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
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.
The National Institute for Occupational Safety and Heath (NIOSH) has developed a definition of hazardous drug that includes six criteria used to identify a hazardous drug.
USP's mission is “to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.” Standards for an article recognized in a USP compendium are expressed in the article's monograph, the General Notices, and applicable general chapters (such
Pharmacists, pharmacy technicians, oncology nurses, and other nursing personnel have the highest risk for HD exposure, but all healthcare workers who come into contact with HDs are at risk, including those in shipping/receiving, housekeeping, laundry, and waste disposal.
Are radiopharmaceuticals classified as NIOSH hazardous drugs because of the radiation hazard? No. National Institute for Occupational Safety and Health (NIOSH) definition of hazardous drugs excludes radiopharmaceuticals, which are regulated by the Nuclear Regulatory Commission.
The delay was made “to provide a unified approach to quality compounding” by aligning USP <800> with the timeline of an earlier chapter already in force, USP <797>, the organization said in a statement announcing the postponement.
drug-specific and general stability documentation
What is the scope of USP <800>? USP <800> only applies to handling of hazardous drugs (HDs) where there is a risk of exposure to patients, healthcare workers, and the environment.
Meanwhile, USP <800> will still take effect on December 1. The Healthcare Quality and Safety team at USP explained that it would only be “informational and not compendially applicable.” The delay was due to the number of appeals that USP received about certain provisions in <795>, <797>, and <825>.
USP <800> is designed to complement both USP <795> and USP <797>. Some facility requirements will necessitate a revision to USP <797>. All future revisions of USP standards will use this language.
USP General Chapter <797> pertains to the compounding of both hazardous and nonhazardous drugs. USP <800> describes hazardous drug handling related to the receipt, storage, compounding, dispensing, administration, and disposal of both sterile and nonsterile products and preparations.
Interference With Cognitive and Motor Performance: Since Klonopin produces CNS depression, patients receiving this drug should be cautioned against engaging in hazardous occupations requiring mental alertness, such as operating machinery or driving a motor vehicle.
USP standards are recognized in various provisions of the federal Food, Drug and Cosmetic Act (FDCA) and in laws, regulations and policies promulgated by states. These standards are enforced by the U.S. Food and Drug Administration (FDA), states and other oversight organizations.
USP <800> was designed to address the proper handling of hazardous drugs in the pharmacy setting, and its guidelines are plainly aimed at promoting patient and worker safety in and around sterile and non-sterile compounding. The first section of USP <800> covers compounding in its purest form.
USP 797 applies to everyone involved in sterile compounding: pharmacists, nurses, physicians and pharmacy technicians. Staff USP 797 training should cover best practices and core competencies for each type of employee, ideally in a hands-on, situation-based learning format with both practical and written exams.
WARFARIN, OXYTOCIN, CLONAZEPAM—registerednurses administer millions of these drugs daily with lit- tle awareness that they are hazardous, as defined by the Centers for Disease Control and Prevention/Nation- al Institute for Occupational Safety and Health (CDC/ NIOSH).
"First Air—The air exiting the HEPA filter in a unidirectional air stream that is essentially particle free." "Segregated Compounding Area—A designated space, either a demarcated area or room, that is restricted to preparing low-risk level CSPs with 12-hour or less BUD.
The objective of the USP <797> Standard is to describe conditions and practices to prevent harm, including death, to patients resulting from a contaminated or improperly made compounded sterile preparations (CSPs).
General chapter <800> was published in USP–NF on February 1, 2016 and will become official on December 1, 2019. The revisions to <795> and <797> published on June 1, 2019 and which make reference to <800>, have been postponed until further notice, pending resolution of appeals of those chapters.
1For nonsterile preparations, a ventilated engineering control, such as a fume hood or Class I BSC can be used. A containment ventilated enclosure (CVE), such as a powder hood, also may provide adequate protection.
Exposure to hazardous drugs can occur through4: skin absorption. inhalation of aerosols and drug particles. ingestion from contaminated food or drink or other hand to mouth contact.
Do not use gloves with pin holes or weak spots. When used for sterile compounding, the outer chemotherapy gloves must be sterile. Chemotherapy gloves should be changed every 30 minutes unless otherwise recommended by the manufacturer's documentation and must be changed when torn, punctured, or contaminated.
