Pharmacy Law Final Review 1

alchemist04's version from 2018-12-10 00:56


Question Answer
List 3 valid considerations of "policies powers", which allow the state to enact laws(1) State laws do not conflict w/ the U.S. Constitution (2) Does not Conflict with the Federal Laws (3) They bear a reasonable relationship to the protection of the public health, safety and welfare
List 3 legal tests a regulation must generally meet to be valid(1) regulation must be w/n the SCOPE of the agency’s authority (2) Regulation must be based on a Statute that gives the agency the authority to promulgate the regulation (3) It must bear reasonable relationship to the public health, safety and welfare
Which law prevents/prohibits false and fraudulent statements as to drug identity (labeling)? The Pure Food And Drug Act of 1906
What is the intent of FDCA?Safety
Which law requires that new drugs must be proven safe before being marketed?FDCA
Which of the ff is true about FDCA? (a) All drugs must have a label with "adequate directions for use" (b) drug must contain a warning about habit-forming properties (c) The law applies to cosmetics and devices as well (d) Label must contain, "Caution: Federal law prohibits dispensing w/o prescription". Pick all that appliesa, b, c


Question Answer
What is the difference btw Durham-Humphrey Amendment of 1951 and Kefauver-Harris Amendment of 1962?Durham-Humphrey Amendment created 2 types of drugs; The OTC and Legend (prescription) while the Kefauver-Harris Amendment indicates that drug must provide proof of efficacy
Which of the ff is NOT true of Prescription Drug Marketing Act (PDM) (a) it establishes sales restriction for prescription samples (b) Record keeping requirements for prescription drug samples (c) prohibits hospital and other health entities from selling their pharmaceutical purchases to other businesses (d) requires the state licensing of drug wholesale. Pick all that appliesNone of the above
Identify the Act that requires companies to implement risk evaluation and mitigation strategiesFDAAA
How is FDAMA different from FDAAA?(FDAMA) was passed primarily to streamline regulatory procedures to ensure the expedited availability of safe and effective drugs and devices.
What is "Labeling"?it includes the display of written, printed or graphic matter upon the immediate container of any article plus information “accompanying” the drug such as the package insert.


Question Answer
When not in line with GMP, this is called... (a) Misbranding (b) Adulteration (c) bothb
Class I recalls are issued whenthere is a reasonable probability that the product will cause Serious adverse health consequence or death
Class II recalls occur whenthe product may cause temporary or medically reversible adverse health consequences, but the probability of serious adverse consequences is remote
Class III recalls apply toproducts that are not likely to cause adverse health consequences.
Class I and II recalls requiresWritten Notice


Question Answer
What are the adequate components of labeling?(a) Name of the drug (b) pharmacological category of the drug (c) Name and address of the manufacturer, parker or distributor (d) The net quantity of the contents of the package (e) Cautions and warnings needed to protect the consumer (f) adequate directions for use (g) a "drug facts"
What are the components of "Drug Facts"?(a) Active ingredient (b) Drug purpose (c) Uses (d) Warnings
What are the components of adequate directions for use?(a) Quality or dosage for individual patient (b) Frequency of Adm or Application (c) The duration of Adm or Application (d) Time of adm or application (e) Route or method of adm or application (f) Preparation necessary for use
How many letters are in the NDC 10 - 11
What does the 1st segment of NDC stands for?Labeler or Manufacturer ID
What does the 2nd segment of NDC stands for?Product strength, dosage, form and formulation
What does 3rd segment of NDC stands for?Package code