USP Republishes Proposed Chapters on Metallic Packaging for Pharmaceuticals

The United States Pharmacopeia (USP) has republished two proposed general chapters on metallic packaging systems in Pharmacopeial Forum (PF 51(5)):

• <662> Metallic Packaging Systems and Their Materials and Components
• <1662> Materials and Manufacturing Processes for Metallic Packaging Systems

The updated <662> replaces the previous version from PF 50(4), while <1662> supports <662> by detailing materials, construction, and manufacturing processes. Although no changes are proposed to <1662>, it is republished to allow stakeholders additional comment opportunities, with a deadline of 30 November 2025.

Metal packaging systems, valued for lightness and protection against moisture and light, currently lack harmonized regulatory standards. Chapter <662> outlines functional tests such as burst pressure, particulate matter, surface coatings, tube integrity, and foil pinholes, along with chemical extractables testing. USP will delay implementation for five years and engage stakeholders to facilitate adoption and understanding of these standards.

22-09-2025