HHS Submits Peptide Interim Access Policy to OMB for Review

HHS has submitted a peptide interim access policy to the White House OMB, the first formal step toward a legal compounding pathway for certain unapproved peptides.

HHS has submitted a peptide interim access policy to the White House OMB, the first formal step toward a legal compounding pathway for certain unapproved peptides.

TG SAFE issued a public advisory warning consumers and healthcare providers about unapproved peptides sold online, including BPC-157, retatrutide, and tesamorelin.

UK regulators seized over 12,000 counterfeit retatrutide and tirzepatide pens worth £2 million in Birmingham, warning the products were never assessed for safety.

The Center for Science in the Public Interest is pressing FDA to overrule its advisory committee's recommendation to add six peptides to the 503A bulk drugs list, citing safety concerns and panel conflicts.

Brazil's ANVISA ordered seizure of FarmaUSA tirzepatide lot HXTZ251015 and separately banned unregistered tirzepatide and retatrutida products sold on named Brazilian websites.

The Washington Post published patient accounts of adverse effects from unapproved peptides including BPC-157, TB-500, and MOTS-c, weeks after FDA advisory votes.

CBS News reports two FDA adverse-event filings involving products sold as retatrutide, an unapproved experimental drug. Both patients suffered cardiac arrest.

FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list remains unfinalized as of October 11, 2026, with no final rule published.

More than ten weeks after FDA's PCAC voted favorably on six peptides, none have been added to the 503A Bulk Drugs List. FDA has published no rulemaking timeline.

The FDA has proposed removing semaglutide, tirzepatide, and liraglutide from the 503B bulks list. No final decision has been issued.