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
AHA resource: Economic Impact of Disparities in Health Outcomes
The AHA Aug. 11 released a new resource guide designed to address a critical gap by helping leaders understand and quantify the economic burden of…
Headline
Two people die in Michigan from cyclosporiasis outbreak
Two individuals have died in Michigan in connection to the current multistate cyclosporiasis outbreak, the Michigan Department of Health and Human Services…
Headline
AHA releases report on rural sepsis care
The AHA’s Living Learning Network, in partnership with the Centers for Disease Control and Prevention, July 22 released “Rural Sepsis Care in Action: Real-…
Headline
CDC issues advisory to healthcare providers on cyclosporiasis cases
The Centers for Disease Control and Prevention July 14 released an advisory on the growing cyclosporiasis cases across the U.S. The advisory said that the…
Headline
Cyclosporiasis continues to spread across country
The Centers for Disease Control and Prevention has reported 843 cases of cyclosporiasis across 31 states, with 86 people hospitalized. State health departments…
Headline
FDA issues alert for certain Medline convenience kits 
The Food and Drug Administration has issued an early alert for specific lots of BD ChloraPrep Applicators by Medline because of a potential breach of sterility…