summary
Introduced
02/19/2026
02/19/2026
In Committee
02/19/2026
02/19/2026
Crossed Over
Passed
Dead
Introduced Session
2026 Regular Session
Bill Summary
The bill provides that, if the action is undertaken in accordance with applicable federal and state law: ! A licensed person may compound a drug or device in the state; ! A state-licensed pharmacy or a distribution facility registered with the federal food and drug administration (licensed 503B outsourcing facility) may supply a compounded drug or device to a licensed health-care provider, pharmacy, facility, or organization; and ! A licensed health-care provider, pharmacy, facility, or organization may obtain, dispense, or administer a compounded drug or device supplied by a state-licensed pharmacy or a licensed 503B outsourcing facility. In addition, the bill prohibits the state board of pharmacy from adopting rules that are more restrictive than federal or state law regarding the compounding of drugs or devices. Current law exempts drugs that are intended solely for investigational use by experts qualified by scientific training and experience and that are plainly labeled for investigational use only from the sales and delivery prohibition for new drugs. The bill also exempts from the prohibition: ! Drugs that are reviewed by an institutional review board and plainly labeled for investigational use only; and ! Compounded drugs and devices if the compounding of the drug or device is undertaken in accordance with applicable federal and state law.
AI Summary
This bill, titled the "Colorado Patient Access and Compounding Clarity Act," aims to modernize state laws regarding the compounding of drugs and devices to ensure clarity, reduce regulatory duplication, and maintain patient access to essential medications, aligning with evolving federal standards. It permits licensed individuals to compound drugs and devices in the state, including in sterile or non-sterile environments, provided these actions comply with applicable federal and state laws. The bill also allows state-licensed pharmacies and registered 503B outsourcing facilities, which are specialized pharmacies that prepare compounded medications in bulk for healthcare providers, to supply these compounded items to licensed healthcare providers, pharmacies, facilities, or organizations. Furthermore, it grants these entities the authority to obtain, dispense, or administer such compounded drugs and devices. Crucially, the bill prohibits the state board of pharmacy from creating rules for compounding that are more restrictive than existing federal or state laws, and it exempts compounded drugs and devices, when prepared according to federal and state law, 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.
Committee Categories
Health and Social Services
Sponsors (4)
Last Action
House Health & Human Services Hearing (00:00:00 3/10/2026 Room 0112) (on 03/10/2026)
Official Document
bill text
bill summary
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bill summary
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bill summary
| Document Type | Source Location |
|---|---|
| State Bill Page | https://leg.colorado.gov/bills/HB26-1262 |
| Fiscal Note FN1 | https://leg.colorado.gov/bill_files/112831/download |
| BillText | https://leg.colorado.gov/bill_files/112331/download |
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