Colorado law allows specified pharmacies and outsourcing facilities to supply compounded drugs or devices when the work follows applicable federal and state standards.
Licensed people may compound drugs or devices, and specified pharmacies and outsourcing facilities may supply them to health care providers and other organizations. The work must follow applicable federal and state standards.
Compounded drugs or devices made under applicable federal and state standards are excluded from this section’s rules on when new drugs may be sold.
Licensed people may compound drugs or devices, and specified pharmacies and outsourcing facilities may supply them to health care providers and other organizations. The provisions cover licensed people who compound drugs or devices; specified resident and nonresident pharmacies and 503B outsourcing facilities; and licensed health care providers, pharmacies, facilities, or organizations. The activity must follow applicable federal and state law, including FDA-recognized standards and applicable United States Pharmacopeia processing standards. The law says lawful compounding is not manufacturing and does not expand or alter the pharmacy board’s enforcement authority. The act applies to conduct on or after its effective date. The text does not state that date.
Compounded drugs or devices that meet applicable federal and state standards are excluded from this section’s rules on when new drugs may be sold. The exclusion applies to compounded drugs or devices made in accordance with those standards. Compounding must follow applicable federal and state law, including FDA-recognized standards and applicable United States Pharmacopeia processing standards. The act applies to conduct on or after its effective date. The text does not state that date.
No hearings or votes scheduled.