US peptide policy, dated, from 2019 to October 2026
The rules on compounded peptides have moved in steps: a list created by rule, an interim policy, a safety category, withdrawals, committee votes and a rulemaking that has not yet started. Here is each step in order.
Most of what changes the legal status of a peptide in the United States happens in documents few people read: the Federal Register, FDA briefing packages and committee minutes. This page lists those steps in date order, with the source for each. It covers the 503A bulk drug substances list (the list that decides what a compounding pharmacy may build a preparation from), FDA's interim "category" system, the Pharmacy Compounding Advisory Committee (PCAC), the GLP-1 shortages, and enforcement. The policy hub links the deeper pages on each strand.
The timeline
| Date | What happened |
|---|---|
| 19 Feb 2019 | FDA final rule creates the 503A bulks list (84 FR 4696). Four criteria and a balancing test. Six substances placed on the list; four (oxitriptan, piracetam, silver protein mild, tranilast) not included. None of the six is a peptide. |
| 5 Sep 2019 | Proposed rule would add five more substances and decline 26 (84 FR 46688). |
| Mar to Dec 2022 | Semaglutide and tirzepatide products go on FDA's drug shortage list, which lets compounders make copies. Detail on the GLP-1 compounding policy page. |
| Sep 2023 | FDA places a group of peptides in Category 2 of its 503A interim policy, "bulk drug substances that raise significant safety risks". FDA's own table dates several entries (GHRP-2, GHRP-6, ipamorelin under 503B, kisspeptin-10) to 29 September 2023. |
| 7 Dec 2023 | FDA issues a revised draft of its 503A interim policy guidance. |
| Late Sep 2024 | FDA updates its categories after several nominators withdraw peptide nominations. It keeps some of the withdrawn substances on the PCAC agenda anyway. |
| 29 Oct 2024 | PCAC votes against ipamorelin (0 to 12, 1 abstention), kisspeptin-10 (0 to 11), ibutamoren (1 to 13) and L-theanine (1 to 12). |
| 4 Dec 2024 | PCAC votes against CJC-1295 in all five forms (0 to 13, or 1 to 12 for the acetate), AOD-9604 (0 to 12) and thymosin alpha-1 (4 to 17). |
| 19 Dec 2024 | FDA declaratory order: the tirzepatide injection shortage is resolved. |
| 7 Jan 2025 | Final 503A interim policy guidance published (90 FR 1136), replacing the 2017 version. |
| 21 Feb 2025 | FDA declares the semaglutide injection shortage resolved. Grace periods end 22 April (503A) and 22 May 2025 (503B). |
| 30 Jul 2025 | Sen. Tommy Tuberville writes to HHS about peptide compounding, as cited in a later House letter. |
| 9 Sep 2025 | FDA announces a crackdown on deceptive drug advertising: "thousands" of letters and about 100 cease-and-desist letters. |
| 10 Nov 2025 | Rep. Diana Harshbarger asks Secretary Kennedy to have FDA use enforcement discretion for six peptides, including BPC-157 and TB-500. |
| 23 Dec 2025 | FDA Commissioner Marty Makary, on a podcast, says "If a therapy has good data, we'd like to see it." |
| 6 Feb 2026 | FDA says it will take "decisive steps to restrict GLP-1" ingredients used in mass-marketed compounded drugs. |
| 27 Feb 2026 | Secretary Kennedy on The Joe Rogan Experience: "I'm a big fan of peptides." |
| 1 Apr 2026 | FDA clarifies its compliance policy for compounded GLP-1 copies, including a four-prescriptions-a-month threshold for 503A pharmacies. |
| 15 Apr 2026 | FDA announces it will remove 12 peptides from Category 2 after their nominators withdrew, and schedules PCAC review: seven in July 2026, the rest before the end of February 2027. |
| 16 Apr 2026 | Federal Register notice of the July PCAC meeting (91 FR 20465). |
| 30 Apr 2026 | PCAC charter renewed to 25 April 2028. |
| 1 May 2026 | FDA proposes not to put semaglutide, tirzepatide or liraglutide on the 503B bulks list (91 FR 23431). Comments later extended to 30 July 2026. |
| 12 May 2026 | Makary resigns as FDA commissioner. Kyle Diamantas becomes acting commissioner. |
| 14 May 2026 | FDA updates its category lists. GHK-Cu for non-injectable routes returns to Category 1. Kisspeptin-10 is the one peptide left in 503A Category 2. |
| 29 Jun 2026 | FDA releases the July meeting roster, with several new members. |
| 22 Jul 2026 | House passes the FY2027 defense bill (216 to 212) with a section barring the Pentagon from listing "legally available peptides" as prohibited supplements. |
| 23 to 24 Jul 2026 | PCAC recommends six of seven peptides for the 503A list against FDA staff advice. Emideltide (DSIP) is not recommended. |
| 1 Aug 2026 | Louisiana Act 374 takes effect, limiting what state licensing boards may do to restrict peptide prescribing and compounding. |
| 24 Aug 2026 | FDA warning letters to online sellers of "research use only" peptides, including Peak Performance Peptides. |
| 1 Sep 2026 | Rep. Nancy Mace introduces the PEPTIDES for Veterans Act (H.R. 10212). |
| 21 Sep 2026 | WADA publishes the 2027 Prohibited List, adding the word "peptides" to its non-approved substances class. GLP-1 drugs stay permitted. |
| 15 Oct 2026 | No proposed rule adding any peptide to the 503A list has been published in the Federal Register. |
Three patterns in the record
FDA staff and the committee have not always agreed. In 2024 the committee sided with FDA's reviewers on every peptide put to it, usually by wide margins. In July 2026 a committee with several new members voted the other way on six of seven, by one or two votes. The members and votes page sets the two years side by side.
