FDA Peptide Regulation: Complete 2025-2026 Timeline
The FDA's approach to peptide regulation shifted dramatically starting in late 2023. What had been decades of relative tolerance toward compounded peptides gave way to a rapid-fire sequence of category designations, shortage declarations, enforcement actions, and lawsuits that rewrote the rules for
The FDA's approach to peptide regulation shifted dramatically starting in late 2023. What had been decades of relative tolerance toward compounded peptides gave way to a rapid-fire sequence of category designations, shortage declarations, enforcement actions, and lawsuits that rewrote the rules for patients, clinicians, and compounding pharmacies alike.
This timeline tracks every major regulatory event from the first Category 2 designations through early 2026, explains the three-tier classification system the FDA uses to decide which substances pharmacies can compound, and breaks down what each change means for people who use or prescribe peptides.
If you are a patient wondering why your pharmacy can no longer fill your peptide prescription, or a provider trying to figure out what you can still legally compound, this is the reference document.
Table of Contents
- The Category System Explained
- Background: How We Got Here (Pre-2023)
- 2023: The Crackdown Begins
- 2024: Category Designations and PCAC Reviews
- January 2025: Revised Interim Guidance
- February-March 2025: Semaglutide Comes Off the Shortage List
- April-May 2025: Compounding Deadlines Hit
- Mid-2025: State Attorneys General Step In
- Late 2025: The SAFE Drugs Act
- Early 2026: Where Things Stand Now
- Which Peptides Fall in Each Category
- What This Means for Patients
- What This Means for Compounding Pharmacies
- What This Means for Prescribers
- FAQ
- The Bottom Line
- References
The Category System Explained
To understand the timeline, you first need to understand how the FDA classifies bulk drug substances for compounding purposes. The agency uses a three-category system under its interim policy for both Section 503A (traditional compounding pharmacies) and Section 503B (outsourcing facilities).
Category 1: Eligible for Compounding
Substances the FDA has determined can be safely compounded. The agency "does not intend to take action against a compounder for compounding drugs using bulk drug substances listed in Category 1," provided all other legal and regulatory conditions are met.
For a substance to be compounded legally under Section 503A, it must either:
- Be the active ingredient in an FDA-approved drug
- Have a U.S. Pharmacopeia (USP) monograph
- Appear on the FDA's Category 1 list
Category 2: Prohibited (Safety Concerns)
Substances the FDA has flagged as having "significant safety risks." Compounding pharmacies that use Category 2 substances risk enforcement action from the FDA or state regulators.
Being placed in Category 2 does not mean a substance is inherently dangerous in all contexts. It means the FDA has concluded there is insufficient evidence of safety and quality for compounding purposes, or that specific risks (such as immune reactions, contamination, or lack of human safety data) make compounding inappropriate.
Category 3: Insufficient Evidence for Evaluation
Substances for which the FDA lacks enough data to place them in either Category 1 or Category 2. These also may not be compounded.
The distinction between Categories 2 and 3 matters procedurally but the practical effect is the same: neither can be legally compounded.
Background: How We Got Here (Pre-2023)
For years, the FDA took a light-touch approach to peptide compounding. The agency's focus was on traditional small-molecule compounding issues -- sterility, potency, contamination -- rather than on whether specific peptides should be compounded at all.
This created an environment where hundreds of clinics prescribed compounded peptides like BPC-157, thymosin alpha-1, CJC-1295, and ipamorelin without significant regulatory pushback. Patients had access. Clinicians had prescribing freedom. Compounding pharmacies had a growing market.
The regulatory tolerance was never formal approval. It was more accurately described as non-enforcement. The peptides in question lacked USP monographs, had never been FDA-approved, and had not been placed on the 503A bulks list through the required notice-and-comment process.
Three things changed the calculus:
- The GLP-1 explosion. Demand for semaglutide and tirzepatide created a massive compounding market worth billions of dollars. Drug manufacturers -- particularly Novo Nordisk and Eli Lilly -- began pushing back hard.
- Safety signals. The FDA received hundreds of adverse event reports associated with compounded peptides, particularly compounded GLP-1 medications.
