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When it does, the practical impact is narrower than many online summaries suggest: Scenario Category 2 (pre-vote default) 503A Bulks List (PCAC recommended) FDA approval No No 503A compounding Not permitted Permitted (pending final rulemaking) 503B outsourcing facilities Separate list (503B bulks list) Separate determination required Commercial drug product Not available Still not available without NDA Research/laboratory use Legal for research Legal for research (unchanged) In plain terms: Category 1 status lets a patient with a valid prescription get BPC-157 prepared by a state-licensed compounding pharmacy
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If you want a deeper dive into pumping and supply, our article on how much milk you should pump is a helpful next step
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