US lets pharmacies make 6 unapproved peptides for now, despite FDA doubts

Two weeks ago, Biohack reported that the US health department had sent the White House a draft policy on pharmacies making certain unapproved peptides, with its details still secret (our earlier article). Now the policy is out. On Wednesday, October 28, the Department of Health and Human Services (HHS) said it will temporarily allow certain licensed providers to make six unapproved peptides while the Food and Drug Administration (FDA) considers a formal rule change.¹

Peptides are short chains of amino acids, the building blocks of proteins.² Some are approved medicines, such as insulin and the Ozempic-style diabetes and weight-loss drugs.² The six in this policy are not approved for any use.¹

What the policy does

According to an HHS notice, the agency will use “enforcement discretion.” In plain words, it will not take action against eligible providers that make the six substances.¹ The peptides are BPC-157, epitalon, KPV, MOTS-c, semax and TB-500.¹ None of them is currently on the FDA’s list of bulk ingredients that compounding pharmacies are allowed to use.¹ Compounding pharmacies mix custom versions of medicines for individual patients.²

The policy comes with conditions. Pharmacies must certify the identity and purity of the peptides and report side effects.¹ The side-effect reporting was not required under the earlier arrangements the agency described.¹

The policy is temporary. Before an ingredient can be added to the approved compounding list, the FDA has to propose a rule, take public comments and issue a final rule.¹ The temporary policy lets eligible providers go ahead while that work continues.¹ Reports differ on how long that takes: one says several months,¹ another says 12 to 24 months.³

HHS spokesperson Emily Hilliard framed the policy as a safety step:

“Under President Trump’s leadership, HHS is working to put prevention and patient safety at the center of health care—and that includes confronting the risks of black-market peptides.”

That quote was reported by Oduu.¹ The same report stresses that the temporary policy is not FDA approval and does not establish that the six peptides are safe and effective for people.¹

What is known about the six peptides

The peptides are promoted online for things like tissue repair, faster healing, better-looking skin and longevity.¹ FDA scientists concluded that the available evidence is not enough to establish their safety and effectiveness.¹ Most of the data on these peptides comes from animal studies.⁴

In its reviews, the FDA looked at specific medical uses. These were ulcerative colitis for BPC-157, wound healing and inflammatory conditions for KPV, wound healing for TB-500, and obesity and osteoporosis for MOTS-c.⁵ It also looked at stroke-related brain injury, migraine and a facial nerve pain condition for semax, and insomnia for epitalon.⁵

Here is what the agency’s staff found on some of them:

• BPC-157: The five studies FDA staff reviewed “were of short duration, had small sample sizes and evaluated doses that were likely exploratory in nature.”⁶ AJMC described its only human clinical evidence as a decades-old meeting summary that was never published.³ Most of its animal research comes from one Croatian group, which AJMC said holds undisclosed patents and company ties connected to the peptide.³
• TB-500: Regulators said they could not find any human studies using it.⁶
• KPV: When the FDA restricted it in 2023, the agency said it had “not identified any human exposure data” on products containing it.⁵

The FDA had earlier placed BPC-157 and more than a dozen other injectable peptides on its list of substances too risky for pharmacies to make. It cited possible contamination, allergic reactions and tumor growth.⁴ That list, called Category 2, is where the FDA places bulk ingredients that “may present significant safety risks.”⁷

What this decision does not settle

This is a change in how rules are enforced, not new scientific data. Nothing in the announcement adds evidence about whether these peptides help or harm people. The FDA’s formal review is still going on.¹ The agency has scheduled meetings with outside groups, including Medivant Healthcare, a compounding pharmacy that offers peptides.¹

It is also unclear exactly what product a name like TB-500 refers to. That substance is not recognized as an official drug ingredient in the US. “There’s no way to know what the substance actually is, was or will be tomorrow because that name has no legal meaning,” Russell Wesdyk, an associate director in the FDA’s drug center, said in July.⁶

Who is pushing for it, and who objects

Health Secretary Robert F. Kennedy Jr. has said he is a “big fan” of peptides and has taken them himself.² Public Citizen reported that he has used them to treat his own injuries.⁵ Kennedy has argued that US pharmacies must be allowed to sell peptides because Americans were turning to “gray market” products made in China and elsewhere.⁴ In April he wrote on X that easing the limits “begins to restore regulated access and will immediately begin shifting demand away from the black market.”²

That gray market sells peptides labeled “for research use only,” which lets sellers claim they are not meant for people, even while they are promoted for wellness.¹ Independent lab tests of such products have found bacterial contamination, heavy metal and solvent residues, and doses below what the label said, according to Tech Times as cited by AJMC.³

Some backers have business ties to peptides. Some of the biggest figures in the Make America Healthy Again movement sell peptide injections and supplements.⁴ The telehealth company Hims & Hers welcomed the FDA’s earlier plans as a way to move peptides “out of the gray market.”²

Critics say the policy gets ahead of the science. Dr. Peter Lurie, a former FDA official who leads the Center for Science in the Public Interest, said it expands access before the benefits are known. He called the approach effectively “turning a blind eye” to unproven drugs.¹ Shabbir Safdar of the Partnership for Safe Medicines said: “Imagine what it means for the nation’s top drug regulator to announce they won’t enforce the laws on people making completely untested compounds and distributing them to the public.”¹

How this fits the story so far

In September 2023, the FDA under the Biden administration barred compounding pharmacies from making a group of peptides it saw as possible safety risks.² On February 27, 2026, Kennedy announced that about 14 of 19 restricted peptides would be moved back to allowed status.³ BioPharma Dive reported the FDA’s plan as covering 12 peptides, to be reviewed by an advisory panel in two batches.²

At the July meeting, that panel of outside advisers voted 8 to 6, with one abstention, to recommend the peptides for pharmacy compounding (our report on the vote).⁶ FDA staff scientists had unanimously recommended against adding the first four peptides they reviewed.³ Before the meeting, people with ties to the peptide industry were added to the panel. Accounts of how many differ: the AP said more than a half-dozen,⁶ Oduu said six,¹ and AJMC said eight new members, most with financial ties to peptide businesses.³ Panel members from academic backgrounds mostly voted no.⁶

The vote was not binding.⁶ Oduu reported that during the meeting, some members worried that approving these ingredients could complicate future FDA decisions on other unapproved drugs.¹ In mid-October, HHS sent an “interim access policy” to the White House budget office for review.⁴ Today’s announcement is that policy taking effect.

What to watch next

• The formal rule. Whether the FDA proposes adding the six peptides to its compounding list, and what public comments say.¹
• Side-effect reports. The new reporting requirement may, over time, give regulators data on problems that have been hard to track.¹
• The next batch. A later panel meeting, to be held before the end of February 2027, is set to consider LL-37, GHK-Cu, Dihexa acetate, Melanotan II and mechano growth factor.⁵

For now, the six peptides remain unapproved drugs with little human data behind them. What has changed is how the government says it will treat pharmacies that make them.¹