October 6, 2023

FDA puts some peptides off-limits

Last Friday, the FDA announced that it has updated the list of bulk drug substances nominated for use under section 503A. Notably, GHK-Cu (with some limitations) and L-Theanine have been added to Category 1, making them eligible to use as active ingredients in 503A compounding. In addition, among other substances, several peptides have been added to Category 2 “because FDA has identified significant safety risks with [those] substances,” the agency said.

While the FDA definitions of categories 2 and 3 don’t state overtly that substances in those categories may not be compounded, they do state that FDA can take regulatory action against pharmacies using those substances.

“We’ve reviewed last week’s updates, particularly the addition of some peptides to Category 2,” said APC’s Scott Brunner. “There’s been no groundswell from our members about challenging these items, perhaps because they don’t meet the criteria under 503A.”

Under Section 503A of the Food, Drug & Cosmetic Act, an eligible bulk drug substance for compounding must be a component of an FDA-approved drug, must have a USP or NF monograph, or must appear on FDA’s 503A Bulks List or Interim Bulks List Category 1. The peptides now listed in Category 2 have never met those criteria.

Here’s where to view the full list of changes.