Peptide Regulatory Timeline: 2024-2026

A comprehensive chronological timeline of all major peptide regulatory events. Each entry links to its detailed note where available.

Current status, in one line: as of July 24, 2026, none of the peptides on this timeline is on the 503A bulks list, and compounding them is not permitted. An FDA advisory committee recommended six for listing on July 23-24, 2026; FDA has not adopted that recommendation. See FDA-503A-Category-System for why a category placement and an advisory recommendation are both different from being listed.

2024

Q1-Q2 2024

• 2023-2024: FDA issues Category 2 designations for multiple peptides, including BPC-157, TB-500, CJC-1295, Ipamorelin, GHRP-2, GHRP-6, AOD-9604, and Melanotan II. These substances are restricted from compounding under Section 503A.

Q3 2024

• August 2024: All American Peptide operators (the Kovaleskis) face DOJ prosecution for selling misbranded and unapproved drugs, including prescription substances like tadalafil, through their website from 2014-2019. Part of broader DOJ enforcement wave.

Q4 2024

• October 2024: Tailor Made Compounding (TMC) pleads guilty to one felony count of distributing unapproved new drugs (BPC-157, CJC-1295, Ipamorelin, LGD-4033). Owner Jeremy Delk receives 3 years probation, 4 months home incarceration, $20,000 fine. Company forfeits $1,788,906. See DOJ-Peptide-Criminal-Prosecutions-2025.

• December 19, 2024: FDA resolves Tirzepatide injection shortage. 503A pharmacies given 60-day enforcement discretion window; 503B outsourcing facilities given 90 days. See Semaglutide-Compounding-Shortage-Resolution.

2025

January 2025

• January 7, 2025: FDA publishes revised interim policy on compounding using bulk drug substances. Ends the Category system for new nominations. Newly nominated substances must complete full PCAC evaluation before compounding is permitted. Existing categories (1, 2, 3) remain in effect.

• January 1, 2025: California Assembly Bill 1887 takes effect, requiring research peptides shipped to California to include state-specific disclosure statements. See State-Level-Peptide-Enforcement-2025-2026.

February 2025

• February 18, 2025: 503A enforcement discretion period for compounding Tirzepatide expires.

• February 21, 2025: FDA resolves Semaglutide shortage, removing all Semaglutide presentations from the drug shortage list. 503A pharmacies given until April 22, 2025; 503B facilities until May 22, 2025.

• February 24, 2025: Outsourcing Facilities Association (OFA) files lawsuit in Fort Worth, Texas challenging FDA’s Semaglutide shortage resolution determination.

March 2025

• March 19, 2025: 503B enforcement discretion period for compounding Tirzepatide expires.

• March 20, 2025: Court in OFA v. FDA Semaglutide case schedules hearing on joint motion for April 24, 2025.

April 2025

• April 2025: Eli Lilly files lawsuits against Strive Compounding Pharmacy and Empower Clinic Services in District of New Jersey over compounded Tirzepatide. See GLP1-Manufacturer-Litigation-2025.

• April 2025: FDA issues warning letter to Empower’s Texas facility.

• April 22, 2025: 503A enforcement discretion period for compounding Semaglutide expires.

May 2025

• May 22, 2025: 503B enforcement discretion period for compounding Semaglutide expires. As of this date, all enforcement discretion periods for both Semaglutide and Tirzepatide have ended.

June 2025

• June 2025: FDA raids Amino Asylum warehouse in Memphis, Tennessee — the first physical raid on a major peptide vendor. Site goes dark overnight. Thousands of orders frozen. Multiple smaller vendors shut down or relocate offshore in the following weeks.

• June 17, 2025: All compounding enforcement discretion periods officially concluded.

July 2025

• July 25, 2025: Eli Lilly files lawsuit against Empower Clinic Services in S.D. Texas (after voluntarily dismissing the New Jersey case), accusing Empower of unlawfully manufacturing and selling unapproved weight-loss drugs. See GLP1-Manufacturer-Litigation-2025.

