Texas MPJE Exam Questions and
Answers 100% Pass
What is the Food, Drug, and Cosmetic Act of 1938? - CORRECT ANSWER-
Passed by Congress
Requires new drugs to prove their safety prior to marketing (the primary federal
law dealing with food, drug, cosmetic, and medical device safety).
Established the FDA.
What is the Durham - Humphrey Amendment of 1951? - CORRECT ANSWER-
Establishes 2 classes of drugs (Prescription and OTC).
Allows for verbal prescriptions and prescription refills.
What is the Kefauver-Harris Amendment of 1962? - CORRECT ANSWER-
Requires drug companies to prove safety & efficacy for their claimed use
Increases the safety requirements for drugs
Establishes Good Manufacturing Practices (GMPs)
Gave FDA jurisdiction over prescription drug advertising
,What is the Prescription Drug Marketing Act of 1987? - CORRECT ANSWER-
Bans re-importation of prescription drugs and insulin products (except by the
manufacturer).
Bans sales/trade/purchase of prescription drug samples
Mandates the storage/handling/recordkeeping requirements for prescription drug
samples
Prohibits resale of prescription drugs purchased by hospitals or healthcare facilities
What is the Drug Quality and Security Act of 2013? - CORRECT ANSWER-
Encompasses the Drug Compounding Quality Act (DCQA - large scale
compounding) and the Drug Supply Chain Security Ac (DSCSA - track and trace
system of prescription drugs throughout the supply chain)
What is Section 503A? - CORRECT ANSWER-Regulation of State Licensed
Compounding Pharmacies (compounds individual prescriptions/medical orders;
has limited anticipatory compounding)
Regulated by the state
Follows USP <797>
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,What requirements are section 503A pharmacies exempted from if they meet
DCQA's requirements? - CORRECT ANSWER-501(A)(2)(B): current GMP
requirements
502(F)(1): labeling w/ adequate directions for use
505: new drug approval requirements
What is Section 503B? - CORRECT ANSWER-Regulation of Outsourcing
Facilities (compounds w/o pt-specific prescriptions/medical orders)
Regulated by FDA
Follows current GMP
What requirements are section 503B pharmacies exempted from if they meet
DCQA's requirements? - CORRECT ANSWER-582: Drug Supply Chain Security
Requirements (DSCSA)
502(F)(1): labeling w/ adequate directions for use
505: new drug approval requirements
What is the Drug Supply Chain Security Act (DSCSA)? - CORRECT ANSWER-
Uniform national framework for an electronic track and trace system for
prescription drugs as they move through the supply chain.
Sets national standards for states to license drug wholesaler distributors.
, What are Manufacturers required to provide according to DSCSA? - CORRECT
ANSWER-Transaction Data (Transaction Information; Transaction History;
Transaction Statement) for each product sold
What is included as Transaction Information (as part of Transaction Data)? -
CORRECT ANSWER-Product's Name, Strength, Dosage Form
NDC Number
Container Size and Number of Containers
Date of Transaction
Name/Address of distributor and receiver of ownership
What is the Transaction History (as part of Transaction Data)? - CORRECT
ANSWER-Paper/Electronic Statement including prior transaction information for
each prior transaction back to the manufacturer
What is the Transaction Statement (as part of Transaction Data)? - CORRECT
ANSWER-Paper/Electronic statement by Seller that states they are an authorized
seller, the product is from an authorized person, the seller received the transaction
information and history from the prior owner, they have systems and processes
that comply with verification requirements, and did not knowingly ship a
suspect/illegitimate product or provide false transaction information
COPYRIGHT ©️ 2025 ALL RIGHTS RESERVED
Answers 100% Pass
What is the Food, Drug, and Cosmetic Act of 1938? - CORRECT ANSWER-
Passed by Congress
Requires new drugs to prove their safety prior to marketing (the primary federal
law dealing with food, drug, cosmetic, and medical device safety).
Established the FDA.
What is the Durham - Humphrey Amendment of 1951? - CORRECT ANSWER-
Establishes 2 classes of drugs (Prescription and OTC).
Allows for verbal prescriptions and prescription refills.
What is the Kefauver-Harris Amendment of 1962? - CORRECT ANSWER-
Requires drug companies to prove safety & efficacy for their claimed use
Increases the safety requirements for drugs
Establishes Good Manufacturing Practices (GMPs)
Gave FDA jurisdiction over prescription drug advertising
,What is the Prescription Drug Marketing Act of 1987? - CORRECT ANSWER-
Bans re-importation of prescription drugs and insulin products (except by the
manufacturer).
Bans sales/trade/purchase of prescription drug samples
Mandates the storage/handling/recordkeeping requirements for prescription drug
samples
Prohibits resale of prescription drugs purchased by hospitals or healthcare facilities
What is the Drug Quality and Security Act of 2013? - CORRECT ANSWER-
Encompasses the Drug Compounding Quality Act (DCQA - large scale
compounding) and the Drug Supply Chain Security Ac (DSCSA - track and trace
system of prescription drugs throughout the supply chain)
What is Section 503A? - CORRECT ANSWER-Regulation of State Licensed
Compounding Pharmacies (compounds individual prescriptions/medical orders;
has limited anticipatory compounding)
Regulated by the state
Follows USP <797>
COPYRIGHT ©️ 2025 ALL RIGHTS RESERVED
,What requirements are section 503A pharmacies exempted from if they meet
DCQA's requirements? - CORRECT ANSWER-501(A)(2)(B): current GMP
requirements
502(F)(1): labeling w/ adequate directions for use
505: new drug approval requirements
What is Section 503B? - CORRECT ANSWER-Regulation of Outsourcing
Facilities (compounds w/o pt-specific prescriptions/medical orders)
Regulated by FDA
Follows current GMP
What requirements are section 503B pharmacies exempted from if they meet
DCQA's requirements? - CORRECT ANSWER-582: Drug Supply Chain Security
Requirements (DSCSA)
502(F)(1): labeling w/ adequate directions for use
505: new drug approval requirements
What is the Drug Supply Chain Security Act (DSCSA)? - CORRECT ANSWER-
Uniform national framework for an electronic track and trace system for
prescription drugs as they move through the supply chain.
Sets national standards for states to license drug wholesaler distributors.
, What are Manufacturers required to provide according to DSCSA? - CORRECT
ANSWER-Transaction Data (Transaction Information; Transaction History;
Transaction Statement) for each product sold
What is included as Transaction Information (as part of Transaction Data)? -
CORRECT ANSWER-Product's Name, Strength, Dosage Form
NDC Number
Container Size and Number of Containers
Date of Transaction
Name/Address of distributor and receiver of ownership
What is the Transaction History (as part of Transaction Data)? - CORRECT
ANSWER-Paper/Electronic Statement including prior transaction information for
each prior transaction back to the manufacturer
What is the Transaction Statement (as part of Transaction Data)? - CORRECT
ANSWER-Paper/Electronic statement by Seller that states they are an authorized
seller, the product is from an authorized person, the seller received the transaction
information and history from the prior owner, they have systems and processes
that comply with verification requirements, and did not knowingly ship a
suspect/illegitimate product or provide false transaction information
COPYRIGHT ©️ 2025 ALL RIGHTS RESERVED
