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Outsourcing Facilities Association Settlement Will Accelerate FDA Review of Bulk Pharmaceutical Ingredients

WASHINGTON–(BUSINESS WIRE)–The Outsourcing Facilities Association (OFA) today announced that it has reached a settlement agreement with the United States Food and Drug Administration that prompts the FDA to quickly review long-pending appointments for active pharmaceutical ingredients for use by FDA-registered outsourcing facilities for patient-needed compound drugs.

Settlement of a federal lawsuit filed by the OFA will allow establishments registered under Section 503B of the Federal Food, Drug, and Cosmetic Act to improve access for health care providers and patients to certain medications, such as treatments for heart disease, infections, pain and eye complications. after cataract surgery – and to quickly alleviate drug shortages.

Congress created the Class 503B outsourcing facility in 2013 to ensure the security of the nation’s supply of sterile compounded drugs, in response to an urgent security crisis. The FDA has been tasked with identifying active pharmaceutical ingredients – APIs or bulk drug substances – for which there is a clinical need. The FDA is accepting nominations for this list of “clinical needs,” but many of those nominations have stalled in the first step of the agency’s review and categorization process.

According to the settlement agreement, the FDA will promptly classify pending and new API nominations. First, the FDA intends to categorize within one year all uncategorized nominations that were pending as of June 14, 2022. Second, within the following three months, the FDA will review nominations that were initially incomplete but for which the FDA received additional information by June 14, 2022. Third, the FDA will endeavor to categorize new appointments on the first business day of each month, or at least every three months.

“The FDA’s commitment to prioritizing the nomination process is a welcome step toward identifying all APIs for which there is clinical need,” said Lee H. Rosebush, partner at law firm BakerHostetler. and President and General Counsel of OFA. “This goal will remain central to OFA as a key part of our public health mission – patients expect these therapies.”

The settlement agreement resolved a complaint filed on June 14, 2022 by the OFA against the FDA and the U.S. Department of Health and Human Services, alleging violations of the Administrative Procedures Act. Following the settlement, the case was voluntarily dismissed by the OFA on October 4 in U.S. District Court for the District of Columbia.

About the Association of Outsourcing Facilities

The Outsourcing Facilities Association (OFA) is the trade association representing FDA-registered 503B outsourcing facilities that focus on providing hospitals, physicians, and patients with critically needed compound medications. OFA works with industry, government and healthcare providers to advocate for the outsourcing of facilities and their products. For more information, visit