Working Draft of Compounding Regulations

Revisions to Previous Drafts

Changes made as of 5/4/26:

  • Replaced prepackaging with repackaging throughout (48.B, F, 50.A)
  • Edited B(4) to replace low- with minimal
  • Edited F to include statement on intent of including reference to USP chapters and FDA guidance
  • Edited F(1) to insert existing immediately before standards and replace stated above with that directly impact patient safety immediately after standards
  • Edited section F to incorporate whole section I as item #2
    • The remaining sections within Compounding generally will be reordered at a later date
  • Reworded section G to incorporate standard of care and need to protect patient safety
    • Identified minimum expectations for policies and procedures, including a continuous quality management system, handling and disposal of hazardous and infectious materials, training requirements for personnel, and environmental monitoring and cleaning
  • Edited L(2) to replace appropriate data with compendia literature, medical or scientific literature, and/or practical experience in the art of compounding
  • Edited L(2) to remove last two sentences and the list of items to consider when developing a BUD in absence of data
  • Edited M to insert for no less than two years and readily available immediately after maintained in section
  • Edited M to add cleaning and environmental monitoring records to list of required records in section