Quick answer: the FDA peptide compounding crackdown is a series of actions from 2023 to 2026, not a single rule. FDA placed more than a dozen peptides in its Category 2 “significant safety risk” group in 2023, ended the GLP-1 shortages that had allowed mass compounding of tirzepatide (December 19, 2024) and semaglutide (February 21, 2025), won every round of the resulting lawsuits, and sent waves of warning letters in September 2025, March 2026 and August 2026.[1][3][4][5] At the same time, in April 2026 it removed 12 peptides from Category 2, so the picture is mixed.
This guide walks through each type of enforcement. For the policy reversal on BPC-157 and others, see FDA peptide ban 2026. For exact dates in one table, see our FDA peptide regulation timeline, and for the broader topic, the FDA & Regulation hub.
Why FDA regulates compounded peptides
Compounding means a pharmacy mixes a drug for a patient. Under section 503A of the FD&C Act, a state-licensed pharmacy is exempt from new drug approval, labeling and manufacturing rules only if it meets set conditions, including using permitted bulk ingredients. Section 503B outsourcing facilities follow manufacturing-quality rules but face their own limits on bulk ingredients.[2] Our 503A vs 503B compounding guide explains the difference.
Compounded drugs are not FDA-approved, which means FDA does not review them for safety, effectiveness or quality before they are sold.[8]
1. Category 2 placements (2023)
In 2023, FDA placed a group of nominated peptides into Category 2 of its interim 503A policy. Its public safety page cites risks such as immune reactions, peptide-related impurities and a lack of human safety data. Substances like GHRP-2, GHRP-6, kisspeptin-10 and ibutamoren (MK-677) carry a placement date of September 29, 2023.[1] FDA does not extend enforcement discretion to compounding with Category 2 substances. Popular peptides such as BPC-157, TB-500 and thymosin alpha-1 were also caught up in this period; their nominations were later withdrawn.[1]
2. Ending the GLP-1 shortages (2024–2025)
While a drug is on FDA’s shortage list, compounders can make copies that would otherwise be barred. When the shortages of tirzepatide and semaglutide ended, so did that allowance.
| Drug | Shortage resolved | 503A grace period | 503B grace period |
|---|---|---|---|
| Tirzepatide | Oct 2, 2024; re-confirmed Dec 19, 2024 | Feb 18, 2025, extended until the court ruled on March 5, 2025 | March 19, 2025 |
| Semaglutide | Feb 21, 2025 | April 22, 2025, extended until the court ruled on April 24, 2025 | May 22, 2025 |
Sources: FDA’s tirzepatide memorandum, semaglutide declaratory order and compounding policy updates.[2][3][4]
On April 30, 2026, FDA went further and proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound them from bulk powder. Comments closed June 29, 2026; a final decision was pending when we checked.[10]
FDA has also tracked harms. As of May 31, 2026, it had received 990 adverse event reports linked to compounded semaglutide and more than 730 linked to compounded tirzepatide.[11] These reports do not prove the drug caused each event. More detail is in compounded tirzepatide and compounded semaglutide vs Ozempic.
3. The court cases: OFA v. FDA
The Outsourcing Facilities Association (OFA), a compounders’ trade group, sued FDA in the Northern District of Texas over both shortage decisions.
- Tirzepatide (No. 4:24-cv-00953): preliminary injunction denied March 5, 2025.[2]
- Semaglutide (No. 4:25-cv-00174): preliminary injunction denied April 24, 2025.[2]
- Appeals: on August 27, 2026, the Fifth Circuit affirmed in both cases. It held that any error in skipping notice-and-comment procedures under the Administrative Procedure Act was harmless and that FDA’s decisions were not arbitrary or capricious.[5]
4. Warning letters and advertising actions
Warning letters are public notices that FDA believes a company is breaking the law. They are not court findings, but they can lead to seizures or injunctions.
| Date | Target | What FDA alleged |
|---|---|---|
| Sept 9, 2025 | Drug advertisers broadly, plus compounded GLP-1 sellers | FDA announced about 100 cease-and-desist letters and thousands of letters on misleading ads |
| Feb 6, 2026 | Mass-marketed compounded GLP-1s | Intent to restrict GLP-1 ingredients for non-approved copies and to act on “generic” or “same as” claims |
| March 3, 2026 | 30 telehealth companies | False or misleading claims that compounded GLP-1s are the same as approved drugs |
| Aug 24, 2026 | 5 online “research” peptide sellers | Selling unapproved new drugs under FD&C Act sections 201(g)(1), 301(d) and 505(a) |
Sources: FDA press releases and warning letters.[6][7][8][12][13]
The August 2026 letters went to Peak Performance Peptides, Royal Peptides LLC, NuScience Peptides LLC, Peptide Partners LLC and TXP Innovations LLC. FDA found that “research use only” disclaimers did not change the products’ intended use, citing dosing guidance, calculators and bacteriostatic water sold alongside peptides such as tesamorelin, retatrutide and SS-31.[12][13] See research use only peptides for more.
5. Import alert 66-80 and the GLP-1 green list
FDA’s Import Alert 66-80 lets border staff detain GLP-1 active ingredients without physical examination unless the maker is on FDA’s “green list.” It covers semaglutide, tirzepatide, liraglutide, exenatide, dulaglutide, lixisenatide and orforglipron, among others. FDA’s current posting is dated October 9, 2026, and describes a major revision following a March 19, 2026 CDER memo.[9] FDA has said the alert does not stop legal imports from compliant manufacturers.[11]
What happens after a warning letter
A warning letter starts a process rather than ending one. Each of the August 2026 letters gave the company 15 business days to respond with the steps it had taken to fix the violations. FDA warned that failing to do so could lead to legal action without further notice, including seizure of products and a court injunction.[12][13] FDA’s February 2026 statement on compounded GLP-1s used similar language, saying it would use all available compliance and enforcement tools.[7]
Import detention works differently. Under Import Alert 66-80, a shipment of GLP-1 ingredient from a firm not on the green list can be held at the border, and the importer must show the product meets U.S. requirements before it is released.[9]
What it means for patients
If you use a compounded GLP-1 or peptide, ask your prescriber how the pharmacy is licensed, whether the product is patient-specific, and where the ingredient comes from. Our peptide import laws and FDA warning letters on peptides guides go deeper.
This is general information, not legal advice. FDA policies in this area changed several times in 2025 and 2026; check FDA’s compounding pages for current status.
