If you are a hospital pharmacy director, physician, or healthcare administrator searching for qualified compounding partners, your first step should be the FDA's official list of registered 503B outsourcing facilities. This list is the authoritative source for verifying that a compounding pharmacy is federally registered and subject to FDA oversight.
This guide walks you through everything you need to know about the FDA 503B outsourcing facilities list: what it is, how to access and search it, how many facilities are currently registered, and how to evaluate facilities for your healthcare organization.
What is the FDA 503B Outsourcing Facilities List?
The FDA 503B outsourcing facilities list is the official public registry of all compounding pharmacies that have voluntarily registered with the U.S. Food and Drug Administration as outsourcing facilities under Section 503B of the Federal Food, Drug, and Cosmetic (FD&C) Act.
This list was established as part of the Drug Quality and Security Act (DQSA) of 2013, which Congress enacted following the tragic 2012 fungal meningitis outbreak caused by the New England Compounding Center (NECC). The legislation created a new category of FDA-regulated compounding entities designed to produce medications at scale under federal oversight.
Every facility on this list has:
- Voluntarily registered with the FDA as an outsourcing facility
- Agreed to comply with Current Good Manufacturing Practices (cGMP)
- Submitted to routine FDA inspections
- Committed to reporting adverse events to the FDA
- Provided semiannual product reports detailing all compounded medications
The list is maintained by the FDA's Office of Regulatory Affairs and is updated as facilities register, renew, or withdraw their registration.
How to Access the Official FDA List of 503B Outsourcing Facilities
The FDA publishes its list of registered outsourcing facilities on its official website. Here is how to access it:
- Visit the FDA's Registered Outsourcing Facilities page directly.
- The page displays a searchable table of all currently registered 503B outsourcing facilities.
- You can search by facility name, state, or other identifying information.
- Each entry includes the facility name, location, and initial registration date.
The FDA also provides a downloadable dataset for those who need the data in spreadsheet format.
Alternatively, you can use our interactive 503B pharmacy directory which enriches the FDA's data with additional information including inspection history, warning letters, Form 483 observations, and facility contact details.
How Many 503B Outsourcing Facilities Are Currently Registered?
As of early 2026, there are approximately 93 FDA-registered 503B outsourcing facilities across the United States. This number fluctuates as new facilities register and others withdraw or have their registration revoked.
The number of registered facilities has grown steadily since the category was created in 2013, reflecting the healthcare industry's increasing reliance on outsourced compounding services. However, the total remains relatively small compared to the thousands of traditional 503A compounding pharmacies that operate under state regulation.
Distribution by State
Registered 503B facilities are concentrated in states with large healthcare markets and favorable regulatory environments. The states with the most registered facilities include:
- Florida — The largest concentration, with facilities including BPI Labs, Olympia Pharmaceuticals, Genogenix, and others
- Texas — Home to Empower Pharma, Wells Pharma, VitalRx, and more (see our Texas directory)
- New Jersey — A pharmaceutical industry hub with Quva Pharma, Imprimis NJOF, Hikma, and others
- California — West coast operations including McGuff Outsourcing Solutions, Vivasor, and MediSourceRx
- Colorado — Including BSO LLC and Staq Pharma
You can browse our full directory by state to see all facilities in your area.
How to Verify a 503B Outsourcing Facility on the FDA List
Verifying a facility's FDA registration is a critical step before establishing a compounding partnership. Here is a step-by-step guide:
Step 1: Check the FDA Registry
Visit the FDA's Registered Outsourcing Facilities page and search for the facility by name. If the facility appears on this list, it is currently registered.
Step 2: Review the Registration Date
Note the facility's initial registration date. Facilities that have been registered longer generally have a more established compliance track record, though newer facilities may have modern infrastructure and processes.
Step 3: Check for FDA Inspection Results
The FDA conducts routine inspections of 503B outsourcing facilities. You can search the FDA Inspections Database for the facility to see if any Form 483 observations or warning letters have been issued.
Key things to look for:
- Form 483 Observations: These are documented findings of regulatory non-compliance noted during an FDA inspection. While receiving a Form 483 is common and not necessarily disqualifying, the nature and severity of the observations matter. (Learn more about Form 483s)
- Warning Letters: A warning letter is a more serious enforcement action indicating that the FDA found significant violations. Facilities with outstanding warning letters warrant additional scrutiny.
