New USP Guidance Focuses on Extractables and Leachables for Oral Medications

The USP has released a draft chapter <1664.5> for public comment in Pharmaceutical Forum PF 51(5), providing guidance on assessing leachables from manufacturing and packaging materials in oral dosage forms (ODFs). The chapter covers liquid (LODFs), semi-solid (SSODFs), and solid (SODFs) oral products, detailing risk-based requirements for extractables and leachables (E&L) testing.

For LODFs without surfactants or solubilising agents, regulatory compliance of packaging is sufficient. However, LODFs containing extraction-promoting excipients may require additional E&L evaluation. SSODFs also require risk-based assessments when regulatory coverage is insufficient. SODFs generally pose low risk; compliance with FDA food contact regulations and USP chapters <661.1>, <661.2>, and <665> is sufficient to waive testing.

The guidance also addresses auxiliary devices, manufacturing systems, and nitrosamine risks. The chapter complements existing USP E&L standards, emphasizing targeted evaluation for higher-risk products. Public comments are open until the end of November, and the draft is available on the USP Pharmacopeial Forum website.

26-09-2025