Effective December 2019, the US Pharmacopoeia (USP) General Chapter<800>is revising standards for the safe handling of hazardous drugs (HDs) to minimize the risk of exposure to healthcare workers, patients, and the environment.
Also asked what is the USP 800?
USP<800>was published on February 1, 2016 with an implementation date of December 2019. The purpose of the chapter is to describe standards of practice and quality for handling hazardous drugs in healthcare settings and to help promote patient safety, occupational safety, and environmental protection.
Also know what the difference is between USP 797 and USP 800 is? Difference Between USP 797 and USP 800 Cleanrooms
USP 800 expands controls to protect workers and the environment from hazardous drug compounds. Unlike USP 797, which only addresses sterile compounding activities, USP 800 takes a 360-degree approach to hazardous drug processing.
And knowing, is USP 800 a law?
USP<800>should be enforceable by July 1, 2018. However, the final release of the document has been delayed to coordinate the planned release of the USP<797>revision on December 1, 2019. These guidelines cover pharmaceutical composition and sterile preparations.
Who should comply with USP 800?
USP<800>applies to all healthcare workers handling HD preparations, including pharmacists , pharmacy technicians, nurses , doctors, physician assistants, home care workers, veterinarians and veterinary technicians.
What is USP 800 compliance?
The U.S. The Pharmacopeial Convention (USP) has issued the USP General Chapter<800>Handling of Hazardous Drugs in Healthcare, which outlines practices and quality standards for handling hazardous drugs (HDs) to promote patient safety, occupational safety, and environmental protection.
Why is clonazepam a dangerous drug?
Following review by the NIOSH committee, the 10-person panel of experts, and public comments, clonazepam was classified as a dangerous drug, primarily due to its teratogenic potential at relative low doses.
What are the three types of dangerous drugs?
DHHS (NIOSH ) Publication No.. The format for the 2014 list has been revised , to include three groups of dangerous drugs: (1) antineoplastic drugs; (2) Non-antineoplastic dangerous drugs; and (3) drugs affecting fertility.
What nine steps should be taken to comply with USP 797?
What nine steps should be taken to comply with USP<797>? – Learn about the new standards – Determine the CSP risk level – Conduct a revised gap analysis to determine the level of current compliance – Develop an action plan – Prioritize action items – Report the results of the gap analysis and the action plan to employees – Assign action plan items
What is USP Chapter 800?
USP General Chapter<800>Hazardous Drugs—Handling in Healthcare Settings. USP General Chapter<800>provides standards for the safe handling of hazardous drugs to minimize the risk of exposure to healthcare workers, patients, and the environment.
Does USP 800 apply to physician offices?
USP 800: Navigating the New Requirements for Handling Dangerous Drugs. dr Yarrington said the key change between USP 797 and USP 800 is that the guidelines now apply to physician offices, in addition to pharmacies, hospitals, healthcare facilities, patient treatment clinics and veterinary offices.
How does USP 800 impact retail pharmacies?
USP<800>applies to all types of pharmacy establishments: retail pharmacy, LTC pharmacy, compounding pharmacy, and any other facility to which the word pharmacy is associated. Non-compliance can even affect the pharmacy license and the responsible pharmacist’s license.
What does USP 797 provide guidelines for?
USP 797 provides minimum practices and quality standards for drug and nutrient CSPs based on current scientific information and best compliance practices for sterile compounding. The chapter covers the USP 797 standards for cleaning and disinfecting pharmacy cleanrooms, including the products to be used.
Who enforces USP?
U.S. Food and Drug Administration
What does USP mean in medical terms?
United States Pharmacopeia
What is considered a dangerous drug?
In the Pharmacology are dangerous drugs drugs that are known to cause harm, including genotoxicity (the ability to cause an alteration or mutation in genetic material). These drugs can be classified as antineoplastic agents, cytotoxic agents, biologic agents, antiviral agents, and immunosuppressive agents.
What is the main purpose of the USP General Chapter 800 Powerpak?
The USP has General Chapters<800>with a public health motivation to provide a legally enforceable standard to limit occupational exposure to HDs to protect patients, healthcare workers and the environment from the effects of handling HDs.
What does USP 795 mean?
USP<795>specifies that compounders use and apply drug-specific and general stability documentation, when available, and the type of drug, degradation, packaging containers, storage conditions, and duration of therapy. Assigning a best-before date.
What are USP guidelines?
USP also sets standards for dietary supplements and food ingredients (as part of the Food Chemicals Codex). USP plays no role in enforcing its standards; enforcement is the responsibility of the U.S. Food and Drug Administration (FDA) and other government agencies in the United States.
Is USP 800 delayed?
According to the USP, the current official chapters of<795>and<797>remain exist for the time being. The<800>General Chapter is not subject to appeals under the USP and its official date will not be moved. General Chapter<800>is scheduled to take effect on December 1, 2019.
What does USP 800 mean for retail pharmacies?
In 2017, the United States Pharmacopeia (USP) and Die Food and Drug Administration has released a set of updated guidelines covering the handling of dangerous drugs. The rules, known as USP<800>, are intended to promote patient and worker safety and environmental protection.
Who developed USP 800?
USP<800>was developed by USP Compounding Expert Committee, USP Compounding with Hazardous Drugs Expert Panel, US Food and Drug Admin (FDA) and US Centers for Disease Control and Prevention (CDC), including NIOSH.