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Laws and Amendents

1906 Federal Food/Drug Act Enacted to stop the sale of inaccurately labeled drugs(misbranded)...manufacturers were required to put truthful info. on the labels brfore selling the drug
1914 Harrison Narcotic Act Enacted because of the excessive number of Opium addicts in the US.People could no longer obtain opium without prescription
1938 Food,drug and Cosmectic Act -added cosmectic -required drug companies to include directions to the consumer regarding use/package inserts on drugs -all narcotics were required to be labeled "Warning: May be Habit- forming(addictive)
1951 Durham-Humphrey Amendment -required the labeling "Caution: federal law prohibits dispensing without a prescription(on the stock bottle) -made certain drugs require a doctor's order/supervision -made the initial distinction b/w legend drugs and OTC mediacation.
1962 Kefauver-Harris Amendments -enacted in an attempt to ensure the safety/effectiveness of all new drugs on the market -prevented the sale of THALIDOMIDE
1970 Comprehension Drug abuse Prevention/Control Act -The Drug Enforcement Agency(DEA) was formed to enforce the laws concerning Narcotics and their distribution -created a stair-step schedule of controlled substances
1983 Orphan Drug Act -the lengthy time requirements of testing a new drug and the cost the accompanied them to provide a medication to persons who had rare disease(s) - Shortened the time of testing a new drug before it being passed by the FDA
1987 Prescription Drug Marketing Act -controlled the use of drugs in animals -required the labeling "Caution:federal laws restrict this drug to use by or in order of a licensed veterinarian."
1990 Anabolic Steroids Control Act (ASCA) helped stiffen regulations on the abuse problem of anabolic steroids and their abuse by athletes
1990 Omnibus Budget Reconciliation Act (OBRA) -deals specifically with practicing pharmacists -enacted because of reimbursement regulations for people who are covered under Medicaid/medicare insurance-pharmacies must council all patients who receive new prescription
1996 Health Insurance Portability and Accountability Act (HIPPA) -deals with patients right to continuance of health insurance even with changing employers -consent form to access this information will have to be signed by the patient
Food and Drug Administration (FDA) -enforce guidelines for manufacturers to ensure the safety and effectiveness of medications
Drug Enforcement Administration (DEA) -to prevent the illegal distribution/misuse of Narcotics
1970 The Poison Prevention Packaging Act (PPPA) -place all medications in containers with childproof caps or packaging
2005 Combat Methamphetamine Epidemic Act -to prevent the sale of Pseudoephedrine -enforcing controls over the sale of Pseudoephedrine
Created by: Japonica13