HHS moves to allow six unapproved peptides via specialty pharmacies

The federal government has long relied on the Food and Drug Administration to vet new drugs, but that process is shifting for a specific class of compounds. On Wednesday, the Department of Health and Human Services posted a draft policy that allows specialty pharmacies to sell six injectable peptides that have not passed FDA review. The move was championed by Health Secretary Robert F. Kennedy Jr.

The policy covers compounds including BPC-157, TB-500, and KPV. These substances are marketed in the wellness industry for purposes such as building muscle, healing injuries, and boosting energy. Under current FDA rules, these chemicals are considered illegal drugs because they have not undergone rigorous safety and effectiveness testing. The new document directs the FDA not to take enforcement action against pharmacies that compound these specific substances.

FDA scientific staffers opposed the change and had limited input on its development. Six people familiar with the deliberations said the agency’s drug staff warned the policy could undermine the mission of keeping unproven products off the U.S. market. The policy was primarily written by HHS officials. Those sources spoke to The Associated Press on the condition of anonymity to discuss confidential government discussions.

Kennedy stated that the change advances patient choice and freedom while protecting consumers from peptides sold online that contain unscreened ingredients. He has previously called himself a big fan of peptides and described using BPC-157 to treat a muscle injury. Lee Rosebush of the American Academy of Peptide Medicine said HHS took a huge step for medical freedom. The group represents people who prescribe or sell peptides.

The policy includes guardrails requiring pharmacies to use ingredients from FDA-registered factories. Compounders must also collect side effect data and verify purity. However, Dr. Peter Lurie of the Center for Science in the Public Interest noted that the FDA does not have the legal authority to enforce these specific pharmacy requirements. He questioned the timing of the release, calling it a wink to Kennedy’s Make America Healthy Again movement days before the midterm election.

Decisions over compounding have typically rested with the FDA. That is because a deadly fungal meningitis outbreak in 2012 linked to a Massachusetts pharmacy increased scrutiny on the industry. HHS is taking the lead in this instance, which former FDA officials said is extremely rare. The policy is a step back from an earlier HHS plan that sought to classify the peptides as safe for compounding. FDA officials warned that scientific staffers would not support that regulation due to safety concerns.

The Alliance for Pharmacy Compounding said details need clarification, including the effective date and how the policy intersects with state pharmacy boards. Major telehealth providers are watching the market closely. Hims & Hers recently announced plans to offer wellness peptides once the government changed its policy. Wall Street analysts estimate the peptide market could be worth more than $2 billion. The public comment period for the draft policy lasts two weeks.