AND CORRECT ANSWERS| ACCURATE REAL EXAM WITH
FREQUENTLY TESTED QUESTIONS|ALREADY A
GRADED|GUARANTEED PASS|LATEST UPDATE 2025
DEA (created 1973) - CORRECT ANSWER-Drug Enforcement Administration
Prescription Drug Marketing Act of 1987 - CORRECT ANSWER-PDMA
Omnibus Budget Reconciliation Act of 1990 - CORRECT ANSWER-OBRA 90 - what does
it stand for
Adulteration
Misbranding
Placing into interstate commerce unapproved new drugs - CORRECT ANSWER-What 3
illegal acts did the Pure Food and Drug Act of 1906 establish
Federal Food, Drug, and Cosmetic Act of 1938 - CORRECT ANSWER-Mandated tests
for drug toxicity and provided means for recall of drugs; established procedures
for introducing new drugs; gave FDA the power of enforcement
,Intended Use - CORRECT ANSWER-A drug is dependent on _____________
Provider, not the user - CORRECT ANSWER-Intended use is determined by
the___________, not the __________
1. In USP, or NF, or Homeopathic P.
2. Articles INTENDED FOR use in the
Diagnosis
Cure
Mitigation
Treatment or Prevention of Disease in man or animal
3. Articles intended to affect the STRUCTURE or FUNCTION of the body (other
than food)
4. Any component of the above - CORRECT ANSWER-Drug
Food and Drug Administration - CORRECT ANSWER-a federal agency in the
Department of Health and Human Services established to regulate the release of
new foods and health-related products
(P)FDA - CORRECT ANSWER-Pure Food and Drug Act of 1906
Federal Food, Drug, and Cosmetic Act of 1938 (6/25/38) - CORRECT ANSWER-FDCA
,Poison Prevention Packaging Act of 1970 - CORRECT ANSWER-PPPA
Controlled Substance of 1970 - CORRECT ANSWER-CSA
Controlled Substance Act of 1970 - CORRECT ANSWER-What act established the FDA
in 1970?
Device - CORRECT ANSWER-Instrument, apparatus, implement, machine, contrivance,
implant, in vitro reagent
A drug works through a chemical reaction and is dependent on metabolism. ;
Devices are only recognized in the USP or NF (Not homeopathic) - CORRECT ANSWER-
What is the difference between how a drug works and a device works
I. Reasonable assurance of safety and effectiveness (referred to as GENERAL
CONTROLS device)
II. Insufficient info for reasonable assurance safety and effectiveness
III. Pre-market approval - CORRECT ANSWER-What are the 3 classes of devices
Class I - CORRECT ANSWER-Device class - Reasonable assurance of safety and
effectivenss
Class III - CORRECT ANSWER-Pre-market approval
, cosmetic - CORRECT ANSWER-Something applied to the body for Cleansing, Beauty,
Altering, Appearance. (NOT SOAP)
True - CORRECT ANSWER-True or False: A item can be both a drug AND cosmetic
Label - CORRECT ANSWER-Written, printed, or graphic on the container or
accompanying it
Label - CORRECT ANSWER-What must always accompany the container because it
conveys intended use
True - CORRECT ANSWER-True or False: A patient may be given a package insert
FDA - CORRECT ANSWER-Labelling must be ________ approved
Contraindications
Warnings
Precautions
Adverse Reactions - CORRECT ANSWER-What is the order of importance of what is
included in a package insert
Essential scientific information; not false or promotional evidence of safe and
effective clinical pharmacology - CORRECT ANSWER-What is the required content of a
package insert