FDA's Most Recent Guidance: Hospitals and Health System Drug Compounding

 

Last week the Food and Drug Administration (FDA) announced three new Draft Guidance documents related to drug compounding under the Sections 503A and 503B of the Food, Drug and Cosmetic Act (FDCA):

  1. Hospital and Health System Compounding
  2. Prescription Requirement Under Section 503A
  3. Clarifying the definition of “Facility” under Section 503B

This article will focus on the Draft Guidance on Hospital and Health System Compounding (Hospital Draft Guidance). The Hospital Draft Guidance explains how Section 503A and 503B apply to hospitals and health systems.

Traditional compounding pharmacies, covered under 503A, are required to obtain valid prescription orders prior to distributing any drug products, amongst other specific requirements.

The new Hospital Draft Guidance clarifies that pharmacies which are part of a hospital or health systems are treated the same under federal law as other traditional compounding pharmacies and are required to comply with the requirements of 503A, unless they are registered as outsourcing facilities.

However, the FDA states it may refrain from enforcing the prescription requirement against hospital-based pharmacies if the compounded drug product is distributed only to facilities under the same ownership and control within a one-mile radius of the pharmacy and administered within the facility pursuant to a patient-specific prescription or order.

The intent of the “one-mile radius” exception is to accommodate centralized drug compounding at a single hospital campus with multiple facilities, but not larger and more geographically diffuse health systems as the FDA remains concerned that distributing compounded drugs across a larger health system is more similar to drug manufacturing.

Hospital pharmacies that wish to distribute compounded drugs outside the one-mile radius without receiving a valid prescription order should, according to the Hospital Draft Guidance, comply with 503B, and register with the FDA as an outsourcing facility or outsource production to an FDA registered outsourcing facility.

Baer Law will have updates on the next two FDA draft guidances shortly.