West Virginia MPJE Practice Questions

West Virginia MPJE Practice Questions Latest Update - Questions and 100% Verified Correct Answers

1906 Pure Food and Drug Act - Adulteration (drug contaminated, altered) vs Misbranding (label inaccurate)

1938: Food Drug & Cosmetic Act - - Provided a legal definition of drug, devices, cosmetics

• Required proof of drug safety (not efficacy yet though)
• Allowed FDA to perform inspections of manufacturing facilities
• Required drug mfgs & repackagers to register with FDA otherwise products are

considered misbranded

1951: Durham Humphrey Amendment - OTC vs Rx defined

Created the concept of refills

1962 Kefauver-Harris Amendment - Thalidomide was given to pregnant people which caused birth defects = resulted in having to show proof of efficacy of drug (in addition to safety)

• New drug applications are required before marketing a new med
• Started review of the older meds

1st clinical phase that's conducted in HUMANS - Phase I

2-Factor Authentication Methods - to prescribe CS electronically - - Digital certificate

• Prescriber fingerprint scan
• Personal security question specific to the prescriber

503A - Traditional compounding (need the triad relationship of prescriber-patient- pharmacy)

503B - Outsourcing facilities (compounding sterile preparation in BULK to distribute to others) - have different labeling requirements than drug manufacturers do

A bottle of MS Contin is missing 1 tablet - what does RPH do? - Do NOT report to DEA

A CSOS order containing CII never got to the pharmacy. Who is responsible for reporting the loss/theft? ("in transit" loss) - The supplier has to use DEA form 106 to report this

A hospital building catches on fire and most of the drug inventory, including CS, is adulterated & can't be dispensed. What form needs to be used to report this to the 1 / 3

DEA? - Form 41 to request permission to destroy the adulterated CS since they cannot be used anymore

A pharmacy is going out of business and the owner wants to sell his entire drug stock to the pharmacy down the street. What forms will be used to document the sale of the drugs? - Invoices and DEA 222 forms

Abbreviated NDA (aNDA) - To approve a generic version for the market (uses PK similarity analyzations)

Above what qty of CALCIUM requires warning statement (ask a doctor before use if you

have: kidney stones, Ca-restricted diet) - 3200 mg

Above what qty of MAGNESIUM requires warning statement (ask a doctor before use if

you have: kidney stones, Mg-restricted diet) - 600 mg

Above what qty of POTASSIUM requires warning statement (ask a doctor before use if

you have: kidney stones, K-restricted diet) - 975 mg

Above what qty of SODIUM requires warning statement (ask a doctor before use if you have a Na-restricted diet) - 140 mg

Acceptable incidental disclosure of PHI - A hospital visitor overhears 2 physicians discussing pt care by the work station

Actiq - Schedule - Fentanyl - CII

Adequate directions for use of OTC - FDA requirements - Directions must be clearly written so that a layperson can use the drug safely and appropriately (should be written for patients with no medical training)

Adipex-P - Schedule - Phentermine - CIV

Adulteration has to do with - Risk of contamination or contaminated drug

All legend drugs - must contain - "Rx only" or "Caution: Federal law prohibits dispensing this drug without rx"

Allowed timeframe for supplier to send copy of 222 form to DEA after filling order - By the end of the month that the order got filled

ANC Equation - ANC = WBC x (% seg + % band/ 100)

Androgel - Schedule - Testosterone gel - CIII

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Authorized to prescribe UNDER hospital DEA - Interns/ residents, NP/PA, foreign- training doctors (basically ig the HCP is authorized by state to prescribe CS and they are employed at the hospital)

Benzos - Schedule - CIV

Biological safety cabinet - Hood used to make hazardous drugs

Butalbital - Schedule - Butisol - CIII

Butrans - Schedule - Buprenorphine patch - CIII

Can a dietary supplement say "regular use of this product will help maintain healthy cholesterol levels" ? - YES - Dietary supplements also have to have statement that they are not FDA approved

Can a dietary supplement say "regular use of this product will help prevent heart disease"? - No - it is not a drug so cannot treat a disease

Can you reused a plastic container and cap for refill? - No this is adulteration

Category 1 - Refrigerated BUD - 24 hours

Category 1 - Room temperature BUD - 12 hours

Category 1 CSP (USP 797) - lowest risk of contamination - - Made in ISO 5 Hood

• Unclassified SEC (ex. segregated compounding area)
• Sterile ingredients

Category 2 - Frozen BUD - 45 days

Category 2 - Refrigerated BUD - 10 days

Category 2 - Room temp BUD - 4 days

Category 2 CSP (USP 797) - medium risk - - Made in ISO 5 Hood

• Cleanroom (actual compounding room)
• Sterile or non sterile ingredients
• NO sterility testing done

Category 3 - Frozen BUD - 180 days

Category 3 - Refrigerated BUD - 120 days

Category 3 - Room temp BUD - 90 days

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