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11 Cards in this Set

  • Front
  • Back
Designated official standards for medications (USP and the National Formulary);specified standards for medication labeling. Requires all medications to be free of impure products
Pure Food and Drug Act
Prohibited manufactures from making fraudulent claims about medication efficacy and therapeutic effects.
Sherley Amendment
Legally classified medications believed to be habit forming as narcotics; regulated importation manufacture, sale and use of narcotic substances
Harrison Narcotic Act
Added the Homeopathic Pharmacopeia of the United States as a third medication standard; required that medication preparation be approved as safe by the FDA befor marketing; further outlined criteria for medication labeling
Federal Food, Drug and Cosmetic Act
Provided for certification of biological products used as medications (eg insulin, antibiotics) on batch basis; allowed for direct supervision and inspection of medication production
Amendment of the Food and Drug Act
Distinguished between prescription (legend) and nonprescription medication (OTC;over the counter)
Durham-Humphrey Amendment
Authorized FDA to supervise medication production to ensure safety and efficacy and to establish official medication names; specified greater controls on investigational medications
Kefauver-Harris Amendment
Set strict controls on manufacture and distribution of controlled medication (possession of controlled substances unlawful without prescription); established government programs to promote prevention and treatment of medication dependence.
Comprehensive Drug Abuse Prevention and Control Act
Shortened the drug investigation process to release drugs sooner to the public.
Drug Regulation Act
Ensures all Medication on the Market undergo vigorous testing.
FDA
Primary intent is to protect the public from unskilled, undereducated, and unlicensed personnel. Defines the scope of a nurse's professional functions and responsibilities. Acts are purposefully broad so as not to limit the professional resposibilities of a nurse.
Nurse Practice Acts