In the July 2, 2014, Federal Register, FDA issued two notices with revised requests for nominations of bulk drug substances (active pharmaceutical ingredients or APIs) that may be used to compound drug products pursuant to FDCA sections 503A and 503B (see "Top News" section for more information on these provisions). In December 2013, FDA had issued similar calls for nominations for bulk drug substances that may be used for compounding under 503A and 503B, but many of the responses were insufficient or inadequate. FDA has provided more details in the current call for nominations to assist stakeholders with making appropriate nominations. Nominations for both lists are due September 30, 2014.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
