The FDA established a cross-sector stakeholder group to engage on issues that affect outsourcing facilities, health care providers that purchase and use their products, and other stakeholders in the ecosystem. The purpose of these meetings is to convene industry experts to share individual perspectives on compounded drug quality, production, demand, and clinical use.

March 24, 2022 – Summary of Proceedings

Participants discussed the following:

• Feedback on the goals and focus areas of the group
  • One goal is to foster an improved understanding of the outsourcing facility sector now and in the coming years, including how the industry serves providers and patients. 
  • Outsourcing facility representatives mentioned their hopes to share best practices with each other, such as strategies to better understand and meet demand and lessons learned from deploying automation or other manufacturing practices at outsourcing facilities. 
  • Drug and workforce shortages, lack of public awareness of the industry, and lack of transparency were mentioned as ongoing problems affecting the industry. 
  • The hospital and clinical representatives mentioned their hopes to raise awareness about the impact of drug shortages, to learn more about the manufacturing side of the industry, and to have a more streamlined process for finding, evaluating, and purchasing 503B drug products.
     
• Future discussion topics
  • Demand and Patient Need 
  • Quality
  • Drug shortages
  • Current and future role of 503B Outsourcing Facilities
  • Education and messaging about the 503B industry
     
• Initial discussion on demand and patient need
  • Participants discussed what key questions are useful to address when examining demand/patient need, such as, “Which products would providers like to buy from 503B outsourcing facilities but cannot?” “What challenges do you face in forecasting demand?” and “What tools could help providers better understand 503B product availability?” 
  • Hospital and clinical stakeholders mentioned they purchase products from multiple 503B outsourcing facilities, but some products may only be available from one 503B outsourcing facility, which can lead to gaps in meeting patient need if the outsourcing facility has downtime due to shortage or shutdowns. 
  • Also discussed was the impact of clinical use guidelines in production and purchase decision-making; these guidelines are followed by prescribers and may vary across clinical specialties. Participants noted knowledge gaps may exist, such as a lack of real-time awareness of product availability and lack of purchaser knowledge of 503B outsourcing facility capacity for certain products.
  • Participants discussed gaps that exist within demand transparency, such as a lack of real-time awareness of product availability and lack of purchaser knowledge of 503B outsourcing facility capacity for certain products.  

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Your feedback is essential to the success of the Center of Excellence. Please email us at: CompoundingQualityCoE@fda.hhs.gov.