FDA sets out compounding limits for semaglutide and tirzepatide

The FDA published an update on April 1 setting out the conditions a compounder must meet to keep making semaglutide and tirzepatide now that neither drug is in shortage. Two numbers carry the document: four or fewer prescriptions of a given compounded product per calendar month for a state-licensed pharmacy, and zero listings for either drug on the two lists that let outsourcing facilities work from bulk substance.

What happened

FDA added the update to its running GLP-1 compounding statement, FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize, on April 1, 2026. The opening line is a reminder, not a new rule: FDA "reminds compounders certain conditions must be met for compounded drugs to qualify for the exemptions under sections 503A and 503B of the FD&C Act." Reuters reported the same day, in wire copy we read on WHTC, that the agency was "signaling tighter limits on their production as national supply conditions improve."

Section 503A covers state-licensed pharmacies and physicians. The update highlights two conditions. The product must be "compounded for an individual patient based on receipt of a prescription." And the compounder must not compound, "regularly or in inordinate amounts," products that are essentially copies of a commercially available drug. FDA's test for a copy, restated from its 2018 guidance, has two limbs: the same active pharmaceutical ingredient "in the same, similar or an easily substitutable strength," and a commercially available product that "can be used by the same route of administration (regardless of how it is labeled)." The exception is narrow — a prescriber has to determine and document that the compounded product "contains a change that produces a significant difference" for an identified individual patient.

Then the sentence the rest of the market will be read against. FDA states that "at this time, it does not intend to take action against a compounder for compounding a drug product that is essentially a copy of a commercially available drug product regularly or in inordinate amounts if the compounder fills four or fewer prescriptions of that compounded drug product during a calendar month." Read literally, that counts prescriptions of one compounded product, filled by one compounder, inside one calendar month. It is a statement of enforcement intent, not permission: the same page repeats that FDA "may still take action regarding violations of any other statutory or regulatory requirements."

Combination products get their own worked example, and it names semaglutide. FDA says it may treat a compounded product combining "semaglutide API and another API, such as vitamin B12 (cyanocobalamin)" as essentially a copy when the products share a route of administration and the amounts of each ingredient sit "within 10% of the strengths of the respective commercially available drug products."

Section 503B covers outsourcing facilities, and there the test is a list check. Facilities may not compound from bulk drug substance unless the substance is on the 503B bulks list or the finished drug is on FDA's drug shortage list "at the time of compounding, distribution and dispensing." FDA's flat statement: "Tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA's drug shortage list." The bulks list itself, last updated August 21, 2023, holds five substances — diphenylcyclopropenone, glycolic acid, quinacrine HCl, squaric acid dibutyl ester and trichloroacetic acid. Neither GLP-1 is among them.

Four dates from 2025 set when the shortage cover lapsed, and they differ by facility type. For tirzepatide, FDA determined the injection shortage resolved on December 19, 2024; enforcement discretion ran 60 days for 503A pharmacies, "until February 18, 2025," and 90 days for 503B facilities, "until March 19, 2025." For semaglutide, FDA determined the shortage resolved on February 21, 2025; the equivalent dates are "until April 22, 2025" for 503A and "until May 22, 2025" for 503B. All four dates carry a condition. FDA attached "or until the date of the district court's decision" in Outsourcing Facilities Association v. FDA (N.D. Tex.) to each of them, whichever ran longer. The court denied the tirzepatide motion on March 5, 2025 and the semaglutide motion on April 24, 2025, so the court date is the operative end for both 503A periods, tirzepatide running to March 5 rather than February 18 and semaglutide to April 24 rather than April 22, while for 503B the later stated dates of March 19 and May 22 govern. FDA's updates of March 10 and April 28 each confirmed the 503A period "has ended." Attaching a 503B date to a 503A pharmacy, or the reverse, gets the answer wrong by a month.

Why it matters

What the FDA document does not show is which of the programs our readers compare are selling these compounded products, and what each one charges. That is the gap between this document and a patient's monthly bill. The rules bind the pharmacy that compounds; the platform that markets the program is usually neither a 503A pharmacy nor a 503B facility, which is why no single brand is the subject of this story and why the effect is spread across the whole weight loss category.

Compounded semaglutide is not a fringe product on that shelf. Here is what our price database holds for the programs our readers compare most:

Put the two tables next to each other and the FDA document becomes a price point. Each compounded row above is a compounded version of a molecule that, on FDA's own statement, sits on neither the 503B bulks list nor the shortage list, the two listings that had carried the shortage exemption until it lapsed in 2025. Our semaglutide cost guide and tirzepatide cost guide track the compounded and branded rows separately for exactly this reason.

In our view the operative question for a buyer is no longer "is this cheaper" but "what is this program's supply arrangement, and does it survive contact with the four-prescription line." One answer has already played out: Hims & Hers stopped advertising compounded GLP-1s on March 9 and moved to branded Novo Nordisk products, without publishing a replacement price. Programs whose pricing depends on compounding are the ones to watch in our price tracker.

What this means for patients

• Ask your program which pharmacy compounds your medication, and whether it is a state-licensed 503A pharmacy or a 503B outsourcing facility. FDA sets different conditions for each, and the answer decides which half of the April 1 page applies to you.
• Nothing in this update requires your program to stop today. It restates conditions that have applied since FDA determined the tirzepatide shortage resolved in December 2024 and the semaglutide shortage resolved in February 2025.
• Compounded products are not FDA-approved products. FDA's page states plainly that "compounded drugs are not approved by FDA" and do not go through the premarket approval process. That is a statement about regulatory status, not about any particular product.
• If your program sells semaglutide combined with another ingredient such as vitamin B12, note that FDA uses that exact pairing as its worked example of a combination it may still treat as a copy.
• Ask in writing what happens to your price and your shipments if your program changes pharmacy or switches you to a branded product. Our true cost calculator puts medication and membership into one monthly number.
• Nothing here is a reason to change your treatment. Questions about your prescription go to your prescriber.