MPJE Federal Food, Drug, and Cosmetic Act 3 — Questions and Answers
Question 1: What does the FD&C Act require for a drug to qualify for the 'Rx-to-OTC switch' pathway?
- Adequate safety data showing it can be used without practitioner supervision (Correct answer)
- A new NDA must be submitted as if the drug were entirely new
- DEA scheduling must be removed before the switch
- FDA must hold a public hearing with mandatory comment period
Correct answer: Adequate safety data showing it can be used without practitioner supervision
An Rx-to-OTC switch requires demonstrating that consumers can safely self-select and use the drug without a prescriber's supervision.
Question 2: Under the FD&C Act, which section establishes the requirement for current Good Manufacturing Practice (cGMP)?
- Section 501(a)(2)(B) (Correct answer)
- Section 502(b)
- Section 505(c)
- Section 503(b)(1)
Correct answer: Section 501(a)(2)(B)
Section 501(a)(2)(B) deems a drug adulterated if it was not manufactured in conformance with cGMP regulations.
Question 3: An 'abbreviated new drug application' (ANDA) relies on which type of existing FDA approval?
- A reference listed drug (RLD) with an approved NDA (Correct answer)
- A drug master file (DMF) submitted by the API manufacturer
- An investigational new drug (IND) application
- A biological license application (BLA)
Correct answer: A reference listed drug (RLD) with an approved NDA
An ANDA references the safety and efficacy data of an approved RLD rather than submitting independent clinical trials.
Question 4: Under FD&C Act Section 503A, which of the following is a requirement for a compounded drug to be exempt from NDA and labeling requirements?
- The drug must be compounded based on a valid prescription for an identified individual patient (Correct answer)
- The drug must be compounded in advance and kept in a large stock inventory
- The compounding pharmacy must be licensed in at least 10 states
- The drug must be on the FDA's shortage list
Correct answer: The drug must be compounded based on a valid prescription for an identified individual patient
Section 503A exemptions apply to patient-specific compounding by licensed pharmacists based on valid prescriptions.
Question 5: What is the purpose of a 'drug master file' (DMF) submitted to FDA?
- To provide confidential detailed information about facilities, processes, or articles used in drug manufacturing (Correct answer)
- To request accelerated approval for a life-saving drug
- To notify FDA of a drug shortage in advance
- To report adverse events associated with a marketed drug
Correct answer: To provide confidential detailed information about facilities, processes, or articles used in drug manufacturing
A DMF allows manufacturers to share proprietary information with FDA without disclosing it to other parties referencing the DMF.
Question 6: Under the FD&C Act, which term describes a drug whose labeling fails to bear required warnings?
- Misbranded (Correct answer)
- Adulterated
- Counterfeit
- Unapproved
Correct answer: Misbranded
A drug is misbranded if its labeling is false or misleading or omits required information such as warnings.
Question 7: Which FD&C Act provision allows FDA to require post-market safety studies or clinical trials as a condition of approval?
- Post-market requirements under Section 505(o) (Correct answer)
- Accelerated approval under Section 506(c)
- Orphan drug designation under Section 526
- Fast track designation under Section 506(b)
Correct answer: Post-market requirements under Section 505(o)
Section 505(o) authorizes FDA to require post-market studies, clinical trials, or labeling changes when new safety information emerges.
MPJE Federal Food, Drug, and Cosmetic Act 3
What does the FD&C Act require for a drug to qualify for the 'Rx-to-OTC switch' pathway?