PeptideJournal
Regulatory & Legal14 min read

Consumer Rights When Peptides Are Restricted

**When the FDA moved 17 therapeutic peptides to Category 2 of the bulk drug substance list in 2023 and 2024, thousands of patients lost access to treatments their doctors had been prescribing through compounding pharmacies.

When the FDA moved 17 therapeutic peptides to Category 2 of the bulk drug substance list in 2023 and 2024, thousands of patients lost access to treatments their doctors had been prescribing through compounding pharmacies. If you're one of them — or if you're worried about losing access in the future — here's what your actual legal options look like.

Table of Contents

What Happened to Peptide Access

Between October 2023 and early 2024, the FDA placed 17 widely used therapeutic peptides on Category 2 of the interim 503A bulks list. Category 2 means the FDA considers the substance to present "significant safety concerns," and compounding pharmacies are prohibited from using it.

The affected peptides included BPC-157, thymosin beta-4 (TB-500), AOD-9604, CJC-1295, ipamorelin, thymosin alpha-1, selank, kisspeptin-10, and several others. These weren't obscure research chemicals — they were treatments that hundreds of compounding pharmacies had been preparing for patients with prescriptions from licensed physicians.

In September 2024, five peptides (AOD-9604, CJC-1295, ipamorelin acetate, thymosin alpha-1, and selank acetate) were procedurally removed from Category 2 after their nominators withdrew. But this wasn't a reprieve. When the Pharmacy Compounding Advisory Committee (PCAC) reviewed these peptides in October and December 2024, it voted against adding any of them to the approved bulks list. Every one was rejected.

Then in January 2025, the FDA eliminated Categories 2 and 3 entirely, streamlining the system. Substances that had been on those lists remain prohibited. Going forward, any new substance must go through the PCAC process to be added to the official bulks lists.

The result: patients who had been receiving peptide therapy through compounding pharmacies — many of them for conditions like chronic pain, gut dysfunction, immune deficiency, and age-related decline — were cut off.

Understanding Your Rights as a Patient

American patients have several legal rights that apply when treatments become restricted, but none of them provide a simple workaround for the peptide situation. Being honest about this is important, because some advocacy organizations oversell what these rights actually accomplish.

You have the right to informed consent. This means your doctor must explain the available treatment options, their risks and benefits, and alternatives. If a peptide your doctor recommended is no longer available, they're obligated to discuss what else might work.

You have the right to seek a second opinion. If your current provider has stopped offering peptide therapy, another physician may have different approaches or access to alternative treatments.

You have the right to participate in clinical trials. This is one of the few direct pathways to accessing investigational peptides legally and safely.

You have the right to petition the FDA. Citizens can submit formal petitions requesting that the FDA reconsider regulatory decisions. This process is slow but legally recognized.

You do not have a blanket right to any specific medication. No law guarantees access to unapproved drugs simply because a patient wants them or because a doctor believes they might help. The FDA's authority to restrict unapproved substances has been upheld repeatedly in court.

Right to Try Laws: What They Do and Don't Cover

The Right to Try Act (formally the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act) was signed into federal law on May 30, 2018. It was designed to give terminally ill patients access to investigational treatments that had passed Phase I clinical trials but hadn't yet received FDA approval.

Here's the critical detail: Right to Try has extremely narrow eligibility requirements.

To qualify, a patient must have been diagnosed with a life-threatening condition, have exhausted all approved treatment options, be unable to participate in a clinical trial for the treatment, and obtain a prescription from their physician.

Even then, the manufacturer must agree to provide the drug. Right to Try does not compel any company to supply its investigational product. It simply removes the FDA's role in approving the request.

What this means for peptides: Right to Try is not a viable pathway for most people seeking peptide therapy. If you're using BPC-157 for a sports injury, ipamorelin for age-related growth hormone decline, or thymosin alpha-1 for immune support, Right to Try doesn't apply. These aren't life-threatening conditions, and most of the restricted peptides haven't completed Phase I trials under an IND.

Right to Try works for an extremely small number of patients with terminal diseases who have run out of options. In practice, it has been used by roughly 100 to 200 patients per year since its passage — far fewer than many advocates expected.

Expanded Access and Compassionate Use

The FDA's Expanded Access program (previously called "compassionate use") is a separate pathway that predates Right to Try and, in practice, is far more commonly used.

Expanded Access allows patients with serious or immediately life-threatening conditions to use investigational drugs outside of clinical trials. Unlike Right to Try, it requires FDA authorization — but the FDA approves more than 99% of Expanded Access requests. For emergency requests, the median FDA response time is less than 1 day. For non-emergency requests, it's about 4 days.

