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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]
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.
Exposure to chemicals in the workplace can cause acute or long-term detrimental health effects. There are many classifications of hazardous chemicals, including neurotoxins, immune agents, dermatologic agents, carcinogens, reproductive toxins, systemic toxins, asthmagens, pneumoconiotic agents, and sensitizers. [4]
NIOSH was created by the Occupational Safety and Health Act of 1970 [27] and began operating in May 1971. [25] It was originally part of the Health Services and Mental Health Administration, and was transferred into what was then called the Center for Disease Control (CDC) in 1973. [27] NIOSH's initial headquarters were located in Rockville ...
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".
The NIOSH occupational exposure banding process has been created to provide a reliable approximation of a safe exposure level for potentially hazardous and unregulated chemicals in the workplace. [6] Occupational exposure banding uses limited chemical toxicity data to group chemicals into one of five bands.
Until 2001 it was maintained by US National Institute for Occupational Safety and Health (NIOSH) as a freely available publication. It is now maintained by the private company BIOVIA [ 1 ] or from several value-added resellers and is available only for a fee or by subscription.
An occupational exposure limit is an upper limit on the acceptable concentration of a hazardous substance in workplace air for a particular material or class of materials. It is typically set by competent national authorities and enforced by legislation to protect occupational safety and health.