What is a 503B Compounding Pharmacy?
Title I of the 2013 Drug Quality Safety Act (“DQSA”) created what are commonly referred to as “Outsourcing Facilities.” These Outsourcing Facilities are permitted to produce large product batches, subject to certain limitations, with or without prescriptions to be sold to healthcare facilities for in-office use. The Outsourcing Facility model enables those pharmacies, who elect to register with FDA, to engage in large scale production of products contained primarily within the FDA Drug Shortage List thereby addressing drug critical access to otherwise unavailable products. Unlike traditional compounding pharmacies, Outsourcing Facilities held to a higher production standard, similar to a traditional pharmaceutical manufacturer, requiring strict adherence to current good manufacturing practices (c-GMP). Despite the FDA releasing several draft and final guidance’s specifically addressing Outsourcing Facilities the regulatory landscape is still rapidly evolving. The table below describes the fundamental differences between the 503A and 503B facilities.
What is 503A Compounding Pharmacy?
DQSA, in addition to creating Outsourcing Facilities, also amended and reauthorized section 503 of the Food Drug Cosmetics Act (“FDCA”) creating section 503a which governs traditional pharmacy compounding. The pharmacies may only compound a particular product upon receipt of a patient specific prescriptions. In accordance with both federal and a majority of state laws these pharmacies are required to compound their products in compliance with the United States Pharmacopeia standards set forth in chapters and . Traditional compounding pharmacies are prohibited from dispensing to physician offices for in-office use and limits the products that can be created for patient use.
Wells Pharmacy Network
Possessing both a 503a and 503b facility permits Wells Pharmacy Network a greater flexibility to product products that can be utilized in either the patient or office setting. In early 2017, Wells Pharmacy Network began manufacturing our sterile implantable pellets within our FDA Registered 503b Outsourcing Facility. Our compounded pellets comply with c-GMP standards similar to the large commercial drug manufacturers. In 2018, we added to our 503b product line BLT Numbing Cream. Physicians are increasingly using Wells’ BLT Numbing Cream, which is formulated to decrease the pain and discomfort, for in-office for procedures such has laser hair removal, tattoo removal, and varicose vein treatment. Our BLT Numbing Cream is intended to be used by a physician in the office and before a procedure.
Currently, we have obtained 36 state licenses to permit Wells to operate as an Outsourcing Facility and Wells is continuing to secure additional licenses throughout the country. What does that mean for you the prescriber? If you are in one of the states that we have obtained our license, you may now place numbing cream or pellet orders for office use.
Learn More About Our 503B Product List
Physicians, contact your Wells Pharmacy Account Team to learn how more about our sterile pellets and numbing cream by emailing firstname.lastname@example.org.
Patients download our Sterile Pellet Flyer Sheet and share it with your Physician.
*Low incidence of side effects, can include: slight bruising, minor bleeding, infection or extrusion of the pellets.