Withdrawal is not approval. The 2024 and 2026 changes to Category 2 both followed nominators withdrawing their nominations. Leaving Category 2 does not put a substance on the 503A list or in Category 1. Law firms advising pharmacies described the 12 peptides removed in April 2026 as being in a "regulatory gray area" until FDA acts. The Category 2 page has the substance-by-substance status.
GLP-1 policy ran on a separate track. Compounded semaglutide and tirzepatide were legal because of a shortage, not because of the bulks list. When the shortages ended, so did the broad permission. That story is on the FDA and compounded GLP-1s page and, in more legal detail, on GLP-1 compounding policy.
What has not happened yet
As of 15 October 2026, FDA has not published a proposed rule on any of the six peptides the committee recommended in July. Under the 2019 rule, a substance joins the 503A list only through notice-and-comment rulemaking. The minutes and transcript of the July meeting were not yet posted on the FDA meeting page when this was written. A second meeting, on the five remaining peptides from the April list, is due before the end of February 2027. Our earlier piece on what the July vote means covers the practical position for pharmacies.
Who said what
The political record is on separate pages: Secretary Kennedy's statements, Commissioner Makary and his successors, Congress, the states, enforcement and sport. Each quotes people in their own words with the date and source, and leaves the reader to weigh them.
Rules change faster than most people's records. If you are on a prescribed peptide, the dose log keeps each dose with the product, the pharmacy and the concentration, and bloodwork sits on the same timeline, so a change of product or source is easier to plan with your prescriber. The peptide library grades how much research exists behind each compound, and that grading does not move when a committee votes. The app is on iOS and Android.
Questions people ask
When did FDA restrict compounded peptides?
In September 2023 FDA placed a group of peptides, including BPC-157, in Category 2 of its 503A interim policy, which covers substances FDA says raise significant safety risks. Pharmacies are not expected to compound from Category 2 substances.
When did peptides come off Category 2?
Some in late 2024 and twelve more announced on 15 April 2026, in each case after the nominators withdrew their nominations. Removal does not place a substance on the 503A list.
What did the July 2026 committee decide?
On 23 and 24 July 2026 the PCAC recommended BPC-157, KPV, TB-500, MOTS-c, semax and epitalon for the 503A list and did not recommend emideltide. FDA staff had recommended against all seven. The votes are advisory.
Has FDA added any peptide to the 503A list?
No. As of 15 October 2026 no proposed or final rule adding a peptide to the 503A list had been published in the Federal Register.
When is the next peptide committee meeting?
FDA has said it will consult the committee on the remaining peptides from its April 2026 list, including GHK-Cu, before the end of February 2027.
Sources
- List of bulk drug substances that can be used to compound drug products under section 503A (84 FR 4696), Federal Register, 19 February 2019
- Certain bulk drug substances for use in compounding that may present significant safety risks, U.S. Food and Drug Administration, content current as of 22 April 2026
- Final summary minutes, Pharmacy Compounding Advisory Committee, October 29, 2024, U.S. Food and Drug Administration, approved 15 January 2025
- Final summary minutes, Pharmacy Compounding Advisory Committee, December 4, 2024, U.S. Food and Drug Administration, approved 21 February 2025
- FDA announces removal of 12 peptides from Category 2 and schedules PCAC meetings, Orrick, 16 April 2026
- Pharmacy Compounding Advisory Committee; notice of meeting (91 FR 20465), Federal Register, 16 April 2026
- Bulk drug substances nominated for use in compounding under section 503A (categories 1, 2 and 3), U.S. Food and Drug Administration, updated 14 May 2026
- Bulk-list bound? PCAC backs majority of peptides in two-day public meeting, McDermott Will and Schulte, 27 July 2026
- List of bulk drug substances for which there is a clinical need under section 503B (91 FR 23431), Federal Register, 1 May 2026
- H.R. 8800, National Defense Authorization Act for Fiscal Year 2027, engrossed in House, Congress.gov
- WADA publishes 2027 Prohibited List, World Anti-Doping Agency, 21 September 2026
- SB 253 (Act 374), 2026 Regular Session: provides relative to peptides, Louisiana State Legislature
