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Pharmacy law
Acts from 1906 to 2006
| Year | Act | Discription |
|---|---|---|
| 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. |
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bedevels
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