Section 503B of the FD&C Act created outsourcing facilities: compounders that register with the FDA, follow current good manufacturing practice requirements and may compound without patient-specific prescriptions.
Signal strength reflects editorial attention across tracked sources — not medical certainty or strength of evidence.
A system check is an automated check of the official sources, not a human review. An editorial review is recorded only when one of our editors has reviewed the page.
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
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance for industry titled "Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates." This guidance describes the FDA's regulatory and enforce…
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…
The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2027 rates for the establishment and reinspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (…
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…
The Food and Drug Administration (FDA, the Agency, or we) is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for outsourcing facilities to use in compounding (…
