Bill > HB1262

This bill, titled the "Colorado Patient Access and Compounding Clarity Act," aims to modernize state laws regarding the compounding of medical items, which are custom-made medications prepared by pharmacies to meet individual patient needs, often when commercially available drugs are not suitable. It clarifies that licensed individuals can compound drugs and devices in Colorado, provided they follow federal and state laws. Furthermore, state-licensed pharmacies and 503B outsourcing facilities, which are specialized pharmacies registered with the federal Food and Drug Administration (FDA) that prepare compounded drugs for distribution to other healthcare providers, can supply these compounded items to licensed healthcare providers, pharmacies, facilities, or organizations. These entities are then permitted to obtain, dispense, or administer these compounded drugs and devices. The bill also prevents the state board of pharmacy from creating rules for compounding that are stricter than existing federal or state laws, aligning Colorado's regulations with federal standards like those outlined in sections 503a and 503b of the Federal Food, Drug, and Cosmetic Act, and incorporating United States Pharmacopeia (USP) standards for sterile and non-sterile compounding. Additionally, it exempts compounded drugs and devices, when prepared according to applicable laws, from certain prohibitions related to the sale and delivery of new drugs, similar to existing exemptions for investigational drugs reviewed by an institutional review board.