CPJE California Prescription Labeling Requirements — Questions and Answers
Question 1: Under CCR 1707.5 (patient-centered labels), what is the minimum font for the most important label items?
- 8-point font in any typeface
- 10-point sans serif font, or 12-point if the patient asks (Correct answer)
- 14-point serif font
- There is no font requirement
Correct answer: 10-point sans serif font, or 12-point if the patient asks
CCR 1707.5 requires the key patient-centered items to be printed in at least 10-point sans serif typeface, or 12-point at the patient's request. The key items are the patient's name, the drug name and strength, the directions for use, and the purpose if stated.
Question 2: Under CCR 1707.5, how much of the label must the patient-centered cluster of information occupy?
- At least 10%
- At least 25%
- At least 50% (Correct answer)
- 100%
Correct answer: At least 50%
The clustered patient-centered items (patient name, drug name and strength, directions, and purpose if indicated) must take up at least 50% of the label. This makes them stand out from pharmacy and administrative information.
Question 3: California B&P 4076 requires which item on most prescription container labels that many other states do not?
- The patient's Social Security number
- A physical description of the dispensed medication, such as color, shape, and identification code (Correct answer)
- The wholesale price of the drug
- The pharmacist's home address
Correct answer: A physical description of the dispensed medication, such as color, shape, and identification code
B&P 4076 requires the label to include a physical description of the dispensed medication, including its color, shape, and any identification code on it, with limited exceptions. This helps patients recognize their medication and catch errors.
Question 4: If the prescriber states the condition or purpose on the prescription, what must the California pharmacy do?
- Leave it off the label for privacy
- Include the condition or purpose on the label (Correct answer)
- Include it only for controlled substances
- Include it only if the patient pays an additional fee
Correct answer: Include the condition or purpose on the label
B&P 4076 and CCR 1707.5 require the condition or purpose to appear on the label when the prescriber indicates it on the prescription. Within the patient-centered cluster this appears as 'for [purpose]'.
Question 5: A patient with limited English proficiency asks for help understanding their prescription label. What is the California pharmacy required to do?
- Refuse to dispense until the patient brings an interpreter
- Provide interpretive services in the patient's language, as required by law (Correct answer)
- Refer the patient to the prescriber for translation
- Nothing, because labels are required only in English
Correct answer: Provide interpretive services in the patient's language, as required by law
California requires pharmacies to provide interpretive services in the patient's language when requested. The Board of Pharmacy also offers translated standardized directions for use that pharmacies may use on labels.
Question 6: Which item is NOT a required element of a California prescription container label under B&P 4076?
- Name of the prescriber
- Date the prescription was dispensed
- Pharmacy name and address
- Patient's date of birth (Correct answer)
Correct answer: Patient's date of birth
B&P 4076 requires the label to show items including the prescriber's name, the dispensing date, the pharmacy's name and address, the prescription number, the patient's name, the drug name and strength, and directions. The patient's date of birth is not a required label element.
