Akin Gump Health Lawyers, in Law360 Article, Discuss FDA’s New Bulk Drug Substance Restrictions

Law360 has published “Takeaways From FDA’s New Bulk Drug Substance Restrictions,” an article by Akin Gump health care and life sciences partners Nathan Brown and Howard Sklamberg, counsel Eli Tomar and associate Sudhana Bajracharya that analyzes two long-awaited final decisions by the Food and Drug Administration pertaining to the compounding of bulk drug substances by outsourcing facilities.

In the first decision, the authors write, the FDA “finalized a draft guidance regarding its approach to evaluating clinical need for outsourcing facilities to use bulk drug substances, the raw active ingredients used to make drugs.” In the second, the agency “decided to exclude two bulk drug substances — vasopressin and nicardipine hydrochloride — from the list of these substances that outsourcing facilities can use.” As a result, they add, the use of bulk drug substances by outsourcing facilities, apart from drug shortages, “is in violation of the Food, Drug, and Cosmetic Act but for some substances is currently subject to the agency’s enforcement discretion.”

The authors offer some background on the FDA guidance, noting that it stems from the Drug Quality and Security Act of 2013, which created a new category of drug compounders. They then discuss what this all means for health care providers, pointing out that, “except for drugs on the FDA shortage list, there are no lawful uses of bulk substances by outsourcing facilities at this time.” They advise that hospitals and providers entering into purchasing arrangements, “should assess whether they are purchasing from outsourcing facilities whose drug preparations are in compliance with federal law.”

To read the full article, which originated as an Akin Gump client alert, please click here.