Three types of Expanded Access exist:

Individual patient access is the most common. A physician files an IND on behalf of a single patient. This requires the manufacturer's agreement to supply the drug, FDA authorization, and Institutional Review Board (IRB) review.

Intermediate-size patient populations allow access for groups of patients that are too small for a full clinical trial but too large for individual access.

Treatment IND/protocol allows widespread access to an investigational drug that's close to receiving FDA approval, typically during the NDA review period.

What this means for peptides: Expanded Access is technically available for investigational peptides that have an active IND — but most of the peptides that were restricted from compounding (BPC-157, TB-500, CJC-1295) don't have active INDs. Without an IND, there's no investigational drug to provide expanded access to. For peptides that are in active clinical trials (like next-generation GLP-1 agonists), Expanded Access may be an option for patients who qualify.

Clinical Trial Access

Participating in a clinical trial is the most straightforward legal way to access an investigational peptide. Unlike Right to Try or Expanded Access, clinical trials don't require a terminal diagnosis. They do require that you meet the trial's inclusion criteria and that a trial is actually running for the peptide and condition you're interested in.

How to find peptide clinical trials:

ClinicalTrials.gov is the most comprehensive database. As of early 2026, there are hundreds of active peptide clinical trials across all phases. You can search by condition, peptide name, or location. The GLP-1 agonist space alone has dozens of active Phase II and Phase III trials.

Your physician can help. Academic medical centers and specialty clinics often participate in clinical trials and can identify relevant studies. If you're interested in a specific peptide, ask your doctor whether any trials are enrolling.

Patient advocacy organizations sometimes maintain lists of clinical trials relevant to their disease area.

Trial limitations are real. You might not be near a trial site. You might not meet the inclusion criteria. The trial might use a placebo group, meaning you could receive no active drug. And trials end — if the peptide doesn't receive FDA approval, your access ends with the trial.

But clinical trials provide something that no other pathway does: access to the peptide under medical supervision with regular monitoring, at no cost for the drug itself, and with the assurance that the formulation has been manufactured to pharmaceutical standards.

Compounding Alternatives That Still Exist

Not all peptide compounding was banned. Some peptides remain available through properly licensed compounding pharmacies.

Peptides that can still be compounded must meet one of these criteria: they are a component of an FDA-approved drug, they have a USP or NF monograph, they appear on the FDA's 503A Bulks List, or they are on Category 1 of the interim 503A Bulks List.

Examples of peptides that still qualify:

Sermorelin — a growth hormone-releasing hormone (GHRH) analog — remains available for compounding. It has a USP monograph and an established safety profile from its time as the FDA-approved drug Geref (withdrawn for commercial, not safety, reasons).

NAD+ remains available through compounding.

Glutathione remains available as a compounding ingredient.

GHK-Cu (topical formulations only) was placed on Category 1 with specific limitations.

What about 503B outsourcing facilities? Section 503B facilities can produce larger batches without patient-specific prescriptions and face stricter federal oversight. The FDA is developing a separate 503B bulks list. Some peptides may be available through 503B facilities even if they're restricted under 503A, though this is a rapidly evolving area.

Finding a compounding pharmacy that still offers legitimate peptide products requires research. Verify that the pharmacy is properly licensed, uses FDA-registered facilities, and provides certificates of analysis for its products.

FDA-Approved Peptide Alternatives

For some conditions, FDA-approved peptide drugs may provide similar benefits to the compounded peptides that were restricted.

For weight management and metabolic health: Semaglutide (Ozempic, Wegovy, Rybelsus) and tirzepatide (Mounjaro, Zepbound) are FDA-approved GLP-1 agonists. An oral formulation of Wegovy was approved in late 2025. These are available by prescription and increasingly covered by insurance, with Medicare coverage expanding in 2026.

For growth hormone deficiency: Tesamorelin (Egrifta) is FDA-approved for HIV-associated lipodystrophy and is sometimes used off-label. Sermorelin can still be compounded. Growth hormone itself is FDA-approved for documented growth hormone deficiency.

For wound healing and tissue repair: No FDA-approved peptide directly replaces BPC-157 or TB-500. However, platelet-rich plasma (PRP), FDA-cleared wound care products, and conventional medical approaches remain available. Several BPC-157 analogs are in early-stage development by pharmaceutical companies.

For immune support: No FDA-approved product directly replaces thymosin alpha-1 for general immune modulation. Thymalfasin (Zadaxin) — the pharmaceutical-grade version of thymosin alpha-1 — is approved in over 30 countries but not in the United States. It has been available in some contexts under Expanded Access.

