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Pharm Law Terms
Dr. G's Lec 1
| Question | Answer |
|---|---|
| Act | a law passed by the legislature |
| administer | direct application (by injection, inhalation, ingestion, etc) of a drug to the body of a pt by a practitioner or his authorized agent or by the pt at the direction of the practitioner |
| adjudication | a formal determination or judgment |
| bioequivalent | term describing products which are pharmaceutical equivalents or alternatives that display comparable bioavailability; the parameters evaluated regarding bioavailability are the rate and extent of absorption |
| CI-CV | denotes a controlled substance in Class I, Class II, etc., as determined in the CSA |
| CE | continuing education |
| CFR | code of federal regulations |
| CGMP | current good manufacturing practices; the standard established by the FDA and applied to all drug manufacturers |
| closed system | as applied to the CSA; refers to the distribution of CS among registrants only |
| common law | refers to law developed from decisions of the courts |
| compounding | preparation, mixing, assembling, packaging, or labeling of a drug/device by a pharmacist or by a practitioner in the course of professional practice. |
| CSA | controlled substances act; federal CSA is enforced by the DEA |
| DEA | drug enforcement administration; under the jurdisdiction of the Dept. of Justice; concerned w/ CS only |
| DEA 222 forms | Drug Enforcement Administration Form 222 for the ordering of CI and CII CS btw registrants |
| Direct supervision of a pharmacist | (in AZ) pharmacist is present |
| dispense | deliver med to an ultimate user on the lawful order of a practitioner |
| distribute | deliver, other than by administering (directly to a pt by the practitioner) or dispensing (on the order/Rx of the practitioner) |
| drug | articles, recognized in the official compendium, intended for the use in the dx, tx, mitigation, cure or prevention of disease; also articles other than food intended to affect the structure or fxn of the body |
| DUE | drug use evaluation |
| DUE process | law in its regular course of administration through the courts; fundamental fairness |
| DUR | drug utilization review/drug use review |
| Ex post facto | after the fact |
| Ex post facto law | law passed after the occurrence of an act which retroactively changes the legal consequences of the act |
| FDA | Federal Food and Drug Administration |
| FDCA (Federal Food, Drug and Cosmetic Act) | (1938)catalyst = sulfanilamide. Reg. drug development, manuf. & marketing (focuse on quality). Only safe and properly labeled drugs may be intro. into interstate commerce. Defined label/labeling (labels must contain adequate SIG); estab. FDA |
| Generic equivalent | contains identical amt. of the same AI in the same dosage form and, if administered in the same amt., will provide comparable therapeutic effects |
| GMP | good manufacturing practices; mandated by the FDCA, with standards for manuf. promulgated in reg. by the FDA |
| internship | the practical, experiential, hands-on training of a pharmacy intern under the supervision of a preceptor |
| jurisdiction | (a) the power to decide a matter; (b) the geographic area over which someone has authority |
| label | written, printed, or graphic matter immediately attached to the container for sale |
| labeling | includes the label and any accompanying material to the container for sale (may be inside the container, like a package insert) |
| legend drug | a drug which is available by RX or medication order only |
| NDA | new drug application: filed with the FDA to get approval for marketing in interstate commerce in the US; drug must be proven safe and effective to be approved. |
| NDC # | national drug code; 9-11 #s specifying the manuf. (1st 4/5#), product (name, strength, dosage form)(next 4#), the package size (last 2#); requested by the FDA to be on the label; not required; widely used when submitting info for dispensing reimbursement |
| new drug | drug not generally recognized by qualified experts as safe and effective for use |
| OBRA '90 | federal Omnibus Budget Reconciliation Act of 1990; mandates that pharmacists (a) provide DUR of Rx orders; (b) offer to counsel pt; and, (c) maintain a written pt hx in order for the state to receive federal funds for Medicaid programs; 1st effective pt c |
| off-label use | use an approvd drug for other than the approved indication |
| Act | a law passed by the legislature |
| administer | direct application (by injection, inhalation, ingestion, etc) of a drug to the body of a pt by a practitioner or his authorized agent or by the pt at the direction of the practitioner |
| adjudication | a formal determination or judgment |
| bioequivalent | term describing products which are pharmaceutical equivalents or alternatives that display comparable bioavailability; the parameters evaluated regarding bioavailability are the rate and extent of absorption |
| CI-CV | denotes a controlled substance in Class I, Class II, etc., as determined in the CSA |
| CE | continuing education |
| CFR | code of federal regulations |
| CGMP | current good manufacturing practices; the standard established by the FDA and applied to all drug manufacturers |
| closed system | as applied to the CSA; refers to the distribution of CS among registrants only |
| common law | refers to law developed from decisions of the courts |
| compounding | preparation, mixing, assembling, packaging, or labeling of a drug/device by a pharmacist or by a practitioner in the course of professional practice. |
| CSA | controlled substances act; federal CSA is enforced by the DEA |
| DEA | drug enforcement administration; under the jurdisdiction of the Dept. of Justice; concerned w/ CS only |
| DEA 222 forms | Drug Enforcement Administration Form 222 for the ordering of CI and CII CS btw registrants |
| Direct supervision of a pharmacist | (in AZ) pharmacist is present |
| dispense | deliver med to an ultimate user on the lawful order of a practitioner |
| distribute | deliver, other than by administering (directly to a pt by the practitioner) or dispensing (on the order/Rx of the practitioner) |
| drug | articles, recognized in the official compendium, intended for the use in the dx, tx, mitigation, cure or prevention of disease; also articles other than food intended to affect the structure or fxn of the body |
| DUE | drug use evaluation |
| DUE process | law in its regular course of administration through the courts; fundamental fairness |
| DUR | drug utilization review/drug use review |
| Ex post facto | after the fact |
| Ex post facto law | law passed after the occurrence of an act which retroactively changes the legal consequences of the act |
| FDA | Federal Food and Drug Administration |
| FDCA (Federal Food, Drug and Cosmetic Act) | (1938)catalyst = sulfanilamide. Reg. drug development, manuf. & marketing (focuse on quality). Only safe and properly labeled drugs may be intro. into interstate commerce. Defined label/labeling (labels must contain adequate SIG); estab. FDA |
| Generic equivalent | contains identical amt. of the same AI in the same dosage form and, if administered in the same amt., will provide comparable therapeutic effects |
| GMP | good manufacturing practices; mandated by the FDCA, with standards for manuf. promulgated in reg. by the FDA |
| internship | the practical, experiential, hands-on training of a pharmacy intern under the supervision of a preceptor |
| jurisdiction | (a) the power to decide a matter; (b) the geographic area over which someone has authority |
| label | written, printed, or graphic matter immediately attached to the container for sale |
| labeling | includes the label and any accompanying material to the container for sale (may be inside the container, like a package insert) |
| legend drug | a drug which is available by RX or medication order only |
| NDA | new drug application: filed with the FDA to get approval for marketing in interstate commerce in the US; drug must be proven safe and effective to be approved. |
| NDC # | national drug code; 9-11 #s specifying the manuf. (1st 4/5#), product (name, strength, dosage form)(next 4#), the package size (last 2#); requested by the FDA to be on the label; not required; widely used when submitting info for dispensing reimbursement |
| new drug | drug not generally recognized by qualified experts as safe and effective for use |
| OBRA '90 | federal Omnibus Budget Reconciliation Act of 1990; mandates that pharmacists (a) provide DUR of Rx orders; (b) offer to counsel pt; and, (c) maintain a written pt hx in order for the state to receive federal funds for Medicaid programs; 1st effective pt c |
| off-label use | use an approvd drug for other than the approved indication |
Created by:
nluong
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