Proper labeling of medications is a critical component of patient safety and effective pharmacotherapy, governed by stringent FDA requirements and state laws. For PharmD students and practicing pharmacists, a thorough understanding of labeling requirements for both prescription and over-the-counter (OTC) drugs is essential. This includes recognizing the difference between a “label” and “labeling,” knowing the mandatory elements for various types of labels (manufacturer’s stock bottle, dispensed prescription, OTC Drug Facts), and appreciating the pharmacist’s role in ensuring clarity and accuracy. Misbranding due to labeling errors can have serious legal and patient safety consequences. This quiz will test your knowledge on the key aspects of pharmaceutical labeling.
1. Under the Food, Drug, and Cosmetic Act (FDCA), the term “label” refers to:
- a) Any advertising material associated with the drug.
- b) The written, printed, or graphic matter upon the immediate container of any article.
- c) The patient package insert only.
- d) Verbal information provided by the pharmacist.
Answer: b) The written, printed, or graphic matter upon the immediate container of any article.
2. The term “labeling” under the FDCA is broader than “label” and includes:
- a) Only the information on the immediate container.
- b) All labels and other written, printed, or graphic matter accompanying the drug product.
- c) Only the information required by state law.
- d) The color and shape of the drug.
Answer: b) All labels and other written, printed, or graphic matter accompanying the drug product.
3. A drug is considered “misbranded” if its labeling is:
- a) Too difficult for a child to open.
- b) False or misleading in any particular.
- c) Printed in black ink only.
- d) Approved by the FDA.
Answer: b) False or misleading in any particular.
4. Which of the following pieces of information is typically required on the manufacturer’s stock bottle label for a prescription drug?
- a) The patient’s name.
- b) The name and address of the manufacturer, packer, or distributor.
- c) The dispensing pharmacy’s phone number.
- d) Directions for patient use.
Answer: b) The name and address of the manufacturer, packer, or distributor.
5. The label of a prescription drug dispensed to a patient by a pharmacy must generally include all the following EXCEPT:
- a) The name and address of the pharmacy.
- b) The serial number (prescription number) of the prescription.
- c) The name of the prescribing practitioner.
- d) The wholesale acquisition cost (WAC) of the drug.
Answer: d) The wholesale acquisition cost (WAC) of the drug.
6. The “Rx only” symbol or statement on a drug label indicates that the drug:
- a) Is an over-the-counter (OTC) medication.
- b) Is a prescription (legend) drug.
- c) Is a controlled substance.
- d) Has a black box warning.
Answer: b) Is a prescription (legend) drug.
7. Over-the-counter (OTC) drug labeling must provide “adequate directions for use.” This means the directions must be clear enough for:
- a) A pharmacist to interpret.
- b) A layperson to use the drug safely and effectively for its intended purpose without professional supervision.
- c) A physician to prescribe.
- d) International use.
Answer: b) A layperson to use the drug safely and effectively for its intended purpose without professional supervision.
8. The standardized format for OTC drug labeling, which includes sections like Active Ingredient, Uses, Warnings, and Directions, is known as the:
- a) Patient Package Insert (PPI).
- b) Drug Facts label.
- c) Medication Guide.
- d) Orange Book.
Answer: b) Drug Facts label.
9. Auxiliary labels are affixed to a dispensed prescription container to:
- a) Increase the price of the medication.
- b) Provide supplementary instructions, warnings, or precautions to the patient (e.g., “May cause drowsiness,” “Take with food”).
- c) List the inactive ingredients.
- d) Indicate the pharmacy’s hours.
Answer: b) Provide supplementary instructions, warnings, or precautions to the patient (e.g., “May cause drowsiness,” “Take with food”).
10. A “Black Box Warning” is the most serious type of warning in prescription drug labeling and is intended to highlight:
- a) Common, mild side effects.
- b) Potentially serious or life-threatening adverse reactions.
- c) The drug’s expiration date.
- d) The manufacturer’s contact information.
Answer: b) Potentially serious or life-threatening adverse reactions.
11. The Pregnancy and Lactation Labeling Rule (PLLR) replaced the previous A, B, C, D, X pregnancy categories. The new labeling requires information to be presented in which subsections?
- a) Pediatrics, Geriatrics, and Adults.
- b) Pregnancy, Lactation, and Females and Males of Reproductive Potential.
- c) Safety, Efficacy, and Cost.
- d) Dosage, Administration, and Storage.
