Peptides
The Ozempic "not withdrawn" finding is about generics, not compounding
On 30 April 2026 the FDA determined that OZEMPIC (semaglutide) solution, 2 mg/1.5 mL, was not withdrawn from sale for reasons of safety or effectiveness (Docket FDA-2025-P-3849). The determination governs whether abbreviated new drug applications referring to that product may be approved. It is not a decision about compounding.
The finding is made under 21 CFR 314.161. A drug is removed from the Orange Book list if the FDA withdraws or suspends approval for reasons of safety or effectiveness, or determines that a listed drug was withdrawn from sale for those reasons. That determination has to be made before the agency may approve an abbreviated new drug application referring to the listed drug.
The 2 mg/1.5 mL presentation is the subject of NDA 209637, held by Novo Nordisk and first approved on 5 December 2017, and it currently sits in the Discontinued Drug Product List section of the Orange Book. A citizen petition dated 15 September 2025 asked the agency to determine whether it had been withdrawn for safety or effectiveness reasons.
The FDA reviewed its files and the literature, found nothing indicating a safety or effectiveness withdrawal, and will continue to list the product in the Discontinued Drug Product List — the section covering products discontinued for reasons other than safety or effectiveness. Abbreviated new drug applications referring to it may be approved provided they meet the other requirements.
It is worth being clear about what this document does not do, because the subject matter invites the assumption. It does not place semaglutide on any bulk drug substances list, it does not address section 503A or section 503B compounding, and it does not speak to the shortage list. Those are separate determinations under separate provisions.
What changed
The FDA has recorded that this presentation of Ozempic was not withdrawn for safety or effectiveness reasons, which keeps the path to generic approval open.
What did not change
Anything about compounding. This determination is made under 21 CFR 314.161 for the purposes of abbreviated new drug applications, and it decides nothing under section 503A or 503B.
Who this reaches
Nobody urgently. It is included here because the question it answers is adjacent to one many operators are actually asking, and conflating the two leads to the wrong conclusion about what may be compounded.
Common questions
Does this mean compounded semaglutide is permitted?
No. The determination is made under 21 CFR 314.161 and decides whether abbreviated new drug applications referring to this product may be approved. Compounding is governed by sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, and this document does not address either.
What is the Discontinued Drug Product List?
A section of the Orange Book that covers, among other things, drug products discontinued from marketing for reasons other than safety or effectiveness. Remaining on it, rather than being removed from the list altogether, is what keeps a product available as a reference listed drug for generic applicants.
Does this reach your business?
Every matter turns on its facts. Mr. Sheehan reviews each inquiry himself.