FDA proposes keeping semaglutide, tirzepatide and liraglutide off the 503B bulks list

FDA said it was proposing to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, "finding no clinical need" for outsourcing facilities to compound these drugs from bulk substances ^[1]. The formal notice appeared in the Federal Register on 1 May 2026 under docket FDA-2018-N-3240 ^[2].

The 503B bulks list covers outsourcing facilities, the larger compounders registered with FDA under section 503B. In most cases these facilities may compound from a bulk drug substance only if the substance is on the 503B list, or if the finished drug is on FDA's drug shortage list at the time of compounding, distribution and dispensing ^[1][2].

FDA Commissioner Marty Makary said that when FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances "unless there is a clear clinical need" ^[1]. For semaglutide news and tirzepatide news readers, the short version is that FDA has proposed closing the bulk-ingredient route for outsourcing facilities for both drugs.

The notice sets two threshold questions for substances that are already in approved drugs. First, whether some attribute of every approved product makes it medically unsuitable for certain patients, and whether the compounded product would address that attribute. Second, whether the compounded product must be made from a bulk substance rather than from an approved product ^[2]. FDA said it did not answer yes to both questions for any of the three substances, so it did not go on to its wider balancing factors ^[2].

FDA also set out what does not count as clinical need. It does not treat supply problems such as shortages or backorders as clinical need, noting that section 503B has a separate shortage route. Nor does it count convenience or the lower cost of a compounded product ^[2].

The nominations had asked for semaglutide injections without propylene glycol, sublingual and buccal forms, and combinations with pyridoxine or an antiemetic. FDA said the data did not suggest a propylene glycol-free formulation would reduce the skin irritation linked to injected therapies, and that the nominations did not explain why patients could not use an approved semaglutide product alongside a separate approved pyridoxine or antiemetic product ^[2].

Yes. The notice lists the approved products FDA took into account: tirzepatide as Mounjaro and Zepbound, semaglutide as Ozempic, Wegovy, Wegovy HD and Rybelsus, and liraglutide as Victoza and Saxenda, among others ^[2]. Our guide to GLP-1 brand names maps each brand to its active ingredient, and the tirzepatide vs semaglutide comparison covers how the two drugs differ.

That approval status is the reason the proposal matters. Because approved products exist and are no longer in shortage, the 503B bulks list is one of the few remaining routes for large-scale compounding from bulk ingredient. FDA's compounding update of 1 April 2026 says tirzepatide and semaglutide do not currently appear on either the 503B bulks list or FDA's drug shortage list ^[4]. FDA declared the tirzepatide injection shortage resolved on 19 December 2024 and the semaglutide injection shortage resolved on 21 February 2025 ^[4].

FDA's press release asked for comments by 29 June 2026 ^[1], while the Federal Register notice gave a deadline of 30 June 2026 ^[2]. On 26 June 2026 FDA published a further notice extending the comment period to 30 July 2026, in response to a request for more time ^[3].

After the comment period, the notice says FDA may finalise its proposal unchanged or modify it in light of new evidence, and will publish a final determination in the Federal Register with its reasons ^[2]. We have not found a final determination on these three substances as of 24 September 2026. Once a final determination is published, FDA says it will stop considering docket comments on that substance, although interested parties can still file a citizen petition ^[2].

The proposal is about outsourcing facilities compounding from bulk ingredient. It does not change the approval status of Ozempic, Wegovy, Mounjaro or Zepbound, and it is not a rule about 503A pharmacies, which work under different conditions, including limits on making essentially copies of commercially available drugs ^[4].

It also has nothing to do with products sold online as research chemicals. FDA's separate warnings about semaglutide and tirzepatide labelled "for research purposes" are a different enforcement issue. The US legal status guide summarises the federal rules, and the semaglutide price comparison and tirzepatide price comparison pages track listed prices without any view on whether a given product is lawful. We will update this report when FDA publishes a final determination.