Current Status of USP Compounding Standards (February 2020)
The December 1, 2019 date has come and gone for the ‘expected’ compliance for the new and newly revised USP compounding standards. Most of us were excited to be able ‘move on’ with other pressing issues facing our practices such as on-going drug shortages, high acute care pharmacy vacancies, evolving immunotherapies, increasing acuity of patients, quality penalties, evolving investigational drug programs, ambulatory expansion, preauthorization challenges, and continual compliance pressures (DEA, EPA, 340B, CMS, TJC, FDA, boards of pharmacy, your favorite compliance agency <insert name here>).
The delay of the standards could be predicted within the June 1, 2019 release of the USP <795> and USP <797> chapters when USP took the stance to lock down the limitations of beyond use dates (BUDs) which is at the forefront of the appeals. (https://www.usp.org/sites/default/files/usp/document/our-work/compounding/usp-bud-factsheet.pdf). Initial notification to the public of the impending appeals was in the USP announcement on August 16, 2019, on the USP website(https://www.usp.org/sites/default/files/usp/document/health-quality-safety/usp-decision-on-appeals-factsheet.pdf). However, most of us learned of the formal appeal from the announcement from USP on September 23, 2019; (https://www.uspnf.com/notices/compounding-chapters-postponement?_ga=2.176695461.1840400677.1581951292-1285640645.1563911825) .
Interestingly, the publishers of the International Journal of Pharmaceutical Compounding journal posted on their website ‘Alternatives to USP <795>, <797> and <800> for State Boards of Pharmacy’ in early 2019 (https://compoundingtoday.com/Compliance/USPAlternatives.cfm). This early publication of ‘alternatives’ chapters may have foreshadowed the impending appeals and the current status of the USP compounding chapters.
There were many other ‘signs’ that the appeal process was in play. Interestingly, USP put out a WebEx to formally educate all of us on a what a USP ‘standard’ is versus a ‘compendial’ chapter well before any hint of an appeal, (https://www.usp.org/sites/default/files/usp/video/hqs/usp-800-applicability-720.mp4). Unbeknownst to most of us, USP changed their bylaws in 2016 to make USP <800> ‘not compendially applicable,’ Meaning that the chapter is an ‘informational’ chapter to support the recognized compounding chapters USP <795> and USP <797>. Since the current 2014 USP <795> and 2008 USP <797> chapters do not reference USP <800>, the chapter, from a regulatory standpoint, is informational at best as noted by USP, (https://www.usp.org/sites/default/files/usp/document/our-work/compounding/compendial-applicability-of-usp-800.pdf). Based on the foreshadowing demonstrated by International Journal of Pharmaceutical Compounding journal folks, is USP <800> in jeopardy? The editor of the journal has recently published a series of weekly newsletters on the topic of applicability of USP versus OSHA (the U.S. Department of Labor’s Occupational Safety and Health Administration) for safeguarding the workforce. I would encourage sites to sign up and follow IJPC’s weekly newsletter for another facet to follow in the on-going compounding compliance battle: https://compoundingtoday.com/Newsletter/Newsletter.cfm .
With that noted, pharmacy leaders and compounding experts should closely follow the status of all compounding chapters with special attention to USP <800>, noting that some state boards of pharmacy have taken the stance to enforce USP <800> now versus waiting for the dust to settle on the revised USP <795> and USP <797> chapters. As this ‘battle’ continues to evolve, Visante recommends sites providing compounded products to patients (hazardous or not) continually ensure that your patients are safe and that your employees feel safe. It would be ‘easy’ to have an attitude of ‘let’s wait and see,’ however, the recent history of compounding incidents leading to patient deaths (https://www.pewtrusts.org/en/research-and-analysis/data-visualizations/2017/us-illnesses-and-deaths-associated-with-compounded-medications-or-repackaged-medications) and the history of delays in regulatory guidance for occupational risks of the work place as concerningly chronicled in Kate Moore’s The Radium Girls: The Dark Story of America’s Shining Women (Source ISBN: 14926509510) should consciously stimulate most to want to do what is best.
The current status of compounding chapters:
|2014 USP <795> Pharmaceutical Compounding – Non-sterile Preparations||Active|
2008 USP <797> Pharmaceutical Compounding – Sterile Preparations
|2019 USP <795> Pharmaceutical Compounding – Non-sterile Preparations||Postponed|
2019 USP <797> Pharmaceutical Compounding – Sterile Preparations
|2019 USP <825> Radiopharmaceuticals||Postponed|
|2016/2019 USP <800> Handling Hazardous Drugs in Healthcare Settings||Check state BOP*|
*Board of Pharmacy statutes