Laws Flashcards
Pure Food and Drug Act (1906)
Forbade the sale, manufacture, and transportation or adulterated or mislabeled foods and drugs.
Shirley Amendment of 1912
Prevented fraudulent therapeutic claims by drug manufacturers.
Harrison Narcotic Act/Federal Narcotic Act of 1914
Word narcotic
Stamp on narcotic drug containers
Regulated importation, manufacture, sale, and use of opium, codeine and its derivatives.
Food, Drug and Cosmetic Act of 1938
No marketing until proven safe and toxicity testing done.
Adverse drug effects be reported.
Durham-Humphrey Amendment (1951)
Replaced laws of 1938.
Required designation of whether the drug was prescription or OTC.
Kefauver-Harris Amendment (1962)
Requires proof of drug safety and efficacy of drug for approval before marketing.
Controlled Substances Act (1970)
Replaced all laws prior concerning drug control. 5 drug schedules put in place based on potential for abuse.
Poison Prevention Packaging Act (1970)
Implemented child resistant packaging.
Drug Listing Act of 1972
FDA can keep a list of drugs. Drugs must have national drug code number.
Drug Regulation and Reformation Act of 1978
Allowed for briefer investigation of new drugs and faster access by the consumer.
Orphan Drug Act of 1983
Established funding for research of rare chronic illnesses for new and old drugs.
Drug price Competition and Patent Term Restoration Act of 1984
Eased requirements for marketing generic drugs.
Omnibus Budget Reconciliation Act (OBRA 1990)
Mandated that OTC drugs be documented.
Anabolic Steroid Control Act of 1990
Placed anabolic steroids into schedule 3 of the controlled substances act (CSA)
Prescription Drug Amendments of 1992
Allowed rapid approval of drugs for life-threatening diseases.
