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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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Beyond-use date — A beyond-use date is the date after which a compounded or opened preparation is not to be used, assigned by convention rather than a stability programme.
82 revisions since 14 October 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.