NEVADA MPJE EXAM QUESTIONS AND
ANSWERS (VERIFIED AND UPDATED)
Laws vs. Regulations - ANS laws - enacted through a federal or state legislative process
regulations - (or rules) provide specific details to help implement the law, and are issued by
state regulatory agencies (e.g. state board of pharmacy)
FDA Drug Approval Process - ANS 1) pre-clinical testing (animals)
2) manufacturer files an investigational new drug (INDA) application with the FDA
3) INDA approval --> begin Phase 1 study, Phase 2, then Phase 3
4) file a new drug application (NDA) or biologic license application (BLA) to FDA
5) If drug approved, phase 4 study (post-marketing surveillance)
Phase 1 study - ANS assesses safety and adverse effects, as well as PK and PD profile. Small
number of healthy subjects (~20-80)
Phase 2 study - ANS focuses on safety and efficacy. subjects have the indicated condition
(~35-100). dose ranging analyzed to determine optimum dose
Phase 3 study - ANS determines efficacy for treating the condition compared to a placebo or
gold-standard treatment. larger number of patients (~300-3000)
@2026/2027 ALLRIGHTS RESERVED.
,Phase 4 study - ANS (post-marketing surveillance). conducted after the drug is approved and
released for use. can be requested by the FDA or initiated by the manufacturer. can be used to
monitor special populations or long-term effects of drug exposure
FDA Drug Approval Time - ANS - the NDA or BLA is evaluated by the FDA through the Center
for Drug Evaluation and Research (CDER)
- CDER is expected to review 90% of applications for standard drugs within 10 months of
receiving the application, and within 6 months for priority drugs
Prescription Drug User Fee Act (PDUFA) - ANS FDA was given authority to collect fees from
the "user" (drug manufacturer) in order for the FDA to review the new drug applications and
supplements. the funds are used to hire reviewers to help expedite the review process
OTC Drug Approval Process - ANS either approved thru NDA process used for Rx's or can be
approved thru the simpler OTC drug monograph process ("three-phase public rulemaking
process")
Generic Drug Approval Process - ANS must complete an Abbreviated New Drug Application
(ANDA). does not require pre-clinical animal studies and clinical studies w/ human subjects.
requires a simpler bioequivalency analysis between the generic and the Reference Listed Drug
Drug Advertising (Rx and OTC) - ANS Rx - regulated primarily by the FDA
OTC - regulated primarily by the Federal Trade Commission (FTC)
- Direct-to-consumer advertising is not federally legislated and FDA pre-approval is not required
Sherman Antitrust Act of 1890 - ANS attempted to outlaw monopolies that blocked
competition by nefarious methods, such as price-fixing, deceptive marketing practices, and
excluding competition from markets
Pure Food and Drug Act of 1906 (the Wiley Act) - ANS -the first legislation in the U.S. that
offered protection to consumers from drug misuse.
-mandated accurate product labeling
@2026/2027 ALLRIGHTS RESERVED.
,-ingredients used in drugs meet the standards of strength, quality, and purity in the USP and NF
-required that the food or drug label could not be false or misleading. presence and amount
dangerous ingredients must be listed
-no adulterated or misbranded drugs could be sent thru interstate commerce
Adulteration vs. Misbranding - ANS Adulteration- involves the drug itself (quality)
Misbranding- incorrect or missing info on the container of labeling
Food, Drug, and Cosmetic Act of 1938 - ANS -after diethylene glycol use as a solvent resulted
in fatalities
-marked the birth of the modern FDA
-required that the manufacturer prove the safety of the drug before it could be marketed
-authorized the FDA to conduct manufacturer and distributor inspections , and established
penalties for using misleading labeling
-product claims must be accurate and all ingredients must be listed on the label so that the
public is aware of what they are ingesting
-defined the terms food, drugs, dietary supplements, devices, and cosmetics
-prohibited adulterated or misbranded drugs in interstate commerce
- drug products marketed prior to 1938 were exempted or "grandfathered"
Public Health Service Act of 1944 - ANS defined biological products. biologics are approved
under a biologics license application (BLA). requires biologic be approved for potency and safety
Durham-Humphrey Amendment of 1951 - ANS -first time a clear distinction was made
between OTC and Rx drugs.
