person compounding pharmaceuticals in lab

503B Outsourcing Facilities and the Role of Pharmacists

May 20, 2021

by Dr. Justin Cole

Most people are familiar with 503A pharmacies, which dispense patient-specific medications pursuant to prescriptions for individual patients. These include your local corner pharmacy, hospital pharmacies, and many others. 503B outsourcing facilities, however, are not as familiar. To understand the important role of 503B outsourcing facilities in today’s drug supply chain, it’s helpful to revisit the necessity for their existence.

Events That Led to 503B Outsourcing Facilities

The genesis of the 503B outsourcing facility designation stems from an unfortunate tragedy dating back to 2012. In that year, 64 patients died and over 750 more were injured after contracting fungal infections, including meningitis, from products contaminated with Aspergillus fumigatus. All of these products were sourced from a single compounding pharmacy — New England Compounding Center. These unfortunate events led to increasing scrutiny of compounding pharmacies from both state and federal officials. The Drug Quality and Security Act was subsequently passed in response, dividing pharmacies into two sectors: 503A pharmacies and 503B outsourcing facilities. This was done in an effort to increase regulatory requirements on compounding pharmacies with the goal of ensuring safe production of compounded drugs.

503B Outsourcing Facilities’ Role in Today’s Drug Supply Chain

The primary role of a 503B outsourcing facility is to produce large batches of sterile products with or without a prescription. These drugs are then procured by healthcare facilities for patient use. 503B outsourcing facilities differ from a traditional pharmacy in a number of important ways. First, 503B outsourcing facilities are subject to oversight from the Food and Drug Administration (FDA). Secondly, all compounding activities must adhere to current good manufacturing practices, or CGMP. FDA personnel make periodic visits to these facilities to ensure adherence to CGMP and other regulatory requirements.

503B outsourcing facilities differ from a traditional pharmacy in a number of important ways.
Unlike traditional pharmacies, large batches of medications can be compounded for multiple patients with or without a prescription from a prescriber. Additionally, a quality assurance program and compliance with robust environmental monitoring standards are unique to 503B outsourcing facilities. One key similarity, though, is that a pharmacist must have oversight of the activities of the facility, just like 503A pharmacies. Thus, 503B outsourcing facilities present a future opportunity for pharmacists to contribute to a safe and reliable drug supply chain infrastructure in the United States. With continued drug shortages of products from traditional pharmaceutical manufacturers, these facilities can play a key role in ensuring that critical medications are available in the hospitals and surgery centers that care for us each day.

Please take a moment to listen to the latest episode of DISRxUPT, where we discuss the importance of 503B outsourcing facilities and CGMP with Jeff Hval, COO and Chief Pharmacist of STAQ Pharma.

Dr. Justin Cole is the Director of the Center for Pharmacy Innovation. He also serves as Associate Professor and Chair of Pharmacy Practice in the Cedarville University School of Pharmacy. Dr. Cole’s interests include pediatrics, pharmacogenomics, immunizations, healthcare leadership, and pharmacy practice advancement.

The Cedarville University School of Pharmacy is equipping its Doctor of Pharmacy students to be on the leading edge of healthcare innovation. Cedarville’s Pharm.D. students are fully prepared to begin a rewarding career as a pharmacist and to use their calling to make a difference for Christ as they serve with excellence and compassion.

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