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Multistate Pharmacy Jurisprudence Exam (MPJE) Review (FEDERAL LAW) (1)
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Multistate Pharmacy Jurisprudence Exam (MPJE) Review (FEDERAL LAW) (1)
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Multistate Pharmacy Jurisprudence Exam (MPJE)Review (FEDERAL LAW)
a federal agency in the Department of Health and Human Services established to regulate the
release of new foods and health-related products - ANS-Food and Drug Administration
Pure Food and Drug Act of 1906 - ANS-(P)FDA
FDCA - ANS-Federal Food, Drug, and Cosmetic Act of 1938 (6/25/38)
PPPA - ANS-Poison Prevention Packaging Act of 1970
CSA - ANS-Controlled Substance of 1970
What act established the FDA in 1970? - ANS-Controlled Substance Act of 1970
Drug Enforcement Administration - ANS-DEA (created 1973)
PDMA - ANS-Prescription Drug Marketing Act of 1987
OBRA 90 - what does it stand for - ANS-Omnibus Budget Reconciliation Act of 1990
What 3 illegal acts did the Pure Food and Drug Act of 1906 establish - ANS-Adulteration
Misbranding
Placing into interstate commerce unapproved new drugs
Mandated tests for drug toxicity and provided means for recall of drugs; established procedures
for introducing new drugs; gave FDA the power of enforcement - ANS-Federal Food, Drug, and
Cosmetic Act of 1938
A drug is dependent on _____________ - ANS-Intended Use
Intended use is determined by the___________, not the __________ - ANS-Provider, not the
user
Drug - ANS-1. In USP, or NF, or Homeopathic P.
2. Articles INTENDED FOR use in the
Diagnosis
Cure
Mitigation
Treatment or Prevention of Disease in man or animal
,3. Articles intended to affect the STRUCTURE or FUNCTION of the body (other than food)
4. Any component of the above
Instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent - ANS-Device
What is the difference between how a drug works and a device works - ANS-A drug works
through a chemical reaction and is dependent on metabolism. ; Devices are only recognized in
the USP or NF (Not homeopathic)
What are the 3 classes of devices - ANS-I. Reasonable assurance of safety and effectiveness
(referred to as GENERAL CONTROLS device)
II. Insufficient info for reasonable assurance safety and effectiveness
III. Pre-market approval
Device class - Reasonable assurance of safety and effectivenss - ANS-Class I
Pre-market approval - ANS-Class III
Something applied to the body for Cleansing, Beauty, Altering, Appearance. (NOT SOAP) -
ANS-cosmetic
True or False: A item can be both a drug AND cosmetic - ANS-True
Written, printed, or graphic on the container or accompanying it - ANS-Label
What must always accompany the container because it conveys intended use - ANS-Label
True or False: A patient may be given a package insert - ANS-True
Labelling must be ________ approved - ANS-FDA
What is the order of importance of what is included in a package insert - ANS-Contraindications
Warnings
Precautions
Adverse Reactions
What is the required content of a package insert - ANS-Essential scientific information; not false
or promotional evidence of safe and effective clinical pharmacology
Any drug after June 25, 1938 that was subject to the Food and Drug Act of 1906 - ANS-New
Drug
Required of all new drugs - ANS-NDA (New Drug Application
, Required of all generic drugs - ANS-ANDA (Abbreviated New Drug Application)
What are the requirements of an ANDA - ANS-Same:
Entity
Strength
Dosage Form
And MUST BE BIOEQUIVALENT
True or False: Both new drugs and generic drugs must be proven to be safe and effective -
ANS-False - just new drugs (prior to interstate commerce)
What a drug is corrupt, debase or made impure by the addition of a foreign or inferior substance
or element - ANS-Adulterated
Label is false or misleading (no label or a false label) - ANS-Misbranding
Caution: Federal law prohibits dispensing without a prescription. (FEDERAL LEGEND) -
ANS-Rx only
True or False: a filled prescription is exempt from misbranding if the drugs has "Federal Legend"
and is properly filled - ANS-True
Dispensing a prescription without prescription is considered_________ - ANS-Misbranding
New drugs must be - ANS-GRAE (generally recognized as effective)
GRAS (generally recognized as safe)
Device class also referred to as General Controls - ANS-Class I
What acronym is Doc My Toes are Purple for? - ANS-The intentions of drugs or devices:
Diagnosis
Cure
Mitigation
Treatment or Prevention of disease in man or animal
What are two ways for an item to be classified as prescription - ANS-1. Lack of safety without
supervision
2. Sponsor's request
How does the patient report adverse events - ANS-1. Call your doctor
2. Call FDA at 1-800-FDA-1088
3. Report online at www.fda.com/medwatch
-database on adverse events and med error reports given to FDA
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