Which of the following is required under the DDA basic rule for OTC medications?

• A. A barcode and lot number
• B. PMOF and a pharmacy label
• C. A prescription from a physician
• D. A patient information leaflet

Answer: (B)

Under the DDA basic rule for OTC medications, the emphasis is on ensuring proper documentation and clear identification to dispense safely. The PMOF provides the official record or authorization for dispensing the medication, while the pharmacy label communicates exactly what is being given—drug name, strength, directions, and other essential dispensing details. Together, they ensure the right product is provided to the right patient with the correct instructions, supporting accountability and safe use. A barcode and lot number, while useful for tracking and recalls, do not by themselves satisfy this labeling-and-record-keeping requirement. A physician’s prescription isn’t needed for OTC meds, and a patient information leaflet, though helpful, isn’t the mandated component of this rule.