GLP‑1 shortage and compounding status: semaglutide and tirzepatide

The Federal Food, Drug, and Cosmetic Act (FD&C Act) exempts compounded drugs from FDA approval only under two sections. Section 503A (21 U.S.C. § 353a) covers state-licensed pharmacies and physicians.[4] Section 503B (21 U.S.C. § 353b) covers outsourcing facilities.[5] Compounded drugs are not FDA-approved under either section.[6]

While an approved drug is on the FDA drug shortage list, both classes of compounder may make copies of it. Section 503B lets an outsourcing facility compound a drug that is essentially a copy of an approved drug only while that drug is on the list.[1][5] Section 503A limits copies of a “commercially available” drug. When a shortage is resolved, the FDA generally considers the drug commercially available again.[1][4]

The grace periods after each delisting were enforcement discretion, not a change in the law. The FDA said it did not intend to take action for violations that depend on the drug being on the shortage list until a set date: 60 calendar days for 503A and 90 calendar days for 503B. It later moved each date to the later of that date and the court ruling on a preliminary injunction.[1]

The FDA can still act during a grace period on other violations, for example a product of substandard quality.[1]

503A pharmacies. A pharmacy may compound semaglutide or tirzepatide for an individual patient, on a prescription. The FDA treats a compounded drug as essentially a copy when it has the same active ingredient in the same, similar or an easily substitutable strength, for the same route of administration. The exception: a prescriber determines and documents that the compounded drug has a change that produces a significant difference for an identified patient.[1]

The test applies to combination products too. The FDA gives the example of semaglutide with vitamin B12: it can be essentially a copy when both amounts are within 10% of the strengths of the commercially available products.[1]

The FDA states that, for now, it does not intend to act against a compounder for making copies “regularly or in inordinate amounts” if it fills four or fewer prescriptions of the copy in a calendar month.[1]

503B outsourcing facilities. A facility may compound from a bulk drug substance only if the substance is on the 503B bulks list, or if the drug is on the FDA drug shortage list at the time of compounding, distribution and dispensing. On April 1, 2026 the FDA confirmed that semaglutide and tirzepatide are on neither list.[1] On April 30, 2026 it proposed not to add semaglutide, tirzepatide or liraglutide to the bulks list, because it found no clinical need. The notice, 91 FR 23431, took comments to June 30, 2026.[7][8]

Since September 5, 2025, an FDA “green list” import alert applies to GLP-1 ingredients. Ingredients from facilities that are not on the list are subject to detention without physical examination.[9]

On February 6, 2026 the FDA said it intends to restrict GLP-1 ingredients for non-approved compounded drugs that are mass-marketed as alternatives to approved drugs. It said companies cannot claim that a compounded product is a generic, the same as an approved drug, uses the same active ingredient, or is clinically proven.[10]

On March 3, 2026 the FDA announced 30 warning letters to telehealth companies. The main violations were claims of sameness with approved products and branding that hid the source of the product.[11] The FDA lists the claims it considers false or misleading on its page for telehealth companies.[12]

We keep a database of FDA warning letters that name a GLP-1 and a list of telehealth programs with a warning letter, both built from the FDA warning letters database.[13]

This page tracks federal status for semaglutide and tirzepatide injection. It does not cover state law, which can be stricter. We read the shortage status from the FDA drug shortage database and the openFDA drug shortages data, and the compounding rules from the FDA’s own statements. Each date is the one the FDA states. We check every source again on each update.[2][3][1]

“Resolved” is a national status. The FDA says patients and prescribers may still see intermittent, localized supply disruptions.[1] This page is not legal advice.