2020–2025 General Chapters–Packaging and Distribution Expert Committee Work Plan

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Focus Areas

  • Standards for packaging systems and their materials of construction (metal, glass, plastic and elastomeric)
  • Packaging definitions; definitions for the proper storage of compendial articles
  • Guidance on procedures and controls for the proper distribution of compendial articles
  • Guidance on good packaging and repackaging practices

Expert Committee Charge

  • The General Chapters–Packaging and Distribution Expert Committee is responsible for developing new and revising existing general chapters related to packaging (container-closure systems), storage, and distribution of pharmaceutical ingredients or dosage forms.

Key Issues

  • Modernization of General Chapter <87> Biological Reactivity, In Vitro and General Chapter <88> Biological Reactivity, In Vivo
  • Modernization of General Chapter <381> Elastomeric Closure for Injections; including methods and specifications for the various elastomeric materials
  • Modernization of General Chapter <660> Containers–Glass; including the replacement of titration methods with quantitative methods
  • Continued work on the updating and development of new plastic standards
  • Development of a general chapter dealing with metal containers
  • Development of general chapters on various Good Distribution Practices topics

Subgroups and Expert Panels

  • Container materials—packaging/glass/plastic/elastomers
  • Packaging performance and compatibility
  • Packaging development/integrity
  • Extractables and leachables
  • Packaging/repackaging
  • Biocompatibility
  • Good distribution practices

Standards Development

  • The latest ballot results can be found here (results can be filtered by particular ECs).  
  • The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here

Contact

  • Desmond Hunt, Ph.D., Principal Scientific Liaison - General Chapters, dgh@usp.org
  • Allison von Berg, M.F.S., J.D., Expert Committee Manager, abv@usp.org