When is written drug information required for patient counseling?

Written drug information is required for patient counseling primarily when the drug is distributed outside the pharmacy. This requirement ensures that patients who receive medications outside the traditional pharmacy setting—such as through mail-order services or other delivery methods—have access to essential information about their medications. Providing this information helps to enhance patient understanding and adherence, as well as promote safety by ensuring that they are aware of important aspects regarding their medication, including usage, potential side effects, and interactions.

The other scenarios, while relevant to patient counseling, do not universally mandate written information. For example, not all prescriptions require written information just because a patient requests it, and the requirement does not extend solely to controlled substances. Providing written drug information for every prescription regardless of the method of distribution is necessary in some cases, but the specific requirement hinges on the mode of distribution, making the distribution outside the pharmacy the correct trigger for mandatory written information.