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Pharmacy law

Acts from 1906 to 2006

1914 Harrison Narcotic Act This acts limits the transportant of opium. In order to purchase opium, a prescription is required.
1938 Food Drug and Cosmetic Act Misbranding or adulteration illegal. Reguires package inserts, habit-forming labels,new drugs proven safe under FDA.
1951 Durham Humphrey Amendment legend drugs from OTC. Requires "Caution: Fed Law Prohibits Despensing without script. Dr supervision for legend drugs. OTC drug label, Product name, Name & address of man. or dist, active ing, quantities of all ingred. active or not.
1962 Kefauver-Harris Admendent 1938 onward safe & effective. GMP, Manf. have to prove safe & effective before marketing, FTC(not FDA) Drug Advertisement, Manuf.must Reg annually, report adverse reactions, be inspected every 2 yrs
1970 Comprehensive Drug Abuse Prevention and Control Act (Controlled Substance Act)CSA DEA formed part of Justice Dept. Controlled substances are now Schedules 1-5 as to how potential for abuse.
1970 Poison Prevention Packaging Act Requires childproof packaging on most drugs. Exemptions Nitroglycerin or if it wouldn't harm a 5yr child.
1983 Orphan Drug Act Enables FDA to promote research and marketing of drugs needed for the treatment of rare diseases. Made for small % of people not economically feasible.
1984 Drug Price Competition and Patent-Term Restoration Act (Hatch-Waxman Admendment) Streamlines process for granting approval of generic drugs. Gives Manuf. incentives to develop new drugs with patent extentions, ability to rely on safty and efficacy findings of inventors after expiration of pattent.
1988 Food and Drug Administration Act FDA an agency Of Dept. of Health and Human Services.Also Script Drug Marketing Act bans the sale, trade, or purchase of drug samples. Adverse drug reactions & outcomes are reported to the FDA.
1990 Omnibus Budget Reconciliation Act (OBRA) Requires pharmacist to attempt or offer to counsel new scripts.Pharmacists required to provide info on all drugs.
1996 Health Insurance Portability and Accountability Act (HIPPA) Privacy and Security of PHI. Makes health ins. portable when switching jobs. Makes health care information more cost effective and efficient.
2006 Combat Methamphetamine Epidemic Act (CMEA) Limits the purchase of pseudoephedrine products 3.6g per day or 9g per 30 days.
1906 Federal Food and Drug Act This act prohibits the sale of adulterated or mislabeled food, drinks, or drugs.
Created by: bedevels



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