FDCA Violations, Adulteration, Misbranding Flashcards
1
Q
FDCA Violations - Interstate Commerce
A
- Introduce/deliver adulterated/misbranded food, drug, device, tobacco, cosmetic
- Adulteration/misbranding of food, drug, device, tobacco, cosmetic
- Receipt of adulterated/misbranded food, drug, device, tobacco, cosmetic and the delivery or offered delivery of such items for pay
- Alteration, mutilation, destruction, obliteration, or removal of whole or part of LABELING of food, drug, device, tobacco, cosmetic while article held for sale after shipment in interstate commerce and results in adulteration/misbranding
- Unsafe dietary supplement introduced
- Introduce/deliver articles in violation of emergency permit control, registration of food facilities, new drugs, authorization of medical products for emergency use laws
2
Q
FDCA Violations - Records
A
Refusal to access/copy/verification FDCA required records, failure to keep records, failure to make required report, violation of any recordkeeping requirement
3
Q
FDCA Violations - Inspections
A
Refusal to permit entry or inspection
4
Q
FDCA Violations - Adulterated/Misbranded
A
- Manufacture
- Introduce/deliver
- Receipt/deliver
5
Q
FDCA Violations - Counterfeit/Forge
A
- Forging, counterfeiting, simulating, falsely representing or w/o authority using mark, stamp, tag, label, or other identification device authorized/required by FDCA
- Counterfeiting drug, sale/dispensing, or holding for sale/dispensing of counterfeit drugs
- Falsification of serious AE report
6
Q
FDCA Violations - Labels/Labeling
A
- Alteration, mutilation, destruction, obliteration, or removal of whole or part of LABELING of food, drug, device, tobacco, cosmetic while article held for sale after shipment in interstate commerce and results in adulteration/misbranding
- Failure of manufacturer/packer/distributor to provide required printed matter to be included in package
7
Q
FDCA Violations - Registration
A
Failure to register in accodance to FDCA
8
Q
FDCA Violations - Dietary Supplement
A
Introduce unsafe dietary supplement
9
Q
FDCA Violations - Importation
A
- Importation of drug or RX drug in violation with FDCA
- Sale, purchase, trade of drug violating FDCA
- Sale, purchase, trade, counterfeiting of coupon in violation of FDCA
10
Q
Adulteration
A
Composition of product violated FDCA by
- Filthy, putrid, decomposed substance, whole or part
- Unsanitary conditions/potential contamination for prepared, packaged, or held
- GMP not met
- Unapproved color additive
- Strength, quality, purity is lower than official standards for drug listed in compendia (unless plainly stated on label)
- Poisonous/deleterious container leach into product
- Drug not recognized in official compendia and strength, purity, quality is lower than listed on label
- Any sub ingredient instead of active drug
11
Q
Misbranding
A
Labeling of product, the exact wording is FDA approved in NDA, is violation of FDCA if
- False, misleading
- Omitted name/address of manufacturer/packer/dist’r
- Required info missing or not prominent/readable
- Missing established name of active drug
- Missing each active ingredient with quantity (except non-human)
- Missing inactive ingredients alphabetical (except non-human or non-rx cosmetics)
- Missing “Rx only”
- Missing precautions if subject to deterioration
- Missing quantity of weight/measure (w/exceptions)
- Inadequate directions for use or warnings for OTC
- Inadequate information for use (Rx)
- Fails to meet compendium requirements
- Drug under the name of a different drug
- Imitates different drug
- Dangerous dosage recommended/suggested
- Fails color additive packing/labeling requirements
- Missing information for use, descriptive material
- Container misbranded
- Unregistered facility manufactured, processed, prepared, propagated, compounded it
- Missing tamper-resistant packaging
- Fails requirements of PPPA 1970
- Pharmacy dispenses Rx-only drug w/o legal prescription or authorized refill