The gap between what was available through compounding and what's available through FDA-approved alternatives is real. For many patients, no approved equivalent exists.

Patient Advocacy: How to Push Back

If you believe the FDA's restrictions on peptide compounding are unjustified, there are legitimate ways to make your voice heard.

Support organized advocacy efforts. The Peptide Legal Fund raises money for legal challenges and research aimed at reversing Category 2 designations. Organizations like Save Peptides organize grassroots advocacy campaigns. The Alliance for Peptide Professionals works with regulators to establish safety and purity standards for clinical-grade peptides.

File a citizen petition. Under 21 CFR 10.30, any person can petition the FDA to issue, amend, or revoke a regulation, or to take or refrain from an action. The FDA is required to respond. This process is slow (the FDA has 180 days to respond but often takes longer), and petitions rarely succeed on their own — but they create a public record and can build pressure for reconsideration.

Contact your elected representatives. Members of Congress can request that the FDA reconsider specific regulatory decisions. Congressional pressure has been a factor in past FDA policy changes. The current political environment under the MAHA (Make America Healthy Again) agenda may be receptive to arguments about health freedom and access to peptide therapy.

Comment on proposed rules. When the FDA proposes new rules — like the GRAS overhaul or changes to compounding regulations — a public comment period is required. Detailed, evidence-based comments from patients, physicians, and advocacy groups carry weight.

Advocate for research funding. One of the FDA's stated reasons for restricting peptides is the lack of adequate human safety data. Advocating for NIH or private funding for clinical trials of peptides like BPC-157 or thymosin alpha-1 addresses the root problem.

Be wary of scams. Some "advocacy" organizations are thinly disguised marketing operations for peptide vendors. Legitimate advocacy focuses on regulatory change and research funding, not on selling you products.

State-Level Protections and Variations

Peptide regulation isn't purely a federal matter. States have their own compounding regulations, medical practice laws, and enforcement priorities.

State medical boards regulate what physicians can prescribe and how they practice. Some states are more permissive than others regarding off-label prescribing and compounding relationships. However, state medical boards cannot override federal FDA restrictions on which substances can be compounded.

State boards of pharmacy regulate compounding pharmacies within their jurisdiction. In 2024 and 2025, several state boards took enforcement actions against pharmacies that continued compounding restricted peptides — in some cases suspending licenses simply for having research-labeled vials of Category 2 peptides on premises.

State attorneys general have become increasingly active in peptide enforcement, using consumer protection statutes and unfair trade practice laws to target companies selling peptides outside of legal channels. This is a newer development — state-level enforcement was previously less common than federal FDA action.

State right-to-try laws exist in 41 states (as of 2025) and generally mirror the federal Right to Try Act. Some state laws have broader eligibility criteria than the federal law, but they still require the manufacturer's cooperation and don't apply to substances that have never entered the IND process.

State-by-state peptide legality varies enough that consulting a healthcare attorney familiar with your state's laws may be worthwhile if you're navigating a complex access situation.

What Your Doctor Can Still Do

Your physician retains significant authority even when specific peptides are restricted from compounding.

Prescribe FDA-approved alternatives. For many conditions that were previously treated with compounded peptides, FDA-approved options exist. Your doctor can evaluate whether approved peptides or other treatments might work for your specific situation.

Prescribe compounded peptides that remain available. Sermorelin, NAD+, and certain other substances are still available through compounding. Your doctor can determine whether these are appropriate for your care.

Refer you to clinical trials. Physicians, especially those at academic medical centers, can connect you with clinical trials for investigational peptides.

Practice off-label prescribing. The FDA regulates drug marketing, not medical practice. Physicians can legally prescribe any FDA-approved medication for any purpose they believe is medically appropriate, even if it's not the drug's approved indication. This doesn't help with unapproved peptides, but it expands the options within the FDA-approved peptide portfolio.

Document your clinical history. If you were benefiting from a compounded peptide that was restricted, your doctor should document your treatment history, outcomes, and the impact of losing access. This documentation matters for advocacy, for potential Expanded Access applications, and for your own medical record.

Advocate on your behalf. Physicians can testify at FDA advisory committee meetings, submit public comments on proposed regulations, and contribute to professional organizations that advocate for patient access.

FAQ

Can I still buy peptides online for "research purposes"?

Peptides labeled "for research use only" (RUO) are technically sold for laboratory research, not human use. The FDA has taken enforcement action against companies that sell RUO peptides together with reconstitution supplies and dosing information, treating the RUO disclaimer as "a ruse to avoid FDA scrutiny." Purchasing and self-administering RUO peptides carries legal risks and significant safety risks — FDA testing has found that up to 40% of online peptide products contain incorrect dosages or undeclared ingredients.

