The regulatory landscape around peptides keeps shifting, and it’s easy to mistake movement for change. On July 23 & 24, the FDA’s Pharmacy Compounding Advisory Committee met and recommended adding several peptides, including BPC-157, TB-500, and Semax, to the Section 503A Bulk Drug Substances List.
Our latest blog breaks down what the committee reviewed, why today’s compliance requirements still apply, the important distinction between 503A pharmacies and 503B outsourcing facilities, and what to watch for as the FDA weighs its next move.