vaccines or immunizations, pharmacists and pharmacy interns must be trained in a PHARMACY-BASED IMMUNIZATION DELIVERY COURSE ACCREDITED AS DETAILED IN REGULATION 19.01.10(B).
	b.  	The prescription drug outlet must maintain and follow written policies and procedures for handling and disposal of used and contaminated equipment and supplies.  The prescription drug outlet must obtain a physician protocol for addressing allergic reactions to immunizations.
	c.  	The prescription drug outlet must give the appropriate “Vaccine Information Statement” (VIS) to the patient or legal representative with each dose of vaccine covered by these forms.  The pharmacist must ensure that the patient or legal representative has received and signed the informed consent form and has had their questions answered prior to the administration of the vaccine.
	d.  	The prescription drug outlet must report adverse events as required by the Vaccine Adverse Events Reporting System (VAERS) and to the primary care provider as identified by the patient.
19.01.40  	Recordkeeping.
	a.  	The following information must be maintained by the prescription drug outlet for three years for each dose of vaccine administered:
	(1)  	The name, address, and date of birth of the patient;
	(2) 	Patient responses to screening questions for indications/contraindications to the vaccine being administered;
	(3)  	The date of the administration and site of injection of the vaccine;
	(4)  	The name, dose, manufacturer, lot number, and expiration date of the vaccine or immunization;
	(5)  	The name and address of the patient’s primary health care provider as identified by the patient;
	(6)  	The name or identifiable initials of the administering pharmacist. If the administration is by a pharmacy intern, the initials of both the intern and supervising pharmacist;
	(7)  	The signed informed consent document for each administration;
	(8)  	Which vaccine information statement was provided; and
	(9)  	The date the VIS was provided.
	b.  	The above records shall be maintained separately from other records of the prescription drug outlet.