Compounding pharmacies can now temporarily manufacture select peptide products from bulk ingredients, according to a new policy quietly adopted by the U.S. Department of Health and Human Services (HHS).
Nor does the decision mean that it’s legal for compounders to manufacture these peptides. Instead, HHS will exercise “enforcement discretion,” meaning the agency will look the other way when compounding pharmacies make and sell these products.
An industry group representing compounding pharmacies frames the move as positive for public health, given the number of Americans who are buying these peptides from unlicensed “gray market” providers, seeking to boost their health and longevity.
“Right now, far too many patients are obtaining peptides from illicit suppliers with little assurance about what’s actually in the vial,” the Alliance for Pharmacy Compounding said in a statement released Thursday. “That’s an existing public health threat, and one that isn’t going away simply because compounding of the substances is prohibited.”
Allowing licensed pharmacies to prepare these medications “offers a more accountable alternative,” the statement reads.
But doctors have serious concerns. “This is dangerous. These ‘peptides’ are not known to be safe and effective in humans — full stop,” says Jamie Alan, PharmD, PhD, an associate professor of pharmacology and toxicology at Michigan State University in East Lansing. “People will be hurt, and people will probably die.”
What Are Peptides, and Which Ones Can People Now Buy From Compounders?
- BPC-157 for ulcerative colitis
- Epitalon for insomnia
- KPV for wound healing and inflammatory conditions
- MOTS-c for obesity and osteoporosis
- Semax for migraine, cerebral ischemia, and trigeminal neuralgia
- TB-500 for wound healing
Does the New Rule Mean These Peptides Are Safe?
No, the new rule does not mean that these peptides are safe.
“Demonstrating efficacy and safety of an investigational drug is a rigorous, arduous process for ultimately one reason: Do no harm to patients,” says Arindam Bhattacharjee, PhD, a professor of pharmacology and toxicology at the State University of New York at Buffalo. “That is why clinical trials are extensive — and expensive — and the FDA uses concrete data to ultimately make the decision whether to approve a new drug or not.”
The peptides listed by this new HHS policy “have not gone under the typical rigorous testing of clinical trials,” Dr. Bhattacharjee says. He calls the act of bypassing the FDA “dangerous,” adding, “The FDA’s mission is to protect the public and the well-being of patients who are taking drugs.”
The HHS decision is not backed by any new research on these peptides, and the new policy does not claim the peptides are safe and effective. HHS “is just saying they won’t take action if compounders make this, which is not the same as saying this is safe and it works,” Alan says.
The new HHS rule does have some guardrails, Bhattacharjee says. “The ingredients used to make these peptides must come exclusively from FDA-registered factories,” he says. “The final product must undergo stringent chemical identity and purity testing.”
Alan recommends that people think about using peptides this way: “If they are so safe and effective, why isn’t big pharma already selling them?” Alan also recommends being wary of any compounding pharmacies that sell these peptides, licensed or not. “I would not buy this from anyone who thinks it is ethical to engage in compounding of a product that we do not have adequate safety data on,” she says.
Do You Need a Prescription to Get One of These Peptides?
Federal law, including Section 503A of the Federal Food, Drug, and Cosmetic Act, says that traditional compounding pharmacies require a valid prescription written by a licensed healthcare provider for an identified individual patient, Alan says.
It’s Important to Speak to Your Doctor First
Most people use peptides to address a health issue, and asking your provider about these drugs may open the door to conversations about scientifically proven treatments.
“Please talk to your healthcare provider,” Alan says. “Even if you plan to take peptides against medical advice, at least have an honest conversation so that your provider can help keep you safe.”
Among other things, peptides may interact with other medications you’re on, making it crucial to disclose their use to your doctor, Bhattacharjee says.
Ultimately, Alan says that peptide use is a “buyer beware situation.”
