NJ STATE LICENSURE REVIEW 2026
QUESTIONS WITH SOLUTIONS TESTED
QUESTIONS.
⩥ Durham-Humphrey required that OTC drugs contain _____ in the
*Drug Facts Label*.. Answer: -adequate directions for use
*e.g. safety in pregnancy and breast feeding, calcium, sodium,
magnesium, potassium content, etc.
⩥ Kefauver-Harris Amendment (1962) description. 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 _____.. 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 _____..
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 _____.. Answer: -
NDC number
,⩥ The NDC number contains _____ digits with _____ segments..
Answer: -10-11
-3
⩥ three segments of an NDC. 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 _____.. 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).
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).
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). Answer: 1.
streamline generic drug approvals
2. grant patent protection to drug innovators
⩥ Hatch-Waxman Act (1984) description. 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*
QUESTIONS WITH SOLUTIONS TESTED
QUESTIONS.
⩥ Durham-Humphrey required that OTC drugs contain _____ in the
*Drug Facts Label*.. Answer: -adequate directions for use
*e.g. safety in pregnancy and breast feeding, calcium, sodium,
magnesium, potassium content, etc.
⩥ Kefauver-Harris Amendment (1962) description. 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 _____.. 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 _____..
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 _____.. Answer: -
NDC number
,⩥ The NDC number contains _____ digits with _____ segments..
Answer: -10-11
-3
⩥ three segments of an NDC. 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 _____.. 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).
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).
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). Answer: 1.
streamline generic drug approvals
2. grant patent protection to drug innovators
⩥ Hatch-Waxman Act (1984) description. 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*
