Reed Smith Client Alerts

On June 18, 2020, the Food and Drug Administration (FDA) published an announcement in the Federal Register for public comment entitled “Obtaining Information to Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities.” The comment period is open until August 17, 2020 under Docket No. FDA-2019-N-3077.
Several boxes with medicines in interior under prescipcion medica

By way of background, the Drug Quality and Security Act of 2013 amended the Food, Drug, and Cosmetic Act (FDCA) to create a new class of drug compounders known as “outsourcing facilities.” Under Section 503B of the FDCA, outsourcing facilities are exempt from FDA’s new drug approval process, yet are held to federal current good manufacturing practices (cGMP). Outsourcing facilities deliver compounded medication for hospitals, clinics, and other providers.

FDA recognizes the vital role that outsourcing facilities serve for patients in need of medications that are not otherwise available on the commercial drug market. Nevertheless, according to the agency, five years since its inception the industry is experiencing “growth and market challenges,” a purported state of affairs that FDA does not further describe in its announcement.

In order to address these “challenges” and “support compliance and advancement” within the outsourcing facility industry, FDA intends to undertake several initiatives. The first step, according to the agency, is to embark on a research program to collect a broad range of information from and about the industry. FDA is primarily focused on investigating operational barriers and opportunities related to:

  1. Outsourcing facility market and business viability;
  2. Compliance with federal policies and good quality drug production; and
  3. Outsourcing facility interactions with the agency.