USP Republishes Draft Chapters <662> and <1662> on Metal Packaging for Pharmaceuticals

The USP has republished two proposed chapters on metallic packaging materials in Pharmacopeial Forum PF 51(5): <662> Metallic Packaging Systems and Their Materials and Components and <1662> Materials and Manufacturing Processes for Metallic Packaging Systems. These updates follow feedback on the previous PF 50(4) proposals, with chapter <662> replacing the earlier draft and chapter <1662> republished for stakeholder comment. Comments are open until 30 November 2025.

The chapters aim to harmonize standards for pharmaceutical metal packaging, ensuring safety, compatibility, and suitability. Chapter <662> details functional and chemical testing, including burst pressure, particulate matter, surface coatings, tube air tightness, tube deformation, foil pinholes, and extractables analysis through solvent-mediated or thermal extraction.

To support industry adaptation, USP plans a five-year delayed implementation and stakeholder engagement sessions to facilitate understanding and adoption of the new requirements for metallic packaging systems.

27-09-2025