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Laws and Amendents
| Question | Answer |
|---|---|
| 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
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