BRIEFING

 〈1664.2〉 Parenteral Drug Products (Intramuscular, Intravenous, and Subcutaneous). It is proposed to add this new chapter as a companion to Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems 〈1664〉. This new chapter addresses specific considerations for leachables in parenteral drug products (PDPs). It focuses on drug products (injections) administered by intramuscular, intravenous, and subcutaneous routes. Note that the following discussion is primarily devoted to organic leachables. For consideration of inorganic (i.e., elemental) leachables, see 〈1664〉.

 (GCDF: R. Kaja)

 Case ID—SUB-1487