USP´s Intent to Revise Chapters on Biocompatibility of Packaging Systems and Medical Devices

The U.S. Pharmacopeial Convention (USP) proposes to revise the following general chapters:

• <87> Biological Reactivity, In Vitro,
• <88> Biological Reactivity, In Vivo,
• and <1031> The Biocompatibility of Materials used in Drug Containers, Medical Devices and Implants.

USP posted a notice regarding its intent to revise on December 30, 2016.

The General Chapters—Biological Analysis Expert Committee proposes the revision "to modernize the family of USP General Chapters dealing with biocompatibility of materials used in packaging systems, medical devices and implants (<87> Biological Reactivity, In Vitro, <88> Biological Reactivity, In Vivo and <1031> The Biocompatibility of Materials used in Drug Containers, Medical Devices and Implants). The General Chapters will provide baseline biocompatibility requirements for selection of elastomeric and plastic materials and components used for medical devices and packaging components, along with information on best practices for biocompatibility testing."

A workshop at USP Headquarters in Rockville, MD was held on June 20-21, 2016 to initiate an open dialog with stakeholders regarding this revision. The input received during this workshop will be used by the Expert Committee to develop the initial revision draft of these general chapters.

Suppliers and users of elastomeric and plastic materials and components used in medical devices and packaging systems (primary packaging components) for drug product are invited to give their input concerning biocompatibility testing of elastomeric and plastic materials and components used for medical devices and packaging components. Input Deadline is January 30, 2017 and the final draft chapters are estimated to be published in Pharmacopeial Forum (PF) 43(5) [Sep.–Oct. 2017].

Furthermore, as reported in Drafts of revised USP plastic packaging chapters <661.1> and <661.2>: removal of the biological reactivity test for oral and topical dosage forms drafts of the revised USP general chapters <661.1> Plastic Materials of Construction and <661.2> Plastic Packaging Systems for Pharmaceutical Use were published for comment in Pharmacopeial Forum (PF) 42(4) [Jun-Jul 2016]. With these drafts, the USP General Chapters - Packaging and Distribution Expert Committee removed the requirement for compliance with <87> for plastic packaging materials and systems for oral and topical dosage forms. Depending on the current revisions of <87> and <88> the two packaging chapters may be revised again to align with those chapters.

For more information please visit the USP website under "Notices".