Is it mandatory for all oral dosage units to have an imprint according to regulations?

Imprinting on oral dosage units is a mandatory requirement for the identification of pharmaceuticals. All solid dosage forms intended for human consumption, such as tablets and capsules, must have a unique identifier stamped or imprinted on them. This imprinted information is crucial for preventing medication errors, enhancing patient safety, and enabling healthcare professionals to accurately identify medications.

The regulations mandate that the imprint allows for the easy recognition of the drug, including its name, dosage strength, and manufacturer, which is important for avoiding confusion with other medications that may look similar. The requirement applies universally across all forms, not distinguishing between prescription and non-prescription drugs, ensuring consistency and safety across the board. Therefore, the assertion that all oral dosage units must have an imprint in accordance with regulatory standards is accurate.