BPC-157 and compounded peptides: FDA’s 2026 actions

Current as of October 21, 2026. Next review: when FDA issues the interim access policy.

The short version

FDA’s interim policy on compounded peptides went to the White House for review on October 14, 2026, and is not yet public.
In July, FDA’s advisory committee reportedly backed six of seven peptides, including BPC-157. FDA’s own briefing documents had recommended against all seven.
Until the policy issues, nothing has changed. None of these peptides is on FDA’s 503A bulks list, and FDA is still sending warning letters to “research use only” sellers.

Paul’s take

We’re still waiting on the details, but the direction is clear. There is a real push to give people a safe, legitimate way to get these products. My read is that FDA, HHS and Secretary Kennedy are working around antiquated regulations to find one. People are going to use peptides either way.

I managed supplier relationships for peptide product lines as a chief legal officer, and what wins here is trust. A 503A pharmacy should verify the certificate of analysis on every lot it buys and know exactly where its ingredient comes from. Plenty of people are interested in peptides but on the fence, because they aren’t sure they’re safe. The answer is a supply chain you can verify end to end, so what goes into someone’s body is what the label says. There may not be a perfect way to do that today. Whoever gets there first will lead this market.

— Paul Albarrán

What has FDA done on BPC-157 and compounded peptides in 2026?

BPC-157, also known as Bepecin or PL-14736, is a peptide that FDA’s briefing describes as reportedly made of 15 amino acids. FDA’s briefing says BPC-157 is marketed in the United States as an ingredient in dietary supplement capsules and tablets. In July 2026, FDA’s briefing documents proposed that BPC-157 not be added to the 503A bulks list. In August 2026, FDA warned online sellers of research-use-only peptides.

FDA’s interim access policy for compounded peptides is not yet public. Reginfo.gov lists FDA’s notice “Interim Access Policy for Compounding Using Certain Peptides” as pending review under Executive Order 12866. The listing shows a received date of October 14, 2026. It gives the title, stage and dates, but not the policy’s text. No Federal Register document with that title had appeared as of October 20, 2026.

Section 503A of the Federal Food, Drug, and Cosmetic Act sets conditions for drugs compounded by licensed pharmacists and physicians. Drugs that meet those conditions are exempt from three requirements, including the new drug application requirement.

What does section 503A require before a peptide can be compounded?

Under section 503A, a compounder may use a bulk drug substance only if it meets one of three conditions. It must comply with an applicable United States Pharmacopeia or National Formulary monograph, if one exists. If no monograph exists, a component of an FDA-approved drug qualifies, under section 503A(b)(1)(A)(i)(II). If no monograph exists and it is not a component of an FDA-approved drug, it must appear on the 503A bulks list. FDA develops that bulks list through regulations. The codified list, 21 CFR 216.23(a), names six substances. The six do not include BPC-157, KPV, TB-500, MOTS-c, emideltide, epitalon or semax.

While the list is developed, FDA’s interim policy sorts nominated substances into three categories. FDA does not intend to take action against compounding from a Category 1 substance if certain conditions are met. Those conditions include registered manufacturers, a valid certificate of analysis and compliance with the rest of section 503A. Category 2 holds substances that FDA says raise significant safety risks, and the Category 1 policy does not cover them. FDA’s guidance of January 7, 2025 says FDA does not intend to categorize substances nominated on or after that date.

FDA says state boards of pharmacy generally oversee state-licensed pharmacies day to day, except those registered with FDA as outsourcing facilities.

What changed for peptides in April and May 2026?

FDA’s Category 2 safety page, updated April 22, 2026, lists substances previously in Category 2 whose nominations were withdrawn by the nominators. The list includes BPC-157, KPV, TB-500, MOTS-c, emideltide, epitalon and semax. For each, the page still describes potential safety concerns, such as immunogenicity or limited safety information. FDA’s guidance says a withdrawal does not reflect an FDA determination about the validity of the nomination.

BPC-157, KPV, TB-500, MOTS-c, emideltide, epitalon and semax appear in no category of FDA’s list updated May 14, 2026. So none of them is within the Category 1 policy described above. The same May 14 update added GHK-Cu back to Category 1, except for injectable routes of administration.

What happened at FDA’s advisory committee meeting in July 2026?

FDA’s Pharmacy Compounding Advisory Committee met on July 23 and 24, 2026. It considered seven peptides for the 503A bulks list: BPC-157, KPV, TB-500, MOTS-c, emideltide, semax and epitalon. FDA’s briefing documents proposed that none of the seven be included on the list. The briefing notes that each nomination had been withdrawn, and that FDA elected to proceed with the presentations anyway.

