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United States Pharmacopeia on Compounding

Delay of USP <797> <795> Implementation, effects on USP <800> Enforcement

Today the pharmacist board members, board secretary and legal counsel had a powerful conversation about the US Pharmacopeia’s September 23rd announcement of the postponement of the implementation date of the revised Chapters <797> - Sterile Compounding, <795> - Non-Sterile Compounding and <825> Radiopharmaceuticals and what effects it has on the PA’s new compounding regulations implementation and enforcement.

For those of you wondering why USP delayed implementation, it did so through following its own bylaws on appeal processes.  The new versions proposed significant revisions to the beyond use dating of both compounded sterile preparations (CSPs) as well as non-sterile compounded preparations (NSCPs).  Some organizations (such as the International Association of Compounding Pharmacy and others) have expressed disagreement on the level of scientific evidence surrounding the new shortened BUDs as well as changes to the allowance to extend BUDs.

At home in Pennsylvania, the Compounding Regulations were finalized in April of this year.  The specific wording reads:

27.601. Compounding of preparations.

The compounding of sterile and nonsterile preparations shall be done in accordance with section 503a of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.A. § 353a), Federal regulations promulgated thereunder, and the current version of the USP chapters governing compounding.

The authors of the regulation intended this to allow for Pennsylvania pharmacists to follow the most up to date versions of USP’s applicable compounding chapters, as USP is written by a panel of experts and under goes a rigorous peer review and public comment process, and is continuously updated.  Thus the PA compounding regulations are flexible and allow inspectors to survey for and enforce the current posted versions of USP <797> (2008) and <795> (2014) today, and then when new versions are approved and implemented, the board can begin enforcing the future them. 

The next question discussed, with input from Board Prosecution Liaison was “Where does the enforcement of USP 800 stand?”

Per the US Pharmacopeia website:

General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings is not subject to any pending appeals and will become official on December 1, 2019. During the postponement and pending resolution of the appeals of <795> and <797>, <800> is informational and not compendially applicable. USP encourages utilization of <800> in the interest of advancing public health” 

The purposed new versions of USP <797> and <795> directly reference USP 800 for the respective sterile and non-sterile compounding of Hazardous Drugs, while the current versions do not mention USP <800>.

Since PA Compounding Regulations are currently reflecting to and enforcing the current versions of USP <797> and <795>, and neither of these versions mention USP 800, at this time the BOP inspectors will not be enforcing USP 800. 

However, Board Inspectors do care about informational chapters and it would be expected that if they notice issues concerning healthcare worker exposure to hazardous drugs, they would share such information with the pharmacy being inspected.  (Unofficially, board inspectors may likely take notice of facilities’ stage of working towards compliance with USP 800 for future risk-based inspections schedules)

USP Chapter 800 is currently informational only, but these practices are critical to worker safety and are in concert with the National Institute for Occupational Safety and Health (NIOSH) Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Setting and OSHA’s Controlling Occupational Exposure to Hazardous Drugs.

Controlling Occupational Exposure to Hazardous Drugs - US Department of Labor

Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings - CDC


Hazardous Drug Handling

OSHA’s 2016 Publication on Controlling Occupational Exposure to Hazardous Drugs

National Institute of Occupational Safety and Health (NIOSH)
NIOSH 2016 Hazardous Drug List Update

NIOSH 2004 – Preventing Occupational Exposure to Antineoplastic and Other hazardous Drugs in Health Care Settings


Federal Compounding Regulations

The FDA has become increasingly involved in the oversight of pharmacy compounding.  Follow the links for more information about purposed and current regulations.

Information on Outsourcing Facilities

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