Use new delays to catch up to more stringent USP requirements

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 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.