Law exam final Flashcards
(25 cards)
How many Indiana state senators and representatives are there?
-1 Indiana state senator
-1 Indiana state representative
How is united states code (law) written?
title-USC-section-subsection
21 USC s353(b)
how is the code of federal regulations written?
title-CFR-section-subsection
21 CFR s 1306.04(a)(1)
What is the pure food and drug act?
1906, Federal law
-defined misbranding anf adulteration
-recognized USP and national formulary as standard drug references
-established bureau of chemistry –> FDA
What is adulteration?
-concerned with integrity of product inside the bottle
-needs to be correct strength, quality, purity
-refusing or delaying inspection
-adulteration of devices is included in this
-not using cGMP
What are class I devices?
not used for supporting human life or preventing impairment of human health and do not present a potential unreasonable risk of illness or injury
What are class II devices?
moderate risk to use, requires special controls to assure safety and effectiveness of devices
What are class III devices?
high risk to use, support or sustain human life or preventing impairment of human health, and do present a potential unreasonable risk of illness or injury
What is misbranding?
if the packaging containing the product is what it is intended to be
-labeling that is false/misleading
-labeling that does not contain the manufacturer, packer, distributor, accurate statement of the quantity in terms of weight, measure, count
-directions and required warnings are not put on the label
-if advertisements do not include required information
-if REMS is not done correctly
-if required to be dispensed in special packaging and is not in it
-if a drug does not have a package insert
-PPIs –> estrogens and contraceptives
-if a medguide is required to be dispensed and is not
What qualifies a drug as adulterated and misbranded?
examples:
-product is stored outside its recommended temperature, leading to the label falling off
-expired drug is counted and put into a prescription bottle, then dispensed to a patient
-if you are not registered with the FDA
What is the 1938 Federal food, drug, and cosmetic act?
-required drugs to be shown safe before marketing
-authorized factory inspections
-began requirement for prescription medications
-created the official requirements for something to be considered a drug
What is the definition of a drug according to the 1938 food, drug, and cosmetic act?
-needs to be recognized in the official compendia
-needs to be intended for the diagnosis, cure, mitigation, treatment, or prevention of disease
-has to be intended to affect the structure or any function of the body in man/animals
-intended for use as a component of any articles specified in the first 3
What is the 1951 Durham-Humphrey amendment?
-OTC medications need to be labeled with adequate directions for use
-legend medications need to be dispensed under supervision of a healthcare professional AND have the statement “Caution: federal law prohibits dispensing without a prescription”
-also allowed verbal prescriptions & refills.
What was the Kefauver-Harris amendment established in 1962?
required medications to prove their efficacy as well as their safety
*applied to all drugs marketed between 1938-1962
established cGMP
prescription drug advertising became FDA’s responsibility
-required informed consent and reporting adverse drug events in trials
What must be included on a medication compounded in a 503(b) facility?
-lot/batch #
-the statement “this is a compounded drug”
-name, address, phone # of the outsourcing facility
-statement “not for resale”
-beyond use date
-storage/handling instructions
-NDC
-list of active/inactive ingredients
-established name of the drug (does not need to be propietary)
-dosage/strength
-quantity/volume
What was the purpose of the DESI in 1968?
to determine if drugs between 1938-1962 were effective
What is the orphan drug act passed in 1983?
-encourages drug companies to develop medications for rare diseases
-provided tax incentives, enhanced patent protection, clinical research subsidies, government incentives to engage in drug research
What is the Hatch-Waxman Act passed in 1984?
-allowed companies to prepare for approval before the patient expires for generics
-only have to prove bioequivalence and cGMP
-established the aNDA
What is the Poison Prevention Packaging Act passed in 1970?
required special packaging
-at least 90% of adults can open it after 10 minutes
-20% or less of children under 5 can open the packaging after 10 minutes
What are the exemptions to special packaging?
prescription-by-prescription waivers or blanket waivers (patient authorization only)
What is the exception to reusing packaging?
if it is glass and a new cap is used
What are the classes and severity of recalls?
class I recall: can cause serious harm
class II recall: may cause some affects, but temporary/reversible
class III recall: unlikely to cause any serious harm
What is the Federal anti-tampering act passed in 1983?
-aftermath of chicago tylenol murders
-have to make it obvious if product was tampered with
-capsules need to be sealed with tamper evident technology
What are the types of REMS?
- patient-friendly labeling - med guides/patient package inserts
- communication plans - information sent directly to healthcare practitioners informing them about the drug & how to mitigate issues for patients
- elements to assure safe use - things done prior to prescribing, dispensing, or receiving a product
- implementation system - quality assurance process to ensure risks are being mitigated successfully
