The U.S. Pharmacopeial Convention (USP) has introduced proposed guidelines which include several revisions to General Chapter <797> Pharmaceutical Compounding – Sterile Preparations, and is seeking comments on these proposed guidelines. The General Chapter has been under review since 2010. It has been significantly revised to clarify requirements and reflect stakeholder feedback and learnings since the last revision became official in 2008.
The TPA ad hoc Compounding Committee is seeking feedback from TPA members regarding these proposed guidelines, to assist in crafting comments to USP. All TPA members interested in providing information to the TPA ad hoc Compounding Committee should send their comments and concerns to micah@localhost by the close of business on Friday, January 22, 2016. USP will accept comments through January 31, 2016.
Specific information about the proposed guidelines and how to submit comments directly to USP are included below:
Proposed USP <797> Guidelines:
<797> Pharmaceutical Compounding – Sterile Preparations
Major revisions of the General Chapter include:
- Reorganization of existing sections and placement of procedural information in boxes.
- Collapsing of the three compounded sterile preparation (CSP) microbial risk categories (low-, medium-, and high-risk) into two categories (Category 1 and 2), distinguished primarily by the conditions under which they are made and the time within which they are used.
- Removal of information on handling hazardous drugs and addition of cross-references to <800> Hazardous Drugs – Handling in Healthcare Settings.
- Introduction of the terminology “in-use time” to refer to the time before which a CSP, or a conventionally manufactured product used to make a CSP, must be used after it has been opened or punctured.
Instructions for Submitting Comments Directly to USP: Please use the USP submission template and send your comments to CompoundingSL@usp.org. Comments should include line numbers corresponding to the proposed revisions to the General Chapter. Comments will be accepted by USP until January 31, 2016. Should you have any questions for USP, please contact the Healthcare Quality Standards team atCompoundingSL@usp.org.