- Political pressure. Congressional scrutiny of drug compounding intensified following several high-profile contamination incidents unrelated to peptides, but which highlighted weaknesses in compounding oversight generally.
2023: The Crackdown Begins
October 2023
The FDA begins placing peptide bulk drug substances on Category 2 of the interim 503A bulks list. This is the first systematic effort to classify individual peptides for compounding purposes.
The initial wave targets peptides that had been nominated for inclusion on the 503A bulks list but which the FDA determined had safety concerns. The Pharmacy Compounding Advisory Committee (PCAC) begins scheduling reviews.
Key Impact
Compounding pharmacies that had been producing these peptides for years suddenly faced the prospect of enforcement action. Many continued compounding while the regulatory picture remained unclear, particularly because the Category 2 designations came through interim guidance rather than formal rulemaking.
2024: Category Designations and PCAC Reviews
February 2024
By this point, 17 popular peptides have been placed on Category 2 of the FDA's bulk drug substances list. These include:
- BPC-157 (pentadecapeptide)
- TB-500 (thymosin beta-4 fragment)
- Thymosin alpha-1
- CJC-1295 (with and without DAC)
- Ipamorelin acetate
- AOD-9604
- Selank
- KPV
- Melanotan II
- Kisspeptin-10
- GHK-Cu (injectable routes)
September 20, 2024
A significant development: the FDA announces that five peptide bulk drug substances are being removed from Category 2 because their nominators withdrew the nominations. The five substances are:
- AOD-9604
- CJC-1295
- Ipamorelin acetate
- Thymosin alpha-1 (Ta1)
- Selank acetate (TP-7)
What this actually meant: Removal from Category 2 did not mean these peptides were approved for compounding. It meant they were no longer actively classified as safety concerns under the interim policy. The FDA scheduled PCAC reviews for October and December 2024 to evaluate whether any of these should be added to the Category 1 (approved) list.
The PCAC had previously reviewed and rejected nominations for several of these peptides. The withdrawn nominations were a procedural step, but the underlying scientific evaluation had not changed.
October 2, 2024
Tirzepatide is removed from the FDA's drug shortage list. The Outsourcing Facilities Association (OFA) files a lawsuit challenging this determination.
December 4, 2024
PCAC meets to evaluate CJC-1295, thymosin alpha-1 acetate, and thymosin alpha-1 (free base) for potential inclusion on the 503A bulks list. The committee reviews safety data and hears public comment.
December 19, 2024
FDA reaffirms its determination that the tirzepatide shortage has ended. The agency announces enforcement discretion periods:
- 503A compounding pharmacies: until February 18, 2025
- 503B outsourcing facilities: until March 19, 2025
December 20, 2024
FDA removes semaglutide from the drug shortage list, a move with enormous implications for the compounding industry.
January 2025: Revised Interim Guidance
January 2025
The FDA releases its final revised interim guidance on bulk drug substances for both 503A and 503B compounding. This document supersedes the 2017 versions and represents the most comprehensive regulatory statement on peptide compounding to date.
Key provisions:
- 503A pharmacies can compound substances that are active ingredients in FDA-approved drugs, have USP monographs, or are on the Category 1 list. They cannot compound Category 2 or Category 3 substances.
- 503B outsourcing facilities can only compound drugs on the Category 1 list of the 503B bulks list, or FDA-approved drugs that are in shortage.
- The FDA will continue evaluating new nominations on a rolling basis.
What Changed from the 2017 Guidance
The revised guidance formalized the three-category system and closed several loopholes. Under the old policy, the lack of a formal determination on many peptides created ambiguity that compounders exploited. The new policy effectively says: if a substance is not explicitly on Category 1, and it does not have a USP monograph or FDA approval, it cannot be compounded.
New Additions to Category 1
A few peptides gained Category 1 status:
- GHK-Cu was added to Category 1 for non-injectable routes of administration (topical use). Injectable GHK-Cu remains off the approved list.
- Gonadorelin acetate was added to Category 1, as a peptide previously FDA-approved (as Lutrepulse).
- Sermorelin remains available for compounding under existing provisions.
