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15 terms

Adulteration v. Misbranding

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Adulteration
contains filthy, putrid, or decomposed substance
Adulteration
has been prepared or held under unsanitary conditions where it may have been contaminated
Adulteration
methods of manufacture do not conform to GMPs
Adulteration
container is composed of poisonous or deleterious substance which may contaminate the drug
Adulteration
it contains an unsafe color additive
Adulteration
if the strength differs, or it's quality or purity falls below the compendium standard unless the difference is clearly stated on the label or what it represents
Adulteration
mixed or packed with any substance which reduces its strength or quality or the drug has been substituted in whole or in part
Misbranding
labeling is false or misleading
Misbranding
if the label fails to contain the following information: name and address of manufacturer, packer or distributor; name of the drug; net quantity of the drug; weight of active ingredient per dosage unit; "Rx Only"; specific routes of administration; storage instructions; lot number; expiration date; adequate information for use
Misbranding
OTC fails to contain the following information: display panel including identity of product; name and address of the manufacturer, packager, distributor; net quantity of contents; cautions and warning needed to protect user; adequate directions for safe and effective use; "Drug Facts"; active ingredients; purpose; uses; warnings; directions; other information; inactive ingredients in alphabetical order; questions--telephone number
Misbranding
if drug is liable to deterioration unless it is packed or labeled accordingly
Misbranding
container is made, formed, or filled as to be misleading
Misbranding
is an exact imitation of another drug offered for sale under the name of another drug
Misbranding
dangerous to health when used in the dosage or manner suggested by the labeling
Misbranding
is packaged or labeled in violation of the Poison Prevention Packaging Act