TX MPJE EXAM PRACTICE QUESTIONS WITH
VERIFIED ANSWERS NEW MODIFIED CURRENTLY
TESTED AND APPROVED 2026 LATEST UPDATE
If a hospital is operating a class A pharmacy under its class C license, is it required to have a
class A license? --CORRECT ANSWER--No, the hospital is not required to have a class A
license because only one license may be issued to a location. However, it must follow class A
rules for the outpatient pharmacy including the class A ratio of pharm techs to pharmacists
Prescription Drug Marketing Act of 1987 (PDMA) --CORRECT ANSWER--- bans re-
importation of Rx drugs and insulin products produced in the US (except by the
manufacturer)
- bans the sale, trade, or purchase of Rx drug samples (TX exception: pharmacies owned by a
charitable organization or by a city, state or county gov't and that are part of a healthcare
entity providing care to indigent or low income pts at no or reduced cost -> samples may only
be provided at no charge)
- mandates the storage, handling, and record keeping requirements for Rx drug samples
- prohibits, w certain exceptions, the resale of Rx drugs purchased by hospitals or healthcare
facilities
Drug Quality and Security Act of 2013 (DQSA) --CORRECT ANSWER--- addressed large
scale compounding by pharmacies
- established a track and trace system for Rx drugs throughout the supply chain
Drug Compounding Quality Act (DCQA) --CORRECT ANSWER--- established section
503B that allows facilities that are compounding sterile preparations to register with the FDA
as an "outsourcing facility" -> may compound without pt-specific Rx and subjected to cGMP
Page 1 of 151
,- outsourcing facilities that meet the Act's requirements are exempt from the new drug
provisions (FDCA section 505), adequate directions for use (FDCA section 502(f)(1)), and
drug track and trace provisions (FDCA section 582)
- compounding pharmacies that are not registered w FDA as an "outsourcing facility" are
referred to as 503A pharmacies -> may compound products pursuant to a pt-specific Rx only
or limited anticipatory compounding & subjected to USP 797 for sterile compounding
Drug Supply Chain Security Act (DSCSA)(Track and Trace) --CORRECT ANSWER---
uniform national electronic track and trace system for Rx drugs throughout the supply chain
- sets national standards for states to license wholesale distributors
- applies to Rx drugs for human use in finished dosage form (exempted: blood and blood
components, radioactive drugs, imaging drugs, certain IV products for fluid replacement,
dialysis solutions, medical gases, compounded drugs, certain combo drugs, sterile water and
products for irrigation)
- manufacturers required to provide "transaction data" for each product sold, and pharmacies
required to receive "transaction data" and pass this info along if they further distribute the
product
- pharmacies that are distributing must have a wholesale distribution license and must pass
DSCSA transaction data w that distribution (exception: distribution bw 2 entities affiliated or
under common ownership; dispenser providing product to another dispenser on a pt-specific
basis; dispenser distributing under emergency medical reasons; dispenser distributing
"minimal quantities" to a licensed practitioner for office use)
- other provisions of DSCSA will be implemented gradually, eventually requiring electronic
tracking and tracing product using a unique product identifier on each package by 2023
Food, Drug, and Cosmetic Act of 1938 --CORRECT ANSWER--- after deaths by
sulfanilamide elixir that contained antifreeze in 1937
- required new drugs to be proven safe before marketing
Page 2 of 151
,Durham-Humphrey Amendment of 1951 --CORRECT ANSWER--- established 2 classes of
drug: Rx and OTC
- authorized verbal Rx and refills
Important to know that certain products may be either Rx or OTC depending on the product
or strength (e.g., some insulins are OTC whereas Lantus and Humalog are Rx only; ibuprofen
200mg is OTC whereas 400, 600, and 800mg are Rx)
Kefauver-Harris Amendment of 1962 --CORRECT ANSWER--- required new drugs to be
proven safe and effective before marketing
- increased safety requirements
- established GMPs for manufacturing of drugs
- gave FDA jurisdiction over Rx drug advertising
Transaction data (part of track and trace) --CORRECT ANSWER--- transaction info
- transaction hx
- transaction statement
Transaction info (track and trace) --CORRECT ANSWER--- product name, strength, and
dosage form
- NDC #
- container size and # of containers
- date of transaction
- name and address of transferer and transferee
Page 3 of 151
, Transaction hx (track and trace) --CORRECT ANSWER--Paper or electronic statement that
includes prior transaction info for each prior transaction back to the manufacturer
Transaction statement (track and trace) --CORRECT ANSWER--Paper or electronic
statement by seller that:
- the seller is authorized (licensed)
- received the product from an authorized (licensed) person
- received the transaction info and hx from the prior owner if required
- did not knowingly ship a suspect or illegitimate product
- has systems and processes to comply w verification requirements
- did not knowingly provide false transaction info
Distributing --CORRECT ANSWER--providing a drug to anyone other than the
consumer/patient
Dispensing --CORRECT ANSWER--Providing a drug to the pt/consumer
A drug is adulterated if --CORRECT ANSWER--- drug contains any filthy, putrid, or
decomposed substance
- drug prepared or held under unsanitary conditions
- methods of manufacturing not conforming to cGMP
- container composed of any poisonous or deleterious substance
- drug contains unsafe color additive
- drug purports to be a drug in an official compendium and its strength differs from or its
quality of purity falls below the compendium standard, unless the difference is clearly stated
on the label
