MPJE Federal Food, Drug, and Cosmetic Act Questions and Answers

Question 1

A pharmacist discovers that a batch of hydrochlorothiazide tablets from a manufacturer was stored at an improper temperature in the pharmacy's storeroom, potentially altering the drug's efficacy and safety.
The drug has not yet been dispensed.
Under the Federal Food, Drug, and Cosmetic Act, this batch of medication is considered:

Accepted Answer

Adulterated

Answer

Misbranded

Answer

A counterfeit drug

Answer

Subject to a Class I recall

Question 2

The Durham-Humphrey Amendment to the FD&C Act established the distinction between prescription and over-the-counter (OTC) drugs. Which of the following is a key provision of this amendment?

Accepted Answer

It authorized the legality of oral prescriptions and prescription refills.

Answer

It required manufacturers to prove drug efficacy in addition to safety.

Answer

It established the Good Manufacturing Practices (GMPs) for the pharmaceutical industry.

Answer

It created the five schedules for controlled substances.

Question 3

A manufacturer issues a voluntary recall for a widely used blood pressure medication because some bottles may contain a small glass fragment, which could cause serious or life-threatening harm if ingested. How would the FDA MOST likely classify this recall?

Accepted Answer

Class I Recall

Answer

Class II Recall

Answer

Class III Recall

Answer

Market Withdrawal

Question 4

A 75-year-old patient with severe arthritis tells the pharmacist that she has great difficulty opening her child-resistant prescription vials. She requests that all her future prescriptions from this pharmacy be filled in non-child-resistant containers. According to the Poison Prevention Packaging Act (PPPA), what is the appropriate action for the pharmacist to take?

Accepted Answer

Honor the patient's blanket request for all future prescriptions, preferably after obtaining it in writing.

Answer

Inform the patient that a new request must be made for each individual prescription.

Answer

Tell the patient she must get her prescriber to authorize the use of non-child-resistant containers.

Answer

Refuse the request, as only specific drugs are exempt from PPPA requirements.

Question 5

Which of the following pieces of information is required by the FD&C Act to be included in the 'Drug Facts' panel on the package of an over-the-counter (OTC) medication?

Accepted Answer

The active ingredients and their purpose.

Answer

The pharmacy's phone number.

Answer

The National Drug Code (NDC) number.

Answer

The lot number and expiration date.

Question 6

Under the Federal Food, Drug, and Cosmetic Act, a prescription drug dispensed by a pharmacist is exempt from certain manufacturer labeling requirements, but the dispensed vial's label must contain specific information. Which of the following is NOT a federally mandated requirement for the prescription label?

Accepted Answer

The discard date or 'beyond-use date'.

Answer

The name and address of the dispenser.

Answer

The serial number of the prescription.

Answer

The name of the prescribing practitioner.