Submit comments for USP <795> revisions

by NCPA | Jun 14, 2018

USP Chapter <795> is undergoing revisions and is open for public comment until July 31, 2018. This chapter provides standards for compounding quality nonsterile preparations. It describes requirements for the compounding process, facilities, equipment, components, documentation, quality controls, and training. Chapter <795> also provides general guidelines for assigning beyond-use dates to nonsterile preparations. Major revisions include:

  • Reorganized existing chapter to improve clarity and to place key procedural information in boxes.
  • Removed information on handling of hazardous drugs and added references to General Chapter <800> Hazardous Drugs–Handling in Healthcare Settings.
  • Expanded guidance for assigning beyond-use dates (BUD) for compounded nonsterile preparations (CNSP) in the absence of stability information.
  • Removed the existing categories of compounding.
  • Defined personnel and facility requirements.

NCPA will comment on the proposed revisions to ensure community pharmacy's concerns are addressed. NCPA encourages its members to submit comments as well.