INTRODUCTION

This chapter applies to labeling instructions and information on prescription containers that are directly dispensed to the patient to promote better patient understanding. These standards do not apply when a prescription drug will be administered to a patient by licensed personnel who are acting within their scope of practice. Medication misuse has resulted in more than 1 million adverse drug events per year in the United States. One of patients' primary sources of information regarding the medications they have been prescribed is on the prescription container label. Although other written information and oral counseling may be available, the prescription container label must fulfill the professional obligations of the prescriber and pharmacist. These obligations include giving patients the essential information they will need to understand how to safely and appropriately use the medication and how to adhere to the prescribed medication regimen.