PDA Announces Collaboration with the U.S. FDA Concerning Services for Pharma Compounders 14 February, 2024

PDA is proud to announce a new four-year collaboration with the U.S. Food and Drug Administration's (FDA) Compounding Quality Center of Excellence, established to support outsourcing facilities and related stakeholders in their efforts to provide high-quality drugs for patients who need them. Through the partnership, PDA will expand its current training course opportunities for professionals in the outsourcing facility and compounding community and establish an ongoing interactive in-person and virtual interest group forum.

Pharmaceutical compounding is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient and can be utilized when a patient cannot be treated with an FDA approved drug or in cases of drug shortages or unavailability. Compounding can be performed in pharmacies, hospitals, clinics, and healthcare facilities, or at outsourcing facilities which provide compounded drugs to healthcare facilities without receiving a patient-specific prescription.

"PDA is proud to work with the FDA Compounding Quality Center of Excellence to continue to offer the training curriculum, develop new and exciting training courses and provide an interest group for the professionals in this critical segment of the pharmaceutical industry," said David Talmage, PDA VP of Education.

Michael Porter has joined the PDA Education team to oversee the deployment of the new training courses and to liaise with the FDA. He brings a wealth of experience and expertise to PDA, having worked previously for Pharmatech Associates, a USP Company, PPD, and Eli Lilly.

The training courses will take advantage of the entire gambit of multimedia modalities, including in-person, virtual, and self-guided online training courses. The learning journey is further supported with PDA's new interactive interest group forum established for open conversations about pharmaceutical compounding among leaders in outsourcing facilities, compounding, the FDA, and other committed stakeholders.

In 2024, as part of the Center of Excellence, PDA will offer:

• In-Person, Instructor-Led Trainings primarily held at PDA's Training and Research Institute in Bethesda, MD. These two- or three-day courses will address specific pharmaceutical compounding aspects with case studies and hands-on activities designed for real-world application.
• Virtual, Instructor-Led Trainings are interactive between student and instructor to learn more about Current Good Manufacturing Practice (CGMP) regulations as they pertain to pharmaceutical compounding, ask real-time questions, and engage with others from across the outsourcing facility and compounding industry. These sessions are conducted on four consecutive half-days.
• Self-Guided Online Trainings provide an overview of select CGMP regulations and compounding policy topics. Modular self-guided training courses are available to everyone on-demand.
• PDA's Compounding Interest Group (IG) will create community collaborations between liked-minded professionals. This new interest group will launch at PDA Week 2024 followed by virtual meetings starting in April and May. A second in-person meeting is scheduled at the 2024 PDA/FDA Joint Regulatory Conference in September.

*Funding for this statement, publication, press release, etc. was made possible, in part, by the Food and Drug Administration through grant (1UE5FD008142). Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.*

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