February-March 2025: Semaglutide Comes Off the Shortage List
This period represents the most turbulent stretch in the timeline, with overlapping deadlines, lawsuits, and enforcement actions.
February 11, 2025
FDA clarifies that enforcement discretion for tirzepatide compounding will continue until the district court rules on the OFA's preliminary injunction motion in Outsourcing Facilities Association v. FDA.
February 18, 2025
The enforcement discretion period for 503A pharmacies compounding tirzepatide expires. Pharmacies must stop producing, distributing, and dispensing compounded tirzepatide.
February 19, 2025
The National Association of Attorneys General sends a letter to acting FDA commissioner Sara Brenner requesting action against "bad actors" selling counterfeit or improperly compounded GLP-1 medications.
February 21, 2025
The FDA issues a Declaratory Order formally resolving the semaglutide shortage. The agency establishes wind-down periods:
- 503A pharmacies: April 22, 2025
- 503B outsourcing facilities: May 22, 2025
As of this date, the FDA had received more than 455 adverse event reports associated with compounded semaglutide and more than 320 reports associated with compounded tirzepatide.
February 24, 2025
The OFA files a second lawsuit against the FDA in Fort Worth, Texas, this time challenging the semaglutide shortage resolution. The OFA argues the FDA's finding was "arbitrary and capricious."
February 28, 2025
Cumulative adverse event reports for compounded GLP-1s exceed 775. These reports include dosing errors, contamination, incorrect formulations, and injection site reactions.
March 5, 2025
A U.S. District Court judge denies the OFA's motion for a preliminary injunction on tirzepatide, upholding the FDA's determination that the shortage had ended. 503A pharmacies must cease tirzepatide production immediately. 503B outsourcing facilities have until March 19, 2025.
March 10, 2025
FDA issues formal guidance stating that all 503A and 503B compounders must cease compounding semaglutide injection products or face enforcement action.
March 19, 2025
Deadline for 503B outsourcing facilities to stop compounding tirzepatide.
April-May 2025: Compounding Deadlines Hit
April 22, 2025
503A pharmacies can no longer compound semaglutide under the shortage exception. Many clinics that built their business models around compounded semaglutide lose access to their primary revenue source.
May 22, 2025
503B outsourcing facilities face their semaglutide deadline. Whether it extends beyond this date depends on the still-pending OFA litigation.
May 21, 2025
Connecticut's Attorney General issues a statewide notice to weight-loss clinics and medspas: compounding of semaglutide and tirzepatide is no longer permitted.
Mid-2025: State Attorneys General Step In
The second half of 2025 brings a new enforcement actor onto the stage: state attorneys general.
Key Developments
- 38+ state attorneys general send a coordinated letter to the FDA describing a national network of counterfeit, contaminated, and research-grade GLP-1 products entering the U.S. through unregulated channels.
- Alabama's Attorney General obtains a temporary restraining order in November 2025 against a company selling unapproved peptide products.
- Connecticut requires a peptide seller to cease operations in the state and accept a monetary judgment.
- Multiple states begin auditing clinics that specialized in peptide therapy, reviewing prescribing practices and patient records.
The state enforcement is significant because it uses consumer protection law, unfair trade practice statutes, and public health authority -- tools that operate independently from the FDA's pharmaceutical regulatory framework. Companies operating in legal gray areas that may have avoided FDA scrutiny now face action from their home-state regulators.
Late 2025: The SAFE Drugs Act
September 2025
The FDA and HHS launch an enforcement initiative targeting misleading advertising in the compounded drug space. Warning letters go out to telehealth providers and companies promoting compounded GLP-1 products. Claims about "generic" or "clinically proven" versions of approved GLP-1 therapies are flagged as potentially misbranded.
December 9, 2025
Representatives Rudy Yakym (R-IN) and Andre Carson (D-IN) introduce the SAFE Drugs Act of 2025 (H.R. 6509). Key provisions:
- Redefines "essentially a copy": Any compounded drug with the same active ingredient as an FDA-approved medication is considered a copy unless a clinically significant change is made for an individual patient.
- Monthly production cap: 503A pharmacies cannot produce more than 20 copies of any single drug product per month.