Answer: b) Pregnancy, Lactation, and Females and Males of Reproductive Potential.
12. If a drug’s strength is less than what is declared on its label, it is considered:
- a) Only adulterated.
- b) Only misbranded.
- c) Both adulterated and misbranded.
- d) Properly labeled if the difference is minor.
Answer: c) Both adulterated and misbranded.
13. Failure to include the established name of the drug on the label of a prescription drug would render it:
- a) Adulterated.
- b) Misbranded.
- c) A counterfeit drug.
- d) An investigational drug.
Answer: b) Misbranded.
14. The expiration date on a manufacturer’s stock bottle refers to the date until which the manufacturer guarantees the drug will remain:
- a) At its peak market price.
- b) Stable and potent when stored under recommended conditions in the unopened original container.
- c) Available for purchase.
- d) Free of all side effects.
Answer: b) Stable and potent when stored under recommended conditions in the unopened original container.
15. The “Beyond-Use Date” (BUD) on a prescription label for a dispensed medication is determined by:
- a) The patient’s insurance coverage period.
- b) The pharmacist, based on factors such as the nature of the drug, the original manufacturer’s expiration date, and the container in which it is dispensed, often guided by USP standards.
- c) The date the prescription was written by the doctor.
- d) A random date set by the pharmacy computer.
Answer: b) The pharmacist, based on factors such as the nature of the drug, the original manufacturer’s expiration date, and the container in which it is dispensed, often guided by USP standards.
16. For controlled substances, the label of the dispensed medication must typically include which federal warning?
- a) “Warning: May be habit forming.”
- b) “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”
- c) “For investigational use only.”
- d) “This product not evaluated by the FDA.”
Answer: b) “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”
17. The information on a prescription label must be easily understandable to:
- a) Other pharmacists only.
- b) The patient or caregiver.
- c) The FDA inspectors.
- d) The pharmaceutical sales representative.
Answer: b) The patient or caregiver.
18. If a pharmacy dispenses a drug without a required Medication Guide when one is mandated by the FDA, the drug may be considered:
- a) Adulterated.
- b) Misbranded.
- c) An OTC product.
- d) Exempt from labeling requirements.
Answer: b) Misbranded.
19. Medication Guides are FDA-approved patient handouts that are required for certain prescription drugs that pose a:
- a) Low risk of side effects.
- b) Serious and significant public health concern, to help patients avoid serious adverse events.
- c) High cost.
- d) Need for refrigeration.
Answer: b) Serious and significant public health concern, to help patients avoid serious adverse events.
20. The principal display panel (PDP) of an OTC drug product is the part of the label:
- a) Intended for the pharmacist only.
- b) Most likely to be displayed or examined under customary conditions of display for retail sale.
- c) Containing only the inactive ingredients.
- d) That is thrown away after purchase.
Answer: b) Most likely to be displayed or examined under customary conditions of display for retail sale.
21. A unit-dose package label for a drug dispensed in an institutional setting must typically include all the following EXCEPT:
- a) The established name of the drug and its strength.
- b) The lot or control number.
- c) The expiration date.
- d) The patient’s name.
Answer: d) The patient’s name. (Patient name is on the medication administration record, not usually individual unit doses within a hospital cart system for general stock).
22. If a pharmacist dispenses a generic drug for a brand name drug, the label on the dispensed vial should generally indicate:
- a) Only the brand name.
- b) The generic name, and often the brand name it is equivalent to, or “generic for [Brand Name]”.
- c) A proprietary code name.
- d) No drug name to avoid confusion.
Answer: b) The generic name, and often the brand name it is equivalent to, or “generic for [Brand Name]”.
23. Which of the following is a key purpose of the National Drug Code (NDC) number found on drug labels?
- a) To indicate the drug’s therapeutic class.
- b) To serve as a universal product identifier for human drugs.
- c) To determine the drug’s price.
- d) To provide dosing instructions.
Answer: b) To serve as a universal product identifier for human drugs.
24. The NDC number is typically divided into three segments identifying:
- a) Patient, prescriber, and pharmacy.
- b) Manufacturer/labeler, product (drug, strength, dosage form), and package size/type.
- c) Drug class, mechanism of action, and side effects.
- d) Year of approval, clinical trial number, and patent number.
Answer: b) Manufacturer/labeler, product (drug, strength, dosage form), and package size/type.
