USP delays official effective dates of new and revised compounding standards

Sep 23, 2019 - 03:14 PM
compliance-deadline

The United States Pharmacopeia today notified stakeholders that it is postponing the official effective dates of several new and revised standards pertaining to pharmaceutical handling until further notice while it reviews appeals to the standards. Those standards include general chapters <795> (Pharmaceutical Compounding – Nonsterile Preparations), <797> (Pharmaceutical Compounding – Sterile Preparations), and <825> (Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging). In addition, due to the pending appeals, USP new general chapter <800> (Hazardous Drugs Handling in Healthcare Settings) will remain official, but only informational and will not be applicable until the appeals process is complete. The AHA in November 2018 urged USP to delay the official dates of both USP <797> and <800> due to expedited implementation and compliance concerns.

Related News Articles

Headline
CDC releases advisory on Marburg virus outbreak in Ethiopia; ASPR to provide support 
The Centers for Disease Control and Prevention issued an advisory Dec. 3 on an outbreak of Marburg virus in Ethiopia. The agency said a risk of spread to the U…
Headline
AHA resource: Improving Care for People with Disabilities 
The AHA Dec. 4 released a new resource outlining how hospitals and health systems can take action to improve care for people with disabilities. Solutions were…
Headline
AHA report finds hospitals continue to improve performance on key patient safety measures, outcomes 
The AHA released a report Dec. 4 that found patient safety in hospitals and health systems across the nation continues to improve. The report, which uses data…
Headline
Webinar to provide strategies on protecting hospital leadership
The AHA will host a webinar Dec. 18 at 1 p.m. ET on strategies to better protect senior leaders in hospitals. Attendees will learn ways to reduce…
Headline
JAMA article shows patient safety measures surpass pre-pandemic levels 
A JAMA article co-authored by AHA Chief Physician Executive Chris DeRienzo, M.D., and leaders from Vizient highlights that hospitals and health systems have…
Headline
Infant formula recall expands as botulism outbreak cases grow
ByHeart has expanded its voluntary recall to include all Whole Nutrition Infant Formula cans and Anywhere Pack products amid an investigation by the Food and…