21.00.20	Casual Sales/Distribution of Compounded Products.
	a.	An in-state prescription drug outlet shall only distribute a compounded product to:
		(1)	Practitioners licensed and located in Colorado and authorized by law to prescribe the drug;
		(2)	Colorado licensed/registered acupuncturists, direct-entry midwives, or naturopathic doctors who are located in Colorado and authorized by law to obtain the drug; 
		(3)	Hospital prescription drug outlets registered and located in Colorado; or 
		(4)	Other outlets registered and located in Colorado.
	Except as provided by Rule 21.00.20(d), distribution of the compounded product pursuant to this rule shall be for the sole purpose of drug administration.  In-state Prescription Drug Outlets shall not distribute compounded products outside of the state. In-state Prescription Drug Outlets shall dispense compounded products and ship them out of the state only pursuant to patient-specific prescription orders.
	b.	Unless otherwise allowed by state and federal law, nonresident prescription drug outlets shall not distribute compounded products into Colorado pursuant to 21 U.S.C. secs. 331(a), 353(b) and 355(a). 
	c.	Unless otherwise allowed by state and federal law, nonresident prescription drug outlets registered in Colorado may dispense compounded products and ship them into Colorado only pursuant to valid, patient-specific prescription orders.
	d.	A nonresident prescription drug outlet may distribute a compounded product to a Colorado-licensed veterinarian who is located in Colorado and authorized by law to prescribe the drug only if: 
		i)	The nonresident prescription drug outlet provides the Board with a copy of the outlet’s most recent report detailing an inspection by the National Association of Boards of Pharmacy Verified Pharmacy Program, for which third-party inspection the nonresident prescription drug outlet shall obtain and pay for on an annual basis, and the Board approves the inspection report as satisfactorily demonstrating proof of compliance with the Board’s own inspection procedures and standards; and
		ii)	The nonresident prescription drug outlet provides the Board, on an annual basis, with a copy of the outlet’s current manufacturer registration obtained from the Drug Enforcement Administration.
	e.	Distribution of a compounded product to a Colorado-licensed veterinarian may be for the purpose of dispensing by the receiving veterinarian only if:
		i)	The compounded product is necessary for the treatment of  an animal patient’s emergency medical condition; 
		
		ii)	As determined by the veterinarian, the veterinarian cannot access, in a timely manner, the compounded product from a prescription drug outlet or nonresident prescription drug outlet.  
	f.	Except as provided under CRS 12-42.5-118(15)(a), (b)(I) and (b)(II), the amount of compounded drug product a prescription drug outlet compounds and distributes shall be no more than ten (10) percent of the total number of drug dosage units the prescription drug outlet dispenses and distributes on an annual basis, and no more than ten (10) percent of the total number of drug dosage units the nonresident prescription drug outlet dispenses and distributes into Colorado on an annual basis pursuant to Board Rules 21.00.20(d) and (e). An in-state compounding prescription drug outlet registered pursuant to CRS 12-42.5-117(9) may distribute compounded product pursuant to CRS 12-42.5-118(15)(a), (b)(I) and (II).  All prescription drug outlets shall comply with all applicable federal laws and rules pertaining to the distribution of controlled substance preparations. 
	g.	The distributing prescription  drug  outlet  or compounding prescription drug outlet must retain the following information on a current basis for each practitioner, hospital prescription drug outlet or hospital other outlet or, when allowable, each prescription drug outlet, to whom it distributes compounded products:
		(1) 	Verification of practitioner’s license, or hospital prescription drug outlet’s or hospital other outlet’s registration; and
		(2)  	Verification of practitioner’s or hospital prescription drug outlet’s or hospital other outlet’s current Drug Enforcement Administration registration, if controlled substances are distributed;
	h.  	Labeling of compounded products which are distributed shall comply with rule 21.11.10(c) or (d) or 21.21.70(c) or (d), whichever is applicable.
	i.	Records of distribution shall comply with rule 11.07.10 or 11.07.20, whichever is applicable.