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Drug Reg. & Control
Drug Regulation & Control
| Question | Answer |
|---|---|
| The Leading enforcement agency at the federal level for regulations concerning drug products | Food and Drug Administration |
| the agency which controls the distribution of drugs that may be easily abused | Drug Enforcement Administration (DEA) |
| Prohibited interstate commerce in adulterated or misbranded food, drinks, and drugs. Goverment pre-approval of drugs is required. | Food and Drug Act of 1906 (FDA) |
| In response to the fatal poisoning of 107 people,primarily children, by an untested sulfanilamide concoction, this comprehensive law requires new drugs be shown to be safe before marketing. | 1938 Food , drug and Cosmetic (FDC) Act |
| this law defines what drugs require a prescription by a licensed practitioner and requires them to include this legend on the label "Caution: Federal Law prohibits dispensing without a prescription." | 1951 Durham-Humphrey Admendment |
| The Leading enforcement agency at the federal level for regulations concerning drug products | Food and Drug Administration |
| Requires drug manufacturers to provide proof of both safety and effectiveness before marketing the drug. | 1962 Kefauver-Harris Amendments |
| the agency which controls the distribution of drugs that may be easily abused | Drug Enforcement Administration (DEA) |
| Requires child-proof packaging on all controlled and most prescription drugs despensed by pharmacies. | 1970 Poison Prevention Packaging Act |
| Prohibited interstate commerce in adulterated or misbranded food, drinks, and drugs. Goverment pre-approval of drugs is required. | Food and Drug Act of 1906 (FDA) |
| In response to the fatal poisoning of 107 people,primarily children, by an untested sulfanilamide concoction, this comprehensive law requires new drugs be shown to be safe before marketing. | 1938 Food , drug and Cosmetic (FDC) Act |
| Among other things, this act required pharmacists to offer counseling to Medicaid patients regarding Medications, Effectively putting the common practice into Law. | 1990 Omnibus Budget Reconciliation Act (OBRA) |
| this law defines what drugs require a prescription by a licensed practitioner and requires them to include this legend on the label "Caution: Federal Law prohibits dispensing without a prescription." | 1951 Durham-Humphrey Admendment |
| Provided broad and stringent regulations to protect patients' privacy. | 1996 Health Insurance Portability and Accountability Act (HIPAA) |
| Requires drug manufacturers to provide proof of both safety and effectiveness before marketing the drug. | 1962 Kefauver-Harris Amendments |
| Requires child-proof packaging on all controlled and most prescription drugs despensed by pharmacies. | 1970 Poison Prevention Packaging Act |
| The CSA classifies drugs that may be easily abused and restricts their distribution. It is enforced by the Drug Enforcement Administration (DEA) within the Justice Department. | 1970 Controlled Substances Act (CSA) |
| Among other things, this act required pharmacists to offer counseling to Medicaid patients regarding Medications, Effectively putting the common practice into Law. | 1990 Omnibus Budget Reconciliation Act (OBRA) |
| Patients in a trial are always "blind: to the treatment, i.e., they are not told which control group they are in. In a "double-blind" test, neither the patients nor the physicians know what the medication is. | Blind Tests |
| Provided broad and stringent regulations to protect patients' privacy. | 1996 Health Insurance Portability and Accountability Act (HIPAA) |
| A patent for a new drug gives its manufacturer an exclusive right to market the drug for a specific period of time under a brand name. A drug patent is in effect for 17 years from the date of the drug's discovery. The Hatch-Waxman Act of 1984 provided f | Patent protection |
| Inactive substances, not real medications, that are used to test the effectiveness of drugs. | placebos |
| All new drugs, whether made domestically or imported, require FDA approval before they can be marketed in the United States. | new drugs |
| Tests on proposed new drugs (investigational drugs) are "controlled" by comparing the effect of a proposed drug on one group of patients with the effect of a different treatment on other patients. | Clinical tests |
| Patients in a trial are always "blind: to the treatment, i.e., they are not told which control group they are in. In a "double-blind" test, neither the patients nor the physicians know what the medication is. | Blind Tests |
| A patent for a new drug gives its manufacturer an exclusive right to market the drug for a specific period of time under a brand name. A drug patent is in effect for 17 years from the date of the drug's discovery. The Hatch-Waxman Act of 1984 provided f | Patent protection |
| Once a patent for a brand drug expires, other manufacturers may copy the drug and release it under its pharmaceutical or "generic" name. | generics |
| All drugs are required to have clear and accurate information for all labels, inserts, packaging, and so on, but there are different information requirements for various categories of drugs. | labels and product labeling |
| the minimum requirements on prescription labels for most drugs are as follows; name and address of dispenser, prescription serial number, date of prescription or filling, name of prescriber, name of patient, directions for use, and cautionary statements. | prescription drug labels |
| The number assigned by the manufacturer. Each NDC number has three parts or sets of numbers: The first set indicates the manufacturer; the next set indicates the medication, its strength, and dosage form; the last set indicates the package size. | NDC ( National Drug Code) number |
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