Drugs and FDA
HHS eases access to six unapproved wellness peptides
HHS will not enforce rules against pharmacies compounding six unapproved peptides, although FDA scientists say evidence does not establish their safety or effectiveness.
The Department of Health and Human Services said it will exercise enforcement discretion for pharmacies that compound six peptides promoted for wellness. That means the FDA will not take action against certain pharmacies that make BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500, although the peptides have not been approved by the FDA. NPR reported that the policy applies to smaller 503A compounding pharmacies, not larger 503B facilities.
FDA scientists opposed easing the restrictions and said there was insufficient evidence that the peptides are safe and effective, according to NBC News. The policy directs compounders to verify the peptides’ identity and purity and collect information on side effects. HHS said the change offers an alternative to products sold on the gray market. NBC News reported that the agency is continuing work on a formal rule change.
Reporting on this story
- CBS News Dr. Jon LaPook explains why peptide sales are controversial (opens in a new tab)
- NPR Trump administration will allow pharmacies to make popular peptides (opens in a new tab)
- MedPage Today RFK Jr. Eases Access to Unproven Peptides Despite Opposition From FDA Scientists (opens in a new tab)
- Time The Peptide Rush Has Begun (opens in a new tab)
- The Guardian FDA scientists opposed Trump administration’s move to ease peptide access (opens in a new tab)
- The Hill HHS to allow sale of unapproved peptides under review (opens in a new tab)
- NBC News RFK Jr. takes shortcut to make some unapproved peptides available for use (opens in a new tab)