August 2025

• August 4, 2025: Novo Nordisk files lawsuits against 12 defendants, including several pharmacies. See GLP1-Manufacturer-Litigation-2025.

• August 2025: Novo Nordisk files 14 additional lawsuits, expanding into targeting pharmacies claiming “personalization” exemptions and telehealth companies steering patients to compounded Semaglutide.

September 2025

• September 16, 2025: FDA issues 55+ warning letters to online sellers of compounded GLP-1 medications — the largest single-day enforcement action against the compounding industry. Targets false equivalence claims, brand name misuse, and post-shortage sales.

October 2025

• October 2025: FDA Commissioner Marty Makary announces broader clampdown on illegal GLP-1 compounders. Second batch of warning letters issued.

• Late 2025: BioPeptide Labs charged with conspiracy to commit wire fraud and distribute misbranded drugs. See DOJ-Peptide-Criminal-Prosecutions-2025.

Q4 2025

• Late 2025 - Early 2026: Ohio Board of Pharmacy issues consent agreements and fines to at least three pharmacies for peptide compounding violations. See State-Level-Peptide-Enforcement-2025-2026.

• Florida: State regulators begin suspending clinic licenses for possession of research-labeled peptide vials in clinical settings.

• December 2025: EMA adopts Guideline on Development and Manufacture of Synthetic Peptides (EMA/CHMP/CVMP/QWP/367182/2025), effective June 1, 2026. See EMA-Synthetic-Peptide-Guideline-2026.

• December 2025: Lilly v. Empower case paused at critical procedural moment in S.D. Texas.

2026

January 2026

• January 2026: Science.Bio shuts down, citing regulatory pressure.

• January 2026: Columbus, Ohio compounding pharmacy agrees to $15,000 fine for preparing bulk Semaglutide without patient-specific prescriptions.

• January 14, 2026: Strive Compounding Pharmacy files antitrust lawsuit against Eli Lilly and Novo Nordisk (W.D. Texas), alleging exclusionary conduct to suppress compounded GLP-1 products. See GLP1-Manufacturer-Litigation-2025.

February 2026

• February 2026: HHS Secretary Robert F. Kennedy Jr. announces intent to reclassify 14+ peptides from Category 2 back to Category 1. The formal reclassification was never completed as announced. What actually happened in April 2026 is that roughly a dozen peptides were removed from Category 2 — not moved to Category 1. Most now appear in no interim category, which is not permission to compound.

• February 2026: TGA tightens Australian peptide import restrictions. All imports require formal use declarations; quantities over 3-month supply automatically flagged. Burden of proof shifted to importers.

• February 2026: Ohio Board of Pharmacy publishes guidance requiring all compounded peptides to be prepared pursuant to valid patient-specific prescriptions.

March 2026

• March 2026: Peptide Sciences shuts down, citing regulatory environment. One of the largest and most established research peptide vendors.

April 2026

• April 2026: FDA continues enforcement. New warning letters issued. Kennedy reclassification not formalized.

• Mid-April 2026: FDA removes roughly a dozen peptides from Category 2 — BPC-157, TB-500, Semax, Epitalon, MOTS-c, Melanotan II, GHK-Cu, KPV, DSIP, Dihexa, Selank and certain Ipamorelin salt forms — after the nominations were withdrawn. This is not authorization to compound. They enter a transitional state in no category; they must still clear PCAC review and formal notice-and-comment rulemaking to reach the 503A bulks list.

• By April 2026: Novo Nordisk has filed 132 complaints across 40 states; 44 permanent injunctions secured against compounders.

• Over the preceding 6 months: FDA has sent thousands of warning letters to pharmaceutical and telehealth firms — more than the entire preceding decade combined.

• April 22, 2026: GHK-Cu is removed from the interim Category 1 list after its nominations are withdrawn.

