NEVADA MPJE
Exam/Updated/182 Questions
with Detailed Answers/Verified
Laws vs. Regulations - -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 - -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 - -assesses safety and adverse effects, as well as PK and
PD profile. Small number of healthy subjects (~20-80)
-Phase 2 study - -focuses on safety and efficacy. subjects have the
indicated condition (~35-100). dose ranging analyzed to determine
optimum dose
-Phase 3 study - -determines efficacy for treating the condition
compared to a placebo or gold-standard treatment. larger number of
patients (~300-3000)
-Phase 4 study - -(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 - -- 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) - -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 - -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 - -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) - -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 - -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) - --the first legislation
in the U.S. that offered protection to consumers from drug misuse.
-mandated accurate product labeling
-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 - -Adulteration- involves the drug itself
(quality)
Misbranding- incorrect or missing info on the container of labeling
-Food, Drug, and Cosmetic Act of 1938 - --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 - -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 - --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".
-Kefauver-Harris Amendment of 1962 - --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 - --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 - -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 - --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
Exam/Updated/182 Questions
with Detailed Answers/Verified
Laws vs. Regulations - -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 - -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 - -assesses safety and adverse effects, as well as PK and
PD profile. Small number of healthy subjects (~20-80)
-Phase 2 study - -focuses on safety and efficacy. subjects have the
indicated condition (~35-100). dose ranging analyzed to determine
optimum dose
-Phase 3 study - -determines efficacy for treating the condition
compared to a placebo or gold-standard treatment. larger number of
patients (~300-3000)
-Phase 4 study - -(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 - -- 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) - -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 - -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 - -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) - -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 - -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) - --the first legislation
in the U.S. that offered protection to consumers from drug misuse.
-mandated accurate product labeling
-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 - -Adulteration- involves the drug itself
(quality)
Misbranding- incorrect or missing info on the container of labeling
-Food, Drug, and Cosmetic Act of 1938 - --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 - -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 - --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".
-Kefauver-Harris Amendment of 1962 - --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 - --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 - -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 - --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
