FDA Peptide Compounding Crackdown: What It Means

For years, compounding pharmacies were the primary way Americans accessed peptides like BPC-157, thymosin alpha-1, CJC-1295, and ipamorelin. A doctor wrote a prescription. A compounding pharmacy mixed the peptide from bulk powder. The patient received an injectable or nasal spray that cost a fraction of what FDA-approved alternatives would.

That system is, for most popular peptides, over.

Starting in late 2023 and accelerating through 2025, the FDA systematically restricted which substances compounding pharmacies can use, classified the most popular peptides as having "significant safety concerns," and shut down the compounding of blockbuster GLP-1 medications once drug shortages ended. The result is the most restrictive compounding environment for peptides in U.S. history.

This article explains what happened, why it happened, which peptides are affected, and what options remain for patients and prescribers.

Table of Contents

Understanding 503A and 503B Pharmacies
What the FDA Actually Did
Which Peptides Are Affected
The GLP-1 Compounding Shutdown
Why the FDA Cracked Down
The Legal Battles
Impact on Patients
Impact on Compounding Pharmacies
Impact on Prescribers and Clinics
What Can Still Be Compounded
The SAFE Drugs Act: What Is Coming Next
Practical Guidance for Patients
FAQ
The Bottom Line
References

Understanding 503A and 503B Pharmacies

Before getting into the specifics of the crackdown, you need to understand the two types of compounding pharmacies in the United States. They operate under different sections of the Federal Food, Drug, and Cosmetic Act (FDCA), with different rules and different capabilities.

Section 503A: Traditional Compounding Pharmacies

These are your local compounding pharmacies -- the ones down the street from your doctor's office. Under Section 503A:

They compound patient-specific prescriptions. A doctor writes a prescription for a specific patient, and the pharmacy fills it.
They are regulated primarily by state boards of pharmacy, not the FDA.
They can compound drugs using substances that have USP monographs, are active ingredients in FDA-approved drugs, or appear on the FDA's approved Category 1 bulk drug substances list.
They generally cannot ship large quantities across state lines (with some exceptions).

Section 503B: Outsourcing Facilities

These are larger-scale operations that produce compounded drugs in bulk. Under Section 503B:

They do not need patient-specific prescriptions. They can compound drugs in advance, in larger batches.
They are registered with and inspected by the FDA, similar to drug manufacturers.
They must follow current Good Manufacturing Practices (cGMP).
They can distribute across state lines.
They can only compound drugs listed on the 503B bulks list (Category 1) or FDA-approved drugs that are in shortage.

Why This Matters

The distinction is important because the FDA's crackdown affects 503A and 503B pharmacies differently. 503B facilities face stricter limits on what they can compound and are subject to FDA inspection. 503A pharmacies have slightly more flexibility through the bulks list but are increasingly subject to state-level regulation.

When you hear about a "compounding ban," both types of pharmacies are affected, but the timelines, rules, and enforcement mechanisms differ.

What the FDA Actually Did

The crackdown happened in three phases, each building on the last.

Phase 1: Category Classifications (2023-2024)

Starting in October 2023, the FDA began classifying individual bulk drug substances into three categories under its interim policy:

Category 1: Can be compounded. The FDA has determined these substances do not pose significant safety risks.
Category 2: Cannot be compounded. The FDA has identified "significant safety concerns."
Category 3: Cannot be compounded. Insufficient data for evaluation.

By February 2024, 17 popular peptides had been placed on Category 2. This was not a blanket ban on all peptide compounding -- it was targeted at specific substances. But the specific substances targeted happened to be the ones that generated the vast majority of peptide prescriptions.

The Pharmacy Compounding Advisory Committee (PCAC) reviewed nominations for several peptides and rejected them. The committee found that the safety data submitted by nominators was insufficient to support placement on the approved bulks list.

