TEXAS MPJE SET COMPREHENSIVE EXAM
QUESTIONS AND ANSWERS SURE A+
✔✔Adulteration - ✔✔-Filthy, putrid, or decomposed
-Prepared or held under unsanitary conditions and may have been contaminated
-Manufacturing does not conform to cGMP
-Delay, deny, or limit an inspection/refusing to permit entry or inspection
-Container composed of poisonous or deleterious substance that may contaminate the
drug
-Unsafe color additive
-It is in an official compendium, and strength differs from or its quality or purity falls
below compendium standard, unless clearly stated
-Not in a compendium, and strength differs from or quality falls below what is on the
label
-Mixed or packed with any substance that reduces its strength or quality, or has been
substituted in whole or part
✔✔If the strength differs from what is represented on the label, is it misbranded or
adulterated? - ✔✔Both
✔✔Misbranded in manufacturing - ✔✔-Labeling is false or misleading
-Drug that could deteriorate unless packaged accordingly
-Container made to be misleading
,-Imitation of another drug
-Dangerous when used in manner on label
-Violates PPPA
Rx drug and manufacturer label does not have:
-Name and address of manufacturer
-Brand/generic name
-Net qty
-Wt of AI per unit
-Federal legend "RX ONLY"
-Unless oral, specific route of admin
-Storage instructions
-Control/lot number
-Expiration
-Info for use
OTC drug and manufacturer label does not have:
-Principal display panel (including statement of identity)
-Name and address of manufacturer
-Net qty of contents
-Cautions and warnings
-Adequate directions for use
-Drug facts panel...1) AI 2) Purpose 3) Use/indications 4) Warnings 5) Directions
6) Other Info 7) Inactive ingredients 8) Questions? Contact #
✔✔Drug not packaged in child resistant container when required is... - ✔✔Misbranded
✔✔Misbranded & Adulterated as an RPh - ✔✔-Dispensing without Rx = MISBRANDED
-Misfilling = MISBRANDED
-Misfill with wrong strength from script is also ADULTERATED
-REMS not satisfied= MISBRANDED
-False advertising of compounded med = MISBRANDED
-Manufacturer bottle expired is ADULTERATED, and if filled with BUD after expiration,
also MISBRANDED
-Tabs counted on tray with residue = ADULTERATED
-Meds not adequately temp controlled/stored = ADULTERATED
-Not in child-resistant container = MISBRANDED
✔✔OTC's not in tamper resistant packaging are... - ✔✔Adulterated and misbranded
✔✔Drug approval process - ✔✔Animal studies --> IND --> clinical studies in humans
after IRB review--> NDA --> post market studies
✔✔Study phases - ✔✔1. Healthy volunteers, focus on safety and side effects, generally
20-80 people.
, 2. Is drug effective in people with a certain disease or condition? Safety and side effects
still studied. Generally 12-300 people.
3. Larger scale, different populations, and using in combo with other drugs. Generally a
few hundred - 3,000 people.
✔✔OTC dispensed as prescription - ✔✔OTC labeling requirements do not have to be
followed, but prescription drug labeling requirements would apply.
