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Step 04 Lyophilization Partially stoppered vials transfer directly into trays for lyophilization, a controlled freeze-drying cycle that sublimates water under vacuum to preserve the compound and keep it stable at room temperature

In every case where the committee voted yes, it did so against the written recommendation of FDA career staff, who had concluded after months of review that none of the seven substances met the agency's four-part evidentiary standard for inclusion on the 503A Bulk Drug Substances List

Regulatory statements confirm there is no legal provision for BPC-157 as a pharmaceutical product or as a food or dietary supplement ingredient

Adriane Fugh-Berman, a physician and professor at Georgetown University, also challenged the idea that allowing legal versions would eliminate this gray market