-classified conditions that would make a drug available by prescription: drugs are habit-forming,
considered unsafe for use except under medical supervision due to toxicity concerns, etc.
-required "legend" placed on prescription drugs: "caution: federal law prohibits dispensing w/o
a prescription." Later simplified to "Rx only"
-OTC drugs required to contain adequate directions for use in the "Drug Facts Label".
@2026/2027 ALLRIGHTS RESERVED.
, Kefauver-Harris Amendment of 1962 - ANS -after thalidomide near-catastrophe there was a
need for more stringent laws regarding drug safety
- for the first time, required manufacturers prove to the FDA that a drug is both safe AND
effective for the claims made in the product's labeling
-safety and efficacy results should be achieved by conducting controlled investigations
-required manufacturers to maintain records of adverse events associated with drugs and report
them to the FDA
-created the NDA and the supplemental NDA (sNDA)
-role of the institutional research board (IRB) was established for investigational new drugs
Drug Manufacturer Requirements - ANS -current good manufacturing practices (CGMPs) are
required for drug manufacturing
-manufacturers must register with the FDA and must be inspected every 2 years
-all drugs must come from a factory registered w/ the FDA or they are considered misbranded
-if standards of strength, quality, or purity are lacking, the drug is considered adulterated
Controlled Substances Act of 1970 - ANS established the Drug Enforcement Agency (DEA) and
the regulations that every registrant of the DEA must follow for all aspects of controlled
substances
Poison Prevention and Packaging Act of 1970 - ANS -enforced by the Consumer Product
Safety Commission
-requires a number of household substances and drugs to be packaged in child-resistant
packaging
-packaging must be significantly difficult for children under 5 years of age to open within a
reasonable time, and not difficult for normal adults to use properly
Drug Listing Act of 1972 - ANS -required drug establishments that are engaged in the
manufacturing, preparation, propagation, compounding, or processing of a drug to register all
of their drugs with the FDA
-each drug is required to have a unique NDC number
@2026/2027 ALLRIGHTS RESERVED.
ANSWERS (VERIFIED AND UPDATED)
Laws vs. Regulations - ANS laws - enacted through a federal or state legislative process
regulations - (or rules) provide specific details to help implement the law, and are issued by
state regulatory agencies (e.g. state board of pharmacy)
FDA Drug Approval Process - ANS 1) pre-clinical testing (animals)
2) manufacturer files an investigational new drug (INDA) application with the FDA
3) INDA approval --> begin Phase 1 study, Phase 2, then Phase 3
4) file a new drug application (NDA) or biologic license application (BLA) to FDA
5) If drug approved, phase 4 study (post-marketing surveillance)
Phase 1 study - ANS assesses safety and adverse effects, as well as PK and PD profile. Small
number of healthy subjects (~20-80)
Phase 2 study - ANS focuses on safety and efficacy. subjects have the indicated condition
(~35-100). dose ranging analyzed to determine optimum dose
Phase 3 study - ANS determines efficacy for treating the condition compared to a placebo or
gold-standard treatment. larger number of patients (~300-3000)
@2026/2027 ALLRIGHTS RESERVED.
,Phase 4 study - ANS (post-marketing surveillance). conducted after the drug is approved and
released for use. can be requested by the FDA or initiated by the manufacturer. can be used to
monitor special populations or long-term effects of drug exposure
FDA Drug Approval Time - ANS - the NDA or BLA is evaluated by the FDA through the Center
for Drug Evaluation and Research (CDER)
- CDER is expected to review 90% of applications for standard drugs within 10 months of
receiving the application, and within 6 months for priority drugs
Prescription Drug User Fee Act (PDUFA) - ANS FDA was given authority to collect fees from
the "user" (drug manufacturer) in order for the FDA to review the new drug applications and
supplements. the funds are used to hire reviewers to help expedite the review process
OTC Drug Approval Process - ANS either approved thru NDA process used for Rx's or can be
approved thru the simpler OTC drug monograph process ("three-phase public rulemaking
process")
Generic Drug Approval Process - ANS must complete an Abbreviated New Drug Application
(ANDA). does not require pre-clinical animal studies and clinical studies w/ human subjects.
