Who does USP 800 apply to?

Asked By: Elana Rief | Last Updated: 6th April, 2020
Category: pets veterinary medicine
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USP <800> applies to all healthcare personnel who handle HD preparations including pharmacists, pharmacy technicians, nurses, physicians, physician assistants, home healthcare workers, veterinarians, and veterinary technicians.

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Hereof, does USP 800 apply to physician offices?

USP 800: Navigating the New Requirements for Handling Hazardous Drugs. Dr Yarrington said the most important change between USP 797 and USP 800 is that the guidelines now apply to physician practices in addition to pharmacies, hospitals, healthcare institutions, patient treatment clinics, and veterinarian offices.

Secondly, what is the purpose of 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 practice and quality standards for handling hazardous drugs in health care settings and help promote patient safety, worker safety, and environmental protection.

Correspondingly, is USP 800 a law?

USP <800> was intended to be enforceable starting on July 1, 2018. However, the final document release has been postponed to coordinate with the scheduled December 1, 2019, publication of the USP <797> revision. These guidelines cover pharmaceutical compounding and sterile preparations.

Does USP 800 apply to retail pharmacy?

USP <800> affects all types of pharmacy operations: Retail pharmacy, LTC pharmacy, compounding pharmacy, and every other facility with the word pharmacy associated with it. Because every pharmacy has the ability to handle and dispense hazardous drugs.

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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 Center for Disease Control and Prevention (CDC) including NIOSH.

What is the difference between USP 797 and USP 800?

Difference Between USP 797 and USP 800 Cleanrooms
USP 800 expands controls for the protection of workers and environments against hazardous drug compounds. In contrast to USP 797, which only remedies sterile compounding activities, USP 800 takes a 360-degree approach for processing hazardous drugs.

What are USP guidelines?

USP also sets standards for dietary supplements and food ingredients (as part of the Food Chemicals Codex). USP has no role in enforcing its standards; enforcement is the responsibility of the U.S. Food and Drug Administration (FDA) and other government authorities in the United States.

Has USP 800 been delayed?

General Chapter <800> is not subject to appeals, according to USP, and will not have its official date delayed. General Chapter <800> is scheduled to go into effect December 1, 2019. United States Pharmacopeial Convention. USP Postpones new Chapter <795> and <797> effective dates.

Who enforces USP?

U.S. Food and Drug Administration

What are three types of hazardous drugs?

DHHS (NIOSH) Publication No.
The format for the 2014 list was revised to include three groups of hazardous drugs: (1) Antineoplastic drugs; (2) Non-antineoplastic hazardous drugs; and (3) Drugs with reproductive effects.

What is considered a hazardous drug?

In pharmacology, hazardous drugs are drugs that are known to cause harm, which may or may not include genotoxicity (the ability to cause a change or mutation in genetic material). These drugs can be classified as antineoplastics, cytotoxic agents, biologic agents, antiviral agents and immunosuppressive agents.

What is USP in medicine?

United States Pharmacopeia: Abbreviated USP. A publication, established in 1820, that contains legally recognized standards of identity, strength, quality, purity, packaging, and labeling for drug substances, dosage forms, and other therapeutic products, including nutritionals and dietary supplements.

Why is clonazepam a hazardous drug?

Following review of clonazepam by the NIOSH committee, the 10-member expert panel and public comment, it was classified as a hazardous drugs, based primarily on its teratogenic potential at relatively low doses.

What nine steps should be taken toward USP 797 compliance?

What nine steps should be taken toward USP <797> compliance? -Educate yourself on the new standards-Determine CSP risk level-Complete revised gap analysis to determine level of current compliance-Develop action plan -Prioritize action items-Report gap analysis results and action plan to staf-Assign action plan items

What are USP General Chapters?

'Applicable general chapters' refers to the general chapters numbered below 1,000 in USP–NF that are made applicable to an article through reference in General Notices, a monograph, or another applicable general chapter numbered below 1,000. General chapters numbered above <1,000> in USP–NF are typically informational.

What does USP 797 guidelines include?

USP 797 provides minimum practice and quality standards for CSPs of drugs and nutrients, based on current scientific information and best sterile compounding compliance practices. The chapter addresses USP 797 standards for cleaning and disinfecting the pharmacy cleanroom, including the products that must be used.

What does USP 795 mean?

USP <795> specifies that compounders use and apply drug-specific and general stability documentation when available and consider the nature of the drug, degradation, packaging containers, storage conditions, and the duration of therapy when assigning a beyond-use date.

Does USP 800 apply to nursing homes?

According to USP <800>, all HDs must be handled under conditions that promote patient safety, worker safety, and environmental protection. As the main point of care for patients receiving HDs like chemotherapy, oncology nurses are directly involved with implementation of USP <800> in practice.

What is USP 800 compliance?

USP General Chapter <800> provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment.

What PPE is required by USP 800?

According to the introduction of section 7 of USP Chapter <800>, appropriate PPE must be worn when handling HDs, including during receipt; storage; transport; compounding (both nonsterile and sterile); administration, deactivation/decontamination, cleaning, and disinfecting; spill control; and waste disposal.

Does USP 800 replace USP 797?

USP <800> is designed to complement both USP <795> and USP <797>. Some facility requirements will necessitate a revision to USP <797>.