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