MPJE Federal Food, Drug, and Cosmetic Act Questions and Answers — 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:
- Adulterated (Correct answer)
- Misbranded
- A counterfeit drug
- Subject to a Class I recall
Correct answer: Adulterated
A drug is considered adulterated if it has been held under insanitary conditions or under conditions where it may have been contaminated or rendered injurious to health. Storing a drug at an improper temperature that could affect its strength, quality, or purity meets this definition. Misbranding relates to labeling issues, counterfeit refers to fraudulent imitation, and the recall class would be determined by the FDA based on the level of hazard.
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?
- It required manufacturers to prove drug efficacy in addition to safety.
- It established the Good Manufacturing Practices (GMPs) for the pharmaceutical industry.
- It authorized the legality of oral prescriptions and prescription refills. (Correct answer)
- It created the five schedules for controlled substances.
Correct answer: It authorized the legality of oral prescriptions and prescription refills.
The Durham-Humphrey Amendment of 1951 explicitly authorized the taking of original prescriptions orally (by phone) and the refilling of prescriptions, which were not permitted before this law. Proving efficacy was part of the 1962 Kefauver-Harris Amendments, GMPs were also formalized by Kefauver-Harris, and the scheduling of controlled substances was established by the Controlled Substances Act of 1970.
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?
- Class II Recall
- Class I Recall (Correct answer)
- Class III Recall
- Market Withdrawal
Correct answer: Class I Recall
A Class I recall is the most serious type, used in situations where there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. The presence of a glass fragment poses such a risk. A Class II recall is for temporary or reversible health consequences, and a Class III recall is for situations not likely to cause adverse health consequences.
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?
- Inform the patient that a new request must be made for each individual prescription.
- Tell the patient she must get her prescriber to authorize the use of non-child-resistant containers.
- Honor the patient's blanket request for all future prescriptions, preferably after obtaining it in writing. (Correct answer)
- Refuse the request, as only specific drugs are exempt from PPPA requirements.
Correct answer: Honor the patient's blanket request for all future prescriptions, preferably after obtaining it in writing.
The Poison Prevention Packaging Act (PPPA) allows a patient or their agent to make a 'blanket waiver' request for all of their prescriptions to be dispensed in non-child-resistant packaging. While the law does not require this request to be in writing, it is highly recommended that the pharmacy document it with the patient's signature. Prescribers can only request non-child-resistant packaging for an individual prescription and its refills, not a blanket waiver for all of a patient's medications.
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?
- The pharmacy's phone number.
- The National Drug Code (NDC) number.
- The lot number and expiration date.
- The active ingredients and their purpose. (Correct answer)
Correct answer: The active ingredients and their purpose.
The FDA requires a standardized 'Drug Facts' label on all OTC medications, which must list, in a specific order, the active ingredient(s), uses, warnings, directions, and inactive ingredients. The purpose of each active ingredient must be stated. While the NDC, lot number, and expiration date are required on the packaging, they are not part of the standardized 'Drug Facts' panel itself.
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?
- The name and address of the dispenser.
- The serial number of the prescription.
- The name of the prescribing practitioner.
- The discard date or 'beyond-use date'. (Correct answer)
Correct answer: The discard date or 'beyond-use date'.
While including a beyond-use date (BUD) or discard date is a standard of practice and required by most state laws, it is not explicitly required by the federal FD&C Act for a dispensed prescription label. The FD&C Act does require the name and address of the dispenser (pharmacy), the serial (prescription) number, the date of the prescription or of its filling, and the name of the prescriber.
MPJE Federal Food, Drug, and Cosmetic Act Questions and Answers
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: