Use New Delays to Catch Up to More Stringent USP Requirements

By A.J. Plunkett and Brian Ward

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 health care 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, a pharmacist 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, founder of Patton Healthcare Consulting.

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 new USP <800> Hazardous Drugs—Handling in Healthcare Settings 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 delays 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 shorted 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 record keeping. 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 twice yearly pharmacist competency assessment will include media fill testing and gloved finger-tip testing, and hospitals should be prepared for that.

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