Texas MPJE, Ultimate Texas MPJE 2022 |
343 Questions with 100% Correct Answers
Texas pharmacist can administer all vaccines Correct Answer: True
What age can pharmacist administer influenza Correct Answer: 7
What is the min age for all other vaccines Correct Answer: 14
How many hours for nuclear training Correct Answer: 700 hours
State board is made up of how many members Correct Answer: 11
How many pharmacists are on the state board Correct Answer: 7
How many techs are on the state board Correct Answer: 1
How many public members are on the state board? Correct Answer: 3
What are pharmacists requirements to be on the board? Correct Answer: resident of texas, actively
practicing pharmacy, been licensed for 5 years prior to appointment
How long do board members serve Correct Answer: 6 years
Special CE requirements Correct Answer: Texas pharmacy laws or rules 1 hr
Pain management 1 hr
Prescribing and monitoring controlled substances 2 hrs
Mental health awareness 1 hr
Preceptor CE if certified preceptor
When does license renew Correct Answer: every 2 years from birth month
Food Drug and Cosmetic Act Correct Answer: Established FDA and required new drugs to be proven safe
prior to marketing
Durham-Humphrey Act of 1951 Correct Answer: Established Rx and OTC drug class; authorized verbal
prescriptions and prescription refills
Kefauver-Harris Amendment Correct Answer: Required new drugs to be proven safe and effective,
established GMPs, FDA jurisdiction over prescription drug advertising
Prescription drug market act Correct Answer: Bans reimportation of prescription drugs and insulin
products produced in the US except by manufacturer. Bans sale, trade or purchase of samples
Drug Quality and Security Act Correct Answer: Allows facilities that are compounding sterile that are not
patient specific to register as outsourcing facility
,Outsourcing facilities Correct Answer: have a licensed pharmacist, report to secretary of HHS every 6
months, be inspected by FDA, report serious ADR within 15 days , label as compounded drug
Drug Supply Chain Security Act Correct Answer: Requirements for tracing prescription drug products
through pharmaceutical supply distribution chain. Transaction data
Adulteration Correct Answer: contains filthy, putrid, or decomposed substance, prepared or held in
unsanitary conditions, manufacturing methods dont conform to GMP, container is composed of
poisonous substance, has unsafe color additive, different strength, mixed or packed with substance that
reduces strength and quality
Misbranding Correct Answer: Labeling of a product that is false or misleading; label information must
include directions for use; safe and/or unsafe dosages; manufacturer, packer, or distributor; quantity;
and weight, Rx only, route of admin, special storage instructions, Lot number, expiration, package insert
Only pharmacies allowed to work with drug samples Correct Answer: Pharmacy owned by charitable
organization or government serving indigent population; Class D
Three constituents of data required to be provided by manufacturer for each product sold Correct
Answer: Transaction information, history, and statement
Transaction Information constituents Correct Answer: Drug name strength dose and NDC, container size
and count, transaction date, name and address of seller and buyer
Transaction history Correct Answer: Prior transaction information for each prior transaction
Transaction Statement Correct Answer: States seller is authorized for transaction, information and
history were provided and are correct, and product is legitimate and has processes to comply with
verification requirements, previous seller was legitimate and provided true information
Exceptions to distributing without a license Correct Answer: Distributing between common ownership,
patient specific basis, emergency medical reasons, or minimal quantities to a practitioner for office use
Adulteration Correct Answer: Actual contents of product is below standard or is unsafe.
Misbranding Correct Answer: Labeling that is misleading or missing required information, non-
compliant with PPA
Requirements for manufacturer's label of prescription drugs Correct Answer: Manufacturer name and
address, drug name, dose quantity, route for non-PO, lot, and expiration, package insert, storage
instructions, Rx only legend
Requirements for OTC drug labels Correct Answer: Principal display panel, including statement of
identity of product
Manufacturer name and address
Net qty of contents
Cautions and Warnings
, Adequate *directions* for use
"Drug Facts" panel: active ingredients, purpose, indication, warning, directions, other info, inactive
ingredients, questions followed by phone #
Special warning requirement ingredients Correct 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 Correct Answer: Serious ADE or death possible
FDA Class II Recall Correct Answer: Temporary/reversible ADE or serious ADE remote
FDA Class III Recall Correct Answer: Not likely to cause ADE
When are package inserts required for institutionalized/hospitalized patients? Correct Answer: Prior to
first administration and every 30 days for OC, estrogen, and progesterone products.
Misbranded without insert.
