MPJE Federal Food, Drug, and Cosmetic Act 5 — Questions and Answers
Question 1: Under the FD&C Act, what is the definition of a 'dietary supplement'?
- A product intended to supplement the diet that contains a vitamin, mineral, herb, amino acid, or other dietary ingredient (Correct answer)
- Any OTC product that provides nutritional benefits without a prescription
- A food product fortified with vitamins approved by FDA as safe for addition
- A drug product derived from natural plant sources sold without a prescription
Correct answer: A product intended to supplement the diet that contains a vitamin, mineral, herb, amino acid, or other dietary ingredient
Section 201(ff) of the FD&C Act defines dietary supplements as products intended to supplement the diet, taken by mouth, containing a dietary ingredient.
Question 2: The FD&C Act's Drug Supply Chain Security Act (DSCSA) provisions require trading partners to track and trace drugs using which identifier?
- Serialized National Drug Code (sNDC) with transaction history (Correct answer)
- DEA registration number linked to each shipment
- FDA establishment registration number
- Universal Product Code (UPC) barcode only
Correct answer: Serialized National Drug Code (sNDC) with transaction history
DSCSA requires a serialized identifier on each smallest saleable unit and electronic transaction information (TI, TH, TS) to track drugs through the supply chain.
Question 3: Which FD&C Act section grants FDA authority to mandate a Risk Evaluation and Mitigation Strategy (REMS) for a drug?
- Section 505-1 (Correct answer)
- Section 503(b)
- Section 502(f)
- Section 510(k)
Correct answer: Section 505-1
Section 505-1 of the FD&C Act authorizes FDA to require a REMS when necessary to ensure that benefits of a drug outweigh its risks.
Question 4: Under the FD&C Act, a compounding outsourcing facility registered under Section 503B must:
- Comply with cGMP and report adverse events to FDA (Correct answer)
- Compound only based on individual patient prescriptions
- Limit distribution to the state where the facility is located
- Obtain an NDA for each drug it compounds
Correct answer: Comply with cGMP and report adverse events to FDA
Section 503B outsourcing facilities must follow cGMP, report adverse events, and can compound without patient-specific prescriptions but must register with FDA.
Question 5: A drug that was previously approved but has been withdrawn from the market for safety reasons may not be used as a reference listed drug for an ANDA because:
- FDA removes withdrawn drugs from the Orange Book, blocking ANDA submissions referencing them (Correct answer)
- The ANDA applicant must submit full clinical safety data independently
- DEA scheduling automatically changes upon market withdrawal
- The patent protection period is waived upon voluntary withdrawal
Correct answer: FDA removes withdrawn drugs from the Orange Book, blocking ANDA submissions referencing them
Drugs withdrawn for safety or effectiveness reasons are removed from the Orange Book, and FDA will not approve ANDAs referencing them.
Question 6: Under the FD&C Act, which labeling element is specifically required on the immediate container of a prescription drug dispensed to a patient?
- Name and address of the dispenser, prescription serial number, date, prescriber name, and patient name (Correct answer)
- Full package insert approved by FDA at time of NDA
- NDC number, lot number, and expiration date only
- Manufacturer's name and country of origin
Correct answer: Name and address of the dispenser, prescription serial number, date, prescriber name, and patient name
Section 503(b)(2) requires the prescription container to bear the dispenser's name/address, serial number, date of dispensing, prescriber name, and patient name.
Question 7: Which of the following is an example of an 'imminent hazard' that allows FDA to immediately suspend a drug's approval under the FD&C Act?
- A drug linked to sudden cardiac death with no known safe dose (Correct answer)
- A drug with a label that omits the phone number for adverse event reporting
- A drug that has exceeded its expiration date by 30 days
- A drug manufactured in a facility with minor cGMP deviations
Correct answer: A drug linked to sudden cardiac death with no known safe dose
An imminent hazard justifying immediate suspension exists when continued marketing presents an unreasonable risk of serious injury or death to consumers.
MPJE Federal Food, Drug, and Cosmetic Act 5
Under the FD&C Act, what is the definition of a 'dietary supplement'?