Texas MPJE: Dr. C's Review Chapter
1 Exam Questions and Answers
100% Pass
What was the first legislative act that Congress passed in response to the deaths
caused by sulfanilamide elixir in 1937? - CORRECT ANSWER-Food, Drug, and
Cosmetic Act of 1938 (FDCA)
- required new drugs to be proven safe prior to marketing
What act established the FDA? - CORRECT ANSWER-Food, Drug, and
Cosmetic Act of 1938 (FDCA)
- primary federal law for food, drug, cosmetic, and medical device safety
What amendment differentiated between prescription and OTC drug classes?
What did these amendments additionally authorize? - CORRECT ANSWER-
Durham-Humphrey Amendments of 1951
- authorized verbal prescriptions and prescription refills
,What amendment required new drugs to be proven safe and effective for their
claimed use? What did this establish for the manufacturing of drugs? - CORRECT
ANSWER-Kefauver-Harris Amendments of 1962
- established Good Manufacturing Practices (GMPs) for manufacturing of drugs
What amendment gave FDA jurisdiction over prescription drug advertising? -
CORRECT ANSWER-Kefauver-Harris Amendments of 1962
- also required new drugs to be proven safe and effective
- established GMPs for manufacturing of drugs
What act bans the re-importation of prescription drugs and insulin products
produced in the United States? Who is the exception to this? - CORRECT
ANSWER-Prescription Drug Marketing Act of 1987 (PDMA)
- except by the manufacturer
What act bans the sale, trade, or purchase of prescription drug samples? -
CORRECT ANSWER-Prescription Drug Marketing Act of 1987 (PDMA)
- mandates the storage, handling, and recordkeeping requirements for Rx drug
samples
- also bans re-importation of drugs produced in USA (except by manufacturer)
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,What pharmacies are exempt from the prohibition of possessing prescription drug
samples? - CORRECT ANSWER-- owned by a charitable organization or city,
state, or county government
- part of a healthcare entity providing care to indigent or low-income patients at no
or reduced cost
(such samples may only be provided at no charge to patients; Class D allowed to
have samples)
What act prohibits, with certain exceptions, the resale of Rx drugs purchased by
hospitals or healthcare facilities? What is this law intended to prevent? -
CORRECT ANSWER-Prescription Drug Marketing Act of 1987 (PDMA)
- prevent diversion of drugs (due to price differentials because hospitals generally
receive lower prices for drugs than community pharmacies)
- also bans drug re-importation and samples
What two primary topics (acts) did the Drug Quality and Security Act of 2013
(DQSA) address? - CORRECT ANSWER-1. large-scale compounding by
pharmacies -- Drug Compounding Quality Act (DCQA)
2. establishment of a framework for a uniform track and trace system for Rx drugs
throughout the supply chain -- Drug Supply Chain Security Act (DSCSA)
Under the Drug Compounding Quality Act (DCQA), Section 503B in the FDCA
is established. What does Section 503B allow? - CORRECT ANSWER-Allows
, "Outsourcing Facilities" -- sterile-compounding facilities that are not based on
patient-specific prescriptions to register with the FDA as an outsourcing facility
(note - Section 503A maintains regulation of traditional compounding)
Outsourcing 503B facilities that meet DCQA requirements are exempt from what?
- CORRECT ANSWER-- new drug provisions
- adequate directions for use
- drug track and trace provisions
True or False: outsourcing 503B facilities are not permitted to compound sterile
products without receiving patient-specific prescriptions or medication orders -
CORRECT ANSWER-False -- they are permitted
- they are primarily regulated by FDA and are subject to FDA's current GMPs
(cGMPs)
503A facilities may only compound pursuant to an __________________; they
are permitted to do limited ___________________, and are subject to USP
Chapter ______ quality standards for sterile compounding. - CORRECT
ANSWER-1. individual prescription or medication order
2. anticipatory compounding
3. 797
COPYRIGHT ©️ 2025 ALL RIGHTS RESERVED
1 Exam Questions and Answers
100% Pass
What was the first legislative act that Congress passed in response to the deaths
caused by sulfanilamide elixir in 1937? - CORRECT ANSWER-Food, Drug, and
Cosmetic Act of 1938 (FDCA)
- required new drugs to be proven safe prior to marketing
What act established the FDA? - CORRECT ANSWER-Food, Drug, and
Cosmetic Act of 1938 (FDCA)
- primary federal law for food, drug, cosmetic, and medical device safety
What amendment differentiated between prescription and OTC drug classes?
