HHS Opens Compounding Pharmacies to Six Unapproved Peptides Under RFK Jr.

Health and Human Services Secretary Robert F. Kennedy Jr. filed a draft policy this week. It allows small compounding pharmacies to prepare six peptide drugs that have never received Food and Drug Administration approval. These compounds have circulated on the gray market and been sold through unregulated online sellers for years.

The six substances are BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500. Wellness influencers and some clinicians have promoted them for claims ranging from recovery and anti-aging to cognitive enhancement. Evidence supporting their safety and effectiveness is thin. Kennedy's draft policy was filed Wednesday; it opens for public comment Friday and runs through Nov. 13, according to CBS News.

What the policy actually does

Compounding pharmacies mix ingredients to create medications tailored to individual patients. The new HHS policy tells regulators to exercise enforcement discretion. In practice, that means licensed small pharmacies that prepare these six peptides by prescription will not be penalized. The policy does not make them FDA-approved. "The policy does not grant FDA approval or establish clinical safety and effectiveness," an HHS spokesperson told CBS News.

The policy covers only 503A pharmacies. These are the smaller operations that compound drugs for individual patients. Larger 503B outsourcing facilities, which produce medications at higher volumes, are not covered. To compound these peptides, a pharmacy must use an FDA-registered ingredient supplier and obtain a lab certificate for raw materials. Prescriptions must be written for specific patients. Pharmacies must also report serious side effects to federal regulators.

How RFK Jr.'s support shaped this peptide and compounding pharmacy decision

Peptides are strings of amino acids that can have strong effects on the body. Some occur naturally, and others are synthetic variations. Several FDA-approved drugs are peptide-based. These include insulin and GLP-1 drugs used for diabetes and obesity treatment, which have passed full clinical review. The six substances in Kennedy's policy have not completed that review process. The FDA has not confirmed their safety or effectiveness for any use.

Kennedy has said publicly that he uses some of these peptides himself and has been a vocal advocate for wider access. His policy cites a July vote by an FDA advisory panel that recommended allowing the six substances to be compounded. That recommendation went against the advice of the FDA's own scientists, who said the evidence of safety and effectiveness is insufficient to justify removing restrictions. Kennedy wrote in the policy that the move improves patient access and choice while keeping safety protections in place.

Before the new policy, these peptides were barred from compounding. They remained available online, sold as research-use-only products and often sourced from overseas suppliers with little oversight. HHS argues that regulated pharmacy compounding offers more accountability. Pharmacies must trace ingredients, conduct quality testing, and submit safety reports. Unregulated gray-market sellers face none of those requirements.

Supply could lag behind consumer demand

Even with regulatory pressure lifted, getting these compounds from a licensed pharmacy may take time. Joshua Fritzler, president of Olympia and Wesley Pharmaceuticals in central Florida, said his company expects to compound only one of the six peptides at first. His facility also needs to be prepared before dispensing any. "We won't be able to meet demand," Fritzler told NPR. He added that he does not believe all of the country's 503A pharmacies combined could satisfy consumer interest in these compounds.

Ingredient suppliers must verify their materials meet the policy's requirements first. Only then can pharmacies begin filling orders. That process adds lead time before patients can get these compounds through licensed channels. Scott Brunner, CEO of the Alliance for Pharmacy Compounding, backed the decision. He called it a more accountable option for people who have been buying gray-market peptides. Brunner said the new rules bring patients into a framework with pharmacy standards, regulatory oversight, and adverse-event reporting.

Consumer advocates warn of health and safety risks

Several advocacy groups raised sharp objections. Public Citizen's Health Research Group Director, Dr. Robert Steinbrook, said Kennedy acted on his own rather than through the standard rulemaking process. Steinbrook said that weakens the FDA and puts public health at risk. He also said all peptide substances should go through standard FDA approval. He urged clinicians to warn patients about contamination risks and other possible adverse effects.

The Partnership for Safe Medicines, a coalition of pharmacy and pharmacist organizations, filed a citizen petition last week. It asked the FDA to disregard its advisory panel's July recommendation. Executive director Shabbir Safda said the decision leaves Americans uncertain about whether these peptides are safe. He noted that the FDA's own scientists had recommended against expanded access because the evidence is inadequate.

Earlier CBS News reporting showed the dangers of the unregulated market. A lab test on an experimental peptide drug called retatrutide, purchased from a Brooklyn bodega, found the sample had no detectable peptide at all. Separate CBS News reporting found that clinics around the country have been advertising retatrutide even though the FDA has not reviewed it and it remains in clinical trials.

What comes next for patients and pharmacies

The public comment period runs from Friday through Nov. 13. Kennedy's policy will stay in effect until the FDA finalizes a separate formal rule on compounded peptides. The FDA has not yet proposed one. That means the current policy could govern access to these compounds for some time.

The six peptides remain unapproved drugs. The new policy does not change their legal status. It creates a supervised path for licensed 503A pharmacies to dispense them by prescription without triggering federal enforcement action. Patients who want access through licensed channels will need a prescription and can expect stricter sourcing, testing, and reporting standards than unregulated online sellers provide.