Injectable products were proposed or evaluated for six of the seven peptides. BPC-157 was also proposed as oral capsules, a nasal spray, a rectal suppository and a transdermal cream. Semax was also proposed as a nasal spray. FDA’s slides note that a listed substance can be compounded for any use or route, unless its entry says otherwise.

FDA’s reviewers found each peptide not well characterized, chemically and physically. For BPC-157, TB-500, MOTS-c, emideltide, epitalon and semax, they also raised possible immunogenicity concerns for injectable forms, citing aggregation and peptide-related impurities. For BPC-157 and semax, FDA raised the same immunogenicity concern for nasal spray forms. KPV’s nomination proposed a topical cream or gel. For KPV, FDA cited a lack of human data by any route, including information to assess immunogenicity or aggregation. The committee was asked to vote on each substance, in both its free base and acetate forms.

FDA’s slides cite 28-day rat and dog studies in which BPC-157 injections produced signals possibly related to blood clotting and the liver. For epitalon, FDA said telomere lengthening raises concern that chronic exposure could let cells evade senescence and become cancerous. For emideltide, FDA said opioid-system stimulation could lead to addiction, and it found no nonclinical studies of that liability. For semax, FDA flagged a possible bleeding risk and a mouse dopamine finding typical of drugs of abuse. FDA noted that BPC-157 and TB-500 are on the World Anti-Doping Agency’s prohibited list.

FDA says its advisory committees make non-binding recommendations, which FDA generally follows but is not legally bound to follow. As of October 20, 2026, FDA’s meeting page posts the briefing documents, questions, agenda, roster, webcast information and FDA’s presentations. It does not list minutes or vote results.

RAPS’s Regulatory Focus reported on July 24, 2026 that the committee voted to recommend six of the seven. AJMC reported on July 31, 2026 that the committee voted 8 to 6, with one abstention, to recommend BPC-157, KPV and TB-500. AJMC reported a 7 to 5 vote for MOTS-c, with two abstentions. Regulatory Focus reported votes of 7 to 5 for epitalon, with one abstention, and 8 to 5 for semax. Both reports say the committee voted down emideltide, 7 against to 6 for, with one abstention. AJMC described the votes as overriding FDA’s career scientists, who had recommended against all seven.

What did FDA’s August 2026 letters say about research-use-only peptides?

FDA’s drug center issued five warning letters dated August 24, 2026, to online sellers of peptide products. Each came from the Office of Unapproved Drugs and Labeling Compliance in FDA’s Center for Drug Evaluation and Research. Products named across the letters included semaglutide, tirzepatide, retatrutide, tesamorelin and PT-141. FDA posts its letters in its warning-letter index.

Each seller’s labels said the products were for research or laboratory use, or not for human use. Each letter stated that evidence from the seller’s website established the products were intended as drugs for human use. FDA pointed to sales of bacteriostatic water for reconstitution, and in some letters to a peptide calculator.

The letters called the products unapproved new drugs and asked for a written response within 15 business days. They warned that failing to address the violations may lead to regulatory or legal action, including seizure and injunction.

What did FDA’s September 2026 letter say about telehealth prescriptions?

On September 18, 2026, FDA’s drug center issued a warning letter to a 503A compounding pharmacy after an inspection. FDA stated that some of its products appeared to be essentially copies of commercially available semaglutide and tirzepatide products. Those products combined tirzepatide with niacinamide, or semaglutide with cyanocobalamin.

Section 503A bars compounding essentially copies of a commercially available drug regularly or in inordinate amounts. The statute excludes a change that, as the prescriber determines, produces a significant difference for an identified patient.

FDA said many prescriptions repeated the same significant-difference wording verbatim, suggesting pre-generated statements. FDA added that third-party technology platforms offering pre-selected menu options call the individualized nature of those determinations into question. The letter also alleges adulteration from insanitary conditions under section 501(a)(2)(A), and CGMP violations under 21 CFR parts 210 and 211. For products FDA called ineligible under section 503A, the letter alleges unapproved new drug violations of sections 505(a) and 301(d). It also alleges misbranding under section 502(f)(1). The letter asks for a written response within 15 working days.

The letter also notes when FDA’s enforcement discretion for 503A copies of these drugs ended. It ended for tirzepatide injection products on March 5, 2025, and for semaglutide injection products on April 24, 2025.

What happens next?

Reginfo.gov lists the interim access policy as pending review, with no legal deadline.

FDA says the committee will meet again before the end of February 2027, at a time and place not yet set. It will consider cathelicidin LL-37, GHK-Cu, dihexa acetate, Melanotan II and pegylated mechano growth factor. GHK-Cu is already back in Category 1 for routes other than injection, under the May 14, 2026 update.

The final policy text, the second meeting and further FDA letters are the next public events.

The information on this site is general information, not legal advice.