Six Peptides Get a Pharmacy Pass; FDA Found No Human Data on Three

Every product made under the new federal peptide policy has to carry a label saying it is a compounded drug product and not for resale, according to a summary of the policy's Appendix B. That label is a disclosure, not a seal of approval, and the gap between those two things is most of this story.

On Wednesday, Oct. 28, the Department of Health and Human Services filed a notice for a draft policy covering six peptides: BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500. The notice is scheduled to publish in the Federal Register on Friday, Oct. 30, and nothing in it approves any of the six.

The notice is a pledge not to enforce, not an approval

So, is BPC-157 legal now? Nothing has been approved, added to a federal list or finalized. What the HHS notice, signed by Secretary Robert F. Kennedy Jr., announces is a choice about whom the government will pursue:

"HHS does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a peptide bulk drug substance found in Appendix A."

HHS notice, Docket No. HHS-OASH-2026-0496

That is enforcement discretion: a regulator's choice about which violations to chase, not a change in what the statute allows. The notice says the draft "does not establish any rights for any person and is not binding on HHS or the public." HHS may revisit it if "a safety signal or product quality issue arises." An HHS spokesperson told CBS News the policy "does not grant FDA approval or establish clinical safety and effectiveness."

Section 503A of federal law governs compounding by traditional pharmacies, meaning a pharmacist or physician preparing a medicine for an individual patient on a prescription. Under 503A, raw ingredients (bulk drug substances) must comply with a U.S. Pharmacopeia or National Formulary monograph where one exists; if none does, they must be components of FDA-approved drugs or appear on a list FDA develops through regulation, the "503A bulks list" (21 U.S.C. 353a). These six are on no such list. The policy applies "while" that list "is developed through rulemaking"; CBS reported FDA has not yet proposed a rule.

Online posts and searches such as "rfk peptides category 1" show the confusion over whether the peptides were "moved to Category 1." They were not. FDA sorts nominated compounding ingredients into categories. Category 1 substances "may be eligible for inclusion on the 503A bulks list" and Category 2 means FDA "has identified significant safety risks." FDA's Category 2 page lists all six only in the table of substances "previously in category 2," withdrawn by the people who nominated them. Withdrawn from Category 2 is not placed in Category 1; the policy rests on its own Appendix A. The Associated Press reported that in 2023 FDA listed more than a dozen peptides, including BPC-157 and TB-500, as ones that should not be compounded, citing allergic reactions, kidney damage and tumor growth.

On timing, the notice states no separate effective date, so nothing in it says when pharmacies may start. Comments are open for two weeks after publication, which puts the deadline at Friday, Nov. 13, through regulations.gov under the docket number above.

What a compliant pharmacy has to do

Lawful access runs through a prescription, filled by a state-licensed 503A pharmacy, a federal facility or a licensed physician. The policy leaves every other requirement of the Food, Drug, and Cosmetic Act in place, including the ban on insanitary conditions. Per a summary of the policy's Appendix B, the conditions are these:

• One listed active ingredient per product. A BPC-157 plus TB-500 vial is outside the policy.
• A bulk substance matching the identity in Appendix B, made by an FDA-registered facility that follows current good manufacturing practice, with a valid certificate of analysis. Repackers and resellers must have validated the maker and its certificate.
• Only the listed salt form and route for each peptide, and for oral forms, documentation of adequate oral bioavailability.
• No delivery device except an FDA-cleared (510(k)) syringe.
• Reports of products, serious adverse events and quality problems to FDA's MedWatch system and to the relevant states.
• A label stating the product is compounded and not for resale.

That is tighter than ordinary 503A status, a comparison that is my reading rather than HHS's. FDA's July slides noted that a 503A product "is not required to have a label to inform patients and providers how to use it," need not follow current good manufacturing practice, and that compounders "are not required to report adverse events" to FDA. Unless a listing says otherwise, a listed substance can be compounded "for any use or via any route." The interim policy adds route limits, a manufacturing standard and mandatory reporting. On devices, Bob Pollock of Lachman Consultants, a regulatory firm, wrote: "[M]ore complex drug delivery devices introduce additional patient risk."

Much stays outside. Law firm Frier Levitt wrote that the policy does not independently extend enforcement discretion to 503B outsourcing facilities, a separate category from 503A pharmacies, and that it does not displace state pharmacy-board rules. The firm also lists as uncovered other peptides, combination products, forms outside Appendix B, unrestricted manufacturing for general distribution, and importation. Becker's Hospital Review reported that HHS aims to discourage research-use-only peptides from foreign manufacturers, offering "a more controlled alternative."

"Peptide" is also not one product. An Australian coroner delivered findings on Oct. 28, reported by ABC Australia, on the death of actor Richard Norton, 75, from complications of using two unapproved peptide products, CJC1295 and Ipamorelin, compounded by a licensed pharmacy. According to ABC's report on the coroner's findings, he took more than the prescribed dose. Neither is among the six.

For a reader weighing a pharmacy's offer, the policy supplies things a reader can check: a prescription, the label statement, and a certificate of analysis from an FDA-registered maker. The notice itself says: "Compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed."

What FDA's reviewers found, peptide by peptide

The policy changes the enforcement posture, not the evidence. The table sets what FDA reviewed, proposed and the committee voted beside what HHS now allows.