Phase 2: Revised Interim Guidance (January 2025)

In January 2025, the FDA released revised final interim guidance for both 503A and 503B compounding. This guidance superseded the 2017 versions and formalized the three-category system.

Key changes:

Closed the ambiguity gap. Under the old policy, substances that had not been formally reviewed existed in regulatory limbo. The new policy is clearer: if a substance is not on Category 1, does not have a USP monograph, and is not an active ingredient in an FDA-approved drug, it cannot be compounded.
Established that the agency would continue evaluating new nominations on a rolling basis.
Placed additional substances on Category 1, including GHK-Cu (topical routes only) and gonadorelin acetate.

Phase 3: GLP-1 Shortage Resolutions (Late 2024 - Mid 2025)

This was the most commercially significant action. During the nationwide shortages of semaglutide and tirzepatide, compounding pharmacies were allowed to produce copies under a drug shortage exception. Thousands of pharmacies and telehealth companies built businesses around compounded GLP-1 medications, offering them at $100 to $300 per month compared to $800 to $1,300 for brand-name versions.

When the FDA declared the shortages resolved, that exception disappeared:

Tirzepatide: Removed from shortage list October 2, 2024. Final enforcement deadline for 503A: February 18, 2025. For 503B: March 19, 2025.
Semaglutide: Removed from shortage list December 20, 2024. Formal resolution declared February 21, 2025. Final enforcement deadline for 503A: April 22, 2025. For 503B: May 22, 2025.

By mid-2025, compounding of both drugs was effectively over.

Which Peptides Are Affected

Peptides Banned from Compounding (Category 2)

These peptides have been specifically designated as having safety concerns and cannot be compounded by any pharmacy:

Peptide	Why It Was Popular	FDA's Concern
BPC-157	Gut healing, tissue repair, injury recovery	No human clinical trial data; synthetic origin; unknown long-term effects
TB-500 (Thymosin Beta-4 fragment)	Wound healing, tissue repair, inflammation	Potential immune reactions; limited safety data
AOD-9604	Fat loss	Nomination withdrawn; PCAC rejected
Ipamorelin	Growth hormone secretion	Nomination withdrawn; PCAC rejected
Kisspeptin-10	Reproductive health, hormone regulation	Insufficient safety evidence
Melanotan II	Tanning, sexual function	Cardiovascular and other safety concerns
KPV	Anti-inflammatory (gut health)	Insufficient safety evidence
GHK-Cu (injectable)	Anti-aging, wound healing	Only topical routes placed on Category 1

Peptides Removed from Category 2 but Not Yet Approved

In September 2024, five substances were removed from Category 2 after their nominators withdrew nominations:

This was procedural, not a green light. These peptides were scheduled for PCAC review in October and December 2024. The PCAC had already rejected several of these nominations in earlier reviews. Removal from Category 2 does not equal approval for compounding -- it means they are back in regulatory limbo while the formal review process plays out.

GLP-1 Peptides No Longer Available as Compounded

Peptide	Brand Names	Compounding Status
Semaglutide	Ozempic, Wegovy, Rybelsus	Cannot be compounded; shortage resolved Feb 2025
Tirzepatide	Mounjaro, Zepbound	Cannot be compounded; shortage resolved Oct 2024

See compounded semaglutide vs. brand-name comparison for details on how the compounded versions differed from the originals.

The GLP-1 Compounding Shutdown

The GLP-1 story deserves separate attention because of its scale and impact.

How Big the Market Was

During the shortages, the compounded GLP-1 market exploded. Telehealth companies like Hims & Hers, Ro, and dozens of smaller operations offered compounded semaglutide and tirzepatide at deeply discounted prices. Compound pharmacies large and small pivoted to GLP-1 production. Some estimates placed the compounded GLP-1 market in the billions of dollars.

The Adverse Events

The FDA's position was strengthened by adverse event data. By February 28, 2025, the agency had received:

More than 455 adverse event reports for compounded semaglutide
More than 320 adverse event reports for compounded tirzepatide

These reports included dosing errors, contamination, incorrect concentrations, allergic reactions, and injection site complications. The FDA argued these events demonstrated the risks of compounded versions relative to manufactured, FDA-approved products.