Page 4 of 151
VERIFIED ANSWERS NEW MODIFIED CURRENTLY
TESTED AND APPROVED 2026 LATEST UPDATE
If a hospital is operating a class A pharmacy under its class C license, is it required to have a
class A license? --CORRECT ANSWER--No, the hospital is not required to have a class A
license because only one license may be issued to a location. However, it must follow class A
rules for the outpatient pharmacy including the class A ratio of pharm techs to pharmacists
Prescription Drug Marketing Act of 1987 (PDMA) --CORRECT ANSWER--- bans re-
importation of Rx drugs and insulin products produced in the US (except by the
manufacturer)
- bans the sale, trade, or purchase of Rx drug samples (TX exception: pharmacies owned by a
charitable organization or by a city, state or county gov't and that are part of a healthcare
entity providing care to indigent or low income pts at no or reduced cost -> samples may only
be provided at no charge)
- mandates the storage, handling, and record keeping requirements for Rx drug samples
- prohibits, w certain exceptions, the resale of Rx drugs purchased by hospitals or healthcare
facilities
Drug Quality and Security Act of 2013 (DQSA) --CORRECT ANSWER--- addressed large
scale compounding by pharmacies
- established a track and trace system for Rx drugs throughout the supply chain
Drug Compounding Quality Act (DCQA) --CORRECT ANSWER--- established section
503B that allows facilities that are compounding sterile preparations to register with the FDA
as an "outsourcing facility" -> may compound without pt-specific Rx and subjected to cGMP
Page 1 of 151
,- outsourcing facilities that meet the Act's requirements are exempt from the new drug
provisions (FDCA section 505), adequate directions for use (FDCA section 502(f)(1)), and
drug track and trace provisions (FDCA section 582)
- compounding pharmacies that are not registered w FDA as an "outsourcing facility" are
referred to as 503A pharmacies -> may compound products pursuant to a pt-specific Rx only
or limited anticipatory compounding & subjected to USP 797 for sterile compounding
Drug Supply Chain Security Act (DSCSA)(Track and Trace) --CORRECT ANSWER---
uniform national electronic track and trace system for Rx drugs throughout the supply chain
- sets national standards for states to license wholesale distributors
- applies to Rx drugs for human use in finished dosage form (exempted: blood and blood
components, radioactive drugs, imaging drugs, certain IV products for fluid replacement,
dialysis solutions, medical gases, compounded drugs, certain combo drugs, sterile water and
products for irrigation)
- manufacturers required to provide "transaction data" for each product sold, and pharmacies
required to receive "transaction data" and pass this info along if they further distribute the
product
- pharmacies that are distributing must have a wholesale distribution license and must pass
DSCSA transaction data w that distribution (exception: distribution bw 2 entities affiliated or
under common ownership; dispenser providing product to another dispenser on a pt-specific
basis; dispenser distributing under emergency medical reasons; dispenser distributing
"minimal quantities" to a licensed practitioner for office use)
- other provisions of DSCSA will be implemented gradually, eventually requiring electronic
tracking and tracing product using a unique product identifier on each package by 2023
Food, Drug, and Cosmetic Act of 1938 --CORRECT ANSWER--- after deaths by
sulfanilamide elixir that contained antifreeze in 1937
- required new drugs to be proven safe before marketing
Page 2 of 151
,Durham-Humphrey Amendment of 1951 --CORRECT ANSWER--- established 2 classes of
drug: Rx and OTC
- authorized verbal Rx and refills
Important to know that certain products may be either Rx or OTC depending on the product
or strength (e.g., some insulins are OTC whereas Lantus and Humalog are Rx only; ibuprofen
200mg is OTC whereas 400, 600, and 800mg are Rx)
Kefauver-Harris Amendment of 1962 --CORRECT ANSWER--- required new drugs to be
proven safe and effective before marketing
- increased safety requirements
- established GMPs for manufacturing of drugs
- gave FDA jurisdiction over Rx drug advertising
Transaction data (part of track and trace) --CORRECT ANSWER--- transaction info
- transaction hx
- transaction statement
Transaction info (track and trace) --CORRECT ANSWER--- product name, strength, and
dosage form
- NDC #
- container size and # of containers
- date of transaction
- name and address of transferer and transferee
Page 3 of 151
, Transaction hx (track and trace) --CORRECT ANSWER--Paper or electronic statement that
includes prior transaction info for each prior transaction back to the manufacturer
Transaction statement (track and trace) --CORRECT ANSWER--Paper or electronic
statement by seller that:
- the seller is authorized (licensed)
- received the product from an authorized (licensed) person
- received the transaction info and hx from the prior owner if required
- did not knowingly ship a suspect or illegitimate product
- has systems and processes to comply w verification requirements
- did not knowingly provide false transaction info
Distributing --CORRECT ANSWER--providing a drug to anyone other than the
consumer/patient
Dispensing --CORRECT ANSWER--Providing a drug to the pt/consumer
A drug is adulterated if --CORRECT ANSWER--- drug contains any filthy, putrid, or
decomposed substance
- drug prepared or held under unsanitary conditions
- methods of manufacturing not conforming to cGMP
- container composed of any poisonous or deleterious substance
- drug contains unsafe color additive
- drug purports to be a drug in an official compendium and its strength differs from or its
quality of purity falls below the compendium standard, unless the difference is clearly stated
on the label
Page 4 of 151
