503A compounding

Who this applies to

Compounding by licensed pharmacists and physicians for individual patients

Definitions

Bulk drug substance

An active pharmaceutical ingredient used in compounding.

Essentially a copy

A compounded drug that has the same active ingredients and is generally for the same use as a commercially available drug product.

Commercially available

For 503A purposes, a drug not on FDA's drug shortage list.

Decision flow

1. Is the prescriber/licensed pharmacist compounding for a specific patient?
2. Is the bulk substance on the 503A bulk list, a component of an approved drug, or compliant with an applicable USP/NF monograph?
3. Is the product essentially a copy of a commercially available drug?
4. Are state pharmacy rules satisfied?

Examples

• • During a drug shortage, compounding copies of an approved peptide may be allowed; once the shortage resolves, the copy restriction generally returns.
• • BPC-157 is in Category 2 of the 503A bulk list, so it does not have a lawful 503A pathway.

Common mistakes / limitations

• ✗ 503A products are not FDA approved and are primarily overseen by state regulators.
• ✗ FDA can still take action for safety, adulteration, or misbranding concerns.

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.