It should be noted that adverse event reporting is voluntary and the absolute numbers need to be interpreted in the context of millions of prescriptions. But the pattern gave the FDA the safety data it needed to justify ending the shortage exceptions.

The Timeline

The wind-down was rapid:

October 2, 2024: Tirzepatide off shortage list
December 20, 2024: Semaglutide off shortage list
February 18, 2025: 503A pharmacies must stop compounding tirzepatide
February 21, 2025: FDA formally declares semaglutide shortage resolved
March 5, 2025: Court upholds FDA's tirzepatide determination; denies preliminary injunction
March 19, 2025: 503B outsourcing facilities must stop compounding tirzepatide
April 22, 2025: 503A pharmacies must stop compounding semaglutide
May 22, 2025: 503B outsourcing facilities must stop compounding semaglutide

Why the FDA Cracked Down

The FDA's stated reasons center on patient safety:

Lack of human safety data. Many compounded peptides (BPC-157, TB-500, etc.) have never been through human clinical trials. The animal and in-vitro research, while often promising, does not meet the FDA's standard for determining that a substance is safe for human use.
Manufacturing quality concerns. Compounded drugs are not manufactured to the same standards as FDA-approved products. Testing by the FDA and independent labs has found that some compounded peptides contained incorrect doses, contaminants, or degradation products.
Adverse event signals. The 775+ adverse event reports for compounded GLP-1 medications provided concrete evidence of harm. For other peptides, the concern is less about documented harm and more about the unknown -- what happens when millions of people use substances that have never been formally studied in humans?
Industry pressure. This is the part the FDA does not emphasize. Major pharmaceutical companies -- particularly Novo Nordisk and Eli Lilly -- lobbied intensely to end GLP-1 compounding. Their products were losing market share to cheaper compounded versions. While the FDA insists its decisions are safety-based, the timing and intensity of enforcement correlated closely with the brand-name manufacturers' advocacy.
Broader compounding reform. The crackdown on peptides is part of a larger post-2012 effort to tighten compounding regulation. The New England Compounding Center (NECC) contamination tragedy in 2012, which killed 64 people, led to the Drug Quality and Security Act of 2013. The peptide actions represent the FDA using the tools that legislation provided.

The Legal Battles

The compounding industry has not accepted the crackdown quietly.

Outsourcing Facilities Association v. FDA

The OFA filed two major lawsuits:

October 2024: Challenged the removal of tirzepatide from the shortage list.
February 2025: Challenged the removal of semaglutide from the shortage list.

The OFA argued that the FDA's shortage determinations were "arbitrary and capricious" and that the agency failed to adequately consider patient access and affordability.

On March 5, 2025, a U.S. District Court judge denied the OFA's preliminary injunction request for tirzepatide, effectively ending the legal challenge to keep compounding tirzepatide alive. The semaglutide lawsuit continues to make its way through the courts.

Constitutional and Administrative Law Arguments

Some legal scholars argue the FDA overstepped its authority. The argument is that the FDA used interim guidance -- not formal rulemaking with public comment -- to effectively ban substances that had been legally compounded for years. Formal rulemaking under the Administrative Procedure Act requires notice, public comment, and a reasoned decision. The interim guidance approach bypasses much of this process.

Law firms specializing in pharmacy compounding, including Frier Levitt and Holt Law, have published detailed analyses arguing that the FDA's Category 2 designations are legally vulnerable. But so far, the courts have sided with the FDA on the specific questions they have been asked to decide.

State-Level Enforcement

A separate enforcement track has emerged at the state level. In 2025:

A coalition of 38+ state attorneys general sent a letter to the FDA describing problems with counterfeit and research-grade GLP-1 products.
Alabama's Attorney General obtained a temporary restraining order against a company selling unapproved peptide products.
Connecticut forced a peptide seller to cease operations and accept a monetary judgment.
Multiple states began auditing peptide therapy clinics.

