Quick answer: the FDA peptide regulation timeline for 2025 and 2026 runs from the semaglutide shortage ending on February 21, 2025, through a wave of GLP-1 warning letters, to the April 15, 2026 removal of 12 peptides from Category 2 and the July 23–24, 2026 advisory committee votes recommending six peptides for compounding.[3][11][14] No compounded wellness peptide has been added to the 503A bulks list as of October 2026.
Use the table below as a reference. For context on what each event means, see FDA peptide ban 2026, the FDA peptide compounding crackdown, and the longer history of peptide regulation. All of our regulatory guides live in the FDA & Regulation hub.
How to read this timeline
- Who acted: most entries are FDA actions. Court rulings and statements by the Department of Health and Human Services (HHS) are labeled as such.
- Effective vs announced: where FDA announced a change that took effect later, both dates are given.
- Verified: each date was checked against FDA, Federal Register, Drugs@FDA or court documents where possible. Where we relied on a law firm or news report, the citation shows it.
Key terms used in this timeline
A few terms appear again and again in FDA’s peptide notices. Knowing them makes the dates easier to follow.
- Section 503A pharmacy: a state-licensed pharmacy that compounds drugs for individual patients with a prescription. It may use a bulk ingredient only if the ingredient has a USP monograph, is part of an FDA-approved drug, or is on FDA’s 503A bulks list.[10]
- Section 503B outsourcing facility: a larger compounder registered with FDA that follows manufacturing-quality rules and can make batches without individual prescriptions, but has its own list of allowed bulk ingredients.
- Categories 1, 2 and 3: while FDA reviews nominations for the 503A bulks list, it sorts them into Category 1 (under evaluation, generally tolerated), Category 2 (significant safety risks) and Category 3 (nominated without enough support).[1]
- Pharmacy Compounding Advisory Committee (PCAC): outside experts who vote on whether a substance should be added to the bulks list. Their votes are advice; FDA makes the final call through rulemaking.
- Drug shortage list: while an approved drug is on it, compounders can make copies that are otherwise restricted. When FDA declares a shortage resolved, it usually gives a short grace period before enforcing again.[3]
- Warning letter: a public FDA letter saying a company appears to be breaking the law. It is not a court ruling, but ignoring it can lead to seizure or an injunction.
Three threads running through 2025 and 2026
Most of the events below belong to one of three separate stories. They move at different speeds and sometimes in opposite directions.
1. Winding down compounded GLP-1 copies. When tirzepatide and semaglutide came off the shortage list, FDA gave 503A pharmacies about 60 days and 503B facilities about 90 days to stop making essentially copies. The Outsourcing Facilities Association sued and lost at every stage, ending with the Fifth Circuit’s ruling on August 27, 2026.[2][16] In April 2026, FDA also proposed keeping these GLP-1 ingredients off the 503B bulks list for good.[13]
2. Reconsidering “wellness” peptides. In 2023 FDA placed many popular peptides in Category 2. In 2026 the direction changed: 12 peptides left Category 2 in April after their nominations were withdrawn, and in July the PCAC recommended six of seven reviewed peptides for the bulks list, against the advice of FDA’s own reviewers.[11][14] None of these steps is drug approval.
3. Enforcement against sellers and advertisers. FDA’s September 2025 advertising crackdown, the February and March 2026 actions on GLP-1 marketing claims, the GLP-1 import alert and the August 2026 letters to “research use only” peptide sellers all target how products are sourced and sold, rather than which ingredients pharmacies may use.[4][9][15]
Background: late 2024
| Date | Action |
|---|---|
| Oct 2, 2024 | FDA declares the tirzepatide shortage resolved; later sent back for re-evaluation in litigation.[2] |
| Dec 4, 2024 | Pharmacy Compounding Advisory Committee (PCAC) votes against adding thymosin alpha-1 (4–17), AOD-9604 and CJC-1295 to the 503A bulks list. See thymosin alpha-1.[18] |
| Dec 19, 2024 | FDA re-confirms the tirzepatide shortage is resolved.[2] |
2025 timeline
| Date | Action |
|---|---|
| Jan 7, 2025 | FDA finalizes its interim policy on 503A bulk drug substances, which sorts nominations into Categories 1, 2 and 3.[1] |
| Feb 21, 2025 | FDA declares the semaglutide injection shortage resolved; 503A grace to April 22, 503B to May 22, 2025.[3] |
