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Multistate Pharmacy Jurisprudence Exam (MPJE) Review (FEDERAL LAW)

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Food and Drug Administration Correct Answer: a federal agency in the Department of Health and Human Services established to regulate the release of new foods and health-related products (P)FDA Correct Answer: Pure Food and Drug Act of 1906 Federal Food, Drug, and Cosmetic Act of 1938 (6/25/...

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Multistate Pharmacy Jurisprudence
Exam (MPJE) Review (FEDERAL LAW)
Food and Drug Administration Correct Answer: a federal agency in the Department of Health and
Human Services established to regulate the release of new foods and health-related products

(P)FDA Correct Answer: Pure Food and Drug Act of 1906

Federal Food, Drug, and Cosmetic Act of 1938 (6/25/38) Correct Answer: FDCA

Poison Prevention Packaging Act of 1970 Correct Answer: PPPA

Controlled Substance of 1970 Correct Answer: CSA

Controlled Substance Act of 1970 Correct Answer: What act established the FDA in 1970?

DEA (created 1973) Correct Answer: Drug Enforcement Administration

Prescription Drug Marketing Act of 1987 Correct Answer: PDMA

Omnibus Budget Reconciliation Act of 1990 Correct Answer: OBRA 90 - what does it stand for

Adulteration
Misbranding
Placing into interstate commerce unapproved new drugs Correct Answer: What 3 illegal acts did the
Pure Food and Drug Act of 1906 establish

Federal Food, Drug, and Cosmetic Act of 1938 Correct Answer: Mandated tests for drug toxicity and
provided means for recall of drugs; established procedures for introducing new drugs; gave FDA the
power of enforcement

Intended Use Correct Answer: A drug is dependent on _____________

Provider, not the user Correct Answer: Intended use is determined by the___________, not the
__________

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 Correct Answer: Drug

,Device Correct Answer: Instrument, apparatus, implement, machine, contrivance, implant, in vitro
reagent

A drug works through a chemical reaction and is dependent on metabolism. ; Devices are only
recognized in the USP or NF (Not homeopathic) Correct Answer: What is the difference between how a
drug works and a device works

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 Correct Answer: What are the 3 classes of devices

Class I Correct Answer: Device class - Reasonable assurance of safety and effectivenss

Class III Correct Answer: Pre-market approval

cosmetic Correct Answer: Something applied to the body for Cleansing, Beauty, Altering, Appearance.
(NOT SOAP)

True Correct Answer: True or False: A item can be both a drug AND cosmetic

Label Correct Answer: Written, printed, or graphic on the container or accompanying it

Label Correct Answer: What must always accompany the container because it conveys intended use

True Correct Answer: True or False: A patient may be given a package insert

FDA Correct Answer: Labelling must be ________ approved

Contraindications
Warnings
Precautions
Adverse Reactions Correct Answer: What is the order of importance of what is included in a package
insert

Essential scientific information; not false or promotional evidence of safe and effective clinical
pharmacology Correct Answer: What is the required content of a package insert

New Drug Correct Answer: Any drug after June 25, 1938 that was subject to the Food and Drug Act of
1906

NDA (New Drug Application Correct Answer: Required of all new drugs

ANDA (Abbreviated New Drug Application) Correct Answer: Required of all generic drugs

Same:
Entity
Strength
Dosage Form

, And MUST BE BIOEQUIVALENT Correct Answer: What are the requirements of an ANDA

False - just new drugs (prior to interstate commerce) Correct Answer: True or False: Both new drugs and
generic drugs must be proven to be safe and effective

Adulterated Correct Answer: What a drug is corrupt, debase or made impure by the addition of a
foreign or inferior substance or element

Misbranding Correct Answer: Label is false or misleading (no label or a false label)

Rx only Correct Answer: Caution: Federal law prohibits dispensing without a prescription. (FEDERAL
LEGEND)

True Correct Answer: True or False: a filled prescription is exempt from misbranding if the drugs has
"Federal Legend" and is properly filled

Misbranding Correct Answer: Dispensing a prescription without prescription is considered_________

GRAE (generally recognized as effective)
GRAS (generally recognized as safe) Correct Answer: New drugs must be

Class I Correct Answer: Device class also referred to as General Controls

The intentions of drugs or devices:
Diagnosis
Cure
Mitigation
Treatment or Prevention of disease in man or animal Correct Answer: What acronym is Doc My Toes
are Purple for?

1. Lack of safety without supervision
2. Sponsor's request Correct Answer: What are two ways for an item to be classified as prescription

1. Call your doctor
2. Call FDA at 1-800-FDA-1088
3. Report online at www.fda.com/medwatch Correct Answer: How does the patient report adverse
events

FDA Adverse Event Reporting System (FAERS) Correct Answer: -database on adverse events and med
error reports given to FDA
-info used to ID possible safety concerns
-manufacturers who receive adverse drug event report must submit info to FDA

FDA Recall Class I Correct Answer: Threat to LIfe (what FDA Recall Class)

FDA Recall Class II Correct Answer: Temporary or reversible adverse health consequences (what FDA
Recall Class)

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