Impact on Patients

The crackdown has hit patients in three ways:

1. Loss of Access

Patients who relied on compounded peptides like BPC-157, CJC-1295/ipamorelin stacks, or thymosin alpha-1 can no longer get them through legal channels. The peptides are gone from compounding pharmacies, full stop.

For GLP-1 patients, the shift from compounded to brand-name medications means dealing with insurance barriers, prior authorizations, and significantly higher costs.

2. Higher Costs

Brand-name GLP-1 medications cost $800 to $1,300 per month without insurance. Compounded versions typically cost $100 to $300. For patients who were paying cash for compounded semaglutide, the switch to brand-name Wegovy or Ozempic can represent a 4x to 10x cost increase.

Manufacturer savings programs (Novo Nordisk's savings card, Eli Lilly's savings programs) can help but often have income limits or insurance requirements.

3. Driven Underground

Some patients have turned to "research-grade" peptides purchased online. These are sold as "not for human consumption" and are technically legal to buy for laboratory use. But they lack pharmaceutical-grade manufacturing standards, certificates of analysis may or may not be reliable, and self-administering them without medical supervision creates real risks.

The irony is that the crackdown, intended to improve safety, may push some patients toward less safe alternatives.

Impact on Compounding Pharmacies

Revenue Loss

Compounding pharmacies that built significant business around peptide formulations have lost that revenue stream. Some pharmacies derived 30% to 50% of their revenue from peptide and GLP-1 compounding.

Compliance Costs

The new regulatory environment requires:

Auditing current formularies against updated category lists
Ensuring all APIs are pharmaceutical-grade (not "research use only")
Monitoring PCAC schedules and FDA guidance updates
Investing in legal review of state-specific requirements
Implementing new record-keeping for potential SAFE Drugs Act reporting requirements

Consolidation

The policy shift favors larger, well-capitalized 503B outsourcing facilities that can absorb compliance costs. Smaller 503A pharmacies are more vulnerable. Industry analysts expect consolidation -- fewer pharmacies compounding peptides, with the surviving ones being larger and better-resourced.

Impact on Prescribers and Clinics

Physicians and clinics that specialized in peptide therapy face a new reality:

Most popular protocols are gone. BPC-157 and TB-500 stacks, CJC-1295/ipamorelin combinations, and thymosin alpha-1 regimens cannot be prescribed from compounding pharmacies.
Medical board scrutiny is increasing. Several states have begun auditing peptide-prescribing practices. Documentation of medical necessity, informed consent, and clinical rationale is more important than ever.
Liability exposure. Prescribers who continue to facilitate patient access to non-compoundable peptides through gray-market channels face potential medical board disciplinary action and malpractice liability.

Some clinics have pivoted to focus on FDA-approved peptide medications, integrative medicine approaches, or the peptides that remain legally available for compounding (see next section).

What Can Still Be Compounded

Not all peptide compounding is gone. The following remain legally available through compounding pharmacies:

Category 1 Peptides

Peptide	Notes
Sermorelin	GHRH analog; previously FDA-approved as Geref
Gonadorelin acetate	GnRH analog; added to Category 1
GHK-Cu (topical)	Copper peptide; topical routes only
VIP (Vasoactive Intestinal Peptide)	Remains on Category 1
NAD+	Not a peptide, but commonly grouped with peptide therapies

Peptides That Are Active Ingredients in FDA-Approved Drugs

Any peptide that is the active ingredient in a currently FDA-approved drug can potentially be compounded under 503A rules, provided the compounding meets other legal requirements (patient-specific prescription, legitimate medical need, etc.). This includes peptides like:

Oxytocin
Desmopressin
Glucagon
Various GnRH analogs

What About Compounding "Salts" or Modified Forms?

