United States Pharmacopeia (USP)
United States Pharmacopeia (USP) is a non-governmental, nonprofit organization engaged in setting standards for drug quality and safety. It is governed by the USP Convention, including 450 academic institutions, healthcare organizations and patient and government groups, with 900 independent advisory experts. USP standards for sterile and non-sterile compounding of drug products are widely adopted and used by state regulators and the healthcare industry. Currently, USP is in the process of updating its standards on drug compounding.
New Chapter <797> Revisions
Pharmacopeia released its proposed revisions to USP General Chapter <797> Pharmaceutical Compounding –Sterile Preparations for a second round of public comment. General Chapter <797> provides standards for compounding quality sterile preparations.
Since the first public comment period, which began in September 2015, USP has gathered significant stakeholder input from roundtable meetings, discussion forums, and review of more than 8,000 written public comments. To supplement the review, expert consultants have been engaged to assist the Expert Committee during the revision process.
In response to initial comments, USP extended the beyond-use dates (BUDs) for compounded sterile preparations (CSPs), but even so the proposed one-size-fits-all BUDs remain too short. As proposed, even when a CSP is tested, it cannot be used beyond 60 days frozen/45 days refrigerated from the date compounded. ASRS again cautioned USP that making stock items such as cyclosporine and tacrolimus is going to be nearly impossible. The sterility tested BUD is so restrictive that some compounders may elect to avoid testing and just use the Non-Tested BUD (45 days frozen/4 days refrigerated). In our second set of comments, ASRS again urged USP to retain the language in the current version of 797 which allows BUDs to be extended based on the scientific literature or through product-specific experimental studies. The status quo would also ensure that the USP 797 guidelines are in synchrony with FDA guidance which allows testing to determine BUDs.
In June 2019 USP finalized restrictive BUDs such that even when tested, a CSP cannot be used beyond 60 days frozen/45 days refrigerated from the date compounded. USP intended to publish the final revised Chapter on December 1, 2019, yet on September 23, it announced a postponement pending an appeal by industry groups regarding several topics, key among them the BUD provisions. According to USP Bylaws, the official date must be postponed while an appeal is pending. In the interim, the current chapter, last revised in 2008, will remain official. We remain hopeful that USP will stick with science to avert serious cost and access implications for ophthalmologists and patients alike.
FDA Comment Letters
- ASRS Comments on General Chapter <797> Pharmaceutical Compounding—Sterile Preparations -- November 30, 2018
- Joint comment Letter Challenging Proposed USP Policy Change on In-Office Sterile Drug Preparation -- September 2017
- ASRS Comment Urging USP to Stick with Science for BUDs -- February, 2, 2016
- USP Announces Delay in Effective Date for New BUD Standards Sep 25, 2019
- USP Reaches Out to Medicine For Input Sep 30, 2017
- ASRS Urges USP to Stick with Science for Establishing BUDs - February 2, 2016