What did these amendments additionally authorize? - CORRECT ANSWER-
Durham-Humphrey Amendments of 1951
- authorized verbal prescriptions and prescription refills
,What amendment required new drugs to be proven safe and effective for their
claimed use? What did this establish for the manufacturing of drugs? - CORRECT
ANSWER-Kefauver-Harris Amendments of 1962
- established Good Manufacturing Practices (GMPs) for manufacturing of drugs
What amendment gave FDA jurisdiction over prescription drug advertising? -
CORRECT ANSWER-Kefauver-Harris Amendments of 1962
- also required new drugs to be proven safe and effective
- established GMPs for manufacturing of drugs
What act bans the re-importation of prescription drugs and insulin products
produced in the United States? Who is the exception to this? - CORRECT
ANSWER-Prescription Drug Marketing Act of 1987 (PDMA)
- except by the manufacturer
What act bans the sale, trade, or purchase of prescription drug samples? -
CORRECT ANSWER-Prescription Drug Marketing Act of 1987 (PDMA)
- mandates the storage, handling, and recordkeeping requirements for Rx drug
samples
- also bans re-importation of drugs produced in USA (except by manufacturer)
COPYRIGHT ©️ 2025 ALL RIGHTS RESERVED
,What pharmacies are exempt from the prohibition of possessing prescription drug
samples? - CORRECT ANSWER-- owned by a charitable organization or city,
state, or county government
- part of a healthcare entity providing care to indigent or low-income patients at no
or reduced cost
(such samples may only be provided at no charge to patients; Class D allowed to
have samples)
What act prohibits, with certain exceptions, the resale of Rx drugs purchased by
hospitals or healthcare facilities? What is this law intended to prevent? -
CORRECT ANSWER-Prescription Drug Marketing Act of 1987 (PDMA)
- prevent diversion of drugs (due to price differentials because hospitals generally
receive lower prices for drugs than community pharmacies)
- also bans drug re-importation and samples
What two primary topics (acts) did the Drug Quality and Security Act of 2013
(DQSA) address? - CORRECT ANSWER-1. large-scale compounding by
pharmacies -- Drug Compounding Quality Act (DCQA)
2. establishment of a framework for a uniform track and trace system for Rx drugs
throughout the supply chain -- Drug Supply Chain Security Act (DSCSA)
Under the Drug Compounding Quality Act (DCQA), Section 503B in the FDCA
is established. What does Section 503B allow? - CORRECT ANSWER-Allows
, "Outsourcing Facilities" -- sterile-compounding facilities that are not based on
patient-specific prescriptions to register with the FDA as an outsourcing facility
(note - Section 503A maintains regulation of traditional compounding)
Outsourcing 503B facilities that meet DCQA requirements are exempt from what?
- CORRECT ANSWER-- new drug provisions
- adequate directions for use
- drug track and trace provisions
True or False: outsourcing 503B facilities are not permitted to compound sterile
products without receiving patient-specific prescriptions or medication orders -
CORRECT ANSWER-False -- they are permitted
- they are primarily regulated by FDA and are subject to FDA's current GMPs
(cGMPs)
503A facilities may only compound pursuant to an __________________; they
are permitted to do limited ___________________, and are subject to USP
Chapter ______ quality standards for sterile compounding. - CORRECT
ANSWER-1. individual prescription or medication order
2. anticipatory compounding
3. 797
COPYRIGHT ©️ 2025 ALL RIGHTS RESERVED
