Suffice it to say, every pharmacist is well aware of the damage that can be done when a product or an environment is compromised by bacterial (or viral) infection. To defend against such conditions, pharmacists protect themselves and the products they work with both physically (via judicious use of PPE and engineering controls) and through the application of strict, detailed standards and guidelines such as those found in the relevant USP General Chapters. Despite the incredible pressure being exerted on the entire health care community in dealing with COVID-19, pharmacy directors must continue to consider the integrity of their operations in the face of all health challenges. This includes the recent and important updates to USP General Chapters.

As of March 12, 2020 the appeal to USP <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging is denied; that chapter will likely become official within the next 6 months (although additional appeals can be filed during this period, so this ruling may not be final). The appeals to USP <795> and <797> have been granted, which means the changes to these chapters are on hold and pharmacies should revert to the rules in the standing versions. Both chapters are nowremanded back to the Expert Committee to be reviewed further. The Expert Committee is charged with reaching out to the affected players, and to pharmacy in general, to hear their concerns and redraft parts of the rule. Thus, it will be at least 18 months (and perhaps up to 2 years) before these chapters are finalized.

This leaves General Chapter <800> in limbo. It has been approved, but because it references Chapter <797> for some of its steps, it will not be official until <797> is official. Nevertheless, some state boards have indicated that they expect pharmacies to follow Chapter <800> even if it is not finalized.

At PP&P, we believe an ounce of prevention is better than a pound of cure, and while it is important to monitor the situation and see what develops regarding Chapters <795> and <797>, pharmacy should be pursuing the tenets of Chapter <800> with alacrity. Although COVID-19 has changed a great many things about health care, the essential mission of pharmacy remains: The safe and effective management and provision of clinical medications for all parties involved.

All the best,

R. Mitchell Halvorsen
Publisher