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Use new delays to catch up to more stringent USP requirements


January 23, 2020

by A.J. Plunkett (aplunkett@decisionhealth.com) and Brian Ward (bward@hcpro.com)

Check with your state health department or board of pharmacy to see if you must still comply with the requirements under USP chapter <800> Hazardous Drugs—Handling in Healthcare Settings starting December 1.

While the U.S. Pharmacopeia (USP) announced another round of delays in September in implementing new requirements for pharmaceutical compounding, your local authority having jurisdiction (AHJ) may still require them, note compliance experts.

Even if you do have a reprieve, hospitals and other healthcare organizations should use the time wisely and continue efforts toward compliance. The revisions will be implemented eventually, maybe sooner than later, warns Kurt Patton, MS, RPh, pharmacist, founder of Patton Healthcare Consulting, and former director of accreditation services for The Joint Commission (TJC).

“[From] what I have read, it sounds like the appeal process is expeditious, so people are assuming by the end of the first quarter 2020 it should again be official,” says Patton.

Pending industry appeals of some provisions under new and revised chapters USP <795> Pharmaceutical Compounding—Nonsterile Preparations and USP <797> Pharmaceutical Compounding—Sterile Preparations as well as the new chapter USP <825> Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging delayed the scheduled December 1 implementation of those chapters.

Because USP <800> refers to the other chapters, it is considered by USP to be “informational only” until the revisions are final.

The Joint Commission (TJC) has said it will continue to survey hospitals to the current USP compounding chapters, but will expect hospitals to meet the requirements of local AHJs, as always. That includes expectations under USP <800>, noted Robert Campbell, PharmD, clinical director for TJC’s Standards Interpretation Group and director of Medication Management, during the Chicago session of the annual Executive Briefings.

Meeting the requirements of USP <800> is also just a best practice, says Patton.

“USP <800> describes a lot of worker protections, and I would encourage hospitals to implement them all. NIOSH, OSHA, and USP Chapter <800> are very much in alignment regarding worker protections,” says Patton. “Some of the modifications needed for USP <800>, such as negative pressure storage, negative or neutral pressure drug receiving area, may require renovations, thus hospitals should make use of this time now and complete their projects. Many hospitals I visit are behind schedule, so this affords them more time to complete work.” 

Both Campbell and Patton noted that many of the sterile compounding revisions may require physical changes to completely isolate processes or equipment in areas with highly regulated ventilation requirements.

For instance, under USP <797>, “one new and more stringent requirement is the Compounding Aseptic Isolators (CAI), [which] must be placed in an ISO 7 buffer area to use full USP dating,” says Patton.

"These are glass-enclosed compounding devices the pharmacist reaches into through gauntlet gloves. Today these are considered as good as a [laminar flow hood, inside of an ISO 7 buffer room] without placing the CAI inside of an ISO 7 buffer room.”

The delay means “if a hospital has one of these CAIs and has not yet replaced it, they can continue to use it with full expiration dating rather than the shortened new requirement of 12 hours at room temp or 24 hours in a fridge,” says Patton. But the hospital will need to “have a plan on what they will do when the <797> revision does go into effect.”

“If I had a CAI in my main hospital pharmacy, I would be seeking to develop an ISO 7 buffer space around it. The shortened expiration dating is inconvenient to work with and prohibits the efficiency of batch processing with longer-term storage,” says Patton.

Another of the USP <797> revisions is for monthly microbiologic surface sampling instead of just “periodic,” Patton notes.

Devise a plan for surface sampling, he advises. “Right now, many hospitals just have the vendor conduct surface sampling when they come to recertify the hood and room.” But that could lead to two problems: “One, this is expensive, and two, the vendors may be overwhelmed. I would advise purchasing the materials, an incubator, and training one or more staff how to do surface sampling, incubation, and recordkeeping. If you wait to start on the official new date, you might not have the materials or training needed to be thorough,” says Patton. 

In addition, note that twice-yearly competency assessment is on hold now but will be required eventually. That assessment will include media fill testing and gloved finger-tip testing, and hospitals should be prepared.

 “These processes have value, but they also have cost,” Patton warns.

Need help educating your leadership on what’s to be expected during the accreditation process? See the following excerpt from Patton’s new book, published by HCPro, “USP <800>: How to Prepare for the New Hazardous Drug Requirements.” (For the book, http://hcmarketplace.com/usp-800.)

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