Some compounding pharmacies have explored whether they can compound modified versions of restricted peptides -- different salt forms, different amino acid sequences, or "novel" formulations. The FDA has made clear that this approach does not bypass the restrictions. If the active pharmacological ingredient is the same, the substance falls under the same category designation regardless of salt form or formulation.

The SAFE Drugs Act: What Is Coming Next

The regulatory environment is poised to tighten further.

In December 2025, the SAFE Drugs Act (H.R. 6509) was introduced in Congress. If passed, it would:

Redefine "essentially a copy." Any compounded drug with the same active ingredient as an FDA-approved drug would be considered a copy unless a clinically significant change is made for an individual patient.
Cap production. 503A pharmacies would be limited to 20 copies of any single drug product per month.
Require reporting. Pharmacies shipping more than 20 compounded prescriptions out of state would need to file annual reports with the FDA.
Mandate inspections. Large 503B outsourcing facilities (100+ products per year) would face biennial inspections.
Remove fee caps. The bill would eliminate the $15,000 statutory cap on establishment fees for 503B facilities.

At the state level, multiple states have introduced legislation expanding pharmacy oversight, increasing documentation requirements, and extending regulation to clinical settings that administer compounded drugs. For a full timeline of legislative developments, see our FDA peptide regulation timeline.

Practical Guidance for Patients

If you are affected by the compounding crackdown, here is what you can do:

Step 1: Talk to Your Doctor

Have an honest conversation about your current peptide protocol and what alternatives exist. How to talk to your doctor about peptides covers this in detail.

Step 2: Explore FDA-Approved Alternatives

For many conditions, FDA-approved peptide drugs exist:

Weight management: Semaglutide (Wegovy), tirzepatide (Zepbound), liraglutide (Saxenda)
Growth hormone: Tesamorelin (Egrifta), somatropin (multiple brands)
Sexual health: Bremelanotide (Vyleesi), related to PT-141
Tissue repair: No direct FDA-approved peptide alternatives exist for BPC-157 or TB-500; discuss other treatment options with your provider

Step 3: Check What Can Still Be Compounded

Sermorelin remains available for compounding. If you were using CJC-1295/ipamorelin for growth hormone release, sermorelin may be a legal alternative. Find a reputable compounding pharmacy that operates within current regulations.

Step 4: Be Cautious with Research Peptides

If you are considering purchasing "research-use-only" peptides online, understand the risks:

Quality uncertainty. These products are not manufactured to pharmaceutical standards. How to verify peptide purity and how to read a certificate of analysis can help you evaluate quality, but even the best third-party testing cannot replicate the quality controls of FDA-regulated manufacturing.
Legal risk. Enforcement against research peptide sellers marketing to consumers is increasing at both federal and state levels.
Medical risk. Without physician oversight, dosing errors and adverse reactions are more likely.

Step 5: Stay Informed

The regulatory situation is evolving. PCAC reviews could move some peptides back toward Category 1. Congressional action could change the rules. Court decisions in pending litigation could affect enforcement timelines.

FAQ

Is it illegal to possess compounded peptides I already have?

No. The restrictions apply to pharmacies compounding and dispensing these substances. If you have existing supplies of a compounded peptide that was legally obtained before the restrictions took effect, possessing them is not illegal. However, obtaining new supplies through a compounding pharmacy is no longer legal for Category 2 substances.

Can my doctor compound peptides in their own office?

"Office-use" compounding is a gray area that varies by state. Some states allow physicians to compound medications in their office for immediate administration to their own patients. Others restrict or prohibit it. The FDA's Category 2 designations apply to all compounding, including office-use, but enforcement typically targets pharmacies rather than individual physician offices.

What about compounding pharmacies in other countries?

U.S. patients can sometimes obtain compounded medications from pharmacies in other countries where regulations differ. However, importing unapproved drugs into the United States is generally illegal under the FDCA. The FDA exercises enforcement discretion in some cases (such as small quantities for personal use), but this is not a guaranteed protection.

