503B outsourcing facilities
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.
- Editorial attention
- Emerging
- Tracked this week
- 0
- Sources this week
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- Last activity
- Sep 8, 2026
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503B outsourcing facilities at a glance
- About this topic
- 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.
- Current status
- No editor-reviewed status summary yet. The official records below update automatically.
- Last updated
- Primary sources
- Latest official record: Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry; Availability (opens the source in a new tab) (Federal Register, Sep 8, 2026)
- Key facts from tracked records
- Next verified date: Comments close: Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and… —
What’s the latest on 503B outsourcing facilities?
0 totalNo briefings on this topic yet. Official records and trials below are updated continuously.
What do the official records show?
Primary sources and peer-reviewed research- Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry; Availability (opens the source in a new tab)
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…
- Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated Fees (opens the source in a new tab)
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…
- Outsourcing Facility Fee Rates for Fiscal Year 2027 (opens the source in a new tab)
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 (…
- Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (opens the source in a new tab)
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…
- List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act (opens the source in a new tab)
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 (…