The FDA issued an April 1, 2026 reminder clarifying compounding requirements for GLP-1 receptor agonists, reiterating that semaglutide and tirzepatide are not on the 503B bulks list and that 'essentially a copy' restrictions remain in force. Historical articles may no longer reflect current regulatory status. Check the cited primary source.
On April 1, 2026, the FDA published a statement clarifying its compounding policies for GLP-1 receptor agonists as the national supply of semaglutide and tirzepatide continued to stabilize following the resolution of the shortage designations.
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**Neither semaglutide nor tirzepatide is on the 503B bulks list.** The 503B outsourcing facility framework requires bulk drug substances to appear on the FDA's 503B bulks list for lawful compounding at scale. Neither GLP-1 appears on this list, meaning 503B outsourcing facilities cannot lawfully compound standard semaglutide or tirzepatide formulations.
**"Essentially a copy" restrictions remain in force.** Under Section 503A of the FD&C Act, a compounding pharmacy cannot prepare a compounded drug that is "essentially a copy" of a commercially available approved drug. The FDA reiterated that this restriction applies to semaglutide and tirzepatide formulations that are functionally equivalent to Ozempic, Wegovy, Mounjaro, or Zepbound.
**503A individual patient exceptions remain narrow.** Compounding for an individual patient with a documented clinical need that differs from the commercially available product (e.g., a specific concentration not commercially available, documented allergy to a component) may still be possible under 503A with proper physician documentation, but the FDA indicated these exceptions are narrow and the burden of documentation is high.
This statement effectively closes off the remaining interpretive gaps that some compounding pharmacies and telehealth platforms had been using to continue GLP-1 compounding after the shortage exemptions expired. Any 503A or 503B pharmacy continuing to compound standard semaglutide or tirzepatide formulations without a specific documented patient justification is operating in direct conflict with FDA's stated position.
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No. As of April 2026, neither semaglutide nor tirzepatide appears on the FDA's 503B bulk drug substances list. This means 503B outsourcing facilities cannot lawfully compound standard formulations of these drugs.
Standard semaglutide compounding is not permitted as of 2026. The shortage-based exemptions have expired and the FDA has explicitly stated that 'essentially a copy' restrictions apply. Narrow exceptions may exist for individualized patient needs with specific physician documentation, but the FDA has indicated these exceptions are limited.
Under Section 503A of the FD&C Act, a compounding pharmacy cannot prepare a drug that is essentially a copy of a commercially available FDA-approved drug. In the GLP-1 context, this means compounded semaglutide that functions equivalently to Ozempic or Wegovy, and compounded tirzepatide that functions equivalently to Mounjaro or Zepbound, cannot be lawfully compounded under 503A without a specific documented patient justification.