Pharm Law Intro

Front 1

Act

Back 1

A law passed by legislature

Front 2

Adjudication

Back 2

A formal determination or judgment

Front 3

CI - CV

Back 3

Denotes a controlled substance

Front 4

CE

Back 4

Continuing education

Front 5

CFR

Back 5

Code of Federal Regulations

Front 6

CGMP

Back 6

Current good manufacturing practices

Front 7

Closed system

Back 7

Refers to the distribution of controlled substances among registrants only

Front 8

Common law

Back 8

Refers to law developed from decisions of the courts

Front 9

CSA

Back 9

Controlled Substances Act; federal CSA is enforced by the DEA

Front 10

DEA

Back 10

Drug Enforcement Administration; concerned with controlled substances only

Front 11

DEA 222 forms

Back 11

For the ordering of CI and CII controlled substances between registrants

Front 12

Dispense

Back 12

Deliver medication to an ultimate user on the lawful order of a practitioner

Front 13

Distribute

Back 13

Deliver, other than administering or dispensing

Front 14

DUE

Back 14

Drug Use Evaluation

Front 15

DUE process

Back 15

law in its regular course of administration through the courts; fundamental fairness

Front 16

Ex post facto

Back 16

after the fact

Front 17

Ex post facto law

Back 17

law passed after the occurrence of an act with retroactively changes the legal consequences of the act

Front 18

Bioequivalent

Back 18

product that is a pharmaceutical equivalent/alternative that display comparable bioavailability

Front 19

Generic equivalent

Back 19

product that contains an identical amount of the same active ingredients in the same dosage form and, when administered in the same amount, will provide comparable therapeutic effects

Front 20

Jurisdiction

Back 20

(1) The power to decide a matter (2) The geographic area over which someone has authority

Front 21

Legend drug

Back 21

a drug which is available by prescription or medication order only

Front 22

NDC#

Back 22

National Drug Code; 9-11 digits representing manufacturer, product, and package size and dosage form

Front 23

New drug

Back 23

Drug not generally recognized by qualified experts as safe and effective for use

Front 24

What does the OBRA '90 mandate?

Back 24

(1) provide DUR for Rx orders (2) offer to counsel patients (3)maintain a written patient history in order for the state to receive federal funds for Medicaid programs

Front 25

Original state of licensure

Back 25

any state from which the license is obtained by examination and NOT by reciprocity

Front 26

Orange book

Back 26

Approved Drug Products with Therapeutic Equivalence Evaluations; lists all approved drugs in the US a well as therapeutic equivalence information

Front 27

PDMA

Back 27

Prescription Drug Marketing Act

Front 28

Pharmaceutical equivalent

Back 28

Drug product that contain the same active ingredient/dosage form/administration route/strength, but may differ in shape/coloring/flavoring/release mechanism

Front 29

PIC

Back 29

Pharmacist in charge

Front 30

PPPA

Back 30

Poison Prevention Packaging Act; enacted to decrease accidental poisonings of children

Front 31

Prescription (order)

Back 31

an order for dispensing medication, but NOT medication administration (i.e. Medication order in hospitals)

Front 32

Promulgate

Back 32

To announce officially; to make a law known; to put a law into action or force

Front 33

Quid pro quo

Back 33

something for something; exchange

Front 34

Reciprocity

Back 34

Transfer or licensure from one state to another; the state from which the license is transferred must be an original state of licensure

Front 35

Regulation

Back 35

Official guidelines promulgate by agencies of the legislature which interpret and define statutes (NOT LAWS!)

Front 36

Rule

Back 36

Same as regulation

Front 37

Statute

Back 37

a law; promulgated by the legislature

Front 38

Summary suspension

Back 38

suspension of a licences without/before a hearing (usually only for extreme circumstances where there is demonstrated immediate danger to public safety)

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Supercede

Back 39

To override; render unnecessary; to displace

Front 40

The act

Back 40

usually referring to the FDCA

Front 41

Therapeutic alternate

Back 41

drug product containing different therapeutic moieties but which are of the same pharmacologica/therapeutic class that can be expected to have similar therapeutic effects when administered to patients in therapeutically equivalent doses

Front 42

Therapeutic moiety

Back 42

The portion or part of a drug that produces or causes a therapeutic effect or action