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What is the purpose of the USP 800 standard for handling hazardous medications?

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Sarah Oconnell

Published Feb 28, 2026

What is the purpose of the USP 800 standard for handling hazardous medications?

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.

Accordingly, what is the purpose of Chapter 800?

What is the purpose of USP General Chapter <800>? Considering the potential impact on health and safety, the purpose of USP <800> is to define standards for handling hazardous drugs (HDs) and to help promote patient, worker and environmental protection.

Beside above, what is the USP 800 assessment of risk? USP defines an assessment of risk as an "evaluation of risk to determine alternative containment strategies and/or work practices." The assessment of risk of these hazardous drugs must be documented every 12 months.

Regarding this, what does USP 800 apply to?

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.

What is the main purpose of USP General Chapter 800 powerpak answers?

The USP published General Chapter <800> with a public health motivation to provide a legally enforceable standard to limit occupational exposure to HDs to protect patients, health care personnel, and the environment from the effects of handling HDs.

Is USP 800 a law?

The US Pharmacopeia (USP) chapters on Sterile Compounding (USP 797) and Safe Handling of Hazardous Drugs (USP 800) are only legally enforceable when an entity with authority over the medical practice or hospital (eg, a state Board of Pharmacy, state Board of Medicine, or Occupational Safety department) chooses to make

What are the three risk groups for 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.

How many hazardous drug groups are there?

The National Institute for Occupational Safety and Heath (NIOSH) has developed a definition of hazardous drug that includes six criteria used to identify a hazardous drug.

What does USP do?

USP's mission is “to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.” Standards for an article recognized in a USP compendium are expressed in the article's monograph, the General Notices, and applicable general chapters (such

What is the highest risk of exposure to hazardous drugs?

Pharmacists, pharmacy technicians, oncology nurses, and other nursing personnel have the highest risk for HD exposure, but all healthcare workers who come into contact with HDs are at risk, including those in shipping/receiving, housekeeping, laundry, and waste disposal.

Are radiopharmaceuticals considered to be hazardous drugs?

Are radiopharmaceuticals classified as NIOSH hazardous drugs because of the radiation hazard? No. National Institute for Occupational Safety and Health (NIOSH) definition of hazardous drugs excludes radiopharmaceuticals, which are regulated by the Nuclear Regulatory Commission.

Why does Chapter 800 take so long to implement?

The delay was made “to provide a unified approach to quality compounding” by aligning USP <800> with the timeline of an earlier chapter already in force, USP <797>, the organization said in a statement announcing the postponement.

What does USP 795 mean?

drug-specific and general stability documentation

What is the scope of USP 800 >?

What is the scope of USP <800>? USP <800> only applies to handling of hazardous drugs (HDs) where there is a risk of exposure to patients, healthcare workers, and the environment.

Is USP 800 delayed?

Meanwhile, USP <800> will still take effect on December 1. The Healthcare Quality and Safety team at USP explained that it would only be “informational and not compendially applicable.” The delay was due to the number of appeals that USP received about certain provisions in <795>, <797>, and <825>.

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>. All future revisions of USP standards will use this language.

What is the difference between USP 797 and USP 800?

USP General Chapter <797> pertains to the compounding of both hazardous and nonhazardous drugs. USP <800> describes hazardous drug handling related to the receipt, storage, compounding, dispensing, administration, and disposal of both sterile and nonsterile products and preparations.

When did USP 800 become official?

December 1, 2019

Why is Klonopin hazardous?

Interference With Cognitive and Motor Performance: Since Klonopin produces CNS depression, patients receiving this drug should be cautioned against engaging in hazardous occupations requiring mental alertness, such as operating machinery or driving a motor vehicle.

How are USP standards enforced?

USP standards are recognized in various provisions of the federal Food, Drug and Cosmetic Act (FDCA) and in laws, regulations and policies promulgated by states. These standards are enforced by the U.S. Food and Drug Administration (FDA), states and other oversight organizations.

How does USP 800 affect retail pharmacy?

USP <800> was designed to address the proper handling of hazardous drugs in the pharmacy setting, and its guidelines are plainly aimed at promoting patient and worker safety in and around sterile and non-sterile compounding. The first section of USP <800> covers compounding in its purest form.

Who does USP 797 apply to?

USP 797 applies to everyone involved in sterile compounding: pharmacists, nurses, physicians and pharmacy technicians. Staff USP 797 training should cover best practices and core competencies for each type of employee, ideally in a hands-on, situation-based learning format with both practical and written exams.

Is oxytocin a hazardous drug?

WARFARIN, OXYTOCIN, CLONAZEPAM—registered

nurses administer millions of these drugs daily with lit- tle awareness that they are hazardous, as defined by the Centers for Disease Control and Prevention/Nation- al Institute for Occupational Safety and Health (CDC/ NIOSH).

What is first air in clean room?

"First Air—The air exiting the HEPA filter in a unidirectional air stream that is essentially particle free." "Segregated Compounding Area—A designated space, either a demarcated area or room, that is restricted to preparing low-risk level CSPs with 12-hour or less BUD.

What are the USP 797 guidelines?

The objective of the USP <797> Standard is to describe conditions and practices to prevent harm, including death, to patients resulting from a contaminated or improperly made compounded sterile preparations (CSPs).

When was USP 800 last updated?

General chapter <800> was published in USP–NF on February 1, 2016 and will become official on December 1, 2019. The revisions to <795> and <797> published on June 1, 2019 and which make reference to <800>, have been postponed until further notice, pending resolution of appeals of those chapters.

Which engineering controls are appropriate for use with hazardous drugs?

1For nonsterile preparations, a ventilated engineering control, such as a fume hood or Class I BSC can be used. A containment ventilated enclosure (CVE), such as a powder hood, also may provide adequate protection.

How does occupational exposure to hazardous drugs occur?

Exposure to hazardous drugs can occur through4: skin absorption. inhalation of aerosols and drug particles. ingestion from contaminated food or drink or other hand to mouth contact.

When compounding HDs gloves should be changed every?

Do not use gloves with pin holes or weak spots. When used for sterile compounding, the outer chemotherapy gloves must be sterile. Chemotherapy gloves should be changed every 30 minutes unless otherwise recommended by the manufacturer's documentation and must be changed when torn, punctured, or contaminated.

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What is the purpose of the USP 800 standard for handling hazardous medications?