Will BPC-157 ever be available again through compounding?

It is possible but unlikely in the near term. BPC-157 would need either: (a) a successful nomination to the 503A bulks list with PCAC approval, which requires substantial safety data that does not currently exist from human clinical trials; or (b) a pharmaceutical company running it through the full FDA drug approval process. Neither scenario has a short timeline.

Why did the FDA allow compounding for years and then suddenly stop?

The FDA did not formally "allow" compounding of most peptides -- it chose not to enforce against it. The shift came from a combination of factors: the GLP-1 market becoming too large to ignore, accumulated adverse event data, pharmaceutical industry pressure, and the FDA's post-2012 commitment to stricter compounding oversight.

Are topical peptide products (serums, creams) affected?

Topical peptide skincare products are regulated differently from injectable compounded pharmaceuticals. Cosmetic peptide products sold over the counter (like those containing matrixyl, argireline, or copper peptides) are not affected by the compounding crackdown. These are regulated as cosmetics, not drugs. However, a compounding pharmacy making a prescription topical containing a Category 2 substance would be affected.

The Bottom Line

The FDA's compounding crackdown is not a temporary enforcement wave. It is a structural change in how peptides can be accessed in the United States. The agency has built a classification framework (the three-category system), demonstrated willingness to enforce it, survived initial legal challenges, and now has proposed legislation that would make the restrictions even more comprehensive.

For patients, the practical reality is clear: the era of easy access to compounded research peptides through prescribing physicians and compounding pharmacies is ending. What remains is a system centered on FDA-approved drugs, a shrinking list of compoundable substances, and an underground research-chemical market that carries its own risks.

The best path forward is working with knowledgeable physicians who understand the current regulatory framework, exploring the FDA-approved peptide options that do exist (and there are more than most people realize), and staying informed as the PCAC review process and legislative developments continue to reshape the field.

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/
Holt Law. "The Unregulated World of Peptides: What You Need to Know Before You Inject." https://djholtlaw.com/the-unregulated-world-of-peptides-what-you-need-to-know-before-you-inject/
Safe Healthcare Group. "FDA's Overreach on Compounded Peptides: Legal Battles and How Clinics Can Push Back." https://www.safehg.com/fdas-overreach-on-compounded-peptides-legal-battles-and-how-clinics-can-push-back/
Yoon Hang Kim Law. "Legal Peptide Compounding Guide: 503A & 503B Regulatory Compliance." https://www.yoonhangkim.com/post/legal-peptide-compounding-guide503a-503b-regulatory-compliance
NCPA. "FDA Releases Guidance for Compounding Pharmacies." January 13, 2025. https://ncpa.org/newsroom/qam/2025/01/13/fda-releases-guidance-compounding-pharmacies
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
Frier Levitt. "State and Federal Legislative Developments Affecting Drug Compounding." 2026. https://www.frierlevitt.com/articles/state-federal-legislative-developments-drug-compounding-2026/
Foley & Lardner. "GLP-1 Drugs: FDA Removes Semaglutide from the Drug Shortage List." https://www.foley.com/insights/publications/2025/02/glp-1-drugs-fda-removes-semaglutide-from-drug-shortage-list/
Lexology. "FDA Removes Certain Peptide Bulk Drug Substances from Category 2." https://www.lexology.com/library/detail.aspx?g=2e55b76a-3173-4e04-beda-bf021202f18d
Peptide Drug Summit 2026. "FDA Tightens Peptide Rules." https://www.peptide-drug-summit.com/news/new-fda-rules-are-reshaping-the-peptide-industry
Alliance for Pharmacy Compounding. "FDA Releases Final Interim Guidance on Bulk Drug Substances." https://a4pc.org/news/2025-01/fda-releases-final-interim-guidance-on-bulk-drug-substances-for-both-503as-and-503bs