Topic portal·10 articles
Portal:Compounding
Pharmacy compounding, outsourcing facilities and the shortage rules
Introduction
Compounding is the preparation of a medicine for an individual patient outside the manufacturing process that produced the approved product. In the United States the activity is divided between 503A pharmacies and 503B outsourcing facilities, with materially different quality obligations, and its scope for a given drug depends on whether that drug sits on the shortage list.
This portal covers the statutory framework, the quality systems that apply, and the specific and much-litigated case of compounded semaglutide.
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Research use only — Research use only is a labelling and commercial category, not a regulatory approval. Material carrying the label is not approved for human use and is outside the framework that governs medicines.
44 revisions since 30 July 2024. Discussion · history
Articles in this portal
Things you can do
- Keep the shortage-list status current, and date-stamp every statement about it.
- Separate United States law from other jurisdictions more cleanly across these articles.
Items here are deliberately small enough to finish in one sitting. See Project:Verifiability before adding sources.