Texas MPJE (FULL Review) QUESTIONS WITH ANSWERS

Texas MPJE (FULL Review) QUESTIONS |\ |\ |\ |\ |\




WITH ANSWERS |\




Food, drug and cosmetic act (FDCA) of 1938 - CORRECT
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ANSWERS ✔✔(i) Act that required new drugs to be proven *safe*
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prior to marketing
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(ii) established the FDA!
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Note: has had many amendments since (1951, 1962..)
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Which drug triggered the creation of the Food, Drug and
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Cosmetic Act of 1938? - CORRECT ANSWERS ✔✔Sulfanilamide
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elixir


Durham-Humphrey amendment of 1951 (2) - CORRECT ANSWERS |\ |\ |\ |\ |\ |\ |\


✔✔(1) established two classes of drugs: OTC and prescription;
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(2) authorized verbal prescriptions & prescription refills
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Kefauver-harris amendment of 1962 (3) - CORRECT ANSWERS |\ |\ |\ |\ |\ |\ |\ |\


✔✔(1) new drugs must be proven safe *and effective*;
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(2) established "Good Manufacturing Practices" (*GMPs*) for the
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manufacturing of drugs |\ |\




(3) FDA gets jurisdiction over *prescription drug advertising*
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,Prescription Drug Marketing Act of 1987 (PDMA) - CORRECT |\ |\ |\ |\ |\ |\ |\ |\ |\


ANSWERS ✔✔(1) Bans the *re*importation of prescription drugs &
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insulin products produced in the US (and then exported)
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(2) Bans the sale, trade or purchase of *prescription drug
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samples* (most pharmacies can't sell/purchase/trade/possess Rx
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drug samples) |\ |\




(3) Prohibits the re-sale of prescription drugs purchased by
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hospitals or healthcare facilities |\ |\ |\ |\




(with few exceptions, but the point is hospital can't buy for cheap
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and then sell to a community pharmacy)
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^the exception to #2: pharmacy owned by a charitable
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organization OR by a city/state/county gvmt *and* is part of a |\ |\ |\ |\ |\ |\ |\ |\ |\ |\ |\


healthcare entity providing care to *indigent/low-income |\ |\ |\ |\ |\ |\


patients* at no cost / reduced cost. Then you can have samples
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that you can only give at no charge to the patient.
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Under PDMA who CAN reimport drugs? - CORRECT ANSWERS
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✔✔Manufacturer


Drug Quality and Security Act of 2013 - CORRECT ANSWERS
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✔✔Made up of Drug Compounding Quality Act (DCQA) and Drug
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Supply Chain Security Act (DSCSA)
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Drug Compounding Quality Act (DCQA) - CORRECT ANSWERS
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✔✔Est. 503*A* vs. 503*B* sterile compounding
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503A = traditional compounding
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,(i) mostly regulated by the states
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(ii) must be a licensed pharmacy
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(iii) requires an individual Rx to compound + limited anticipatory
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compounding |\




Added 503B = allows facilities to register as an *"Outsourcing
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Facility"* and compound sterile meds NOT based on patient-
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specific Rx |\ |\




(i) regulated by FDA & Texas DPS (more of a manufacturer than
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pharmacy!) |\




(ii) must register as an OF with the FDA & report to Secretary of
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HHS q6months |\




(iii) subject to FDA's cGMPs
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What triggered the Drug Compounding Quality Act? - CORRECT
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ANSWERS ✔✔Fungal meningeal outbreak from new england |\ |\ |\ |\ |\ |\ |\


compounding center |\




Who regulates 503B pharmacies? - CORRECT ANSWERS ✔✔FDA
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Who must 503B report to and how often? - CORRECT ANSWERS
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✔✔Secretary of TX Department of Health and Human Services |\ |\ |\ |\ |\ |\ |\ |\ |\


upon registration and every 6 months (report all drugs sold in
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last 6 months) |\ |\




Which acts are 503B exempt from? - CORRECT ANSWERS ✔✔New
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drug provisions, adequate directions for use, and drug tracking
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and trace provisions|\ |\

, Req for 503B pharmacy? - CORRECT ANSWERS ✔✔(1) Need to
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follow GMP |\




(2) Register as outsourcing facility (does NOT need to be
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registered as a pharmacy) |\ |\ |\




(3) MUST have a pharmacist on staff
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(4) Report to Secretary of TX Department of Health and Human
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Services upon registration and q6 month|\ |\ |\ |\ |\




(5) Report ADE within 15 days (to drug manufacturers)
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(6) Inspected by and pay fees to FDA
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(7) Label products to ID them as compounded
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Who inspects 503B? - CORRECT ANSWERS ✔✔FDA
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503B must report ADE within ____? - CORRECT ANSWERS ✔✔15
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days (similar to drug manufacturers)
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Req for 503A pharmacy? - CORRECT ANSWERS ✔✔(1) May only
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compound pursuant to a pt specific Rx, |\ |\ |\ |\ |\ |\ |\




(2) Can not batch prep - except limited anticipatory prep
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(3) Register w FDA as a Pharmacy,
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(4) Subj to USP 797 - sterile compounding
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Can 503B compound drug products containing bulk drug
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substances? - CORRECT ANSWERS ✔✔No |\ |\ |\ |\