503B outsourcing facilities
Section 503B allows FDA-registered outsourcing facilities to compound drugs without patient-specific prescriptions, but the bulk drug substance must be on the 503B bulk list or a component of an FDA-approved drug, and the product must not be essentially a copy of an approved drug.
Not legal or medical advice.
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Who this applies to
Registered outsourcing facilities that compound sterile or non-sterile drugs in bulk
Definitions
- Outsourcing facility
- A facility registered with FDA under section 503B that complies with current good manufacturing practice and adverse-event reporting.
- Category 1**, Category 2
- FDA's 503B bulk list categories: under evaluation or significant safety risk.
Decision flow
- Is the facility registered as a 503B outsourcing facility?
- Is the bulk substance on the 503B bulk list or a component of an FDA-approved drug?
- Is the product essentially a copy of an approved drug product?
- Are cGMP and labeling requirements met?
Examples
- • Ipamorelin acetate is in 503B Category 2, meaning it raises significant safety risks and is not on the lawful bulk list.
- • Semaglutide is a component of approved drugs; 503B copies are generally restricted unless a shortage applies.
Common mistakes / limitations
- ✗ 503B drugs are not FDA approved.
- ✗ State pharmacy and medical practice laws also apply.
What can change this answer
Rules can change through new legislation, FDA final guidance, declaratory orders, court decisions, or updated bulk-drug-substance lists. Check the latest controlling sources and the update feed for this rule.
Controlling law and sources
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503B
U.S. Food and Drug Administration · Agency list · FDA-2015-N-0030