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MedisourceRx's own pharmacist Pallavi Badkar is a key note speaker on the first day of the summit!

Aseptic Compounding in the 503B Industry: Challenges and Mitigations Pallavi Devurkar-Badkar, Director of Operations-503b, MedisourceRx The NECC tragedy in the compounding industry prompted Congress to sign the Drug Quality and Security Act (DQSA) with the goal of preventing future tragedies.

The 503B Outsourcing Facility designation originated from the DQSA. This type of facility is a primary and preferred manufacturing source of drugs on shortage. They also may manufacture sterile injectables from non-sterile APIs from the FDA approved bulk list. The challenge for this entity is that 503B’s must follow cGMP but payers request small batch sizes of several types of drugs packaged in various containers. While it is most ideal to employ automatic filling machines to ensure sterility assurance of aseptic processing of drugs, these technologies are cost prohibitive, inefficient in changeover, and often not flexible in container choice. Therefore, manual aseptic processing (MAP) is often employed in this industry as well as in traditional compounding pharmacies. While MAP allows for an increased flexibility of the containers used and drug formulations produced, there is a high risk of contamination from human interventions. 

The goal of this presentation is to discuss various approaches to mitigate the challenges of semi-automatic aseptic processing using best practice aseptic techniques to ensure sterility during critical human interventions. Select small batch filling and finishing equipment, closed ready-to-fill systems, and single-use aseptic processing supplies will also be discussed as aids in achieving sterility with MAP. Finally, the importance of sourcing injectable-grade APIs as a manufacturer’s responsibility in preventing adverse drug events will also be discussed.