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# Drug Outsourcing Group/FDA Settle Law Suit
- URL: https://www.fdaweb.com/drug-outsourcing-group-fda-settle-law-suit/
- Published: 2022-10-11T12:00:00.000Z
- Updated: 2026-09-14T18:02:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152943

The [Outsourcing Facilities Association](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.503bs.org%2F&esheet=52940138&newsitemid=20221011005091&lan=en-US&anchor=Outsourcing+Facilities+Association&index=1&md5=c4ff17d64d6ce9778f5eb2f3c88769f8&ref=fdaweb.com) (OFA), which represents [FDA-registered 503B outsourcing facilities](https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities?ref=fdaweb.com) that compound medications, and FDA have reached a settlement agreement to compel the agency to “promptly review long-pending nominations for active pharmaceutical ingredients (API)” for use by such outsourcing facilities.

In its complaint, OFA said that despite a requirement for FDA to maintain a “503B list” that identifies bulk drug substances (active pharmaceutical ingredients), it had only provided four substances in the past nine years. It further complained that “FDA’s eight-year-plus delay is harming public health and undermining the statutory scheme by frustrating Congress’s intent to give health care providers access to sterile drugs” that are compounded in 503B facilities to help patients.

Congress directed FDA to identify APIs or bulk drug substances for which there is a clinical need, the [group said in a release](https://www.businesswire.com/news/home/20221011005091/en/Outsourcing-Facilities-Association%E2%80%99s-Settlement-Will-Expedite-FDA-Review-of-Bulk-Drug-Ingredients?ref=fdaweb.com). “The FDA accepts nominations for this ‘clinical need’ list, but many of these nominations became stuck at the first step in the agency’s review and categorization process,” it explained.

“The settlement of a federal lawsuit filed by OFA will allow facilities registered under Section 503B of the Federal Food, Drug and Cosmetic Act to improve health care provider and patient access to certain medications — such as treatments for heart conditions, infections, pain and ocular complications after cataract surgery — and to ease drug shortages in a timely manner,” the group said.

According to the settlement, OFA says FDA will expeditiously categorize pending and new API nominations. “First, the FDA intends to categorize within one year all uncategorized nominations that were pending as of 6/14/2022,” it said. “Second, within three months thereafter, the FDA will reconsider nominations that were initially incomplete but for which FDA received supplemental information by 6/14/2022\. Third, FDA will endeavor to categorize new nominations on the first business day of each month, or at least every three months.”