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A or M
Adulteration or Misbranding
| Violation | Adulteration or Misbranding |
|---|---|
| contains any filthy, putrid, or decomposed substance | Adulteration |
| prepared or held under unsanitary conditions where it may have been comtaminated | Adulteration |
| methods of manufacture do not conform to current GMP (Good Manufacturing Practice) | Adulteration |
| manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection | Adulteration |
| container is composed of any poisonous or deleterious substance that may contaminate the drug | Adulteration |
| contains an unsafe color additive | Adulteration |
| purports to be a drug in an official compendium, and its strength difers from or its quality or purity falls below the compendium standard, unless the difference is clearly stated on the label | Adulteration *means if the product claims to meet USP standards but its strength or quality does not meet those standards, its is adulterated |
| not in a compendium, and its strength differs from or its quality falls below what it represents (what is on its label) | Adulteration |
| mixed or packed with any substance that reduces it strength or quality, or the drug has been substituted in whole or in part | Adulteration |
| Labeling is false or misleading in any particular way | Misbranding |
| rx drug and the manufacturer's label fails to contain the following information: name and address of the manufacturer, packer, or distributor | Misbranding |
| rx drug and the manufacturer's label fails to contain the following information: brand and/or generic name of the drug or drug product | Misbranding |
| rx drug and the manufacturer's label fails to contain the following information: net quantity weight, quantity, or dosage units) | Misbranding |
| rx drug and the manufacturer's label fails to contain the following information: weight or active ingredient per dosage unit | Misbranding |
| rx drug and the manufacturer's label fails to contain the following information: federal legend (Rx only) | Misbranding |
| rx drug and the manufacturer's label fails to contain the following information: if not taken orally, the specific routes of administation (i.e. for IM injection) | Misbranding |
| rx drug and the manufacturer's label fails to contain the following information: Special storage instructions if appropriate | Misbranding |
| rx drug and the manufacturer's label fails to contain the following information: Manufacturer's control number (LOT number) | Misbranding |
| rx drug and the manufacturer's label fails to contain the following information: Expiration date | Misbranding |
| rx drug and the manufacturer's label fails to contain the following information: Adequate info for use (package insert and med guide or Patient package insert if req'd). inlcuding other info req'd (certain products, BBW to alert healthcare about essential info regarding product | Misbranding |
| It is an OTC drug and fails to contain the following: a principal display panel, including a statement of identity of the product | Misbranding |
| It is an OTC drug and fails to contain the following: name and address of the manufacturer, packer, or distributor | Misbranding |
| It is an OTC drug and fails to contain the following: Net quantity of contents | Misbranding |
| It is an OTC drug and fails to contain the following: Cautions and warnings needed to protect user | Misbranding |
| It is an OTC drug and fails to contain the following: adequate directions for safe and effective use (for layperson) | Misbranding |
| It is an OTC drug and fails to contain the following: Content and format of OTC product labeling in "Drug facts" panel formatting | Misbranding *including: active ingredient, purpose, Use (indication), Warnings, Directions, Other information, Inactive ingredient (alphabetical order), Questions (optional) followed by telephone number |
| It is a drug liable to deterioration unless it is packaged or labeled accordingly | Misbranding |
| Container is made, formed, or filled as to be misleading | Misbranding |
| drug is an exact imitation of another drug or offered for sale uinder the name of another drug | Misbranding |
| dangerous to health when used in the dosage or manner suggested in the labeling | Misbranding |
| Misfilling a rx with the wrong drug , strength, or directions for use | Misbranding |
| misfilled rx involves the wrong strength of the dose prescribed | Misbranding and also adulterated |
| drug subject to REMS and is prescribed or dispensed w/o meeting requirements of REMS | Misbranding (part of the official labeling of the drug |
| advertising or promotion of a compounded drug that is false or misleading | Misbranding |
| expired drug product in a manufacturer's bottle is ______ bc after the expiration date, the strength cannot be assured | Adulterated |
| If a rx is filled using an expired product, it may also be _____ if the pharmacist placed a BUD that is after the expiration date of the drug | Misbranding |
| If a pharmacist counts a medication on a tray that has residue from another medication, the product would be _____ | Adulterated |
| If a pharmacist stores a specific product incorrectly, such as stocking a medication on a pharmacy shelf instead of in the fridge as required, this will lead to the product being _____ | Adulterated |
| fails to dispense a medication in a child-resistant container when required, this would be ______ | Misbranding |
| OTC products not packaged in tamper-evident packaging would be considered _____ and ______ | Adulterated and Misbranding *exceptions to tamper-evident OTC packaging include dermatologicals, dentifrices (toothpaste), insulins, and lozenges |
| Faiure to provide a PPI for drugs (hospitalized or institutionalized pts) would cause them to be _____ | Misbranding *Oral contraceptives, Estrogen-containing products) provided to patient prior to 1st administration of the drug and every 30 days thereafter |
| Faiure to provide a Med guide when dispensing a drug that requires one would cause the drug to be ____ | Misbranding *(Anticoags, Antidepressants, ADHD, Benzos, ESA's, HIV, Lindane shampoo and lotion, Opioid analgesics and cough products, SERMs, TNF inhibitors) |
| If a dietary supplement or medical device has an NDC number on its label, it would be _____ | Misbranding |
| Any product that implies it an an FDA-approved drug and its is not, would also be _____ | Misbranding |
| OTC products must have ______ directions for safe and effective use | ADEQUATE |
| Prescription products must have adequate _______ for use (i.e. package insert) | INFORMATION |
| When a pharmacist does not comply with PPPA, in addition to violating PPPA (CPSC enforced), it is also a _______ violation of the FDCA (FDA enforces) | Misbranding |
Created by:
Xander635
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