FDA Advisory Panel Recommends Loosening Compounding Rules for Experimental Peptides

An FDA-appointed advisory panel held a marathon hearing in late July and voted to support the compounding of six of the seven peptide products under review—BPC-157, TB-500, MOTS-c and four others. The panel’s recommendation does not change the current illegal status of these substances for U.S. pharmacies; the FDA must still decide whether to place the peptides on a “Category One” list that would permit compounding while formal rulemaking proceeds. Agency scientists argued that none of the seven peptides have completed large-scale human trials and warned of safety gaps, but the panel, which included several industry sellers, dismissed those concerns.

ForbesNPR

Peptides have become a staple of the wellness and longevity market, promoted for injury recovery, muscle growth, fat loss and metabolic enhancement. Because the FDA has prohibited compounding of many of them, a gray market has flourished, with products sold under “research-only” labels. Dr. Health and Human Services Secretary Robert F. Kennedy Jr., a self-identified “big fan” of the compounds, has urged the agency to make them available through inspected facilities rather than the unregulated market.

NPR

• Dr. Jessica Duncan, chief medical officer of IVIM Health, says patients are “even more curious” and that the timeline for any approval remains uncertain.

NPR

• Attorney Jesse Dresser (Frier Levitt) predicts the agency may bypass the traditional rulemaking pathway, noting that “it would actually surprise me if this followed the traditional pathway of formal rulemaking.”

NPR

• Dr.

NPR

If the FDA adds the peptides to the Category One list, compounding pharmacies could begin production while the longer formal rulemaking process—potentially several months to over a year—continues.

NPR

• “They are now even more curious,” — Dr. Jessica Duncan

NPR

• “It would actually surprise me if this followed the traditional pathway of formal rulemaking,” — Jesse Dresser

NPR

• “I do think that there is significant pressure here, but the FDA needs to follow the data,” — Ilisa Bernstein, a former FDA official and pharmacist

NPR

• “The gray market space is a lot seedier than what people think,” — Dr. Haleem Mohammed, chief medical officer for Gameday Men's Health

NPR