Adulteration and misbranding are part of the ____.
Food, Drug and Cosmetics Act (FDCA)
What are the provisions for a drug to be considered “adulterated”?
- filthy/putrid/decomposed
- prepared/packed/held under unsanitary conditions
- not manufactured under good practices
- container is composed of a deleterious substance
- contains an unsafe coloring agent
- doesn’t meet/not required to meet official standards ( must say “Not USP” in order to avoid adulteration)
- mixed to reduce quality or substituted
- inspection refusals
Define “Current Good Manufacturing Practices (CGMP)”.
regulations that establish the minimum requirements for manufacturing drug products (humans and animals)
- applies to manufacturers only
- must register with the FDA
- applies to all drugs made for use in the US
Define “misbranding”.
issues with the outside of the product, or issues with the words associated with the product.
What are the provisions for misbranding?
- false/misleading labeling
- incorrect manufacturer information
- incorrect quantity information
- information not prominently displayed
- incorrect/no use of established names in labeling or advertising
- inadequate directions/warnings in labeling
- not packaged as required
- label for deterioration missing
- misleading/imitation container
- dangerous to health as prescribed
- color additive not labeled as an additive
- packaging in violation of the PPPA
- REMS not followed
- fails to bear product identified
What three rules must be followed for a drug to be considered “compounded”?
- for an individual patient
- based on the receipt of a valid prescription from a practitioner
- compounded by a pharmacy or physician
True or false: compounds must follow cGMP and misbranding rules.
false
True or false: compounds CANNOT be a copy of a commercially available product.
true
Define “Class I devices”.
the simplest device type, not used for supporting or sustaining human life; subject to general controls
Define “Class II devices”.
a more serious device type, which requires special controls like performance standards, post-market surveillance, and registries
Define “Class III devices”.
most serious device type, used for supporting or sustaining human life or use presents a potential unreasonable risk of illness or injury; requires pre-market approval
True or false: the FDA cannot issue a mandatory drug recall.
true; they can only request for a manufacturer to recall a product, but they CAN mandate recalls for devices, food, and biological products
Who is ultimately responsible for knowing when a product has been recalled, and preventing it from getting to the patient?
the pharmacist
When would a Class I recall be initiated?
when there is a reasonable probability that use or exposure will cause death/serious consequences (most serious)
When would a Class II recall be initiated?
when there is a reasonable probability that use or exposure could cause temporary or medically reversible condition(s) (less serious)
When would a Class III recall be initiated?
when the use or exposure of a product is unlikely to cause adverse health consequences (least serious)
What would happen if a pharmacy were to disobey the rules related to pharmacy compounding?
they would be labeled as an outsourcing pharmacy (very difficult to actually do, which could end the pharmacy’s ability to compound completely)
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