| Mar 5, 2025 | Court denies the Outsourcing Facilities Association (OFA) preliminary injunction on tirzepatide; FDA’s 503A enforcement discretion for tirzepatide ends.[2] |
| Mar 19, 2025 | 503B grace period for tirzepatide ends.[2] |
| Apr 24, 2025 | Court denies OFA’s preliminary injunction on semaglutide; 503A discretion ends.[2] |
| May 22, 2025 | 503B grace period for semaglutide ends.[2] |
| Sept 2025 | FDA launches the GLP-1 “green list” and Import Alert 66-80 for GLP-1 ingredients. Sources give Sept 5 or Sept 19, 2025 as the start date.[5] |
| Sept 9, 2025 | FDA announces a crackdown on deceptive drug ads, with about 100 cease-and-desist letters and thousands of warning letters; compounded GLP-1 sellers are among those warned.[4] |
| Sept 19, 2025 | FDA approves elamipretide (Forzinity), a mitochondria-targeting peptide. See SS-31.[6] |
| Dec 22, 2025 | FDA approves Wegovy tablets, a new oral dosage form of semaglutide (1.5 mg to 25 mg).[7] |
2026 timeline
| Date | Action |
|---|---|
| Feb 6, 2026 | FDA says it will restrict GLP-1 ingredients used in mass-marketed, non-approved copies and act on “generic” or “same as” marketing claims.[8] |
| Feb 27, 2026 | HHS Secretary Robert F. Kennedy Jr. says publicly that about 14 restricted peptides should become accessible. This was a statement, not an FDA action.[19] |
| Mar 3, 2026 | FDA sends warning letters to 30 telehealth companies over misleading compounded GLP-1 claims.[9] |
| Apr 1, 2026 | FDA approves Foundayo (orforglipron), an oral GLP-1 drug. It is a small molecule, not a peptide. See orforglipron.[17] |
| Apr 15, 2026 | FDA announces removal of 12 peptides from Category 2 after nominators withdrew them, including BPC-157, TB-500 and Semax.[11] |
| Apr 16, 2026 | Federal Register notice schedules PCAC review of seven peptides for July 23–24, 2026 (docket FDA-2025-N-6895).[10] |
| ~Apr 22, 2026 | Category 2 removals take effect. Non-injectable GHK-Cu is removed from Category 1 the same day.[11][12] |
| Apr 30, 2026 | FDA proposes excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list; comments due June 29, 2026.[13] |
| May 14, 2026 | FDA’s updated 503A list says non-injectable GHK-Cu will return to Category 1 after a nominator clarified its withdrawal.[12] |
| Jul 23, 2026 | PCAC recommends BPC-157, KPV, TB-500 and MOTS-c for the 503A bulks list.[14] |
| Jul 24, 2026 | PCAC recommends Semax and epitalon; votes against emideltide (DSIP).[14] |
| Aug 24, 2026 | FDA warning letters to five online “research use only” peptide sellers for selling unapproved new drugs.[15] |
| Aug 27, 2026 | Fifth Circuit affirms FDA’s tirzepatide and semaglutide shortage decisions in OFA v. FDA.[16] |
| Oct 9, 2026 | FDA posts a major revision of Import Alert 66-80.[5] |
| By end of Feb 2027 | Planned PCAC review of LL-37, Dihexa, injectable GHK-Cu, PEG-MGF and Melanotan II.[11] |
How a peptide would reach the 503A bulks list
The July 2026 votes were one step in a longer process. Based on FDA’s notices, the path for any nominated peptide looks like this:
- Nomination. A pharmacy group or other party nominates the substance with supporting data.
- Interim category. FDA places it in Category 1, 2 or 3 while it evaluates.[1]
- FDA review. FDA staff assess the chemistry, safety, effectiveness and historical use for specific conditions. For the July 2026 meeting, FDA reviewed one or a few uses per peptide, such as ulcerative colitis for BPC-157 and insomnia for epitalon.[10]
- Advisory committee vote. The PCAC hears FDA, the nominator and the public, then votes.
- Proposed rule. If FDA agrees, it publishes a proposed rule in the Federal Register and takes public comments.
- Final rule. Only after a final rule is the substance on the 503A bulks list.
As of October 2026, the six peptides recommended in July had completed step 4. FDA had not published a proposed rule for any of them.
What is still pending
As of October 18, 2026:
- July 2026 recommendations: FDA must decide whether to propose a rule adding any of the six peptides to the 503A bulks list. A proposed rule would open a public comment period first.
- 503B GLP-1 exclusion: FDA proposed it in April 2026 and had not announced a final decision when we checked.[13]
- Remaining five peptides: PCAC review is planned before the end of February 2027.[11]
- Still in Category 2: kisspeptin-10 and ibutamoren (MK-677) remain in 503A Category 2 on FDA’s May 14, 2026 list.[12]
For what this means for individual compounds, see BPC-157 legal status and 503A vs 503B compounding.
This is general information, not legal advice. We update this timeline as FDA posts new notices.
