Section 503A of the Federal Food, Drug, and Cosmetic Act governs compounding by state-licensed pharmacies and physicians, generally on the basis of patient-specific prescriptions.
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When FDA lists a drug as in shortage, some federal limits on compounding copies of that drug stop applying; when FDA resolves the shortage, they return. Here is how that works for 503A pharmacies and 503B outsourcing facilities.
AI-assisted · Editor reviewed6 sources2 min read
Federal law gives compounders two routes, with different rules on prescriptions, quality standards, oversight and copies of approved drugs. Here is how they compare, using GLP-1 compounding as the worked example.
AI-assisted · Editor reviewed6 sources3 min read
Every new official record on the Pharmacy, Compounding & Regulatory Intelligence desk since this morning, each linked to its primary source.
Automated from official records6 sources1 min read
IMMEDIATE RELEASE - Tomball, Texas – October 1, 2026 – Greenwich Rx, a 503A compounding pharmacy, is voluntarily recalling specific lots of its compounded glutathione to the consumer level. The product is being recalled due to potential elevated endotoxin levels.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Reg…
