Florida MPJE Questions and Answers
with Verified Solutions
Sherman Antitrust Act ✔✔This act:
Outlaws agreements that restrain trade. Prevent monopolies and mergers that lessen competition
Federal Food Drug and Cosmetic Act ✔✔This act states:
No adulterated or misbranded drugs in interstate commerce
Adulteration ✔✔Gross - Think inside the capsule
Misbranded ✔✔Improperly labeled - think outside the bottle
FDCA ✔✔This act requires:
ingredients are disclosed on bottle
drug must be proven safe before marketing
authorizes FDA inspection of manufactures and distributors
,Public Health Service Act ✔✔This act:
- biologic drugs approved under BLA not NDA
- reviewed for purity, potency, and safety
Durham- Humphrey Labeling Amendments to FDCA ✔✔This act:
- allows for refills
- establishes Rx and OTC
OTC requirements of Durham-Humphrey ✔✔This act states:
- must be labeled with adequate directions for use (drug facts label)
- pregnancy/ breast feeding warning
- domestic contact information to receive ADR report
- OTC drugs approved under OTC monograph or NDA
Rx requirements of Durham-Humphrey ✔✔This act states:
- Rx must be labeled with adequate info for use (package insert)
- Rx approved under NDA - grandfathered pre 1938
,Durham-Humphrey Act established Pregnancy Categories
What are they? ✔✔A - safe in humans
B - safe in animals - no data in humans
C - Unknown safety in humans
D - unsafe in humans - benefits may outweigh risks
X - unsafe in humans - risks always outweighs benefits
Unit Dose Drugs - Labeling requirements ✔✔These items are required on which labels?
- generic name or brand - not both
- strength
- dosage form
- exp date (1 yr or earlier if manufacturer is sooner)
- Lot number
- business name of packager
- qty
-Rx only + Cautionary statement (if applies)
** directions for use are not required on dose but should be stored where can be accessed easily
, Kefauver-Harris Drug Efficacy Amendments to FDCA ✔✔This act states:
- drugs must be proven effective before marketing
- creates NDA and SNDA
Phase I, II, and III research - studies require informed
consent and IRB approval
- IND required to test new drugs in humans (FDA has 30 days to issues "clinical hold" or else
study can proceed
- mandates informed consent in clinical research
- ADRs must be reported to FDA on Med Watch Form
Manufacturers are required to report ADRs
Healthcare professionals and patients are voluntary
- All drug labels must have brand and generic name
- Advertising FDA for Rx FTC for OTC
- Establishes cGMP - current good manufacturing practices
- Manufacturers must register facility and be inspected every 2 years
- If not registered - drugs are Misbranded
- If a facility produces substandards of strength, quality or purity drugs are adulterated
with Verified Solutions
Sherman Antitrust Act ✔✔This act:
Outlaws agreements that restrain trade. Prevent monopolies and mergers that lessen competition
Federal Food Drug and Cosmetic Act ✔✔This act states:
No adulterated or misbranded drugs in interstate commerce
Adulteration ✔✔Gross - Think inside the capsule
Misbranded ✔✔Improperly labeled - think outside the bottle
FDCA ✔✔This act requires:
ingredients are disclosed on bottle
drug must be proven safe before marketing
authorizes FDA inspection of manufactures and distributors
,Public Health Service Act ✔✔This act:
- biologic drugs approved under BLA not NDA
- reviewed for purity, potency, and safety
Durham- Humphrey Labeling Amendments to FDCA ✔✔This act:
- allows for refills
- establishes Rx and OTC
OTC requirements of Durham-Humphrey ✔✔This act states:
- must be labeled with adequate directions for use (drug facts label)
- pregnancy/ breast feeding warning
- domestic contact information to receive ADR report
- OTC drugs approved under OTC monograph or NDA
Rx requirements of Durham-Humphrey ✔✔This act states:
- Rx must be labeled with adequate info for use (package insert)
- Rx approved under NDA - grandfathered pre 1938
,Durham-Humphrey Act established Pregnancy Categories
What are they? ✔✔A - safe in humans
B - safe in animals - no data in humans
C - Unknown safety in humans
D - unsafe in humans - benefits may outweigh risks
X - unsafe in humans - risks always outweighs benefits
Unit Dose Drugs - Labeling requirements ✔✔These items are required on which labels?
- generic name or brand - not both
- strength
- dosage form
- exp date (1 yr or earlier if manufacturer is sooner)
- Lot number
- business name of packager
- qty
-Rx only + Cautionary statement (if applies)
** directions for use are not required on dose but should be stored where can be accessed easily
, Kefauver-Harris Drug Efficacy Amendments to FDCA ✔✔This act states:
- drugs must be proven effective before marketing
- creates NDA and SNDA
Phase I, II, and III research - studies require informed
consent and IRB approval
- IND required to test new drugs in humans (FDA has 30 days to issues "clinical hold" or else
study can proceed
- mandates informed consent in clinical research
- ADRs must be reported to FDA on Med Watch Form
Manufacturers are required to report ADRs
Healthcare professionals and patients are voluntary
- All drug labels must have brand and generic name
- Advertising FDA for Rx FTC for OTC
- Establishes cGMP - current good manufacturing practices
- Manufacturers must register facility and be inspected every 2 years
- If not registered - drugs are Misbranded
- If a facility produces substandards of strength, quality or purity drugs are adulterated
