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3 Cards in this Set

  • Front
  • Back

1962 Kefauver-Harris Amendment

•standardized labeling requirements


•required package inserts on legend drugs


•Mandated good manufacturing process

1970 Controlled Substance Act(CSA)

•regulated use and distribution of medications that could lead to death


•created the DEA


•set-up drug schedules

1970 Poison Prevention Act(PPA)

•Goal: reduce accidental poisoning in children •required use of child safety caps on substances that are potentially harmful (99.99% of drugs)•safety caps should be significantly difficult for a 5 yr old to remove •exceptions: nitroglycerin, topical applications, wavier from the patient( easy-off cap) and birth control