USP Republishes Proposed Chapters on Metallic Packaging Systems for Pharmaceuticals

The U.S. Pharmacopeia (USP) has republished two proposed general chapters in Pharmacopeial Forum (PF) 51(5) addressing metal packaging materials:

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

The new proposal for <662> replaces the earlier version from PF 50(4), while <1662> is republished unchanged to gather further stakeholder feedback, with comments accepted until 30 November 2025.

Metal packaging systems, valued for their lightweight and barrier properties, currently lack harmonized regulatory standards. The new chapters aim to define testing procedures and acceptance criteria for functional (e.g., burst pressure, surface coatings, air tightness) and chemical (extractables) assessments.

Recognizing their broad impact, the USP Packaging and Distribution Expert Committee has proposed a five-year delayed implementation, allowing industry adaptation and promoting stakeholder engagement to support understanding and compliance.

19-10-2025