exam 1 - government overview Flashcards
(23 cards)
federal law is listed where
USC
where is indiana law listed
IC
where are federal rules listed
CFR
where are state rules listed
IAC
how is USC cited
Title USC $ Section (subsection)
how is IC cited
IC title-article-chapter-section
how is CFR cited
Title CFR $ Section (subsections)
how is IAC cited
Title IAC Article-Chapter(rule)-Section
what are the 3 main legal actions and repercussions
criminal
civil action
administrative action
describe the 1906 Pure Food and Drug Act
-recognize the US Pharmacopeia and the National Formulary as standard drug references
-defined misbranding and adulteration and assigned penalties to each practice
-established bureau of chem as the responsible party for enforcement
What does the official compendia consist of
USP
NF
Homoeopathic Pharmacopoeia of US (HPUS)
adulteration parameters
-poisonous or insanitary ingredients/lacks manufacturing controls
-strength, quality, or purity differs from compendia
-strength differs from representation
-mixed w/ another substance to reduce quality or strength
-delayed, denied, or limited inspection or refusal to permit entry or inspection
adulteration of devices
-no w/ performance standards
-not appropriate approval for use
-banned devices
-manufacturing, packing, storage, or instillation of a device not conforming
-failure to comply w/ requirements
class I devices
NOT used for supporting human life and/or preventing impairment of human health
do NOT present potential unreasonable risk of illness or injury
class II devices
moderate risk to use, require special controls to assure safety and effectiveness of devices
class III devices
high risk to use
support or sustain human life
prevent impairment of health
do present a potential unreasonable risk of illness or injury
define misbranding
-labeling that is false or misleading
-labeling missing manufacturer, packer, or distributor and an accurate statement of the quantity of contents
-required info not prominently displayed/stated
-established name not included (at least 1/2 of proprietary name)
-direction and required warning not included
-not in compliance w/ compendia
-packaged appropriately w/ expiration
-drug container is misleading
-drug is dangerous
-is a color additive only
-ads dont contain required info
-packaging safety not met
-REMS needed and not used
-not marked w/ Rx-only or control markings
what did the original 1906 pure food and drug act lack
only prevented false statements on the drugs identity and not false or misleading efficacy claims
what was the 1912 shirley amendment
prohibits manufacturers from intentionally misleading claims about a drugs effectiveness
what is the 1938 federal food, drug, and cosmetic act
-required new drugs to be shown safe before marketing
repealed sherley amendment
-authorized factory inspections
-required selected dangerous drugs to be administered under direction of qualified expert
what criteria must drugs meet according the food, drug, and cosmetic act
-articles recognized in official compendia
-articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention
-articles intended to affect the structure or function of the body
what was the 1950: Alberty food products co case
labeling for directions for use must include purpose and conditions for which drug was intended
what does the durham-humphrey amendment say
OTCs must be labeled w/ adequate directions for use
legend meds must be under supervision w/ caution statement
allows verbal transmission of prescriptions and refills
