What is the difference between USP 797 and USP 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.
Which drugs are required to adhere to USP 800 standards?
Drugs that must follow USP <800> are all antineoplastic agents requiring manipulation such as injectable chemotherapy agents and all hazardous drug active pharmaceutical ingredients (APIs) such as hormone powders. Other drugs on the NIOSH list are eligible for a risk assessment.
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 are the 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 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 is the USP 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.
Which drugs are classified as hazardous drugs?
Hazardous drugs include those used for can- cer chemotherapy, antiviral drugs, hormones, some bioengineered drugs, and other miscella- neous drugs.
What are Group 2 hazardous drugs?
II. Hazardous drugs include those used for cancer che- motherapy, antiviral drugs, hormones, some bio- engineered drugs, and other miscellaneous drugs.