Will the political environment change anything?

HHS Secretary Robert F. Kennedy Jr. has signaled interest in peptide access, stating that the "FDA's war on public health is about to end" with specific mention of peptides. The FDA under his authority removed several experts from the compounding advisory panel, which could lead to more peptide-friendly appointments. However, as of early 2026, no formal regulatory changes have been finalized. The regulatory timeline remains uncertain.

Generally, no. The FDA prohibits the importation of unapproved drugs, and peptides classified as unapproved drugs fall under this prohibition. The FDA's Import Alert 66-78 specifically targets unapproved peptides, and 12 additional peptides were added to this list in 2025. There are narrow exceptions for personal importation of small quantities of drugs approved in other countries but not in the US, but these exceptions are discretionary — the FDA can enforce the prohibition at any time.

What if my doctor prescribed a peptide before the ban?

Previous prescriptions don't create a right to continued access. Once a peptide is restricted from compounding, pharmacies cannot fill new prescriptions or refill existing ones. Your doctor can help you transition to alternative treatments and document your history for advocacy purposes.

Can I sue the FDA over lost access to peptide therapy?

Lawsuits have been filed. The Evexias Health Solutions case resulted in a partial settlement in September 2024, and a lawsuit by a large compounding pharmacy alleged the FDA skipped legally required procedures when adding peptides to Category 2. These legal challenges forced the FDA to hold public advisory meetings. However, no court has ordered the FDA to reverse its peptide restrictions. Litigation is expensive, slow, and has no guaranteed outcome. Supporting established legal fund organizations may be more effective than individual lawsuits.

Are there countries where I can legally access restricted peptides?

Some peptides that are restricted in the US are available in other countries. Thymosin alpha-1 (Zadaxin) is approved in over 30 countries for hepatitis and cancer immunotherapy. BPC-157 research is conducted more openly in some European and Asian countries. However, international peptide legality varies widely, and accessing treatment abroad doesn't change the legal status of bringing peptides back into the US.

The Bottom Line

Losing access to a treatment that was helping you is frustrating, and the peptide restrictions have affected real patients with real medical needs. But the options that actually exist are more limited than many advocacy websites suggest.

Right to Try and Expanded Access are designed for serious or life-threatening conditions — they're not pathways to continue wellness-oriented peptide therapy. Clinical trials are a genuine option but depend on what's being studied, where, and whether you qualify. Compounding alternatives still exist for some peptides, and FDA-approved peptide drugs cover certain indications.

The most productive thing patients can do is work with their physicians to find legal alternatives, support organized advocacy that's pushing for regulatory reform, and participate in the public comment process when the FDA proposes changes. The regulatory environment for peptides is genuinely in flux, and patient voices matter — but they need to be channeled through legitimate pathways to have real impact.

References

  1. FDA. "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A." https://www.fda.gov/media/174456/download

  2. Frier Levitt. "Regulatory Status of Peptide Compounding in 2025." https://www.frierlevitt.com/articles/regulatory-status-of-peptide-compounding-in-2025/

  3. FDA. "Expanded Access." U.S. Food and Drug Administration. https://www.fda.gov/news-events/public-health-focus/expanded-access

  4. PMC. "Understanding the Right to Try Act." Missouri Medicine. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7416898/

  5. PMC. "Expanded Access Versus Right-to-Try." Yale Journal of Biology and Medicine. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7081483/

  6. Congress.gov. "Expanded Access and Right to Try: Access to Investigational Drugs." Congressional Research Service. https://www.congress.gov/crs-product/R45414

  7. Holt Law. "Deep Dive: Regulatory Status of Popular Compounded Peptides." https://djholtlaw.com/deep-dive-regulatory-status-of-popular-compounded-peptides/

  8. EVEXIAS Health Solutions. "An Affront to Health Freedom: The FDA Recategorizes 17 Therapeutic Peptides." https://www.evexias.com/an-affront-to-health-freedom-the-fda-recategorizes-17-therapeutic-peptides/

  9. Florida Healthcare Law Firm. "Are Peptides Legal in the U.S.? Complete 2025 Legal Guide." https://floridahealthcarelawfirm.com/are-peptides-legal/

  10. SafeHG. "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/

  11. CNN. "The trend of unproven peptides is spreading through influencers and RFK Jr. allies." November 2025. https://www.cnn.com/2025/11/15/health/peptides-unregulated-influencers