FDA issues draft guidance on residual solvents in drug produts marketed in the USA

The US Food and Drug Administration has announced the availability of a draft guidance for industry entitled Control of Residual Solvents in Drug Products Marketed in the United States. On July 1, the US Pharmacopeia published a new test requirement for the control of residual solvents, General Chapter 467 - Residual Solvents, which replaced USP General Chapter 467 Organic Volatile Impurities. The change affects all compendial drug products marketed in the USA and this draft guidance reflects the FDA's recommendations on how to comply with those USP changes, the agency says.

For compendial drug products approved under a New Drug Application or Abbreviated NDA, changes made to the specifications in the approved application regarding the revised General Chapter 467 should be in accordance with applicable regulations described in 21 CFR 314.70 and the recommendations in the guidance for industry on Changes to an Approved NDA or ANDA, April 2004. The FDA expects that, in most cases, an annual report can be used to report changes. The agency recommends that applicants who have submitted NDAs or ANDAs to the agency for drug products that are not the subject of an official USP monograph control and limit the presence of residual solvents in the subject drug product as described in the guidance on Q3C Impurities: Residual Solvents.

Marketed compendial drug products that are not approved under an NDA or ANDA (for example, over-the-counter medicines that are marketed under an FDA OTC monograph) are also subject to the provisions of the Federal Food, Drug and Cosmetic Act, the revised General Chapter 467 and current Good Manufacturing Practice requirements, the agency notes.