2015-2020 General Chapters—Packaging and Distribution Expert Committee Work Plan

Latest Updates

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 Good Distribution Practices

Subgroups and Expert Panels

  • Container materials – packaging / glass / plastic / elastomers
  • Packaging performance and compatibility
  • Packaging development / integrity
  • Medical devices / extractables and leachables
  • Packaging / repackaging
  • Toxicology
  • Good distribution practices

Ballot Results and Standards-Development

Upcoming Official Meetings

  • To be determined

Past Meetings – Executive Summaries

Historic Prospectus