An Obligation to Protect Patients Despite the USP 797 and 795 Delay

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Morgan Polen

By Morgan Polen, IEST Membership Vice President

As you may know, updates to USP <797> Pharmaceutical Compounding—Sterile Preparations and USP <795> Pharmaceutical Compounding—Nonsterile Preparations have been postponed indefinitely. However, contamination control is a serious issue for U.S. compounding pharmacies and aseptic facilities. In fact, Americans have died from tainted medicine produced by these facilities.

It is not uncommon for workers in such operations to handle sterile materials with bare hands, wear non-sterile garments, re-use sterile garments, or use non-sterile IPA and non-sterile wipes to “sanitize” sterile areas. There are instances when Biological Safety Cabinets and flow cabinets have been turned off and restarted without suitable decontamination and qualification. Plus, it is a fact that some cleanrooms and sterile compounding rooms even contain leaks in their ceilings.

These unsound practices could lead to disaster—like the tragic meningitis outbreak that took place in 2012. That’s why it’s imperative that compounding pharmacies and aseptic facilities follow best industry practices: lives depend on it.

IEST offers technical guidance to assist compounding facilities in applying critical standards. In fact, we are offering a new training course series, Requirements Needed for Compounding Pharmacies Using USP 797, December 9-13, 2019, in Irving, Texas. This training is intended to make it easier for pharmaceutical staff to adapt their compounding procedures and modify their facilities. Instructors who test and certify as well as design and build thousands of cleanrooms will cover guidelines and best practices for the design, operations, microbiology, and aseptic procedures for cleanroom facilities. We will review the current official chapters of <795> (last revised in 2014) and <797> (last revised in 2008).

Regardless of if and when the USP regulations are revised, we have a duty to follow best practices in the interest of advancing public health. IEST training can help pharmacies prepare—and stay ahead of the curve—as regulations and standards evolve.

Morgan Polen is a contamination control expert with Microrite in Minneapolis, Minnesota.

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