What is a 503B Compounding Pharmacy?
Definition of compounding pharmacy and why medications their medications must be manually encoded.
A 503B outsourcing facility is an FDA-registered compounding pharmacy authorized under Section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA).
These facilities:
- Can compound large batches of sterile medications in advance, without patient-specific prescriptions
- Must follow Current Good Manufacturing Practices (cGMP), the same standards used by drug manufacturers
- Are regularly inspected by the FDA
- Must report product and facility information to the FDA
Hospitals, surgery centers, and clinics often use 503B facilities to obtain ready-to-use sterile medications at scale.
Note: Products from these manufacturers will NOT appear in the RxNorm database and cannot be imported. They must be added manually.