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Drug/Control
Regulations
| Question | Answer |
|---|---|
| Food and Drug Administration (FDA) | Leading enforcement agency that regulates drug products |
| Domestic/Imported drugs require approval before marketed in U.S. | Food and Drug Administration (FDA) |
| Drug Enforcement Administration (DEA) | Controls the distribution of drugs easily abused. |
| Food and Drug Act of 1906 | Prohibited interstate commerce in adulterated/misbranded food, drinks, and drugs. |
| Food, Drug and Cosmetic Act (FDC) | Fatal poisoning from sulfanilamide; new drugs must show to be safe before marketing. |
| The Food Drug Administration was initially named... | Food, Drug, Insecticide Admin(FDIA) |
| Investigational drugs are regulated by... | Food, Drug, and Administration (FDA) |
| Controlled Substance Act is enforced by... | Drug Enforcement Admin. |
| 1970 Controlled Substances Act (CSA) | Classifies drugs easily abused and restricts their distribution. |
| 1970 Poison Prevention Packaging Act (PPPA) | Child proof packaging on all controlled/Rx drugs. |
| Deals with the issue of safety caps on prescription bottles | Poison Prevention Packaging Act |
| 1914 Harrison Tax Act | Requires mfg, pharmacist, importers, and Dr.'s be licensed and pay a tax. |
| 1966 Fair Packaging/Labeling Act | All consumer products be honestly/informately labeled. |
| 1950 Alberty Food Products -vs- U.S. | Ruled that the PURPOSE which a drug is used MUST be on the label. |
| 1951 Durham-Humphrey Amendment | Define what drug require a prescription and a"legend drug" on label"Rx only". |
| 1962 Kefauver-Harris Amendment | Requires mfg to provide proof of safety/effectiveness before market. Thalidomide:signature of understanding risks/actions to treat Multiple Myeloma |
| 1994 Pediatric Labeling Rule | All Drugs have pediatric dosing/safety info on labels if potential use for pediatric. |
| 1990 Omnibus Budget Reconciliation Act (OBRA) | Rph must offer counseling to Medicaid pt about meds. |
| 1984 Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman) | Allowed the extension of drug patent terms and quick intro to low cost generic. |
| Combat Methamphetamine Epidemic Act (CMEA) | Sets daily/monthly limits on OTC sales of pseudoephedrine and ephedrine. |
| National Drug Code (NDC) | The number on the mfg label: indicatingn the mfg # and product info |
Created by:
coquine
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