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Updated Federal Pharmacy Law Exam With Complete Solutions
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Updated Federal Pharmacy Law Exam WithComplete Solutions
What did the Pure Food and Drug Act of 1906 establish? - ANSWER 1. Foods and drugs
that were distributed through interstate commerce could not be adulterated or
misbranded 2. Manufacturers did not need to list ingredients or directions for use 3.
Cosmetic products and medical devices were excluded from regulations
What did the 1938 Food, Drug, and Cosmetic Act create? - ANSWER 1. Required that
any new drug could not be marketed unless it had first been proven to be safe when
used according to directions on the label
2. Labels require adequate directions for use
3. Included cosmetic and medical devices
4. Drugs marketed prior to 1938 were grandfathered and did not have to be labeled or
proven safe
What did the Durham-Humphrey Amendment of 1951 establish? - ANSWER 1.
Amendment of the FDCA that established two classes of drugs:
A. Legend Drugs - Those that required medical supervision to be used safely did not
have to list adequate directions for use, but were required to include the legend
"Caution: Federal law prohibits dispensing without a prescription."
B. Products that did not require medical supervision for their use were classified as OTC
or nonprescription drugs
2. Allowed oral prescriptions and prescription refills
What did the Kefauver-Harris Amendment of 1962 establish? - ANSWER 1. Amendment
to the FDCA that required all new drugs marketed in the US have to be shown to be not
only safe, but also effective
2. Placed authority for regulating prescription drug advertising into the hands of the
FDA
,3. Required informed consent for those who were research subjects in clinical
investigations, reporting of adverse drug reactions, and establishment of requirements
for Good Manufacturing Practice
What was instituted under the Medical Device Amendment of 1976? - ANSWER 1.
Amendment to the FDCA provided better classification of medical devices according the
their specific function, establishment of performance standards for these devices,
pre-market approval requirements, conformance with GMP standards, and
requirements for adherence to record and reporting requirements
What did the Orphan Drug Act of 1983 establish? - ANSWER 1. Provided various tax and
licensing incentives to manufacturers of orphan drugs
2. A rare disease is usually considered one which affects < 200,000 people in the US
What did Hatch-Waxman establish? - ANSWER 1. Amendment to the FDCA that provided
expedited procedure for generic products by requiring only an abbreviated new drug
application (ANDA)
2. Requires that proof of bioequivalence with the brand name counterpart be
established
3. Drug manufacturers were given incentives to produce new drug products by being
granted up to five additional years of patent protection to compensate them for the
extensive amount of time it takes to go through the FDA approval process
What did the Prescription Drug Marketing Act of 1987 establish? - ANSWER 1. That
prescription drug wholesalers must be licensed by states under federal guidelines
2. Banned the re-importation of prescription drugs manufactured in the US
3. Banned selling, trading or buying of Rx drug samples
4. Laid down strict storage, handling, and record keeping conditions for drug samples
5. Banned resale of Rx drugs purchased by hospitals or health facilities
What did the FDA Modernization Act of 1997 establish? - ANSWER 1. Provisions for
fast-track review of some New Drug Application submissions to expedite the approval of
drugs used to treat serious or life threatening conditions
, 2. Clarified the conditions under which pharmacies may perform extemporaneous
compounding
3. The prescription drug legend, "Caution: Federal law prohibits dispensing without a
prescription" is replaced with "Rx only"
4. Removed the "Warning - May be habit forming" label
5. Companies can publicly distribute information about the off-label uses as long as they
include a statement specifying that the use has not been approved by the FDA
6. Incentivized drug companies to conduct pediatric studies by rewarding them with 6
additional months of marketing exclusivity
What did the 2010 Patient Protection and Affordable Care Act commonly known as the
Health Care Reform Act establish? - ANSWER 1. Required that everyone have health
insurance
2. Halt agreements between brand name and generic manufacturers to reduce or delay
competition from the generic drugs
3. Phase out the catastrophic threshold
4. Require timely and transparent claims using standard electronic transactiond
What does it mean for a drug to be listed in USP/NF or HPUS? - ANSWER It must meet
the requirements specified in either book otherwise the designation "Not USP/NF,"
which means the drug is considered to be either misbranded or adulterated.
Published by a private organization
What is the AAC? - ANSWER Actual Acquisition Cost (AAC) - The actual price a
pharmacist pays when purchasing units of the drug
What is the AARP? - ANSWER American Association of Retired Persons (AARP)
What is an ADE or ADR? - ANSWER Adverse Drug Experience (ADE) or Adverse Drug
Reaction (ADR)
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