✔✔Drug recall classes - ✔✔Class I: Recalls for products that have a reasonable
probability of causing severe injury or death
Class II: Recalls for products that could pose a moderate danger to the public and may
cause medically reversible or temporary adverse health events
Class III: Recalls for products that could pose little to no probability of an adverse health
event
✔✔Advertising - ✔✔FDA regulates Rx drugs
FTC regulates OTCs
✔✔PPI required for... - ✔✔Oral contraceptives
Estrogen-containing products
*Failure to provide one = misbranded
✔✔MedGuide required for... - ✔✔-Accutane
-Antidepressants in children & teens
-Coumadin
-Epogen
-Forteo
-Lindane
-Lotronex
-Nolvadex (Tamoxifen)
-NSAIDs
-Remicade
-Trizivar
-Opioids & cough products
-Benzos
*Failure to provide one = misbranded
✔✔REMS - ✔✔iPledge = Isotretinoin
Celgene = Thalidomide
✔✔NDC Numbers - ✔✔4-4-2
QUESTIONS AND ANSWERS SURE A+
✔✔Adulteration - ✔✔-Filthy, putrid, or decomposed
-Prepared or held under unsanitary conditions and may have been contaminated
-Manufacturing does not conform to cGMP
-Delay, deny, or limit an inspection/refusing to permit entry or inspection
-Container composed of poisonous or deleterious substance that may contaminate the
drug
-Unsafe color additive
-It is in an official compendium, and strength differs from or its quality or purity falls
below compendium standard, unless clearly stated
-Not in a compendium, and strength differs from or quality falls below what is on the
label
-Mixed or packed with any substance that reduces its strength or quality, or has been
substituted in whole or part
✔✔If the strength differs from what is represented on the label, is it misbranded or
adulterated? - ✔✔Both
✔✔Misbranded in manufacturing - ✔✔-Labeling is false or misleading
-Drug that could deteriorate unless packaged accordingly
-Container made to be misleading
,-Imitation of another drug
-Dangerous when used in manner on label
-Violates PPPA
Rx drug and manufacturer label does not have:
-Name and address of manufacturer
-Brand/generic name
-Net qty
-Wt of AI per unit
-Federal legend "RX ONLY"
-Unless oral, specific route of admin
-Storage instructions
-Control/lot number
-Expiration
-Info for use
OTC drug and manufacturer label does not have:
-Principal display panel (including statement of identity)
-Name and address of manufacturer
-Net qty of contents
-Cautions and warnings
-Adequate directions for use
-Drug facts panel...1) AI 2) Purpose 3) Use/indications 4) Warnings 5) Directions
6) Other Info 7) Inactive ingredients 8) Questions? Contact #
✔✔Drug not packaged in child resistant container when required is... - ✔✔Misbranded
✔✔Misbranded & Adulterated as an RPh - ✔✔-Dispensing without Rx = MISBRANDED
-Misfilling = MISBRANDED
-Misfill with wrong strength from script is also ADULTERATED
-REMS not satisfied= MISBRANDED
-False advertising of compounded med = MISBRANDED
-Manufacturer bottle expired is ADULTERATED, and if filled with BUD after expiration,
also MISBRANDED
-Tabs counted on tray with residue = ADULTERATED
-Meds not adequately temp controlled/stored = ADULTERATED
-Not in child-resistant container = MISBRANDED
✔✔OTC's not in tamper resistant packaging are... - ✔✔Adulterated and misbranded
✔✔Drug approval process - ✔✔Animal studies --> IND --> clinical studies in humans
after IRB review--> NDA --> post market studies
✔✔Study phases - ✔✔1. Healthy volunteers, focus on safety and side effects, generally
20-80 people.
, 2. Is drug effective in people with a certain disease or condition? Safety and side effects
still studied. Generally 12-300 people.
3. Larger scale, different populations, and using in combo with other drugs. Generally a
few hundred - 3,000 people.
✔✔OTC dispensed as prescription - ✔✔OTC labeling requirements do not have to be
followed, but prescription drug labeling requirements would apply.
✔✔Drug recall classes - ✔✔Class I: Recalls for products that have a reasonable
probability of causing severe injury or death
Class II: Recalls for products that could pose a moderate danger to the public and may
cause medically reversible or temporary adverse health events
Class III: Recalls for products that could pose little to no probability of an adverse health
event
✔✔Advertising - ✔✔FDA regulates Rx drugs
FTC regulates OTCs
✔✔PPI required for... - ✔✔Oral contraceptives
Estrogen-containing products
*Failure to provide one = misbranded
✔✔MedGuide required for... - ✔✔-Accutane
-Antidepressants in children & teens
-Coumadin
-Epogen
-Forteo
-Lindane
-Lotronex
-Nolvadex (Tamoxifen)
-NSAIDs
-Remicade
-Trizivar
-Opioids & cough products
-Benzos
*Failure to provide one = misbranded
✔✔REMS - ✔✔iPledge = Isotretinoin
Celgene = Thalidomide
✔✔NDC Numbers - ✔✔4-4-2
