©THEBRIGHT EXAM STUDY SOLUTIONS 8/21/2024 1:28 PM
Phamacy Law Exam 1 Questions With
Correct Answers
1906 Pure Food and Drug Act - answer✔✔Prohibits the sale and transport of adulterated or
mislabeled food, drinks and drugs.
Prohibits the mislabeling and misbranding of products.
1938 Federal Food, Drug, and Cosmetic Act - answer✔✔Scientific proof of *safety* before a
drug could be marketed. (Sulfonilamide disaster)
1951 Durham-Humphrey Amendment - answer✔✔This act made the distinction between over
the counter drugs (OTC) and legend (prescription drugs) possible. Legend drugs should be
labeled as "Caution: Federal Law prohibits dispensing without a prescription
1962 Kefauver-Harris Amendment - answer✔✔All drugs made from 1938 forward must be
proven safe and EFFECTIVE. Also, the FTC now handles drug advertisements. Stricter
requirements for drug approval. Manufacturers must now register annually, be inspected every 2
years, and report adverse effects of drugs.
1997 FDA Modernization Act - answer✔✔Which act eliminated the requirement for the Legend
statement, provided the labeling contained the words "Rx only."
Off label uses of drugs - answer✔✔Indications other than approved by the FDA
Drug Supply Chain Security Act (DSCSA) - answer✔✔Outlines critical steps to build an
electronic, interoperable system to identify and trace certain prescription drugs as they are
distributed in the United States.
Adulterated definitions - answer✔✔It consists of any filthy, putrid or decomposed substance» It
has been prepared, packaged or held under unsanitary conditions where it may have become
contaminated» Its container is composed of any poisonous or deleterious substance» It has an
unsafe color additive » its quality or strength has been reduced by the addition or substitution of
other substances
MISBRANDING definitions - answer✔✔Labeling of a product that is false or misleading; label
information must include directions for use; safe and/or unsafe dosages; manufacturer, packer, or
distributor; quantity; and weight
, ©THEBRIGHT EXAM STUDY SOLUTIONS 8/21/2024 1:28 PM
What does the FDA regulate? - answer✔✔Food, drugs, cosmetics, Biologics, medical devices,
Veterinary produccts, tobacco products. Does not regulate the practice of medicine or pharmacy.
FDA enforement of the FDCA - answer✔✔Injunctions, criminal proceedings, drug seizure,
warning letter
Rx Label Requirements - answer✔✔1. Name and address of the pharmacy
2. Date of filling
3. Rx #
4. Name of prescriber
5. Name and address of the patient
6. Directions for use
7. Cautionary Statements if indicated on the prescription.
8. Must contain a "side effects statement"
EUA - answer✔✔Allows the FDA to make medical countermeasures available during public
health emergencies. Post marketing surveillance required.
REMS (Risk Evaluation and Mitigation Strategies) - answer✔✔Program for drugs where risks
may outweigh the benefit or the drug has a significant risk association
Compounding - answer✔✔State Board regulated, prepared for 1 patient, immediate demand,
[advertising of drug=ok]*, exempt from NDA & current GMP, traditional pharmacy function
Manufacturing - answer✔✔FDA inspected & regulated, resale to 3rd parties, future demands,
make inordinate amounts, distribute out-of-state, sell wholesale
Insulin OTC - answer✔✔Novolin 70/30, Humulin 70/30, Humulin 50/50, Novolin R, Humulin R
Insulin Rx - answer✔✔Novolog, Levemir, Lantus, Apidra, Humalog, Lispro
Bilogic Agents Facts - answer✔✔Fastest growing segment of the pharmaceutical market.
Ex. Vaccines, therapeutic proteins, monoclonal antibodies
Biosimilar - answer✔✔No clinically meaningful differences between the biologic product and
reference product in terms of: safety, purity, potency
Bioequivalence - answer✔✔No significan difference in the rate and extent to which the active
ingredient is available at the site of action.
Phamacy Law Exam 1 Questions With
Correct Answers
1906 Pure Food and Drug Act - answer✔✔Prohibits the sale and transport of adulterated or
mislabeled food, drinks and drugs.
Prohibits the mislabeling and misbranding of products.
1938 Federal Food, Drug, and Cosmetic Act - answer✔✔Scientific proof of *safety* before a
drug could be marketed. (Sulfonilamide disaster)
1951 Durham-Humphrey Amendment - answer✔✔This act made the distinction between over
the counter drugs (OTC) and legend (prescription drugs) possible. Legend drugs should be
labeled as "Caution: Federal Law prohibits dispensing without a prescription
1962 Kefauver-Harris Amendment - answer✔✔All drugs made from 1938 forward must be
proven safe and EFFECTIVE. Also, the FTC now handles drug advertisements. Stricter
requirements for drug approval. Manufacturers must now register annually, be inspected every 2
years, and report adverse effects of drugs.
1997 FDA Modernization Act - answer✔✔Which act eliminated the requirement for the Legend
statement, provided the labeling contained the words "Rx only."
Off label uses of drugs - answer✔✔Indications other than approved by the FDA
Drug Supply Chain Security Act (DSCSA) - answer✔✔Outlines critical steps to build an
electronic, interoperable system to identify and trace certain prescription drugs as they are
distributed in the United States.
Adulterated definitions - answer✔✔It consists of any filthy, putrid or decomposed substance» It
has been prepared, packaged or held under unsanitary conditions where it may have become
contaminated» Its container is composed of any poisonous or deleterious substance» It has an
unsafe color additive » its quality or strength has been reduced by the addition or substitution of
other substances
MISBRANDING definitions - answer✔✔Labeling of a product that is false or misleading; label
information must include directions for use; safe and/or unsafe dosages; manufacturer, packer, or
distributor; quantity; and weight
, ©THEBRIGHT EXAM STUDY SOLUTIONS 8/21/2024 1:28 PM
What does the FDA regulate? - answer✔✔Food, drugs, cosmetics, Biologics, medical devices,
Veterinary produccts, tobacco products. Does not regulate the practice of medicine or pharmacy.
FDA enforement of the FDCA - answer✔✔Injunctions, criminal proceedings, drug seizure,
warning letter
Rx Label Requirements - answer✔✔1. Name and address of the pharmacy
2. Date of filling
3. Rx #
4. Name of prescriber
5. Name and address of the patient
6. Directions for use
7. Cautionary Statements if indicated on the prescription.
8. Must contain a "side effects statement"
EUA - answer✔✔Allows the FDA to make medical countermeasures available during public
health emergencies. Post marketing surveillance required.
REMS (Risk Evaluation and Mitigation Strategies) - answer✔✔Program for drugs where risks
may outweigh the benefit or the drug has a significant risk association
Compounding - answer✔✔State Board regulated, prepared for 1 patient, immediate demand,
[advertising of drug=ok]*, exempt from NDA & current GMP, traditional pharmacy function
Manufacturing - answer✔✔FDA inspected & regulated, resale to 3rd parties, future demands,
make inordinate amounts, distribute out-of-state, sell wholesale
Insulin OTC - answer✔✔Novolin 70/30, Humulin 70/30, Humulin 50/50, Novolin R, Humulin R
Insulin Rx - answer✔✔Novolog, Levemir, Lantus, Apidra, Humalog, Lispro
Bilogic Agents Facts - answer✔✔Fastest growing segment of the pharmaceutical market.
Ex. Vaccines, therapeutic proteins, monoclonal antibodies
Biosimilar - answer✔✔No clinically meaningful differences between the biologic product and
reference product in terms of: safety, purity, potency
Bioequivalence - answer✔✔No significan difference in the rate and extent to which the active
ingredient is available at the site of action.