25. If a product is marketed as a “dietary supplement” but makes claims to treat, cure, mitigate, or prevent a disease, its labeling may cause it to be regulated as a(n):
- a) Food.
- b) Drug.
- c) Cosmetic.
- d) Medical device.
Answer: b) Drug.
26. The “Directions for use” section on a prescription label should be:
- a) As vague as possible.
- b) Clear, unambiguous, and reflect the prescriber’s intended regimen.
- c) Written in Latin abbreviations only.
- d) Optional if the patient has internet access.
Answer: b) Clear, unambiguous, and reflect the prescriber’s intended regimen.
27. If a pharmacist places the wrong drug in a prescription vial, but the label on the vial is correct for the drug that should have been dispensed, the dispensed product is considered:
- a) Only adulterated (wrong drug).
- b) Only misbranded (label doesn’t match contents).
- c) Both adulterated (wrong drug) and misbranded (label is false/misleading as to the contents).
- d) Correctly filled.
Answer: c) Both adulterated (wrong drug) and misbranded (label is false/misleading as to the contents).
28. “Tall Man Lettering” is a strategy used on labels and in computer systems to help distinguish:
- a) Brand name drugs from generics.
- b) Look-alike, sound-alike (LASA) drug names.
- c) Controlled substances from non-controlled substances.
- d) Expensive drugs from inexpensive ones.
Answer: b) Look-alike, sound-alike (LASA) drug names.
29. The statement of identity on an OTC drug label typically includes the drug’s:
- a) Manufacturer’s internal code.
- b) Established name followed by its general pharmacological category or principal intended action.
- c) Price.
- d) Chemical formula.
Answer: b) Established name followed by its general pharmacological category or principal intended action.
30. For OTC products, the “Warnings” section of the Drug Facts label must include information about:
- a) When the product should not be used and when to consult a doctor.
- b) How to store the product.
- c) The net quantity of contents.
- d) The name of the manufacturer.
Answer: a) When the product should not be used and when to consult a doctor.
31. Who is ultimately responsible for the accuracy of the information on a dispensed prescription label?
- a) The patient.
- b) The prescribing physician.
- c) The dispensing pharmacist.
- d) The pharmacy technician who typed the label.
Answer: c) The dispensing pharmacist.
32. The Federal Anti-Tampering Act requires certain OTC drugs, cosmetics, and devices to be sold in:
- a) Child-resistant packaging.
- b) Tamper-evident packaging.
- c) Biodegradable packaging.
- d) Opaque packaging.
Answer: b) Tamper-evident packaging.
33. Labeling for a prescription drug that has been repackaged by a pharmacy into unit-dose containers for hospital use must still contain certain minimum information, such as:
- a) The patient’s room number.
- b) The drug name, strength, lot number, and beyond-use date.
- c) The hospital’s address.
- d) The name of the nurse who will administer it.
Answer: b) The drug name, strength, lot number, and beyond-use date.
34. If a drug is an imitation of another drug or sold under the name of another drug, it is considered:
- a) Adulterated.
- b) Misbranded.
- c) A generic equivalent.
- d) A biosimilar.
Answer: b) Misbranded.
35. The “inactive ingredients” section of an OTC Drug Facts label is important for individuals who may have:
- a) Questions about the drug’s effectiveness.
- b) Allergies or sensitivities to certain excipients.
- c) Difficulty swallowing pills.
- d) A need for a lower dose.
Answer: b) Allergies or sensitivities to certain excipients.
36. What is the primary purpose of including the pharmacy’s phone number on the prescription label?
- a) For telemarketing purposes.
- b) To allow the patient or other healthcare providers to contact the pharmacy with questions.
- c) To fulfill a contractual obligation with the manufacturer.
- d) For the FDA to conduct surveys.
Answer: b) To allow the patient or other healthcare providers to contact the pharmacy with questions.
37. Is it permissible for a pharmacy to use a prescription label that is difficult to read due to very small font size?
- a) Yes, as long as all required information is present.
- b) No, labeling should be clear and legible to ensure patient understanding and safety.
- c) Only if the patient has good eyesight.
- d) Yes, if it saves on label costs.
Answer: b) No, labeling should be clear and legible to ensure patient understanding and safety.
38. The lot number on a drug label is important for:
- a) Determining the drug’s therapeutic class.
- b) Tracking and identifying specific batches of a drug in case of a recall or problem.
- c) Indicating the drug’s price.
- d) Calculating the beyond-use date.
