Distinguishing between compounding facilities and the development of the 503B bulk drug substance list.

The purpose of this commentary is to describe the differences between 503A and 503B facilities and the policies and restrictions for compounding from bulk drug substances. Due to the 2012 meningitis outbreak linked to compounded steroid injections, the landscape of pharmacy compounding was changed in the United States. This event led to the creation of two distinct types of compounding pharmacies, 503A and 503B facilities. 503B facilities are restricted from compounding using bulk drug substances unless they are on the Food and Drug Administration drug shortage list or appear on the 503B Bulk Drug Substance list. This commentary hopes to bring more attention to the development of the 503B Bulk Drug Substance list being developed by the FDA and to encourage practitioners and pharmacists to provide insight into the drug substances nominated for the list.

Outsourcing facilities and their place in the U.S. drug supply chain.

The purpose of this commentary is to describe the ideal role of 503B outsourcing facilities in the U.S. drug supply chain. We also address the challenges that 503B outsourcing facilities are facing that limit their utilization and offer possible solutions. Section 503B outsourcing facilities are emerging contributors in compounding owing to their ability to compound large quantities of medication without requiring patient-specific prescriptions. As such, they play a valuable role in the U.S. drug supply chain. The use of outsourcing facilities to compound ready-to-use drug products is gaining traction in hospitals and other health care systems. Outsourcing facilities help hospitals that are facing time and cost constraints owing to the evolving regulatory landscape around compounding. Although outsourcing facilities are assets to the drug supply chain, there are several challenges to their use. The lack of a finalized 503B Bulks List has led to outsourcing facilities being overly cautious in compounding products using bulk drug substances. In addition, the time between Food and Drug Administration (FDA) inspections is undefined, and a lack of follow-up information regarding concerns identified during an inspection may result in uncertainties about the current state of the outsourcing facility. Health care providers, outsourcing facilities, and FDA need to work together to ensure that patients are provided the drugs they need in a safe and effective way.