Premier Comments on FDA Compounding Draft Guidance

Premier submitted comments in response to the FDA’s draft guidance on the statutory prohibition on wholesaling for certain compounded drugs in which the agency outlines how it intends to apply the prohibition that was enacted under Section 503B of the Federal Food, Drug, and Cosmetic Act. In its comments, Premier urges the FDA to:

• Clarify that the definition of “dispense” is distinct and different from the term “resale” and that products labeled “not for resale” can be dispensed pursuant to a patient-specific prescription;
• Define “intracompany transfer” and adopt the National Association of Boards of Pharmacy (NABP) model pharmacy act definition of “meaning any transfer between a division, subsidiary, parent, and/or affiliated or related company under the common ownership and control of a corporate entity” to remove any confusion regarding what constitutes an appropriate transfer of a compounded drug; and
• Reverse its interpretation of the wholesaler prohibition as it relates to marketing firms, which currently includes third party entities that provide administrative support to a 503B outsourcing facility, even if the third party does not take possession of the compounded product.

Premier will continue to actively engage with our members as they leverage compounding to combat drug shortages while a longer-term strategy is being developed. To this end, Premier:

• Maintains a network of 503B outsourcing facilities to compound products using current good manufacturing practices (cGMP) and personally audits every 503B outsourcing facility it contracts with using an assessment tool that goes above and beyond FDA and State Board of Pharmacy requirements;
• Created a health system-led 503B Advisory Group for insights on outsourcing needs and supplier challenges to support managing supply disruptions, including insource compounding guidance and available alternatives on the market; and
• Engages with the FDA and sits on the FDA Compounding Center of Excellence workgroup where it helps federal partners understand the impact of 503B regulatory decisions on drug shortages and patient care.