A new general chapter from the U.S. Pharmacopeial Convention (USP) will do more to ensure hazardous drugs are handled properly.
General Chapter <800>, Hazardous Drugs—Handling in Healthcare Settings, published in February 2016, was developed to protect health care workers, including pharmacists, from residual exposure in health care settings. The mandatory rule applies to every site that handles hazardous drugs, as defined by the National Institute for Occupational Safety and Health (NIOSH).
“It’s intended to protect the health care worker, the health care environment, and the patient,” Rick Schnatz, PharmD, senior manager for compounding and healthcare quality standards at USP, told Pharmacy Today.
According to Patricia Kienle, BSPharm, MPA, FASHP, director of accreditation and medication Safety at Cardinal Health Innovative Delivery Solutions, chapter <800> was written for all facilities that handle hazardous drugs, including hospitals, community pharmacies, physician practices, and clinics.
Kienle expects that it will take some coordination for practices to adhere to chapter <800> along with other safety guidelines. She said pharmacists should already be familiar with guidance from the Occupational Safety and Health Administration, which has been in effect for decades.
But chapter <800> will also add to existing compounding chapters that are in USP, including chapter <797> for sterile compounds and chapter <795> for nonsterile compounds.
Compounding pharmacists handling hazardous drugs will need to comply with these existing compounding chapters as well as chapter <800>.
APhA is concerned that chapter <800>, along with the revision of chapter <797> and FDA’s almost-final regulatory framework for compounding, poses problematic timing for pharmacists.
“Everything is in flux, and we are concerned that once everything settles, we’ll have to look at <800> and make another set of revisions to harmonize everything,” said Jillanne Schulte, JD, APhA Director of Regulatory Affairs.
In recognizing that it will take facilities time to conform to the new requirements, USP extended the official implementation date until July 1, 2018.
Kienle said updating health care facilities to meet requirements in chapter <800> will be the most difficult and time-consuming aspect of the chapter.
“People need resources to get that done, which is one reason why USP has allowed this extended time period,” Kienle, who is also a member of the USP Compounding Expert Committee responsible for developing chapter <800>, told Today.