HHS to let small pharmacies compound six unapproved peptides
HHS will not penalize small compounding pharmacies that make six unapproved peptides, NPR reports, but larger facilities are excluded and supply may lag demand.
The story in focus
HHS said it will exercise enforcement discretion for six peptides made by small compounding pharmacies, NPR reported October 28. The policy does not change the peptides' legal status or cover larger 503B outsourcing facilities. Industry and advocacy groups disagree on the risk and on whether supply can meet demand.
- HHS will look the other way when small compounding pharmacies make six unapproved peptides, NPR reported.
- The peptides are BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500.
- The policy does not change their legal status and does not apply to larger 503B outsourcing facilities.
- Olympia's Joshua Fritzler told NPR his company and other small compounders won't be able to meet demand.
- Public Citizen said Kennedy acted unilaterally and urged standard FDA approval for all peptide substances.
What changed
The Department of Health and Human Services said in a new policy that it will exercise enforcement discretion for six peptides that have not been approved by the Food and Drug Administration, essentially declining to penalize small compounding pharmacies that make them. NPR reported the policy on October 28.
The peptides named are BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500. The policy describes compounding as safer than illicit research-use-only peptides sold online, which NPR says are often sourced from overseas suppliers. Health Secretary Robert F. Kennedy Jr. has publicly supported peptides.
Who is covered
The policy does not change the peptides' legal status, and it applies only to 503A compounding pharmacies, not to larger 503B outsourcing facilities that produce higher volumes.
Joshua Fritzler, president of Olympia and Wesley Pharmaceuticals in central Florida, told NPR his company will likely compound only one of the six peptides and must first prepare its facility. He said small compounders nationwide could not meet demand. The Alliance for Pharmacy Compounding's Scott Brunner said pharmacies may need time to verify ingredient suppliers meet the policy's requirements.
Criticism
Public Citizen's Dr. Robert Steinbrook said Kennedy acted outside typical rulemaking and undermined the FDA, arguing all peptide substances should go through standard FDA approval. The Partnership for Safe Medicines filed a citizen petition last week urging the FDA to reject its advisory committee's July recommendation to allow the six peptides. In July, FDA advisers voted for expanded access while FDA scientists recommended against lifting the restrictions.
Does the new HHS policy make these peptides legal?
No. NPR reports the policy only exercises enforcement discretion for small 503A compounding pharmacies. It does not change the six peptides' legal status and does not apply to larger 503B outsourcing facilities.
Sources & further reading
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