• April 30, 2026: FDA proposes to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, and opens a comment docket.

May 2026

• May 5, 2026: One of the GHK-Cu nominators clarifies that it intended to withdraw only the injectable route of administration. FDA states that “GHK-Cu (except for injectable routes of administration) will be added back to category 1.”

• May 14, 2026: FDA’s interim list of nominated 503A bulk drug substances is updated. Non-injectable GHK-Cu is back in Category 1; injectable GHK-Cu remains outside every category. The Category 2 list now contains exactly six substances — cesium chloride, domperidone, germanium sesquioxide, ibutamoren mesylate (MK-677), kisspeptin-10 (Kisspeptin), and quinacrine hydrochloride for intrauterine administration. See FDA-503A-Category-System.

June 2026

• June 1, 2026: EMA synthetic peptide guideline takes effect for EU marketing authorization applications.

• June 29, 2026: The comment window closes on FDA’s proposal to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list. No final determination has been published.

July 2026

• July 23-24, 2026: The Pharmacy Compounding Advisory Committee (PCAC) meets at White Oak under docket FDA-2025-N-6895 and votes on seven peptides, taking separate votes on the free base and the acetate form of each. FDA’s own review team recommended against all seven; every briefing document concludes that “a balancing of the criteria weighs against [substance] being placed on that list.”

  The committee overrode FDA staff and recommended six for the 503A bulks list: BPC-157 (use evaluated: ulcerative colitis), KPV (wound healing, inflammatory conditions), TB-500 (wound healing), MOTS-c (no indication evaluated — the six proposed uses were nominated, not evaluated), Semax (cerebral ischemia, migraine, trigeminal neuralgia) and Epitalon (insomnia, by a narrow majority). It rejected Emideltide (DSIP) — the only rejection, and the only compound where the committee agreed with FDA’s reviewers. Uses evaluated for DSIP: opioid withdrawal, chronic insomnia, narcolepsy.

  Nothing changed legally. The vote is advisory and non-binding. FDA has not adopted it, none of the six is on the 503A bulks list, none is FDA-approved, and compounding them is not permitted. Any change would come through notice-and-comment rulemaking. As of this writing FDA has published no minutes, transcript, or vote summary.

Upcoming

• Before end of February 2027: FDA has stated it intends to consult PCAC on GHK-Cu.

Key Themes

1. Escalation ladder: The enforcement pattern is clear — nominations to categories to warning letters to raids to criminal prosecution. Each step takes months, not years.

2. Multi-front enforcement: Peptide vendors and compounders now face simultaneous pressure from FDA, DOJ, state pharmacy boards, state attorneys general, and private litigation from pharmaceutical manufacturers.

3. “Research use only” is dead as a defense: The Tailor Made prosecution, Amino Asylum raid, and Intended Use Doctrine all demonstrate that labels do not override marketing intent.

4. GLP-1 as the wedge: The Semaglutide/Tirzepatide compounding fight opened the enforcement infrastructure that is now being applied to the broader peptide market.

5. International convergence: The US (FDA/DOJ), Australia (TGA), and EU (EMA) are all tightening peptide regulation simultaneously, reducing safe harbors for vendors.

6. Kennedy reclassification uncertainty: The announced intent to reclassify peptides has not yet been formalized, creating a gap between political signals and legal reality.

Related Notes

• FDA-503A-Category-System — reference on the category framework
• FDA-Category-2-Designations-2023-2024 — initial wave of restrictions
• FDA-Reclassification-Announcement-Feb-2026 — Kennedy’s proposed reversal
• Semaglutide-Compounding-Shortage-Resolution — shortage resolution details
• FDA-Warning-Letters-April-2026 — latest enforcement actions
• Science-Bio-Shutdown-January-2026 — vendor shutdown
• Peptide-Sciences-Shutdown-March-2026 — vendor shutdown