Phamacy Law Exam 1 Questions with Correct Answers Graded A+
1906 Pure Food and Drug Act - Answers 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 - Answers Scientific proof of *safety* before a drug could be
marketed. (Sulfonilamide disaster)
1951 Durham-Humphrey Amendment - Answers 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 - Answers 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 - Answers Which act eliminated the requirement for the Legend statement,
provided the labeling contained the words "Rx only."
Off label uses of drugs - Answers Indications other than approved by the FDA
Drug Supply Chain Security Act (DSCSA) - Answers 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 - Answers 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 - Answers 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
What does the FDA regulate? - Answers Food, drugs, cosmetics, Biologics, medical devices, Veterinary
produccts, tobacco products. Does not regulate the practice of medicine or pharmacy.
FDA enforement of the FDCA - Answers Injunctions, criminal proceedings, drug seizure, warning letter
Rx Label Requirements - Answers 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 - Answers Allows the FDA to make medical countermeasures available during public health
emergencies. Post marketing surveillance required.
REMS (Risk Evaluation and Mitigation Strategies) - Answers Program for drugs where risks may outweigh
the benefit or the drug has a significant risk association
Compounding - Answers State Board regulated, prepared for 1 patient, immediate demand, [advertising
of drug=ok]*, exempt from NDA & current GMP, traditional pharmacy function
Manufacturing - Answers FDA inspected & regulated, resale to 3rd parties, future demands, make
inordinate amounts, distribute out-of-state, sell wholesale
Insulin OTC - Answers Novolin 70/30, Humulin 70/30, Humulin 50/50, Novolin R, Humulin R
Insulin Rx - Answers Novolog, Levemir, Lantus, Apidra, Humalog, Lispro
Bilogic Agents Facts - Answers Fastest growing segment of the pharmaceutical market.
Ex. Vaccines, therapeutic proteins, monoclonal antibodies
Biosimilar - Answers No clinically meaningful differences between the biologic product and reference
product in terms of: safety, purity, potency
Bioequivalence - Answers No significan difference in the rate and extent to which the active ingredient is
available at the site of action.
Biologics Price Competition and Innovation Act - Answers This act establishes generic approval pathway
for biologics (BLA).
FDA Purple Book - Answers Biologic interchangablity book
What is a dietary supplement? - Answers a product taken by mouth that contains a "dietary ingredient"
intended to supplement the diet
Ex. Vitamin, mineral, herbal product
Dietary Supplement Health and Education Act of 1994 - Answers -Mandates the FDA to treat DSs more
as a food than drug.
1906 Pure Food and Drug Act - Answers 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 - Answers Scientific proof of *safety* before a drug could be
marketed. (Sulfonilamide disaster)
1951 Durham-Humphrey Amendment - Answers 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 - Answers 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 - Answers Which act eliminated the requirement for the Legend statement,
provided the labeling contained the words "Rx only."
Off label uses of drugs - Answers Indications other than approved by the FDA
Drug Supply Chain Security Act (DSCSA) - Answers 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 - Answers 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 - Answers 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
What does the FDA regulate? - Answers Food, drugs, cosmetics, Biologics, medical devices, Veterinary
produccts, tobacco products. Does not regulate the practice of medicine or pharmacy.
FDA enforement of the FDCA - Answers Injunctions, criminal proceedings, drug seizure, warning letter
Rx Label Requirements - Answers 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 - Answers Allows the FDA to make medical countermeasures available during public health
emergencies. Post marketing surveillance required.
REMS (Risk Evaluation and Mitigation Strategies) - Answers Program for drugs where risks may outweigh
the benefit or the drug has a significant risk association
Compounding - Answers State Board regulated, prepared for 1 patient, immediate demand, [advertising
of drug=ok]*, exempt from NDA & current GMP, traditional pharmacy function
Manufacturing - Answers FDA inspected & regulated, resale to 3rd parties, future demands, make
inordinate amounts, distribute out-of-state, sell wholesale
Insulin OTC - Answers Novolin 70/30, Humulin 70/30, Humulin 50/50, Novolin R, Humulin R
Insulin Rx - Answers Novolog, Levemir, Lantus, Apidra, Humalog, Lispro
Bilogic Agents Facts - Answers Fastest growing segment of the pharmaceutical market.
Ex. Vaccines, therapeutic proteins, monoclonal antibodies
Biosimilar - Answers No clinically meaningful differences between the biologic product and reference
product in terms of: safety, purity, potency
Bioequivalence - Answers No significan difference in the rate and extent to which the active ingredient is
available at the site of action.
Biologics Price Competition and Innovation Act - Answers This act establishes generic approval pathway
for biologics (BLA).
FDA Purple Book - Answers Biologic interchangablity book
What is a dietary supplement? - Answers a product taken by mouth that contains a "dietary ingredient"
intended to supplement the diet
Ex. Vitamin, mineral, herbal product
Dietary Supplement Health and Education Act of 1994 - Answers -Mandates the FDA to treat DSs more
as a food than drug.
