Texas Pharmacy Law EXAM QUESTIONS WITH ANSWERS

Texas Pharmacy Law EXAM QUESTIONS
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WITH ANSWERS |\




Pure Food and Drug Act 1906 - CORRECT ANSWERS ✔✔-Purity
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Standards (Misbranded, Adulterated) |\ |\




Food, Drug, and Cosmetic Act (1938) - CORRECT ANSWERS ✔✔-
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Created FDA |\




-Required drug to be SAFE when used according to labeled
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direction


Durham-Humphrey Amendment (1951) - CORRECT ANSWERS |\ |\ |\ |\ |\ |\


✔✔-Created OTC and RX distinction: Manufacturers of
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prescription drugs must provide a warning on the label stating,
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"Federal law prohibits dispensing without a prescription"
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-Allowed the authorization of oral prescriptions and refilling
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Kefauver-Harris Amendment (1962) - CORRECT ANSWERS ✔✔- |\ |\ |\ |\ |\ |\


Requires "PROOF-OF-EFFICACY" (passed in response to
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thalidomide)
-Provides the authority to the FDA to regulate prescription drug
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advertisements, must disclose SE (Note that the FTC regulates |\ |\ |\ |\ |\ |\ |\ |\ |\


OTC advertising, not the FDA)
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-Provides good manufacturing practices (GMP) guidelines for drug
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manufacturers
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,Medical Device Act (1976) - CORRECT ANSWERS ✔✔-Passed to
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protect public from dangerous and useless devices
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-Sets GMP standard manufacturing for medical devices
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Orphan Drug Act (1983) - CORRECT ANSWERS ✔✔-Extended
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patent life of drugs to treat rare disorders in order to encourage
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pharmaceutical companies to develop drugs for diseases that |\ |\ |\ |\ |\ |\ |\ |\


have a small market
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Hatch-Waxman Act (1984) - CORRECT ANSWERS ✔✔-A.K.A. Drug |\ |\ |\ |\ |\ |\ |\ |\


Price Competition and Patent Restoration Act
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-ANDA: Abbreviated new drug application for generic drugs,
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generic manufacturing drug companies only have to show
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bioequivalence, no duplicate clinical testing |\ |\ |\ |\




-Increases the patanet term for newly dveloped drugs.
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Encourages innovation |\




Prescription Drug Marketing Act (Dingle Bill Act of 1987) -
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CORRECT ANSWERS ✔✔-Requires states to license wholesale
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distributors under federal guidelines |\ |\ |\




-Provides a minimum standard for prescription drug storage,
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handling, and record keeping |\ |\ |\




-Bans re-importation of prescription drugs produced in the US
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-Bans sale, trade, or purchase of drug samples
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-Mandates storage, handling, and recordkeeping requirements for
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drug samples
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-Prohibits the resale of prescription drugs purchased by hospitals
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or healthcare facilities (certain exceptions)
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,Omnibus Reconciliation Act of 1990 (OBRA-90) - CORRECT
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ANSWERS ✔✔-Prospective Drug Utilization Review
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-Patient Counseling Standards: Dispensing pharmacist must offer
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counseling (In Texas required to counsel, not just offer, must
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document later) |\




FDA Modernization Act (1997) - CORRECT ANSWERS ✔✔-Replaced
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the prescription legend "Caution: Federal law prohibits
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dispensing without a prescription" with "Rx Only".
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-Clarified when a pharmacist may compound prescription drugs
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FDA Rule: OTC Labeling Requirments (1999) - CORRECT
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ANSWERS ✔✔-Standard, easy to read format making it easier for
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self-administration easier and safer |\ |\ |\




Define an "Adulterated" drug - CORRECT ANSWERS ✔✔-"It's dirty"
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-Contaminated, filthy, putrid, decomposed |\ |\ |\




-The manufacturing does not comply with GMP
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-Unsafe color additive |\ |\




-Labeled as "USP" but is not |\ |\ |\ |\ |\




-Strength differs from what the label says
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-If it is mixed or packed with any substance with reduces its
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strength or quality or the drug has been substituted wholly or in
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part


Define a "Misbranded" drug - CORRECT ANSWERS ✔✔-"It's a lie"
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, -Label is false or misleading
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-The manufacture does not include one of the following:
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1) Name and address of the manufacturer, packer or distributor
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2) Quantity
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3) Name of the drug
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4) Strength per dosage unit
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5) Adequate directions for use
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6) The Federal legend: either "Caution: Federal law prohibits
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dispensing without a prescription" or "Rx Only"
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7) Storage directions
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8) Expiration date
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-A pharmacist dispenses a prescription without authorization of
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the practitioner
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-If it is an imitation of another drug or offered for sale under the
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name of another drug |\ |\ |\




-If it violates the Poison Prevention Act it is misbranded
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-OTC products must include the following or it is misbranded:
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(monitored by FTC) |\ |\




1) A principal display panel including a statement of identity of
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the product
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2) The name and address of the manufacturer, packer or
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distributor
3) Net quantity of the contents
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4) Cautions and warnings needed to protect the user
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5) Adequate directions for safe and effective use for a layperson
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6) "Drug facts" panel
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