BRIEFING

 〈1664.4〉 Assessment of Leachables in Topical and Transdermal Drug Products. It is proposed to add this new chapter as a companion to Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems 〈1664〉. Based on comments received, the proposal in PF 51(6) has been canceled and is being replaced with a new proposal. This new chapter 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 focuses on leachables 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 is primarily devoted to organic leachables. For consideration of inorganic (i.e., elemental) leachables, see 〈1664〉.

 (GCDF: R. Kaja)

 Case ID—SUB-3342