About Our Directory
Welcome to 503B Pharmacy Near Me, your comprehensive resource for finding FDA-registered 503B outsourcing compounding pharmacy facilities across the United States.
What is a 503B Outsourcing Facility?
Under Section 503B of the Federal Food, Drug, and Cosmetic Act, outsourcing facilities are entities that compound sterile and non-sterile drugs under FDA oversight. Unlike traditional compounding pharmacies (503A), 503B facilities:
- Are registered with the FDA and subject to current Good Manufacturing Practice (cGMP) requirements
- Undergo regular FDA inspections
- Can compound drugs without individual patient prescriptions
- Can distribute compounded drugs in interstate commerce
- Must report their drug products and adverse events to the FDA
Why Choose a 503B Facility?
503B facilities provide an important service by making compounded medications available to healthcare providers when FDA-approved drugs are in shortage, unavailable, or not suitable for a patient's specific needs. The FDA's oversight ensures higher quality standards and patient safety.
Understanding Compounding Types
Sterile Compounding: Production of medications that must be free from living microorganisms, typically for injectable, ophthalmic, or other routes requiring sterility. Examples include IV medications, injectable solutions, and eye drops.
Non-Sterile Compounding: Production of medications that don't require sterility but must still meet quality standards. Examples include topical creams, oral suspensions, and capsules.
Glossary of Terms
An official FDA communication citing significant violations of regulations. Facilities with warning letters may have quality or compliance issues that need to be addressed.
A Form FDA 145 is a letter that lists inspection observations. While less severe than a warning letter, it indicates areas where the facility needs to improve compliance.
An FDA letter that identifies violations that don't meet the threshold for a warning letter but still require corrective action.
A formal meeting between the FDA and a facility to discuss compliance issues, often following an inspection with findings.
Facilities without any recent warning letters, FMD-145 notices, or other regulatory actions on record.
How to Use This Directory
- Search: Use the search bar to find facilities by name, city, state, or description
- Filter: Narrow results by compounding type (sterile/non-sterile)
- Sort: Organize facilities by name, state, or inspection date
- Quick Filters: Use badges to find recently inspected facilities, those with clean records, or those with regulatory actions
- Map View: Click on map markers to see facility details and locations
- Browse by State: Click on any state to see all facilities in that location
Data Source & Accuracy
All facility information is compiled from the FDA's publicly available database of registered 503B outsourcing facilities. We strive to keep this directory updated regularly, but we recommend verifying information directly with the FDA before making decisions.
Official FDA Resource: FDA Registered Outsourcing Facilities
⚠️ Important Notice
This directory is for informational purposes only. Always verify facility credentials, FDA registration status, and regulatory standing directly with the FDA before engaging services. Inspection dates and regulatory actions are subject to change.
Frequently Asked Questions
503A facilities (traditional compounding pharmacies) compound drugs based on individual patient prescriptions and are regulated primarily by state boards of pharmacy. 503B facilities can compound without individual prescriptions, are registered with the FDA, must follow cGMP, and can distribute drugs across state lines.
No. 503B facilities sell to healthcare providers, hospitals, and medical practices, not directly to patients. You'll need a prescription and your healthcare provider will work with these facilities on your behalf.
This indicates that the FDA has registered the facility but hasn't conducted an inspection yet. New facilities or those recently re-registered may show this status.
The FDA inspects 503B facilities on a risk-based schedule, typically every 2-4 years, though high-risk facilities may be inspected more frequently.
Contact & Feedback
This directory was created to help healthcare providers and facilities connect. If you notice outdated information or have suggestions for improvements, we welcome your feedback.
Last updated: October 15, 2025