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NJ MPJE | 521 Questions with 100% Correct Answers | 68 Pages

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Neither _____ nor _____ are required by an *ANDA*. - -pre-clinical animal studies -clinical studies *bioequivalence only Prescription drug advertising is regulated by the _____, while OTC dru g advertising is regulated by the _____. - -FDA -FTC (Federal Trade Commission) Any false or misleading sta...

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  • September 23, 2022
  • 62
  • 2022/2023
  • Exam (elaborations)
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  • nj mpje
  • while otc drug a
  • nj mpje | 521 questions with 100 correct answers | 68 pages
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NJ MPJE | 521 Questions with 100%
Correct Answers | 68 Pages
Neither _____ nor _____ are required by an *ANDA*. Correct Answer: -pre-clinical animal studies

-clinical studies

*bioequivalence only

Prescription drug advertising is regulated by the _____, while OTC drug advertising is regulated by the
_____. Correct Answer: -FDA

-FTC (Federal Trade Commission)

Any false or misleading statements in a drug advertisement could be considered _____. Correct Answer:
-misbranding

Pure Food and Drug Act (1906) description Correct Answer: -mandated accurate product labeling and
required that the ingredients used in drugs met the *standards of strength, quality, and purity in USP*

-required that the food or drug label *could not be false or misleading*, and the presence and amount
of eleven dangerous ingredients, including alcohol, heroin, and cocaine had to be listed

-required that *no adulterated or misbranded drugs could be sent through interstate commerce*

Food Drug and Cosmetic Act (1938) description Correct Answer: -resulted from the *sulfanilamide
deaths due to diethylene glycol poisoning*

-required that the manufacturer (not the FDA) prove the *safety* of a drug before it could be marketed

-*defined* foods, drugs, dietary supplements, cosmetics, and devices

drug adulteration description Correct Answer: -*filthy, putrid, or decomposed*

-prepared, packaged, or *stored under unsanitary conditions* where it may become contaminated,
including lack of tests that confirm quality and purity

-*does not comply with CGMPs*

-contains an *unsafe color additive*

-contains a drug recognized in the official compendia, but *it's strength is different from official
standards, or the purity or quality is lower than the official standards*

,-contains a drug that is not recognized in official compendia, but its *strength is different from that
listed on the label, or the purity or quality is lower than that listed on the label*

*drugs can be both adulterated AND misbranded (i.e. strength or purity is compromised AND this is not
presented on the label)

drug misbranding description Correct Answer: -*lack of required information* on the package and in
the labeling

-*any false or misleading information*, such as imitating the properties of another drug or promising
false cures

-lack of special precautions needed to prevent decomposition that must be *specified on the package*
(e.g. "protect from light" or "keep in original container)

-illegible information

-lack of the proprietary or established generic name

-the *ingredients differ from the standard strength, quality, or purity as determined by USP*

-lack of the manufacturer, packer, and distributor location

-*improper packaging* (e.g. no package insert or medication guide) or improper or incomplete labeling
of additives

-deficiency in packaging requirements determined by the *Poison Prevention Packaging Act*

Durham-Humphrey Amendment (1951) description Correct Answer: -first time clear distinction was
made between *OTC and prescription drugs*

-drugs that were habit forming, those considered unsafe except under expert supervision due to toxicity,
and those limited to Rx only by the manufacturer's NDA were made available only by prescription

-authorized *refills and telephone prescriptions*

-required adequate *directions for use*

_____ is another term used to describe prescription drugs. Correct Answer: -legend drugs

Durham-Humphrey required that OTC drugs contain _____ in the *Drug Facts Label*. Correct Answer: -
adequate directions for use

*e.g. safety in pregnancy and breast feeding, calcium, sodium, magnesium, potassium content, etc.

Kefauver-Harris Amendment (1962) description Correct Answer: -resulted from the *thalidomide
tragedy*

,-required that manufacturers prove that their drug is *both safe AND effective in clinical studies* before
it can be approved (previously, drugs just needed to be safe)

-required that manufacturers continue to *report serious side effects* to the FDA after their drug is
marketed (e.g. Post-Market Surveillance)

-individuals must give their *informed consent* when they are study subjects of a clinical trial

-FDA must perform *retrospective evaluation of drug effectiveness* for drugs approved between 1938
and 1962

-FDA established *Current Good Manufacturing Practices (CGMPS)* for drug manufacturing and must
perform inspections

-FDA was given oversight to regulate the *advertising of prescription drugs*

The Controlled Substances Act of 1970 was designed to establish a _____ of the manufacturing,
distribution, and dispensing of drugs with the purpose of _____. Correct Answer: -closed system

-reducing drug diversion

The *Poison Prevention and Packaging Act of 1970* requires a number of household substances and
drugs to be packaged in _____. Correct Answer: -child-resistant (C-R) packaging

The *Drug Listing Act of 1970* required that all drug establishments register with the FDA and all drugs
have a unique _____. Correct Answer: -NDC number

The NDC number contains _____ digits with _____ segments. Correct Answer: -10-11

-3

three segments of an NDC Correct Answer: 1. *labeler code*: first 4 or 5 digits assigned by the FDA that
correspond to the manufacturer

2. *product code*: middle 3 or 4 digits determined by the labeler that correspond to the drug's
*strength, dosage, and formulation*

3. *package code*: last 1 or 2 digits determined by the labeler that correspond to the drug's *package
size and type*

The *Federal Anti-Tampering Act of 1982* required that tamper-resistant features be present on all
_____. Correct Answer: -*OTC* medications (passed because of Tylenol tampering)

*certain products are exempt - skin products, insulin, lozenges, tooth cleaning powder

criteria for orphan drugs under the *Orphan Drug Act of 1983* (2) Correct Answer: 1. the drug will treat
a disease that affects *less than 200,000 people in the US*

, OR

2. there is no reasonable expectation that the cost of research and development will be recovered by
the sales revenue

incentives to manufacturers under the *Orphan Drug Act of 1983* (2) Correct Answer: 1. tax credit for
50% of the clinical testing costs

2. 7-year period of exclusivity

purposes of the *Hatch-Waxman Act of 1984* (2) Correct Answer: 1. streamline generic drug approvals

2. grant patent protection to drug innovators

Hatch-Waxman Act (1984) description Correct Answer: -made it possible for generic drug companies to
file either an *Abbreviated New Drug Application (ANDA)* or *505(b)(2) application, also known as a
paper NDA*

-also granted *5 year patent exclusivity* to brand drugs

requirements for an ANDA for generic drugs (5) Correct Answer: 1. same active ingredient

2. same route of administration

3. same dosage form

4. same strength

5. bioequivalent to the branded drug

*the inactive ingredients can be different

requirements for a 505(b)(2) application (paper NDA) Correct Answer: -the generic drug company must
submit evidence of *previously published reports of investigations of safety and effectiveness*

Prescription Drug Marketing Act (1987) description Correct Answer: -made it illegal to buy drugs in
other countries and bring them to the US except under 1 of 2 conditions:

1. the quantity is for a *≤90 day supply* and is for the patient (*cannot be resold*)

2. an effective treatment is *not available in the US*, the *condition is serious*, and the drug being
imported has *no unreasonable risk*

-also *restricted hospital selling of drugs and prohibited selling of drug samples*

Omnibus Budget Reconciliation Act (OBRA) (1990) description Correct Answer: -required the pharmacist
to perform a *prospective drug utilization review and counseling* for all *Medicaid beneficiaries*

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