An Eye Toward Regulatory Alignment

December 2018 - Vol.15 No. 12 - Page #1

This coming year is shaping up to be an important time frame for a final push toward practice compliance with USP’s three primary General Chapters covering pharmacy compounding. Both USP General Chapters <797> and <795>, which govern sterile and non-sterile compounding, respectively, are in the process of being revised; with the intent of presenting a unified and complete approach to safe medication compounding, USP has decided to align the official effectiveness date for these two chapters with the Chapter <800> effectiveness date of December 1, 2019.

With the recent closing of the public comment period for Chapters <797> and <795>, USP is expected to finalize the revisions, which will include references to Chapter <800> where appropriate. USP General Chapter <800> Hazardous Drugs–Handling in Healthcare Settings was completed and published in February 2016 and is not currently under revision. Of note, the current, published versions of USP General Chapters <795> and <797> are official until December 1, 2019.

Similarly, ASHP updated its Guidelines on Handling Hazardous Drugs in October of this year, spearheaded by past PP&P authors and pharmaceutical compounding and safety experts Luci Power and Joe Coyne. Citing the number of significant advances in our understanding of what constitutes safe handling of hazardous drugs since the last version’s guidelines were published in 2006, the purposes of this year’s release are to inform on “new and continuing concerns for healthcare workers handling HDs and provide information on recommendations and requirements, including those regarding controls and equipment, that have been developed since the publication of the 2006 ASHP guidelines.”1

Many hospital pharmacy directors have made significant progress toward implementing new systems, technologies, and methodologies in anticipation of these guidelines, yet time remains for those just getting started. However, the time to act is now. Given what is known about the potentially devastating impact that improper and unsafe handling of hazardous medications can have on patient and practitioner alike, there is a substantial moral obligation to direct effort to this vital area of pharmacy practice.

At PP&P we are aware of the tremendous responsibilities placed upon the shoulders of pharmacy leadership, and ensuring the procurement, production, and administration of quality, safe, and appropriate medications is certainly chief among them. That said, there is no greater asset to the pharmacy than healthy and engaged staff members. Fostering a sense of workplace safety is vital to efficient operations, and the peace of mind created can extend well beyond the walls of the pharmacy. We will continue to encourage you in this regard and will champion all pharmacy leaders in doing so as well.

All the best,

R. Mitchell Halvorsen

  1. Power LA, Coyne JW. ASHP Guidelines on Handling Hazardous Drugs. Am J Health Syst Pharm. 2018 Oct 16. doi: 10.2146/ajhp180564.


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