- Mandatory reporting: Pharmacies shipping more than 20 compounded prescriptions out of state must file annual reports with the FDA.
- Inspections: Large-scale outsourcing facilities (100+ drug products per year) face mandatory initial and biennial inspections.
- Fee changes: Removes the statutory $15,000 cap on establishment fees for 503B facilities and delegates fee-setting to HHS.
The bill is referred to the House Committee on Energy and Commerce.
Early 2026: Where Things Stand Now
As of February 2026, the regulatory picture for peptide compounding is the most restrictive it has ever been:
- GLP-1 compounding is effectively over. Both semaglutide and tirzepatide are off the shortage list, enforcement discretion periods have expired, and ongoing litigation has not reversed the FDA's determinations.
- Most popular research peptides remain on Category 2 or have been rejected by PCAC. BPC-157, TB-500, GHRP-2, GHRP-6, Melanotan II, and others cannot be legally compounded.
- A handful of peptides remain available for compounding: sermorelin, gonadorelin, GHK-Cu (topical only), NAD+, and substances that are active ingredients in FDA-approved drugs.
- State-level enforcement continues to tighten. Multiple states have introduced legislation expanding oversight of compounding pharmacies and extending pharmacy regulation to clinical settings that administer compounded drugs.
- The SAFE Drugs Act remains in committee but signals the direction of congressional intent.
- Research-only peptides sold as "not for human consumption" remain widely available online, but enforcement against sellers who market to consumers (rather than laboratories) is increasing at both the federal and state level.
Which Peptides Fall in Each Category
Category 1 (Can Be Compounded)
| Peptide | Notes |
|---|---|
| Sermorelin | GHRH analog; available for compounding |
| Gonadorelin acetate | GnRH analog; added to Category 1 |
| GHK-Cu | Topical routes only; injectable remains off-list |
| NAD+ | Not technically a peptide, but commonly grouped with peptide therapies |
| VIP (Vasoactive Intestinal Peptide) | Remains on Category 1 |
Category 2 (Cannot Be Compounded -- Safety Concerns)
| Peptide | Reason |
|---|---|
| BPC-157 | No human safety data; synthetic origin concerns |
| TB-500 (Thymosin beta-4 fragment) | Potential immune reactions |
| AOD-9604 | Nomination withdrawn; PCAC rejected |
| Ipamorelin | Nomination withdrawn; PCAC rejected |
| Kisspeptin-10 | Insufficient safety evidence |
| Melanotan II | Safety concerns including cardiovascular effects |
| KPV | Insufficient safety evidence |
| GHK-Cu (injectable) | Only topical approved for Category 1 |
Category 3 (Cannot Be Compounded -- Insufficient Data)
| Peptide | Notes |
|---|---|
| GHRP-2 | Category 3 on 503A list; moved to Category 1 on 503B list for non-injectable, non-nasal routes only |
| Others pending review | New nominations evaluated on rolling basis |
Peptides with PCAC Reviews Pending/Complete
| Peptide | Status |
|---|---|
| CJC-1295 | Reviewed December 2024; awaiting final determination |
| Thymosin alpha-1 | Reviewed December 2024; awaiting final determination |
| Selank | Nomination withdrawn September 2024; status pending |
What This Means for Patients
If You Were Using Compounded GLP-1 Medications
Your options have narrowed considerably. Compounded semaglutide and compounded tirzepatide are no longer available from U.S. pharmacies.
What you can do:
- Switch to brand-name medications. Ozempic, Wegovy, Mounjaro, and Zepbound are the FDA-approved versions. Costs are significantly higher -- often $800 to $1,300 per month without insurance, compared to $100 to $300 for compounded versions.
- Check manufacturer savings programs. Novo Nordisk and Eli Lilly both offer savings cards and patient assistance programs that can reduce out-of-pocket costs.
- Talk to your doctor about alternative medications or treatment approaches. How to talk to your doctor about peptides covers this conversation in detail.
If You Were Using Other Compounded Peptides
The availability of your specific peptide depends on its category:
- Category 1 peptides (sermorelin, gonadorelin, topical GHK-Cu, VIP) can still be compounded by a licensed pharmacy with a valid prescription.
