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Phamacy Law Exam 1 Questions and Correct Answers
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1938 Federal Food, Drug, and Cosmetic Ac
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Phamacy Law Exam 1 Questions and CorrectAnswers
1906 Pure Food and Drug Act
✓ ~~~ 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
✓ ~~~ Scientific proof of *safety* before a drug could be marketed. (Sulfonilamide
disaster)
1951 Durham-Humphrey Amendment
✓ ~~~ 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
✓ ~~~ 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
✓ ~~~ Which act eliminated the requirement for the Legend statement, provided the
labeling contained the words "Rx only."
Off label uses of drugs
, ✓ ~~~ Indications other than approved by the FDA
Drug Supply Chain Security Act (DSCSA)
✓ ~~~ 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
✓ ~~~ 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
✓ ~~~ 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?
✓ ~~~ Food, drugs, cosmetics, Biologics, medical devices, Veterinary produccts,
tobacco products. Does not regulate the practice of medicine or pharmacy.
FDA enforement of the FDCA
✓ ~~~ Injunctions, criminal proceedings, drug seizure, warning letter
Rx Label Requirements
✓ ~~~ 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
✓ ~~~ Allows the FDA to make medical countermeasures available during public
health emergencies. Post marketing surveillance required.
REMS (Risk Evaluation and Mitigation Strategies)
✓ ~~~ Program for drugs where risks may outweigh the benefit or the drug has a
significant risk association
Compounding
✓ ~~~ State Board regulated, prepared for 1 patient, immediate demand, [advertising
of drug=ok]*, exempt from NDA & current GMP, traditional pharmacy function
Manufacturing
✓ ~~~ FDA inspected & regulated, resale to 3rd parties, future demands, make
inordinate amounts, distribute out-of-state, sell wholesale
Insulin OTC
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