Pharmacy Law Test 1

Front 1

What is the law

Back 1

a body of principles that govern conduct and the observance of which can be enforced in courts

Front 2

What is known as the supreme law of the US

Back 2

The constitution

Front 3

What are administrative agencies

Back 3

they make regulations (as a general rule) by a process known as "notice and comment rulemaking"

Front 4

What does DEA stand for

Back 4

drug enforcement administration

Front 5

what is moral turpitude

Back 5

conduct that is against community standards and morals

Front 6

what did the 10th amendment of the constitution grant

Back 6

gives states all powers not delegated to federal government or prohibited by the constitution.

Front 7

what was the main problem in heckler v. chaney

Back 7

drugs being used for lethal injection were not approved by the FDA for that purpose and were therefore being used illegally

Front 8

can administrative agencies refuse to hear cases

Back 8

yes

Front 9

What does FDCA stand for

Back 9

Federal Food Drug and Cosmetic Act

Front 10

When and what did the Pure Food and Drug act institute

Back 10

1906; prohibited alduteration and misbranding; did not prohibit false and misleading efficacy claims

Front 11

When and what did the Food drug and cosmetic act institute

Back 11

1938; drug cannot be marketed until it is proven safe for use under the conditions described on the label and approved by the FDA

Front 12

What was the major trigger for the food drug and cosmetic act of 1938

Back 12

The sulfanilamide elixer that was killling ppl in 1937

Front 13

When and what did the Durham-Humphrey amendment institute

Back 13

1951; established 2 classes of drugs (OTC and Rx); authorized oral prescriptions and allowed refills on Rxs; also known as the prescription drug amendment

Front 14

When and what did the Kefauver-Harris amendment institute

Back 14

1962; added more strength to the FDCA by requiring that drugs be both safe and effective; also gsave FDA jurisdiction over drug advertising

Front 15

When and what did the food and drug administration modernization act institute (FDAMA)

Back 15

1997; streamlined regulatory procedures; insured expedited availability of safe and effective drugs and devices; intent to decrease backlogs; insure timely review of aps; fast track certain apps; expand authority over OTCs

Front 16

What is a food

Back 16

articles used for food or drink for man or other animals, chewing gum, and articles for components of any such article

Front 17

what is a drug

Back 17

articles recognized in the official US pharmacopoeia, official homeopathic pharmacopoeia of the US or the official national formulary

Front 18

what is a counterfeit drug

Back 18

drug not authorized to bear trademark or other identifying marks

Front 19

what is a device

Back 19

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar

Front 20

what is a cosmetic

Back 20

articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance and articles for use as a component of any such articles

Front 21

what is the nutrition labeling and education act (NLEA)

Back 21

mandates nutrition labeling on food products and authorizes health claims on product labeling as long as they are made in compliance with FDA regulations (example: products that contain dietary fiber such as oat cereals)

Front 22

what is a label

Back 22

display of written, printed, or graphic material upon the immediate container of any article

Front 23

what is labeling

Back 23

all labels and other written, printed, or graphic material...broader application than the word label

Front 24

what is a class I product recall

Back 24

reasonable probability that the product will cause serious adverse health consequences

Front 25

what is a class II product recall

Back 25

product may cause temporary or medically reversibel adverse health consequences, but the probability of serious adverse consequences is remote

Front 26

what is a class III product recall

Back 26

product not likely to cause adverse health consequences

Front 27

who is responsible for notifying the sellers of the recall

Back 27

the manufacturer

Front 28

who notifies the patient of a recall if necessary

Back 28

the pharmacy

Front 29

What is adulteration

Back 29

consists in whole or in part of filthy, putrid, or decomposed substances; prepared, packed or held in conditions where it may have been contaminated; exposed to a container that may have been contaminated; mfg under conditions that do not conform to current GMP

Front 30

what are CGMP

Back 30

set of regulations that establishes minimum requirments for the methos, facilities or controls used int he manufatur processing packaging or holding of a drug product; applies to manufacturers, not pharmacies, unless they engage in activities which may be deemed manufacturing

Front 31

what is misbranding

Back 31

if the labeling is false or misleading in any particular way; misbranding focuses on representations made by the mfg on the label or labeling

Front 32

what is an imitation drug

Back 32

a drug is misbranded if is an imitation of another drug (fake marijuana)

Front 33

what is a package insert

Back 33

pamphlet that must accompany the drug product and contains the essential scientific and medical info needed for the safe and effective use of the product by HCPs

Front 34

what is an NDC number

Back 34

It is a national drug code number required on all OTC and Rx labels and labeling; the first five digits identify the mfg or distributor; the last five digits identify the drug name, package size and type of drug

Front 35

what is the purpose of phase 1 trials

Back 35

to determine adverse effects

Front 36

what is the purpose of phase 2 trials

Back 36

determine efficacy of the drug and the dosages at which the efficacy occurs

Front 37

what is the purpose of phase 3 trials

Back 37

determine if results from phase 2 trials can be applied to mass public

Front 38

when is written consent required

Back 38

phase 1 and 2 trials

Front 39

when can verbal consent be accepted

Back 39

phase 3 trials

Front 40

what is DESI

Back 40

Drug efficacy study implementation; stated that all drug from 1938 forward had to have studies to prove efficacy

Front 41

Give some examples of class 1 medical devices

Back 41

needles, scissors, examination gloves, stethoscopes,and toothbrushes

Front 42

give some examples of class 2 medical devices

Back 42

insulin syringes, infusion pumps, thermometers, diagnostic reagents, tampons, and electric heating pads

Front 43

give some examples of class 3 medical devices

Back 43

pace makers, soft contact lenses, replacement heart valves

Front 44

when would a cosmetic be misbranded

Back 44

if it labeling is false, misleads the consumer, or lacks the required info, or if the label info is not clear enough to be read and understood by an ordinary consumer. also, if the container is made or filled so as to be misleading or if the packaging and labeling do not conform to the requirments of the PPPA.

Front 45

when would a cosmetic be adulterated

Back 45

it contains any poisonous or deleterious substances that may injure users; contains any filthy, putrid, or decomposed substance; was prepared under unsanitary conditions; container contains a substance that may contaminate the contents; contains an unsafe color additive but is not a hair dye

Front 46

what amendment to the constitution protects free speech

Back 46

the first amendment

Front 47

what is considered a Rx drug according to the durham - humphrey amendment

Back 47

those drugs that are unsafe for use except under the supervision of a practitioner b/c of the toxicity, method of use or collateral measures; they are subject to NDA approval process

Front 48

what is required to be on a Rx bottle label that is given to a patient

Back 48

*name and address of the dispenser
*serial # and date of the Rx or of its filling
*name of the prescriber
*name of the patient
*directions for use
*cautionary statements

Front 49

The pharmacist MUST insure that

Back 49

*label is not false or misleading
*drug dispensed is not an imitation drug
*drug is not sold under the name of another drug
*package and labeling conform to official compendia standards
*must be packaged & labeled appropriately if the drug subj to deterioration
*packaged in conformance with poison prevention packaging act