requires a simpler bioequivalency analysis between the generic and the Reference Listed Drug
Drug Advertising (Rx and OTC) - ANS Rx - regulated primarily by the FDA
OTC - regulated primarily by the Federal Trade Commission (FTC)
- Direct-to-consumer advertising is not federally legislated and FDA pre-approval is not required
Sherman Antitrust Act of 1890 - ANS attempted to outlaw monopolies that blocked
competition by nefarious methods, such as price-fixing, deceptive marketing practices, and
excluding competition from markets
Pure Food and Drug Act of 1906 (the Wiley Act) - ANS -the first legislation in the U.S. that
offered protection to consumers from drug misuse.
-mandated accurate product labeling
@2026/2027 ALLRIGHTS RESERVED.
,-ingredients used in drugs meet the standards of strength, quality, and purity in the USP and NF
-required that the food or drug label could not be false or misleading. presence and amount
dangerous ingredients must be listed
-no adulterated or misbranded drugs could be sent thru interstate commerce
Adulteration vs. Misbranding - ANS Adulteration- involves the drug itself (quality)
Misbranding- incorrect or missing info on the container of labeling
Food, Drug, and Cosmetic Act of 1938 - ANS -after diethylene glycol use as a solvent resulted
in fatalities
-marked the birth of the modern FDA
-required that the manufacturer prove the safety of the drug before it could be marketed
-authorized the FDA to conduct manufacturer and distributor inspections , and established
penalties for using misleading labeling
-product claims must be accurate and all ingredients must be listed on the label so that the
public is aware of what they are ingesting
-defined the terms food, drugs, dietary supplements, devices, and cosmetics
-prohibited adulterated or misbranded drugs in interstate commerce
- drug products marketed prior to 1938 were exempted or "grandfathered"
Public Health Service Act of 1944 - ANS defined biological products. biologics are approved
under a biologics license application (BLA). requires biologic be approved for potency and safety
Durham-Humphrey Amendment of 1951 - ANS -first time a clear distinction was made
between OTC and Rx drugs.
-classified conditions that would make a drug available by prescription: drugs are habit-forming,
considered unsafe for use except under medical supervision due to toxicity concerns, etc.
-required "legend" placed on prescription drugs: "caution: federal law prohibits dispensing w/o
a prescription." Later simplified to "Rx only"
-OTC drugs required to contain adequate directions for use in the "Drug Facts Label".
@2026/2027 ALLRIGHTS RESERVED.
, Kefauver-Harris Amendment of 1962 - ANS -after thalidomide near-catastrophe there was a
need for more stringent laws regarding drug safety
- for the first time, required manufacturers prove to the FDA that a drug is both safe AND
effective for the claims made in the product's labeling
-safety and efficacy results should be achieved by conducting controlled investigations
-required manufacturers to maintain records of adverse events associated with drugs and report
them to the FDA
-created the NDA and the supplemental NDA (sNDA)
-role of the institutional research board (IRB) was established for investigational new drugs
Drug Manufacturer Requirements - ANS -current good manufacturing practices (CGMPs) are
required for drug manufacturing
-manufacturers must register with the FDA and must be inspected every 2 years
-all drugs must come from a factory registered w/ the FDA or they are considered misbranded
-if standards of strength, quality, or purity are lacking, the drug is considered adulterated
Controlled Substances Act of 1970 - ANS established the Drug Enforcement Agency (DEA) and
the regulations that every registrant of the DEA must follow for all aspects of controlled
substances
Poison Prevention and Packaging Act of 1970 - ANS -enforced by the Consumer Product
Safety Commission
-requires a number of household substances and drugs to be packaged in child-resistant
packaging
-packaging must be significantly difficult for children under 5 years of age to open within a
reasonable time, and not difficult for normal adults to use properly
Drug Listing Act of 1972 - ANS -required drug establishments that are engaged in the
manufacturing, preparation, propagation, compounding, or processing of a drug to register all
of their drugs with the FDA
-each drug is required to have a unique NDC number
@2026/2027 ALLRIGHTS RESERVED.