Patient package inserts are required for which drugs? Correct Answer: oral contraceptives; estrogen-
containing products
Misbranded without insert
iPLEDGE requirements Correct 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 Correct 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 Correct Answer: Generic equivalency book
official name: Approved Drug Products with Therapeutic Equivalence Evaluations
A# are drug products the FDA considers to be _______ equivalent and _______ equivalent Correct
Answer: pharmaceutical and therapeutically
B# are drug products the FDA considers to ____ be _______ equivalent and _______ equivalent Correct
Answer: NOT, pharmaceutical, therapeutically
FDA Purple book Correct Answer: Biologic interchangablity book
official name: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity
or Interchangeability Evaluations
343 Questions with 100% Correct Answers
Texas pharmacist can administer all vaccines Correct Answer: True
What age can pharmacist administer influenza Correct Answer: 7
What is the min age for all other vaccines Correct Answer: 14
How many hours for nuclear training Correct Answer: 700 hours
State board is made up of how many members Correct Answer: 11
How many pharmacists are on the state board Correct Answer: 7
How many techs are on the state board Correct Answer: 1
How many public members are on the state board? Correct Answer: 3
What are pharmacists requirements to be on the board? Correct Answer: resident of texas, actively
practicing pharmacy, been licensed for 5 years prior to appointment
How long do board members serve Correct Answer: 6 years
Special CE requirements Correct Answer: Texas pharmacy laws or rules 1 hr
Pain management 1 hr
Prescribing and monitoring controlled substances 2 hrs
Mental health awareness 1 hr
Preceptor CE if certified preceptor
When does license renew Correct Answer: every 2 years from birth month
Food Drug and Cosmetic Act Correct Answer: Established FDA and required new drugs to be proven safe
prior to marketing
Durham-Humphrey Act of 1951 Correct Answer: Established Rx and OTC drug class; authorized verbal
prescriptions and prescription refills
Kefauver-Harris Amendment Correct Answer: Required new drugs to be proven safe and effective,
established GMPs, FDA jurisdiction over prescription drug advertising
Prescription drug market act Correct Answer: Bans reimportation of prescription drugs and insulin
products produced in the US except by manufacturer. Bans sale, trade or purchase of samples
Drug Quality and Security Act Correct Answer: Allows facilities that are compounding sterile that are not
patient specific to register as outsourcing facility
,Outsourcing facilities Correct Answer: have a licensed pharmacist, report to secretary of HHS every 6
months, be inspected by FDA, report serious ADR within 15 days , label as compounded drug
Drug Supply Chain Security Act Correct Answer: Requirements for tracing prescription drug products
through pharmaceutical supply distribution chain. Transaction data
Adulteration Correct Answer: contains filthy, putrid, or decomposed substance, prepared or held in
unsanitary conditions, manufacturing methods dont conform to GMP, container is composed of
poisonous substance, has unsafe color additive, different strength, mixed or packed with substance that
reduces strength and quality
Misbranding Correct Answer: Labeling of a product that is false or misleading; label information must
include directions for use; safe and/or unsafe dosages; manufacturer, packer, or distributor; quantity;
and weight, Rx only, route of admin, special storage instructions, Lot number, expiration, package insert
Only pharmacies allowed to work with drug samples Correct Answer: Pharmacy owned by charitable
organization or government serving indigent population; Class D
Three constituents of data required to be provided by manufacturer for each product sold Correct
Answer: Transaction information, history, and statement
Transaction Information constituents Correct Answer: Drug name strength dose and NDC, container size
and count, transaction date, name and address of seller and buyer
Transaction history Correct Answer: Prior transaction information for each prior transaction
Transaction Statement Correct Answer: States seller is authorized for transaction, information and
history were provided and are correct, and product is legitimate and has processes to comply with
verification requirements, previous seller was legitimate and provided true information
Exceptions to distributing without a license Correct Answer: Distributing between common ownership,
patient specific basis, emergency medical reasons, or minimal quantities to a practitioner for office use
Adulteration Correct Answer: Actual contents of product is below standard or is unsafe.
Misbranding Correct Answer: Labeling that is misleading or missing required information, non-
compliant with PPA
Requirements for manufacturer's label of prescription drugs Correct Answer: Manufacturer name and
address, drug name, dose quantity, route for non-PO, lot, and expiration, package insert, storage
instructions, Rx only legend
Requirements for OTC drug labels Correct Answer: Principal display panel, including statement of
identity of product
Manufacturer name and address
Net qty of contents
Cautions and Warnings
, Adequate *directions* for use
"Drug Facts" panel: active ingredients, purpose, indication, warning, directions, other info, inactive
ingredients, questions followed by phone #
Special warning requirement ingredients Correct 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 Correct Answer: Serious ADE or death possible
FDA Class II Recall Correct Answer: Temporary/reversible ADE or serious ADE remote
FDA Class III Recall Correct Answer: Not likely to cause ADE
When are package inserts required for institutionalized/hospitalized patients? Correct Answer: Prior to
first administration and every 30 days for OC, estrogen, and progesterone products.
Misbranded without insert.
Patient package inserts are required for which drugs? Correct Answer: oral contraceptives; estrogen-
containing products
Misbranded without insert
iPLEDGE requirements Correct 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 Correct 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 Correct Answer: Generic equivalency book
official name: Approved Drug Products with Therapeutic Equivalence Evaluations
A# are drug products the FDA considers to be _______ equivalent and _______ equivalent Correct
Answer: pharmaceutical and therapeutically
B# are drug products the FDA considers to ____ be _______ equivalent and _______ equivalent Correct
Answer: NOT, pharmaceutical, therapeutically
FDA Purple book Correct Answer: Biologic interchangablity book
official name: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity
or Interchangeability Evaluations
