Multistate Pharmacy Jurisprudence
Exam (MPJE) Review (FEDERAL LAW)
304 Very well Detailed solutions.
Multistate Pharmacy Jurisprudence
Exam (MPJE) Review (FEDERAL LAW)
304 Very well Detailed solutions.
A federal agency in the Department of Health and Human Services established to regulate the release of
new foods and health-related products - ANSWER Food and Drug Administration
Pure Food and Drug Act of 1906 - ANSWER (P)FDA
FDCA - ANSWER Federal Food, Drug, and Cosmetic Act of 1938 (6/25/38)
PPPA - ANSWER Poison Prevention Packaging Act of 1970
CSA - ANSWER Controlled Substance of 1970
What act established the FDA in 1970? - ANSWER Controlled Substance Act of 1970
Drug Enforcement Administration - ANSWER DEA (created 1973)
PDMA - ANSWER Prescription Drug Marketing Act of 1987
OBRA 90 - what does it stand for - ANSWER Omnibus Budget Reconciliation Act of 1990
What 3 illegal acts did the Pure Food and Drug Act of 1906 establish - ANSWER Adulteration
Misbranding
Placing into interstate commerce unapproved new drugs
,Multistate Pharmacy Jurisprudence
Exam (MPJE) Review (FEDERAL LAW)
304 Very well Detailed solutions.
Mandated tests for drug toxicity and provided means for recall of drugs; established procedures for
introducing new drugs; gave FDA the power of enforcement - ANSWER Federal Food, Drug, and
Cosmetic Act of 1938
A drug is dependent on _____________ - ANSWER Intended Use
Intended use is determined by the___________, not the __________ - ANSWER Provider, not the user
Drug - ANSWER 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 - ANSWER Device
What is the difference between how a drug works and a device works - ANSWER 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 - ANSWER 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
,Multistate Pharmacy Jurisprudence
Exam (MPJE) Review (FEDERAL LAW)
304 Very well Detailed solutions.
Device class - Reasonable assurance of safety and effectivenss - ANSWER Class I
Pre-market approval - ANSWER Class III
Something applied to the body for Cleansing, Beauty, Altering, Appearance. (NOT SOAP) - ANSWER
cosmetic
True or False: A item can be both a drug AND cosmetic - ANSWER True
Written, printed, or graphic on the container or accompanying it - ANSWER Label
What must always accompany the container because it conveys intended use - ANSWER Label
True or False: A patient may be given a package insert - ANSWER True
Labelling must be ________ approved - ANSWER FDA
What is the order of importance of what is included in a package insert - ANSWER Contraindications
Warnings
Precautions
Adverse Reactions
What is the required content of a package insert - ANSWER 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 - ANSWER New Drug
, Multistate Pharmacy Jurisprudence
Exam (MPJE) Review (FEDERAL LAW)
304 Very well Detailed solutions.
Required of all new drugs - ANSWER NDA (New Drug Application
Required of all generic drugs - ANSWER ANDA (Abbreviated New Drug Application)
What are the requirements of an ANDA - ANSWER 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 - ANSWER
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 - ANSWER Adulterated
Label is false or misleading (no label or a false label) - ANSWER Misbranding
Caution: Federal law prohibits dispensing without a prescription. (FEDERAL LEGEND) - ANSWER Rx only
True or False: a filled prescription is exempt from misbranding if the drugs has "Federal Legend" and is
properly filled - ANSWER True
Dispensing a prescription without prescription is considered_________ - ANSWER Misbranding
New drugs must be - ANSWER GRAE (generally recognized as effective)
Exam (MPJE) Review (FEDERAL LAW)
304 Very well Detailed solutions.
Multistate Pharmacy Jurisprudence
Exam (MPJE) Review (FEDERAL LAW)
304 Very well Detailed solutions.
A federal agency in the Department of Health and Human Services established to regulate the release of
new foods and health-related products - ANSWER Food and Drug Administration
Pure Food and Drug Act of 1906 - ANSWER (P)FDA
FDCA - ANSWER Federal Food, Drug, and Cosmetic Act of 1938 (6/25/38)
PPPA - ANSWER Poison Prevention Packaging Act of 1970
CSA - ANSWER Controlled Substance of 1970
What act established the FDA in 1970? - ANSWER Controlled Substance Act of 1970
Drug Enforcement Administration - ANSWER DEA (created 1973)
PDMA - ANSWER Prescription Drug Marketing Act of 1987
OBRA 90 - what does it stand for - ANSWER Omnibus Budget Reconciliation Act of 1990
What 3 illegal acts did the Pure Food and Drug Act of 1906 establish - ANSWER Adulteration
Misbranding
Placing into interstate commerce unapproved new drugs
,Multistate Pharmacy Jurisprudence
Exam (MPJE) Review (FEDERAL LAW)
304 Very well Detailed solutions.
Mandated tests for drug toxicity and provided means for recall of drugs; established procedures for
introducing new drugs; gave FDA the power of enforcement - ANSWER Federal Food, Drug, and
Cosmetic Act of 1938
A drug is dependent on _____________ - ANSWER Intended Use
Intended use is determined by the___________, not the __________ - ANSWER Provider, not the user
Drug - ANSWER 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 - ANSWER Device
What is the difference between how a drug works and a device works - ANSWER 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 - ANSWER 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
,Multistate Pharmacy Jurisprudence
Exam (MPJE) Review (FEDERAL LAW)
304 Very well Detailed solutions.
Device class - Reasonable assurance of safety and effectivenss - ANSWER Class I
Pre-market approval - ANSWER Class III
Something applied to the body for Cleansing, Beauty, Altering, Appearance. (NOT SOAP) - ANSWER
cosmetic
True or False: A item can be both a drug AND cosmetic - ANSWER True
Written, printed, or graphic on the container or accompanying it - ANSWER Label
What must always accompany the container because it conveys intended use - ANSWER Label
True or False: A patient may be given a package insert - ANSWER True
Labelling must be ________ approved - ANSWER FDA
What is the order of importance of what is included in a package insert - ANSWER Contraindications
Warnings
Precautions
Adverse Reactions
What is the required content of a package insert - ANSWER 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 - ANSWER New Drug
, Multistate Pharmacy Jurisprudence
Exam (MPJE) Review (FEDERAL LAW)
304 Very well Detailed solutions.
Required of all new drugs - ANSWER NDA (New Drug Application
Required of all generic drugs - ANSWER ANDA (Abbreviated New Drug Application)
What are the requirements of an ANDA - ANSWER 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 - ANSWER
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 - ANSWER Adulterated
Label is false or misleading (no label or a false label) - ANSWER Misbranding
Caution: Federal law prohibits dispensing without a prescription. (FEDERAL LEGEND) - ANSWER Rx only
True or False: a filled prescription is exempt from misbranding if the drugs has "Federal Legend" and is
properly filled - ANSWER True
Dispensing a prescription without prescription is considered_________ - ANSWER Misbranding
New drugs must be - ANSWER GRAE (generally recognized as effective)