- FMD-145 Notices: These are formal notifications related to drug quality or safety concerns.
Step 4: Request Documentation from the Facility
Beyond the FDA registry, request the following from any potential compounding partner:
- Certificate of cGMP compliance
- Most recent FDA inspection report and facility response
- Product-specific certificates of analysis (CoA)
- Evidence of USP testing and stability studies
- Adverse event reporting procedures
Step 5: Use Our Directory for Additional Insights
Our 503B pharmacy directory aggregates FDA registration data with inspection history, warning letters, and facility details in one place. Each facility profile provides a comprehensive compliance snapshot to support your vendor evaluation process.
Understanding FDA Inspection Records for 503B Facilities
FDA inspections are a cornerstone of the 503B regulatory framework. Understanding inspection records helps healthcare providers make informed decisions about compounding partners.
How FDA Inspections Work
The FDA inspects 503B outsourcing facilities on a risk-based schedule. Factors that determine inspection frequency include:
- The facility's compliance history
- The types and risk levels of products compounded (sterile vs. non-sterile)
- The volume of products distributed
- Any reported adverse events
- Whether the facility has been the subject of complaints
During an inspection, FDA investigators evaluate the facility's adherence to cGMP requirements, including cleanroom operations, environmental monitoring, personnel training, batch record documentation, and quality control testing.
Common Inspection Findings
The most frequently cited observations in 503B facility inspections include:
- Aseptic processing deficiencies — Issues with sterile compounding technique, gowning procedures, or cleanroom behavior
- Environmental monitoring gaps — Inadequate air sampling, surface monitoring, or personnel monitoring programs (read our environmental monitoring guide)
- Documentation deficiencies — Incomplete batch records, missing standard operating procedures, or inadequate training documentation
- Quality control failures — Insufficient testing of finished products, missing stability data, or inadequate investigation of out-of-specification results
- Equipment and facility issues — Problems with cleanroom design, HVAC systems, or equipment qualification
Frequently Asked Questions
How many 503B outsourcing facilities are on the FDA list?
As of early 2026, approximately 93 facilities are registered with the FDA as 503B outsourcing facilities. This number changes as new facilities register and others withdraw.
Is there a downloadable PDF of the FDA 503B outsourcing facilities list?
The FDA provides its list in a searchable web format on the Registered Outsourcing Facilities page. The data can be downloaded from the FDA website. Our interactive directory also provides access to all registered facilities with additional enrichment data.
How do I verify if a compounding pharmacy is FDA registered?
Search the FDA's official list of registered outsourcing facilities by facility name. If the pharmacy appears on the list, it is currently registered. Note that only 503B outsourcing facilities register with the FDA; traditional 503A compounding pharmacies are regulated at the state level and do not appear on the FDA registry. (Learn more about the differences)
What is the difference between FDA registered and FDA approved?
"FDA registered" means a facility has voluntarily registered with the FDA as an outsourcing facility and is subject to federal oversight. "FDA approved" typically refers to specific drug products that have gone through the FDA's formal drug approval process. 503B outsourcing facilities are FDA registered, but the compounded medications they produce are not individually FDA approved. This is an important distinction for healthcare providers to understand.
How often is the FDA 503B outsourcing facilities list updated?
The FDA updates its registry as facilities register, renew, or withdraw. There is no fixed update schedule; changes are reflected as they occur. Healthcare providers should periodically verify their compounding partners' registration status.
What happens if a 503B facility is removed from the FDA list?
A facility may be removed from the list if it voluntarily withdraws its registration, fails to renew its annual registration, or has its registration revoked by the FDA due to serious compliance violations. If a facility you work with is removed from the list, you should immediately seek an alternative qualified supplier and verify the status of any products you have in inventory.
Conclusion
The FDA's 503B outsourcing facilities list is the definitive resource for healthcare providers seeking to verify and evaluate compounding partners. By understanding how to access, search, and interpret this list, you can make informed decisions that protect your patients and your organization.
Remember that FDA registration is the starting point, not the end of your due diligence. Always combine registry verification with a review of inspection records, facility documentation, and quality metrics before establishing a compounding partnership.
Ready to explore? Search our interactive directory of all FDA-registered 503B outsourcing facilities, complete with inspection history, compliance data, and facility profiles.