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14 Cards in this Set
- Front
- Back
Pure food and Drug Act of 1906
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Congress passed this law in 1906 to protect ppl from unsanitary and poorly labeled food.
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Food,Drug and Cosmetic Act of 1938
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This law suggest that no new drug can be marketed until proven safe for use by the FDA
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Durham Humphry Amendment of 1951
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*This law is also known as the "drug efficacy amendment"
*It generally differentiates between prescription and OTC drugs. *It authorizes to fill and refill oral presciptions. *It suggest that each drug should be labeled "caution: Federal law prohibits dispensing without a prescription". |
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Kefauver Harris Amedment of 1962
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*It is known as the "Drug Efficacy Admendment"
*This law indicates that new approved drugs must be safe as well as effective. *It also establishes Good Mfg Practice Requirements |
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Medical Device Amendment of 1976
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*This law passed in 1976, it includes #1,the classification od devices. #2, safety and efficacy of medical devices.
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Orphan Drug Act of 1983
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This law was passed for orphan drugs. Congrass passed this act to provide tax relief and other incentives for mfg to develop and market orphan drugs.
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Drug price competition and patent term restoration act of 1984
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This law was passed to provide generic drugs more readily to public
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Nation Drug Code number (NDC)
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1. First 4 indicate the mfg
2. middle 4 identify drug and strength 3. last 2 identify the package. |
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Over the Counter drug (OTC)
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Cat.1: includes ingredients generally considered safe, effective and not misbranded.
Cat.2: Include ingredients that are not considered safe, effective and are misbranded. at.3: Includes ingredients for which data are insufficient to permit the classification. |
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Patient Package Inserts (PPI)
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FDA passed law in the 1970 that certain drugs require PPI's
*Isotretinoin *Oral Contraceptive *Isoproterenol *Ticlid *Progesterone *Estrogen *INtrauterine Device |
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Obra Act of 1190
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It requires the pharmacists to offer counseling to patients.
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Letter coding System
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AA: Drugs that are available in conventional dosage and have no bioequivalence problems.
AT: Topical drugs that meet bioequivalence standards AB: Drugs that meet neccessary bioequivalence requirments BC: Drugs in extended release dosage form with bioequivalence issues. BT: Topical drugs with bioequivalence issues. BX: Drugs with inadequate information to determine the bioequivalence. |
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Posion Prevention Act
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passed in 1973, all drugs need to be in child proof containers.
The drugs Exempt for this law are: *Sublingual dosage of nitroglycerine *Sublimgual and chewable form of Isosobide Dinitrate. *Cholestyramine Powder *Methylprednisolone tablet *Mebendazole tablet *Potassium Supplement *Erythromycin ethyl succinate *Colestipol in powder form *parcrelipase preparations *Prednisone *Oral Contraceptives |
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Controlled Substance Act
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CSA= Controlled Substance act.
DEA= Drug Enforcement Admin. *Attorney Generally of USA has authority to place drugs into one of the five scld. controlled drugs |