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• American Hospital Formulary Service (AHFS) classification system is used to categorize drugs based on their pharmacologic and thera- peutic properties. It's a method to group drugs with similar characteristics, making it simpler for healthcare professionals to compare and understand different medications. The AHFS system uses a four-tier hierarchy, with each level offering increasing specificity. It consists of numeric codes where each drug class is assigned a numeric code, ranging from 2 to 8 digits, representing its position within the hier- archy. Medications are grouped based on their therapeutic and/or pharmacological effects. The AHFS system provides information for each drug, including its indications, dosage, and potential interaction. • Manufacturer's Safe Handling Instructions (MSHI) for hazardous drugs concentrates on minimizing exposure to healthcare professionals and patients and often include specific guide- lines for personal protective equipment (PPE), storage and disposal, decontamination and cleaning, These instructions are critical for miti- gating risks associated with handling potentially dangerous medications. • Biologics License Application (BLA) is a submis- sion to the FDA requesting permission to market a new biological product in the United States. BLAs contain administrative information, pre- scribing information, summaries of the product's properties, manufacturing details (CMC informa- tion), preclinical and clinical study reports. • International Agency for Research on Cancer (IARC) The IARC classifies agents (substances, mixtures, or exposure situations) into four groups based on their potential to cause cancer in humans. These groups, from highest to lowest cancer potential, are Group 1 (Carcinogenic to humans) , Group 2A (Probably carcinogenic to humans), Group 2B (Possibly carcinogenic to humans), and Group 3 (Unclassifiable as to carcinogenicity to humans). There is sufficient evidence that a Group 1 agent causes cancer in humans. Substances classified as Group 2 A are strong that the agent may cause cancer in humans, but the evidence is not conclusive.
There is some evidence that the substance clas- sified as Group 2 B has some evidence, but it is not conclusive that the agent may cause cancer in humans. Substances categorized as Group 3 have no evidence to suggest the agent causes cancer in humans. • The National Toxicology Program utilizes the following criteria to determine whether an agent substance, mixture or exposure should be listed on their Report of Carcinogens (ROC). • Known To Be Human Carcinogen: Sufficient evidence of carcinogenicity from studies in humans, which indicates a causal rela- tionship between exposure to the agent, substance, or mixture, and human cancer. • Reasonably Anticipated to be Human Carcinogen: • Limited proof of carcinogenicity from human studies, which show that causal interpretation is believable, but that alter- native excuses such as chance, bias, or confusing factors, could not sufficiently be excluded, OR • Adequate evidence of carcinogenicity from studies in experimental animals, which indicates there is an increased possibility of malignant and/or a combi- nation of malignant and benign tumors (1) in multiple species or at multiple tissue sites, or (2) by multiple routes of exposure, or (3) to an unusual degree with regard to incidence, site, or type of tumor, or age at onset, OR • Less than sufficient evidence of car- cinogenicity in humans or laboratory animals; however, the agent, substance,
or mixture belongs to a well-defined, structurally related class of substances whose members are listed in a previous Report on Carcinogens as either known to be a human carcinogen or reasonably anticipated to be a human carcinogen, or there is convincing relevant information that the agent acts through mechanisms indicating it would likely cause cancer in humans.
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