TEXAS MPJE QUESTIONS AND CORRECT
DETAILED ANSWERS WELL VERIFIED .GRADED
A+
Requirements for OTC drug labels - ANSWER -Manufacturer name and
address, drug name, quantity, "Drug Facts" panel: active ingredients,
purpose, indication, warning, directions, other info, inactive ingredients
Special warning requirement ingredients - ANSWER -Yellow #5/6,
aspartame, sulfites, mineral oil, wintergreen oil, sodium phosphates (90
mL max), isopreterenol, potassium salts, ipecac syrup, phenacetine,
salicylates (max 36 tabs of 81mg), alcohol for analgesics/antipyretics,
APAP, NSAIDs
,FDA Class I Recall - ANSWER -Serious ADE or death possible
FDA Class II Recall - ANSWER -Temporary/reversible ADE or serious ADE
remote
FDA Class III Recall - ANSWER -Not likely to cause ADE
When package inserts are required for institutionalized/hospitalized
patients - ANSWER -Prior to first administration and every 30 days for
OC, estrogen, and progesterone products
iPLEDGE requirements - ANSWER -Doctor, pharmacy, and patient are
registered, negative pregnancy test, contraceptive use and pregnancy
testing, dispensed as blister packs of no more than 30 day supply, no
refills
Requirements to be considered compounding vs manufacturing -
ANSWER -Patient specific, done by pharmacist or physician, USP
compliance, manufacturer of drug is registered and has certificate of
analysis, excipients comply with USP/NF monograph, not a replica of an
existing product, drug not withdrawn from market due to safety, no
statement from FDA stating difficulty for compounding demonstrating
an ADE, 5% rule
,FDA Orange book - ANSWER -Generic equivalency book,
A# are drug products the FDA considers to be _______ equivalent and
_______ equivalent - ANSWER -pharmaceutical and therapeutically
B# are drug products the FDA considers to ____ be _______ equivalent
and _______ equivalent - ANSWER -NOT, pharmaceutical,
therapeutically
FDA Purple book - ANSWER -Biologic interchangablity book
Poison Prevention Packaging Act - ANSWER -Requires child-resistant
containers for all prescriptions and certain OTC drugs
PPPA exemption request from patient/prescriber - ANSWER -Only
patient can provide blanket request for all future prescriptions. Provider
can only request for single prescription
PPPA exemptions - ANSWER -OC/estrogens/northindrone in
manufacturers package, medroxyprogesterone tablets, nitroglycerin SL,
isosorbide chewable up to 10mg, ASA/APAP effervescents, Unit dose
potassium supplements, sodium fluoride up to 264mg, anhydrous
, chloestyramine/colestipol packets, erythromycin granules for PO
suspension, erythromycin suspension up to 8g, erythromycin tablets up
to 16g, prednisone tabs up to 105mg, methylprednisolone tabs up to
84mg, mebendazole tabs up to 600mg, betamethasone tabs up to
12.6mg, inhalants, pancrelipase, sucrose in glycerol and water
Federal Hazardous Communications Standard, who enforces this
standard? - ANSWER -Requires pharmacies to have a plan including list
of hazardous chemicals with SDSs, and to train workers, OSHA
Federal Hazardous Substances Act - ANSWER -Requires labeling of
hazardous materials including manufacturer, type of danger, "Keep out
of reach of children", handling and storage instructions
Frequency of CMS medication regimen reviews required for long term
care patients - ANSWER -Every 30 days
Alcohol and Tobacco Tax Trade Bureau (TTB) - ANSWER -Issues permits
for tax free alcohol for pharmacies
TTB ________ tax free alcohol for pharmacies while the _______
enforces - ANSWER -regulates, ATFE
DETAILED ANSWERS WELL VERIFIED .GRADED
A+
Requirements for OTC drug labels - ANSWER -Manufacturer name and
address, drug name, quantity, "Drug Facts" panel: active ingredients,
purpose, indication, warning, directions, other info, inactive ingredients
Special warning requirement ingredients - ANSWER -Yellow #5/6,
aspartame, sulfites, mineral oil, wintergreen oil, sodium phosphates (90
mL max), isopreterenol, potassium salts, ipecac syrup, phenacetine,
salicylates (max 36 tabs of 81mg), alcohol for analgesics/antipyretics,
APAP, NSAIDs
,FDA Class I Recall - ANSWER -Serious ADE or death possible
FDA Class II Recall - ANSWER -Temporary/reversible ADE or serious ADE
remote
FDA Class III Recall - ANSWER -Not likely to cause ADE
When package inserts are required for institutionalized/hospitalized
patients - ANSWER -Prior to first administration and every 30 days for
OC, estrogen, and progesterone products
iPLEDGE requirements - ANSWER -Doctor, pharmacy, and patient are
registered, negative pregnancy test, contraceptive use and pregnancy
testing, dispensed as blister packs of no more than 30 day supply, no
refills
Requirements to be considered compounding vs manufacturing -
ANSWER -Patient specific, done by pharmacist or physician, USP
compliance, manufacturer of drug is registered and has certificate of
analysis, excipients comply with USP/NF monograph, not a replica of an
existing product, drug not withdrawn from market due to safety, no
statement from FDA stating difficulty for compounding demonstrating
an ADE, 5% rule
,FDA Orange book - ANSWER -Generic equivalency book,
A# are drug products the FDA considers to be _______ equivalent and
_______ equivalent - ANSWER -pharmaceutical and therapeutically
B# are drug products the FDA considers to ____ be _______ equivalent
and _______ equivalent - ANSWER -NOT, pharmaceutical,
therapeutically
FDA Purple book - ANSWER -Biologic interchangablity book
Poison Prevention Packaging Act - ANSWER -Requires child-resistant
containers for all prescriptions and certain OTC drugs
PPPA exemption request from patient/prescriber - ANSWER -Only
patient can provide blanket request for all future prescriptions. Provider
can only request for single prescription
PPPA exemptions - ANSWER -OC/estrogens/northindrone in
manufacturers package, medroxyprogesterone tablets, nitroglycerin SL,
isosorbide chewable up to 10mg, ASA/APAP effervescents, Unit dose
potassium supplements, sodium fluoride up to 264mg, anhydrous
, chloestyramine/colestipol packets, erythromycin granules for PO
suspension, erythromycin suspension up to 8g, erythromycin tablets up
to 16g, prednisone tabs up to 105mg, methylprednisolone tabs up to
84mg, mebendazole tabs up to 600mg, betamethasone tabs up to
12.6mg, inhalants, pancrelipase, sucrose in glycerol and water
Federal Hazardous Communications Standard, who enforces this
standard? - ANSWER -Requires pharmacies to have a plan including list
of hazardous chemicals with SDSs, and to train workers, OSHA
Federal Hazardous Substances Act - ANSWER -Requires labeling of
hazardous materials including manufacturer, type of danger, "Keep out
of reach of children", handling and storage instructions
Frequency of CMS medication regimen reviews required for long term
care patients - ANSWER -Every 30 days
Alcohol and Tobacco Tax Trade Bureau (TTB) - ANSWER -Issues permits
for tax free alcohol for pharmacies
TTB ________ tax free alcohol for pharmacies while the _______
enforces - ANSWER -regulates, ATFE