- Category 2 and 3 peptides (BPC-157, TB-500, ipamorelin, CJC-1295, AOD-9604, and many others) cannot be legally compounded. You may see these sold as "research chemicals" online, but purchasing them for personal use puts you in a legal gray area that is increasingly subject to enforcement.
- Peptides under PCAC review (CJC-1295, thymosin alpha-1) may eventually be reclassified, but the timeline is uncertain.
Your Rights
You have the right to speak with your doctor about any treatment, including peptides that are not currently available through compounding. If you believe a peptide should be made available, you can submit a nomination to the FDA's bulk drug substances evaluation process, though this is a complex regulatory procedure.
What This Means for Compounding Pharmacies
503A Pharmacies
- Can compound only Category 1 substances, substances with USP monographs, and active ingredients of FDA-approved drugs.
- Cannot compound any substance solely because a physician wrote a prescription for it. The substance itself must meet the regulatory criteria.
- Face potential state-level legislation (inspired by or paralleling the SAFE Drugs Act) that could impose reporting requirements and production caps.
503B Outsourcing Facilities
- More restricted than 503A pharmacies in some respects: can only compound drugs on the 503B Category 1 list or FDA-approved drugs in shortage.
- Face mandatory inspections under proposed legislation.
- Fee structures may change significantly if the SAFE Drugs Act passes.
Compliance Priorities
All compounding entities should:
- Audit current formularies against the latest category lists
- Ensure API sourcing meets pharmaceutical-grade standards (research-use-only APIs cannot be used)
- Monitor the PCAC schedule for upcoming reviews
- Consult legal counsel on state-specific requirements that may be stricter than federal rules
What This Means for Prescribers
Physicians who prescribe peptide therapies face a new set of rules:
- FDA-approved peptides can be prescribed as always. Semaglutide, tirzepatide, liraglutide, tesamorelin, bremelanotide, and dozens of other approved peptide drugs remain fully available with a prescription.
- Category 1 compounded peptides can be prescribed from a licensed compounding pharmacy. A valid patient-specific prescription is required.
- Category 2 and 3 peptides cannot be prescribed from a compounding pharmacy, regardless of clinical judgment. Prescribing these through non-pharmacy channels (such as research chemical suppliers) exposes providers to state medical board scrutiny and potential liability.
- State medical board audits of peptide-prescribing practices have increased in several states. Documentation of medical necessity, informed consent, and clinical rationale is more important than ever.
FAQ
Is BPC-157 banned?
BPC-157 is classified as a Category 2 substance, meaning it cannot be legally compounded by pharmacies for human use. It is not "banned" in the sense that it is illegal to possess -- it can still be sold for research purposes. But using research-grade BPC-157 for self-injection is not legal under FDA rules, and enforcement is increasing.
Can my doctor still prescribe compounded semaglutide?
No. Since the FDA declared the semaglutide shortage resolved in February 2025 and the enforcement discretion periods have expired, compounding pharmacies can no longer produce semaglutide. Your doctor can prescribe brand-name Ozempic, Wegovy, or Rybelsus.
Will any of the Category 2 peptides be reclassified?
It is possible. Peptides whose nominations were withdrawn in September 2024 (including AOD-9604, CJC-1295, ipamorelin, thymosin alpha-1, and Selank) are being evaluated through the PCAC process. If the committee recommends adding them to Category 1 after the notice-and-comment period, they could become available for compounding again. But the PCAC has previously rejected nominations for several of these substances, so reclassification is not guaranteed.
What is the difference between the 503A and 503B lists?
Both use the three-category system, but the specific substances in each category differ. For example, GHRP-2 is Category 3 on the 503A list but was moved to Category 1 on the 503B list for non-injectable, non-nasal routes only. 503A pharmacies compound patient-specific prescriptions; 503B outsourcing facilities can produce larger batches without patient-specific prescriptions.
Can I buy research peptides legally?
Research peptides labeled "not for human consumption" or "for research use only" can be legally sold to laboratories and researchers. Purchasing them as a consumer for self-administration occupies a legal gray area. The FDA and state attorneys general have increasingly targeted sellers who market research peptides in ways that imply human use (for example, selling them alongside syringes or bacteriostatic water).
