The U.S. Pharmacopeial Convention (USP) is urging pharmacist stakeholders to review proposed revisions to General Chapter <797> Pharmaceutical Compounding—Sterile Preparations.
The chapter is one of two national standards for compounding under USP. <797> specifically details requirements for the process, testing, and verification of any compounded sterile preparation, especially ways to prevent microbial contamination and other variances in compounded sterile products in all settings, including community pharmacies, and regardless of who is performing the compounding.
“The goal of revising <797> is to set standards for producing quality compounded preparations, leading to increased patient safety,” said Jaap Venema, PhD, Executive Vice President and Chief Science Officer at USP.
USP works with its Compounding Expert Committee—a group of elected expert volunteers who make USP’s scientific and standards-setting decisions—to improve the clarity of the chapter, based on the latest scientific data and extensive stakeholder input, according to Venema.
“For that purpose, USP has worked closely with compounding practitioners, educators, infection control specialists, government liaisons and other health care professionals. USP’s public standards on compounding ultimately benefit practitioners and patients,” said Venema.
The last revision to <797> took place in 2008, and since 2010, the chapter has been under review. These new revisions seek to clarify requirements, incorporate new scientific and technical information, and reflect stakeholder feedback, specifically on the reorganization of existing sections and placement of procedural information in boxes; collapsing of three compounded sterile preparation (CSP) microbial risk categories into two categories (Category 1 and 2); and removal of information on handling hazardous drugs and added cross-references to <800> Hazardous Drugs—Handling in Healthcare Settings. Additionally, the revisions introduce new terminology, “in-use time,” to refer to the time before which a conventionally manufactured product must be used after it has been opened or punctured or a CSP must be used after it has been opened or punctured.
The practice of traditional compounding under 503A of the Food, Drug & Cosmetic Act is regulated primarily by state boards of pharmacy, and in many states, compliance with <797> carries the force of law based on regulations passed by state legislatures and boards of pharmacy. Aside from compounding done in 503B-registered outsourcing facilities, FDA and DEA only have oversight for the drugs and controlled substances used to prepare compounded medications.
USP said that to allow extra time for stakeholder review and comments, the proposed revisions were posted in advance of their November 2, 2015, publication in Pharmacopeial Forum (PF) 41(6) [Nov. –Dec. 2015]. Comments should be sent to CompoundingSL@usp.org using the submission template. Comments should include corresponding line number to the proposed revisions to the General Chapter. Comments will be accepted until January 31, 2016, the end of the comment period for PF 41(6).
Questions can also be sent to CompoundingSL@usp.org.