Phamacy Law Exam 1 2025/2026 Exam
Questions and Answers 100%
1
Guaranteed Success | Already Rated A+
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.
COPYRIGHT©PROFFKERRYMARTIN 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE.
PRIVACY STATEMENT. ALL RIGHTS RESERVED
,Manufacturers must now register annually, be inspected every 2 years, and
report adverse effects of drugs.
2
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
COPYRIGHT©PROFFKERRYMARTIN 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE.
PRIVACY STATEMENT. ALL RIGHTS RESERVED
, and/or unsafe dosages; manufacturer, packer, or distributor; quantity; and
weight
3
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"
COPYRIGHT©PROFFKERRYMARTIN 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE.
PRIVACY STATEMENT. ALL RIGHTS RESERVED
Questions and Answers 100%
1
Guaranteed Success | Already Rated A+
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.
COPYRIGHT©PROFFKERRYMARTIN 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE.
PRIVACY STATEMENT. ALL RIGHTS RESERVED
,Manufacturers must now register annually, be inspected every 2 years, and
report adverse effects of drugs.
2
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
COPYRIGHT©PROFFKERRYMARTIN 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE.
PRIVACY STATEMENT. ALL RIGHTS RESERVED
, and/or unsafe dosages; manufacturer, packer, or distributor; quantity; and
weight
3
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"
COPYRIGHT©PROFFKERRYMARTIN 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE.
PRIVACY STATEMENT. ALL RIGHTS RESERVED