What does the SAFE Drugs Act do if it passes?
The bill would tighten compounding regulations further by redefining what counts as a copy of an FDA-approved drug, capping production volumes for 503A pharmacies, requiring cross-state shipping reports, and mandating inspections of large outsourcing facilities. It is currently in committee and has not been voted on.
The Bottom Line
The FDA's peptide regulation timeline from 2023 through early 2026 represents a fundamental shift from permissive non-enforcement to active restriction. The three-category system gives the agency a structured framework for deciding which substances can be compounded, and the agency has used it aggressively.
For patients, the practical impact has been significant: most popular compounded peptides are no longer available, compounded GLP-1 medications have disappeared from the market, and the cost of remaining options (brand-name drugs) is substantially higher.
For the industry, the shift has been even more dramatic. Compounding pharmacies have lost major revenue streams, clinics built around peptide therapy have had to restructure, and the "research chemical" market faces unprecedented enforcement pressure.
The direction of travel is clear. Whether through FDA guidance, PCAC review, congressional legislation, or state enforcement, the regulatory environment for peptides will continue tightening. Patients and providers who stay informed about which peptides remain legally accessible -- and through which channels -- will be best positioned to navigate what comes next.
References
- FDA. "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A." January 2025. https://www.fda.gov/media/174456/download
- Frier Levitt. "Regulatory Status of Peptide Compounding in 2025." https://www.frierlevitt.com/articles/regulatory-status-of-peptide-compounding-in-2025/
- Holt Law. "Deep Dive: Regulatory Status of Popular Compounded Peptides." https://djholtlaw.com/deep-dive-regulatory-status-of-popular-compounded-peptides/
- Alliance for Pharmacy Compounding. "FDA Releases Final Interim Guidance on Bulk Drug Substances for Both 503As and 503Bs." January 2025. https://a4pc.org/news/2025-01/fda-releases-final-interim-guidance-on-bulk-drug-substances-for-both-503as-and-503bs
- NCPA. "FDA Releases Guidance for Compounding Pharmacies." January 13, 2025. https://ncpa.org/newsroom/qam/2025/01/13/fda-releases-guidance-compounding-pharmacies
- McDermott Will & Emery. "Semaglutide Shortage Resolved." https://www.mwe.com/insights/semaglutide-shortage-resolved/
- Foley & Lardner. "GLP-1 Drugs: FDA Removes Semaglutide from the Drug Shortage List." February 2025. https://www.foley.com/insights/publications/2025/02/glp-1-drugs-fda-removes-semaglutide-from-drug-shortage-list/
- Stevens & Lee. "GLP-1 Weight Loss Drug Enforcement in 2025: State Attorneys General Step into a Growing Regulatory Gap." https://www.stevenslee.com/health-law-observer-blog/glp-1-weight-loss-drug-enforcement-in-2025-state-attorneys-general-step-into-a-growing-regulatory-gap/
- Dykema. "Congress Introduces SAFE Drugs Act of 2025." https://www.dykema.com/news-insights/congress-introduces-safe-drugs-act-of-2025-expanding-fda-oversight-of-compounded-glp-1-drugs-and-telehealth-providers.html
- Congress.gov. "H.R.6509 - SAFE Drugs Act of 2025." https://www.congress.gov/bill/119th-congress/house-bill/6509/text
- Frier Levitt. "State and Federal Legislative Developments Affecting Drug Compounding." 2026. https://www.frierlevitt.com/articles/state-federal-legislative-developments-drug-compounding-2026/
- Peptide Drug Summit 2026. "FDA Tightens Peptide Rules." https://www.peptide-drug-summit.com/news/new-fda-rules-are-reshaping-the-peptide-industry
- FDA. "PCAC Meeting Materials, December 4, 2024." https://www.fda.gov/media/185641/download
- Safe Healthcare Group. "FDA's Overreach on Compounded Peptides." https://www.safehg.com/fdas-overreach-on-compounded-peptides-legal-battles-and-how-clinics-can-push-back/