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14 Cards in this Set

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Pure food and Drug Act of 1906
Congress passed this law in 1906 to protect ppl from unsanitary and poorly labeled food.
Food,Drug and Cosmetic Act of 1938
This law suggest that no new drug can be marketed until proven safe for use by the FDA
Durham Humphry Amendment of 1951
*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".
Kefauver Harris Amedment of 1962
*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
Medical Device Amendment of 1976
*This law passed in 1976, it includes #1,the classification od devices. #2, safety and efficacy of medical devices.
Orphan Drug Act of 1983
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.
Drug price competition and patent term restoration act of 1984
This law was passed to provide generic drugs more readily to public
Nation Drug Code number (NDC)
1. First 4 indicate the mfg
2. middle 4 identify drug and strength
3. last 2 identify the package.
Over the Counter drug (OTC)
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.
Patient Package Inserts (PPI)
FDA passed law in the 1970 that certain drugs require PPI's
*Isotretinoin
*Oral Contraceptive
*Isoproterenol
*Ticlid
*Progesterone
*Estrogen
*INtrauterine Device
Obra Act of 1190
It requires the pharmacists to offer counseling to patients.
Letter coding System
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.
Posion Prevention Act
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
Controlled Substance Act
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