Does USP 800 replace USP 797?
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 the requirements of USP 797?
Designed to protect both patients and pharmacists, USP 797 requires attention to three main areas to ensure compliance: staff training and ongoing guidance, determination of categories, and development and implementation of appropriate policies and procedures.
Who should comply with 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.
Is USP 797 enforceable?
Like other USP standards numbered below 1,000, USP 797 is enforceable by state Boards of Pharmacy or the FDA. While FDA does not routinely inspect individual pharmacies, it may intervene in the case of injuries, a death, or a complaint.
What are the major differences between USP 795 797 and 800?
USP 797 provides standards for compounding of sterile preparations while USP 800 provides standards for the safe handling of HDs to minimize exposure risks. USP 797 promotes the protection of the sterility of the drug, while USP 800 is focused on the safety of personnel who come in contact with the HDs.
What does USP 800 cover?
USP General Chapter <800> describes requirements including responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating and cleaning; spill control; and documentation.
What does USP 800 apply to?
These standards apply to all healthcare personnel who receive, prepare, administer, transport or otherwise come in contact with hazardous drugs and all the environments in which they are handled.
What does USP 797 stand for?
Pharmaceutical Compounding – Sterile Preparations
USP 797 refers to chapter 797 “Pharmaceutical Compounding – Sterile Preparations,” in the USP National Formulary. It is the first set of enforceable sterile compounding standards issued by the United States Pharmacopeia (USP).
What is the USP 797?
USP 797 is the standard in place governing the sterile preparation of compounded pharmaceuticals. USP 797 covers the compounding of both hazardous and nonhazardous drugs with a focus on the protection of sterile compounds and environments from contamination.
What is the difference between USP Section 797 and USP Section 795?
Chapter 795 focuses on applying good compounding practices to the process of preparing nonsterile compounded formulations, while Chapter 797 provides procedures and requirements for compounding sterile preparations.
What are the three steps taken to comply with USP 800?
We’ve broken down the steps needed right now for getting in compliance for USP <800>.
- Identify Hazardous Drugs (HDs) for their final dosage form.
- Designate a hazardous drugs point person in your store.
- Complete an Assessment of Risk annually.
What are the USP 800 standards?
Written Standard Operating Procedures (SOPs) USP 800 calls for the SOPs to be created and maintained for the safe handling of hazardous drugs in all situations hazardous drugs are used throughout a facility. The SOPs must be reviewed at least every 12 months by the designated person, and the review must be documented.
What does USP 800 stand for?
USP 800 describes practice and quality standards for the handling of HDs involving but not limited to the receipt, storage, compounding, dispensing, administration, and disposal of sterile and non-sterile products. This chapter applies to any personnel who may be exposed to HDs.
What does USP 795 cover?
USP develops standards for compounding nonsterile medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing. USP General Chapter <795> provides standards for compounding quality nonsterile preparations.
What do the USP 800 guidelines regulate?
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.
Can a nurse crush a HD tablet at the bedside?
Nurses can become exposed during any one of several activities, including preparation, manipulation of oral agents (e.g., crushing pills at the bedside), administration (including IV, subcutaneous, and procedural routes), during spill cleanup, and from excreta containing HDs,” Eisenberg says.
What are the differences between USP 795, 797, and 800?
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What effect does USP 797 have on pharmacies?
USP chapter 797 has also had a significant effect on high-risk compounding procedures. The standards for compounding high-risk preparations are much more stringent than those for low- and medium-risk preparations.
What are the USP 797 guidelines?
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How to cite USP 797?
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