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What is the main purpose of USP General Chapter 800?

What is the main purpose of USP General Chapter 800?

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

In summary, the proposed USP <800> sets standards for the appropriate handling of hazardous medications from transport and storage to preparation and administration. The goal of these standards is to minimize exposure of health care personnel, patients, and the environment to these harmful agents.

What is the status of USP 800?

The 2019 revision of USP 797 would have made USP 800 enforceable. Because the revision was remanded, USP 800 remains informational at this time. When a new revision of 797 becomes official, USP 800 will become enforceable, and organizations will need to become compliant with USP 800.

What areas are impacted by USP 800?

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 agency enforces USP 800?

USP 800 Guidelines The USP does not set or enforce regulations. However, some USP standards are enforced by the Food and Drug Administration (FDA), state pharmacy boards, and accrediting agencies such as The Joint Commission.

Has USP 800 been implemented?

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.

Is USP 800 enforceable?

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 …

Why does Chapter 800 take so long to implement?

Some states have said that they are going to enforce <800> beginning on Dec. 1, but we don’t know yet how this will affect those plans.” The delay was due to the number of appeals that USP received about certain provisions in <795>, <797>, and <825>.

Who will enforce USP 800?

When was USP 800 last updated?

December 1, 2019
The U.S. Pharmacopeia Convention (USP) updated the General Chapter USP 800 on December 1, 2019 to set standards of handling hazardous drugs, specifically in clinical pharmacy settings.

When was USP 800 established?

What is the purpose of USP 800?

What is 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.

What is USP 800 requirements?

The requirement of USP 800 is for nursing to utilize a closed system transfer device for the administration of drugs. Having the system closed at the bedside minimizes spills that could impact nursing or the patient.

What is USP 800 compliance?

Basically USP <800> deals with hazardous drug manufacturing, including such key elements as compounding, preparing the drugs, storage, transport, product storage, compounding, preparation, and administration of parenteral and non-parenteral products. Obviously compliance is mandatory and will be enforced.

What is USP <800>?

USP 800 is a newly published protocol and guidelines that are designed to. improve safety measures being taken by hospital pharmacies, compounding pharmacies and medical centers and pharmaceutical mfg to ensure their workers will be safe when handling and making hazardous drugs like chemotherapy.