Answer: b) Tracking and identifying specific batches of a drug in case of a recall or problem.
39. Labeling requirements under the Poison Prevention Packaging Act (PPPA) relate to:
- a) The font size on the label.
- b) Child-resistant packaging and associated labeling statements if applicable (e.g., if easily opened containers are provided for elderly/handicapped).
- c) The color of the label.
- d) Braille labeling for visually impaired patients.
Answer: b) Child-resistant packaging and associated labeling statements if applicable (e.g., if easily opened containers are provided for elderly/handicapped).
40. If a manufacturer makes a significant change to the formulation of an OTC product, but does not update the label to reflect this change, the product could be considered:
- a) Adulterated (if the change affects purity/strength) and misbranded (if labeling is false/misleading due to omission).
- b) Only an improved product.
- c) No longer subject to FDA regulation.
- d) Automatically granted prescription status.
Answer: a) Adulterated (if the change affects purity/strength) and misbranded (if labeling is false/misleading due to omission).
41. The requirement for the name and place of business of the manufacturer, packer, or distributor on a drug label helps to:
- a) Ensure the drug is expensive.
- b) Provide accountability and a point of contact regarding the product.
- c) Market other products from the same company.
- d) Complicate the label.
Answer: b) Provide accountability and a point of contact regarding the product.
42. For compounded non-sterile preparations, the label should generally include:
- a) Only the patient’s name.
- b) The name of all active ingredients and their quantities, a beyond-use date, storage instructions, and other state-specific requirements.
- c) A statement that it is not FDA approved (as compounded Rxs are not FDA-approved new drugs).
- d) Both b and c.
Answer: d) Both b and c.
43. When counseling a patient, it’s important for the pharmacist to ensure the patient understands the information on the prescription label, particularly the:
- a) Pharmacy’s logo.
- b) Directions for use and important warnings.
- c) Barcode.
- d) Type of paper the label is printed on.
Answer: b) Directions for use and important warnings.
44. If a drug is required to have a “black box warning” in its package insert, this information should also be communicated to patients, often through:
- a) A discount coupon.
- b) The prescription label itself (if space/format allows for emphasis), auxiliary labels, and patient counseling, including Medication Guides if required.
- c) A separate advertisement.
- d) A social media post by the pharmacy.
Answer: b) The prescription label itself (if space/format allows for emphasis), auxiliary labels, and patient counseling, including Medication Guides if required.
45. A common labeling error that can lead to patient harm is:
- a) Using a font that is too large.
- b) Ambiguous or confusing directions for use (e.g., “take as directed” without further clarification).
- c) Including too many auxiliary labels.
- d) Using a child-resistant cap.
Answer: b) Ambiguous or confusing directions for use (e.g., “take as directed” without further clarification).
46. The label of a sample prescription drug provided by a manufacturer to a prescriber must still comply with certain FDCA labeling requirements and often states:
- a) “Not for resale.”
- b) “Patient may share with family.”
- c) “No counseling needed.”
- d) “Expires in 10 years.”
Answer: a) “Not for resale.”
47. What is the purpose of the “Net quantity of contents” on an OTC drug label?
- a) To state the total number of inactive ingredients.
- b) To inform the consumer of the amount of product in the container (e.g., number of tablets, fluid ounces).
- c) To indicate the drug’s potency.
- d) To specify the recommended daily dosage.
Answer: b) To inform the consumer of the amount of product in the container (e.g., number of tablets, fluid ounces).
48. If a pharmacy fails to include the name of the patient on a dispensed prescription label, this would be considered:
- a) Good practice for privacy.
- b) A form of misbranding as it omits required information.
- c) Acceptable if the patient is a regular customer.
- d) An issue for the prescriber, not the pharmacy.
Answer: b) A form of misbranding as it omits required information.
49. The labeling of investigational new drugs (INDs) used in clinical trials must contain specific information, including:
- a) The price of the drug.
- b) A statement that it is an investigational drug and limited by Federal law to investigational use.
- c) A guarantee of efficacy.
- d) The names of all trial participants.
Answer: b) A statement that it is an investigational drug and limited by Federal law to investigational use.
50. Ultimately, accurate and comprehensive drug labeling serves to:
- a) Complicate the dispensing process.
- b) Promote the safe and effective use of medications by healthcare providers and patients.
- c) Increase the cost of medications.
- d) Protect manufacturers from lawsuits.
Answer: b) Promote the safe and effective use of medications by healthcare providers and patients.