Peptide	Use FDA evaluated	FDA staff, July	Committee vote (yes-no)	Form named in HHS policy
BPC-157	Ulcerative colitis	Not on bulks list	8-6	Acetate: subcutaneous, intramuscular, oral or topical
TB-500	Wound healing	Not on bulks list	8-6	Acetate: subcutaneous or intramuscular injection
KPV	Wound healing, inflammatory conditions	Not on bulks list	8-6	Acetate: topical or oral
MOTS-c	Obesity, osteoporosis	Not on bulks list	7-5	Acetate: subcutaneous or intramuscular injection
Epitalon	Insomnia	Not on bulks list	7-4	Acetate: subcutaneous or intramuscular injection, intermittent courses
Semax	Cerebral ischemia, migraine, trigeminal neuralgia	Not on bulks list	8-5	Free base: intranasal

Sources: FDA's meeting notice and slides, a law-firm summary of the votes (the Epitalon and Semax tallies come from that summary alone), and the policy's Appendix B. "Not on bulks list" is FDA staff's proposal; the committee vote is a vote to recommend listing.

Start with the half of the six where the human record is empty. In FDA's briefing slides from July 23, reviewers wrote that their literature search "did not identify data, such as clinical studies, on the use of KPV in humans." For TB-500: "FDA did not find any information where TB-500 was administered to patients to treat any disease or condition." For MOTS-c, they identified no publicly available clinical studies of any MOTS-c-related substance given to humans. For KPV and TB-500, FDA wrote that the potential human safety risks are unknown; for MOTS-c it cited a lack of human data and of information to assess immunogenicity. That is the literature as of July, not a finding of harm.

BPC-157, the best known of the six, has some human data, though not much. FDA found small studies: a rectal enema in 24 healthy subjects, an enema in about 26 people with ulcerative colitis, a knee injection in 17 people, a bladder injection in 12, and IV infusion in two healthy subjects. Reviewers called them short and small, and found "no studies that administered BPC-157 to humans via the proposed oral, SC, nasal, or transdermal" routes. The policy allows oral, subcutaneous and topical use.

The one colitis trial, available only as a meeting abstract, enrolled 53 subjects. Disease activity fell by 3.2 points on BPC-157 and 1.6 on placebo, "an estimated difference of 1.6 points (95% CI -4.84, 1.62)." In plain terms, the interval spans zero, so the trial cannot rule out no difference (my translation). In rats and dogs given 28 days of intramuscular treatment, FDA noted signals "potentially related to coagulopathy and the liver"; longer studies were unavailable.

Then the adverse-event reports. FDA found three for BPC-157 in its FAERS database: a 55-year-old woman with nine days of redness and swelling at an injection site, who was also using injectable thymosin; a 28-year-old man with shortness of breath that led to an emergency room visit; and a 40-year-old woman with skin and gum darkening that recurred on rechallenge. FDA wrote it was "unclear if these AEs were attributable to BPC-157."

Epitalon and Semax sit in between. For Epitalon, FDA found no human safety studies; one study of 20 healthy people, given it under the tongue for 20 days, reported no safety data. FDA raised a mechanistic worry that lengthening telomeres "could enable cells to evade senescence and become cancerous" under chronic exposure. For Semax, registered in Russia as nasal drops, FDA found no published human pharmacokinetic studies and one May 2025 report of eye pain and burning after drops bought online, with hospitalization and symptoms lasting at least a year.

Immunogenicity means the immune system reacting to a drug as foreign, and FDA wrote that peptides "may elicit an immunogenic response; this response may be enhanced when peptides are given via the SC and nasal" routes. ProPublica described reactions ranging from rashes to anaphylactic shock.

The committee and the agency read the same record differently

FDA's staff slide for BPC-157 reads: "FDA is proposing that BPC-157 (free base) and BPC-157 acetate NOT be included on the 503A Bulks List." The HHS notice reads: "HHS does not intend to take enforcement action." Both can be true because they answer different questions: one concerns a permanent listing, the other a revocable pledge fenced by conditions.

FDA's Pharmacy Compounding Advisory Committee, meeting at the White Oak campus in Silver Spring, Maryland, voted the other way, narrowly. On BPC-157, KPV and TB-500 the vote to recommend was 8-6, with one abstention each; MOTS-c passed 7-5. That is a margin of two votes. The Alliance for Safe Biologic Medicines, a coalition of patient and physician groups, argued in an Oct. 26 letter that the eight panelists Kennedy added before the review formed the entire affirmative bloc on BPC-157, KPV and TB-500; that claim is theirs. Pollock of Lachman said the policy "clearly follows" the committee's recommendations, though a final decision still needs rulemaking.

The Associated Press reported that most FDA scientific staff opposed the plan, according to six people familiar with its development. HHS had initially wanted FDA to write a rule adding the peptides to the bulks list; FDA officials warned of major safety concerns, and HHS shifted to non-enforcement. AP said FDA staff then helped draft safeguards such as FDA-registered sourcing and side-effect data collection. Kennedy argues, AP reported, that Americans are buying "gray market" products from abroad. He told CBS the policy "advances patient choice and freedom while appropriately protecting patient safety."

As of FDA's July review, four of the six peptides had zero adverse-event reports in its system: KPV, TB-500, MOTS-c and Epitalon. BPC-157 had three, and Semax one. FDA's own footnote says an absence of reports "does not imply that the substance is safe or lacks toxicities," because reporting is voluntary and FDA does not receive all reports, "especially for compounded products." The policy changes that by requiring pharmacies to send serious events to MedWatch, so future counts for these six may draw heavily on that reporting.