Clayton's Basic Pharmacology for Nurses

a biologic product that is close in structure and function to an existing approved biologic product - biosimilar act passed by Congress in 1970, composite law designed to improve the administration and regulation of the manufacturing, distribution, and dispensing of drugs that require control by the government because of their high incidence of abuse - Controlled Substances Act amendment which divides medicines into prescription and nonprescription (OTC) categories based on safety - The Durham Humphrey Amendment amendment which provides greater control and surveillance of the distribution and clinical testing of investigational drugs and requires that a product be proven both safe and effective before release for sale; result of the thalidomide tragedy - The KefauverHarris Drug Amendment amphetamines, morphine, hydrocodone/acetaminophen (Vicodin, Lortab, Norco), methadone, oxycodone/aspirin (Percodan), methylphenidate (Ritalin), and amphetamin/dextroamphetamine (Adderall) are all examples of which schedule of drugs - schedule II