Adulteration v. Misbranding

15 terms by ssc122608 

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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

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