USP Postponing Official Dates of Several Chapters

The United States Pharmacopeial Convention (USP) is postponing the official dates of several recently revised chapters until further notice.¹

The affected chapters—<795> Pharmaceutical Compounding-Nonsterile Preparations; <797> Pharmaceutical Compounding-Sterile Preparations; and <825> Radiopharmaceuticals-Preparation, Compounding, Dispensing, and Repackaging—were the subjects of appeals on certain provisions. USP is anticipating further review of these chapters by an appointed panel. ¹

USP is an independent scientific organization that develops quality standards for medicines, dietary supplements, and food ingredients in an effort to increase the availability of quality medicines, supplements and food for people around the world.

Revisions to chapters <795> and <797> were published June 1, 2019, along with a new chapter, <825>.¹ Formal appeals to provisions in these chapters were filed by chapters of the International Academy of Compounding Pharmacists (IACP). The National Community Pharmacists Association (NCPA), the American Pharmacists Association (APhA), and more than 30 state pharmacy associations also expressed concerns, according to IACP.²

In a prepared statement, IACP Executive Vice President Scott Brunner, CAE, said the organization was pleased with the postponement of USP’s chapters <795>, <797>, and <825>.²

“Our input and concerns regarding the grave impacts of the new chapters’ beyond-use date restrictions on patient access have been shared with USP at every step in this process,” said Brunner.² “We hope this postponement is an indication that USP will work with IACP and our partners to find solutions that assure both patients safety and patient access.”

According to USP, the currently official chapters of <795> and <797> will remain in place in the interim. This includes the section Radiopharmaceuticals as CSPs¹.

General Chapter <800> is not subject to appeals, according to USP, and will not have its official date delayed. General Chapter <800> is scheduled to go into effect December 1, 2019. ¹

References

• United States Pharmacopeial Convention. Compendial Notices: USP General Chapters <795>, <797>, <800>, and <825>. USP website. https://www.uspnf.com/notices/compounding-chapters-postponement?_ga=2.137345779.2114367282.1569350229-2090344936.1569350229. Published September 23, 2019. Accessed September 24, 2019.
• International Academy of Compounding Pharmacists. USP Postpones new Chapter <795> and <797> effective dates. [news release]. Alexandria, VA; September 24, 2019: email. Accessed September 24, 2019.