BRIEFING

 〈1664.4〉 Assessment of Leachables in Topical and Transdermal Drug Products. This newly proposed chapter serves as a companion to Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems 〈1664〉. Chapter 〈1664.4〉 specifically addresses the unique considerations for leachables in transdermal systems as well as topical and transdermal drug products, encompassing a variety of formulations, including patches, creams, gels, ointments, pastes, suspensions, lotions, foams, sprays, aerosols, and solutions. The chapter examines leachables, focusing on those originating from the manufacturing equipment used in the production of the drug product and the container closure systems used to package the drug product throughout its shelf life. Note that the following discussion primarily focuses on organic leachables.

 (GCDF: R. Kaja)

 Case ID—SUB-2479