The policy directs the FDA not to take action against specialty pharmacies that sell a half-dozen wellness peptides, including BPC-157, TB-500 and KPV. Under FDA rules, those chemicals would otherwise be considered illegal drugs because they have not gone through the agency’s review process for safety and effectiveness. The document was primarily written by HHS officials, the Associated Press reported, citing six people familiar with its development who spoke on the condition of anonymity to discuss confidential government deliberations.
The products covered by the draft policy are injectable products promoted within the wellness industry for uses such as building muscle, healing injuries and boosting energy. Health Secretary Robert F. Kennedy Jr. has called himself a “big fan” of peptides and has previously described using BPC-157 to treat a muscle injury. According to the newly posted document, Kennedy determined that the change “advances patient choice and freedom” while protecting people in the United States from products sold online that are often made from unscreened ingredients.
Peptides and the compounding pharmacy route
The draft policy presents compounding as a safer alternative to illicit “research-use-only” peptides sold online, which are often sourced from suppliers overseas and may contain ingredients of unknown origin and quality. The FDA scientists who opposed the change, according to the Associated Press, saw a different risk: a government decision not to enforce its own drug approval rules for products whose safety and effectiveness have not been established.
Peptides debate inside the FDA
The disagreement did not begin with the draft policy. In July 2026, a panel of advisers to the FDA voted in favor of expanded access to six peptides through compounding pharmacies. At the same meeting, the FDA’s own scientists recommended against unwinding the existing restrictions on them, NPR reported. The draft policy follows the advisers’ direction rather than the agency scientists’ recommendation.
Two of the peptides named in the policy, BPC-157 and TB-500, are considered doping substances by international sports authorities, the Associated Press reported. Both are promoted to help heal injuries and build muscle. Other products in the group have been promoted for a wide range of uses, though the evidence for their safety and effectiveness is sparse, NPR reported. Wellness influencers and some clinicians have promoted unproven products for many conditions, while researchers note that the products have not been tested in the large, controlled trials required for FDA approval.
Peptides and what happens next
The draft policy is not yet final. The two-week comment period gives the public, clinicians, pharmacies and other interested parties a chance to respond before HHS finalizes the measure. Comments could address which peptides are included, what standards compounding pharmacies must meet, and how the FDA should handle products that fall outside the policy.
What the policy does not do is approve the peptides. Enforcement discretion means the FDA will not take action against the specified compounding sales while the policy stands, but it does not turn the products into approved drugs with proven safety and effectiveness. That distinction matters for patients, because an approved drug has passed a review of clinical trial data, manufacturing quality and labeling, while an unapproved product has not.