FDA Holds Talks on Temporary Access to Restricted Peptides On 28 September, the Alliance for Pharmacy Compounding (APC) met with FDA officials to propose temporarily allowing selected peptides to be prepared by licensed compounding pharmacies while longer-term regulations are developed. The proposal asks FDA to exercise interim enforcement discretion, subject to conditions including: Peptide APIs sourced from validated cGMP manufacturers. Compounding under applicable USP standards. Patient-specific prescriptions and enhanced risk disclosures. Mandatory reporting of serious adverse events. Collection of data on peptide use. The meeting included APC CEO Scott Brunner, board chair Philip Smyth, advocacy chief Tenille Davis and Emory University researcher Dr Donghai Liang. According to APC, FDA staff asked detailed technical questions, although the agency has made no public commitment. The discussions follow the July FDA advisory committee vote recommending six peptides for compounding: BPC-157, KPV, TB-500, MOTS-c, Semax and Epitalon. The committee voted against emideltide. On 7 October, the Washington Post reported that administration officials were considering temporary access to certain peptides while permanent regulations are developed, citing two people familiar with the discussions. No peptides have been newly authorised as a result of these talks. FDA has not announced an interim policy, identified which substances would qualify or provided an implementation date. The significance is that the compounding industry has now presented FDA with a specific proposal for temporary access, and federal officials are reportedly considering such an approach despite continuing concerns about insufficient safety and efficacy evidence. Sources: a4pc.org/news/fda-digs-into-… washingtonpost.com/health/20…