List of 503B outsourcing facilities: FDA registration and insurance guide.

The FDA maintains the authoritative list of registered 503B outsourcing facilities at fda.gov, updated quarterly. The list is titled "Registered Outsourcing Facilities" and is published as a PDF and accessible spreadsheet. Each entry includes the facility name, address, FDA registration number, and registration status. Approximately 80-120 facilities are typically on the active registration list at any given time across the United States, though this fluctuates as facilities register and deregister.

The number of FDA-registered 503B outsourcing facilities typically runs 80-120 in any given year. The number fluctuates as facilities register and deregister - the 503B regulatory pathway was created by the Drug Quality and Security Act (DQSA) of 2013, and the population of registered 503Bs has stayed relatively stable since the late 2010s. By comparison, there are tens of thousands of 503A traditional compounding pharmacies operating under state board licensure.

Texas anchors one of the densest 503B clusters in the US (Empower Pharmacy, Wells Pharma, BPI Labs, others), followed by California, Florida, Pennsylvania, Indiana, and New Jersey. The Houston / DFW Texas concentration is particularly notable - Mark Cuban Cost Plus Drug Company also operates a 503B in DFW. State distribution roughly tracks both pharma manufacturing tradition (Indiana, NJ) and large hospital system geography (Texas, Florida, California).

503B outsourcing facility insurance is structurally different from 503A compounding pharmacy insurance. The 503B program needs: $5M-$10M products liability primary (driven by hospital purchase contracts), cGMP-aligned property forms with validation loss endorsement, FDA recall extension on the products policy plus typically dedicated recall coverage, hospital purchase contract additional-insured schedules (CG 20 10 + CG 20 37, primary/non-contributory, 30-day notice), druggist professional liability as secondary, $3M-$10M cyber, and workers comp / EPLI / cargo as applicable. Typical annual program cost: $75,000-$400,000+ depending on revenue, product mix, and contract obligations.

503B registration requires submitting Form FDA 3835 (Initial Registration for Outsourcing Facilities) and meeting the conditions specified in Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) - which include compliance with current Good Manufacturing Practice (cGMP), adverse event reporting under 21 CFR 310.305, FDA inspection submission, and product reporting twice annually. Registration is voluntary - operators may register to compound office-stock product for hospitals without patient-specific prescriptions, in exchange for accepting cGMP inspection scope. The annual registration fee is set by FDA and adjusted annually.

The 503B insurance schedule is materially different: 503A operates under druggist professional liability as the primary line (state board oversight, patient-specific prescriptions, $1M-$2M typical products liability), while 503B operates under products liability as the primary line (FDA cGMP oversight, batch manufacturing for hospitals, $5M-$10M typical products liability). 503Bs need cGMP-aligned property forms (validation loss endorsement) where 503As use generic pharmacy property. 503Bs face hospital purchase contract insurance schedules; 503As face PBM credentialing. The transition from 503A to 503B requires rebuilding the program, not just adding endorsements.