What is a 503B outsourcing facility?
Wedgewood operates both FDA-registered 503B outsourcing facilities and state-licensed pharmacies to ensure that veterinary professionals like you can access a comprehensive array of medications for your patients—and your practice. But what is the difference between State-Licensed Pharmacies and 503B Outsourcing Facilities?
Wedgewood Connect, our FDA-registered 503B outsourcing facilities are overseen primarily by the United States Food and Drug Administration (FDA) and State Boards of Pharmacy. They operate under FDA’s current Good Manufacturing Processes (cGMP)—the same regulations that human pharmaceutical manufacturers follow—so 503B outsourcing facilities are able to assign industry-leading Beyond-Use Dates (BUDs) and also dispensemedications for office stock. In many states, the medications produced in our 503B outsourcing facilities are also available for patient-specific prescriptions.
Together, Wedgewood's 503B outsourcing facilities and state-licensed pharmacies deliver a comprehensive range of high-quality compounded veterinary medications. Our dual approach ensures that whether your practice needs large quantities of a standard formulation or a specific, customized medication, we have the expertise and capabilities to meet those needs with unparalleled dedication.
State-Licensed Pharmacies vs. 503B Outsourcing Facilities
| State-Licensed Pharmacies | 503B Outsourcing Facilities | |
|---|---|---|
| Year Established | Traditional practice with roots that can be traced back to the beginnings of medicine | Created in 2013 after the implementation of the Drug Quality and Security Act |
| Oversight | Primarily by State Boards of Pharmacy (SBOP) | United States Food and Drug Administration (FDA) and State Boards of Pharmacy |
| Active Pharmaceutical Ingredients (APIs) | All API is supplied by FDA-registered suppliers | All API is supplied by FDA-registered suppliers |
| Beyond-Use Dating (BUD) | BUD assigned as allowed by United States Pharmacopeia (USP) or the results of stability studies, which include time-point tests of active ingredients, potential degradants, container-closure integrity, preservative effectiveness, and sterility for a sterile drug product | BUD assigned based on results of stability studies which include time-point tests of active ingredients, potential degradants, container-closure integrity, preservative effectiveness, and sterility for a sterile drug product |
| Quality & Compliance Standards | Follow USP Chapters <795>, <797>, and <800>, SBOP Regulations, and FDA guidance documents applicable to state-licensed pharmacies | Follow FDA’s cGMP, USP Standards, SBOP Regulations, and many FDA Guidance Documents |
| Dispensing | Patient-specific dispensing permitted in all states. Veterinarian dispensing permitted in most states. Office stock dispensing follows FDA GFI #256 | Can dispense office stock and patient-specific prescriptions |