Regulation tracker

A dated record of the federal actions shaping peptide and GLP-1 access in the United States. Newest first. Every entry links to where we read it.

Coming up

• Feb 2027

  FDA advisory committee reviews five more peptides

  The Pharmacy Compounding Advisory Committee is scheduled to consider cathelicidin (LL-37), GHK-Cu, dihexa acetate, melanotan II and PEG-MGF for the list of substances pharmacies may compound.

  Source: GoodRx

2026

• Nov 13

  Comment period closes on the HHS peptide policy

  Public comments on the draft enforcement discretion policy were due. HHS has said it may revise the policy.

  Source: National Law Review

• Nov 9

  Hims & Hers announces peptide treatments

  The company said it would begin selling sermorelin, NAD+ and glutathione in November, and later make BPC-157 and TB-500 once rules allowing broad compounding are formalized.

  Source: Reuters via Investing.com

• Oct 30

  HHS publishes an interim policy covering six peptides

  HHS said it does not intend to take action against state-licensed pharmacies, federal facilities or licensed physicians that compound BPC-157, TB-500, KPV, MOTS-c, Semax or Epitalon when conditions on sourcing, testing, labeling and reporting are met. The policy does not approve the peptides, does not cover large outsourcing facilities, and does not change the status of research-use-only products.

  Source: National Law Review

• Oct

  TikTok restricts some peptide searches

  Searches for terms including BPC-157 and retatrutide began returning no results. TikTok said peptide discussion is permitted but marketing of high-risk products is not.

  Source: eMarketer

• Aug 24

  FDA warns five more research-peptide sellers

  Warning letters went to five online sellers whose catalogs included semaglutide, tirzepatide and retatrutide sold under research-use-only labels.

  Source: VialAudit enforcement summary

• Aug 12

  Eli Lilly sues six retatrutide sellers

  The drugmaker filed suits against sellers of retatrutide, an experimental drug that has no FDA approval.

  Source: VialAudit enforcement summary

• Jul 23-24

  Advisory committee recommends six of seven peptides

  The committee voted to recommend adding BPC-157, KPV, TB-500, MOTS-c, Semax and Epitalon to the list of substances pharmacies may compound, and voted against emideltide. FDA reviewers had recommended against all seven. The votes are advisory.

  Source: GoodRx

• Jun 16

  FDA sends 25 warning letters over compounded GLP-1 marketing

  The letters alleged false or misleading website claims about compounded semaglutide and tirzepatide.

  Source: McDermott Will & Schulte

• Apr 30

  FDA proposes keeping GLP-1s off a key compounding list

  The agency proposed excluding semaglutide, tirzepatide and liraglutide from the list that large outsourcing facilities may compound from.

  Source: Health Law Alliance

• Apr

  Twelve peptides leave the FDA's restricted category

  BPC-157, TB-500 and ten others were removed from Category 2, the list of substances flagged for safety concerns, after their nominations were withdrawn. Removal did not make them approved or automatically eligible for compounding.

  Source: Nationwide Compounding

• Mar 31

  FDA warns seven research-use-only peptide sellers

  In letters published April 7, the agency said research-use-only labels did not change that the products were intended as drugs for people.

  Source: Policy Canary

• Mar 3

  FDA announces 30 warning letters to telehealth companies

  The letters targeted claims that compounded GLP-1 drugs were the same as approved ones, and marketing that obscured who made the drug.

  Source: Health Law Alliance

• Feb 27

  Health Secretary signals a reversal on peptides

  Robert F. Kennedy Jr. said about 14 of the 19 peptides restricted in 2023 were expected to become eligible for compounding again.

  Source: AgeMD

Background

• 2024-2025

  GLP-1 shortages end

  The FDA declared the tirzepatide shortage over in December 2024 and the semaglutide shortage over in February 2025, ending the broad allowance for compounded copies.

  Source: GLP1 Numbers

• Sep 2023

  FDA restricts BPC-157 and other peptides

  The agency placed BPC-157 and other peptides in Category 2, which stopped licensed pharmacies from compounding them.

  Source: Nationwide Compounding

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