FDA clarifies when compounded GLP-1 drugs count as copies of approved products
The FDA's April 1 statement defines when compounded GLP-1 products count as copies of approved drugs, a policy that affects which compounded versions pharmacies can keep making.
The FDA said on April 1, 2026 that a compounded drug is "essentially a copy" of a commercially available medicine when it has the same active ingredient at the same, similar or an easily substitutable strength and can be used by the same route of administration [1]. The agency added that it does not intend to take action against a section 503A compounder that fills four or fewer prescriptions for such a product in a calendar month [1].
Foley & Lardner, a law firm that follows compounding rules, said the statement marks the first time the FDA has expressly described what it considers compounding essentially a copy of an approved product "regularly or in inordinate amounts" [2]. The statement restates the conditions compounders must meet for exemptions under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act [1][2].
Under the FDA's test, a compounded product is treated as a copy unless a prescriber determines and documents that it contains a change that produces a significant difference from the approved product for an identified individual patient [1][2]. The agency did not say how much documentation a prescriber must create or keep, according to Foley [2].
The FDA gave an example using semaglutide, the active ingredient in Ozempic, Wegovy and Rybelsus. A compounded product that combines semaglutide with another ingredient, such as vitamin B12 (cyanocobalamin), may be considered essentially a copy when it is given the same way as the approved products, such as by injection, and when the amounts of semaglutide and vitamin B12 are within 10 percent of the strengths of the respective commercially available products [1][2].
Separately, the FDA reminded 503B outsourcing facilities that they may not compound with bulk drug substances unless the substance is on the 503B bulks list or the compounded drug is on the FDA's shortage list at the time it is compounded, distributed and dispensed [1]. Tirzepatide, sold as Mounjaro and Zepbound, and semaglutide do not currently appear on either list [1][2]. The FDA resolved the tirzepatide shortage on December 19, 2024, and the semaglutide injection shortage on February 21, 2025 [1].
Foley noted two limits on the April 1 statement. It is a clarification of FDA policy and does not have the force and effect of law [2]. And compounded drugs are not FDA approved, meaning the agency does not review their safety, effectiveness or quality before they are marketed; without an exemption, a compounded drug may be considered misbranded, which the firm said could lead to a warning letter, seizure or injunction [2].
Why it matters for patients
Compounded GLP-1 products are not FDA approved and are not reviewed by the agency for safety, effectiveness or quality before marketing [2]. The April 1 statement tells compounders and prescribers how the FDA decides whether a compounded semaglutide or tirzepatide product is close enough to an approved one to fall outside the compounding exemptions [1][2].
The four-prescription figure is a limit on when the FDA intends to exercise enforcement discretion, not a legal permission: it applies per compounded drug product, per calendar month, and only to 503A compounders [1][2]. It is not clear from the statement how the agency would learn how many prescriptions a given pharmacy fills [1][2].
Because semaglutide and tirzepatide have been off the FDA shortage list since early 2025 and are not on the 503B bulks list, the FDA's stated position is that compounded versions of these drugs no longer qualify for the shortage-based exemptions that applied during 2024 and early 2025 [1][2]. Patients who receive a compounded GLP-1 can ask their prescriber or pharmacist which active ingredient, strength and route the product uses, since those are the factors the FDA says it examines [1].
What happens next
The statement is dated April 1, 2026 [1]. No further FDA deadlines for compounders were announced in it [1]. It has not been reported whether the agency will issue formal guidance on the prescriber documentation standard for products that are not copies [2].
Sources
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