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Pharm Law Terms

Dr. G's Lec 1

QuestionAnswer
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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