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USP 800 (Hazardous Drugs—Handling in Healthcare Settings) is a guideline created by the United States Pharmacopeia Convention (USP), as one of their General Chapters through which the USP "sets quality standards for medicines, dietary supplements and food ingredients".
Genotoxicity might involve carcinogenicity, the ability to cause cancer in animal models, humans or both; teratogenicity, which is the ability to cause defects on fetal development or fetal malformation; and lastly hazardous drugs are known to have the potential to cause fertility impairment, which is a major concern for most clinicians. [1]
It also maintains List I of chemicals and List II of chemicals, which contain chemicals that are used to manufacture the controlled substances/illicit drugs. The list is designated within the Controlled Substances Act [ 1 ] but can be modified by the U.S. Attorney General as illegal manufacturing practices change.
The drug or other substance has a high potential for abuse. The drug or other substance has no currently accepted medical use in treatment in the United States. There is a lack of accepted safety for use of the drug or other substance under medical supervision. The complete list of Schedule I substances is as follows. [1]
This is the list of extremely hazardous substances defined in Section 302 of the U.S. Emergency Planning and Community Right-to-Know Act (42 U.S.C. § 11002). The list can be found as an appendix to 40 CFR 355. [1] Updates as of 2006 can be seen on the Federal Register, 71 FR 47121 (August 16, 2006). [2]
A closed system drug transfer device or "CSTD" is a drug transfer device that mechanically prohibits the transfer of environmental contaminants into a system and the escape of hazardous drug or vapor concentrations outside the system. Open versus closed systems are commonly applied in medical devices to maintain the sterility of a fluid pathway.
Among others, ISMP maintains and disseminates a list of "do not crush" medications, [3] as well as clinical best practices. [4] The ISMP's Medication Safety Self-Assessment tool has been used in surveys of medication safety in hospitals in the United States and elsewhere. [5] [6] [7] [8]
The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions. Abuse of the drug or other substances may lead to severe psychological or physical dependence. The complete list of Schedule II substances is as follows.