FDA Seeks Public Comments On Medication Guide Regulations

The Food and Drug Administration is seeking public comment on regulations requiring the distribution of medication guides, according to a notice published Dec. 21, 2011, in the Federal Register (76 Fed. Reg. 79194).

FDA regulations require the distribution of medication guides for certain prescription drug and biological products that pose a serious public health concern, the notice said. These medication guides give patients the most important information about these products in order to use them safely and effectively.

Medication guides include information on the drug’s approved uses, contraindications, adverse drug reactions, and cautions for specific patient populations, ...