FDA Issues Guidance for Industry on Section 503A Bulks List Final Rule Questions and Answers: Small Entity Compliance Guide

FDA Issues Guidance for Industry on Section 503A Bulks List Final Rule Questions and Answers: Small Entity Compliance Guide

Today, FDA issued a guidance to provide clear answers to questions on the recently published  final rule that establishes the agency’s criteria for evaluating bulk drug substances that may be used to compound drugs under section 503A of the Federal Food, Drug and Cosmetic Act. That rule places six substances on the 503A bulks list. It also identifies four substances that were considered and were not included on the list. This rule went into effect on March 21, 2019.

FDA also issued a notice to stakeholders regarding compounded oral oxitriptan for patients with tetrahydrobiopterin deficiency on May 2, 2019.

The agency continues to evaluate bulk drug substances that have been nominated under section 503A of the FD&C Act with sufficient information, and address those substances on a rolling basis through notice-and-comment rulemaking.