FDA Releases Draft Guidance on Residual Solvents

August 14, 2008
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration has distributed a draft of Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States for public comment.

Rockville, MD (Aug. 5)-The US Food and Drug Administration has distributed a draft of Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States for public comment.

The guidance is meant to assist companies holding new drug applications (NDAs) or abbreviated new drug applications (ANDAs) for compendial products to comply with the testing requirements in the new USP General Chapter 467, which became official on July 1, 2008 (see related story, "USP 467, Residual Solvents Becomes Official"), as well as 21 CFR 314.70. The draft also aims to help manufacturers of compendial products not marketed under NDAs and ANDAs.

According to the draft guidance, among its recommendations, FDA “will require that US marketed drug products with an official USP monograph (compendial drug products) meet the residual solvents requirements in the new USP General Chapter <467>,” which provides options other than finished drug testing to evaluate compliance. The draft guidance also describes the conditions under which analytical procedures other than those described in USP <467> will be accepted.

See the complete guidance.