1. INTRODUCTION

Radiopharmaceuticals, as defined in this chapter (see Glossary), are a subset of radioactive materials (RAMs) falling under the control of the US Nuclear Regulatory Commission (NRC) or NRC-contracted agreement state agency. Radiopharmaceuticals are also a subset of prescription drugs falling under the control of the US FDA for manufacturing and marketing. Other federal regulatory authorities (e.g., Department of Transportation) have control over certain activities related to radiopharmaceuticals. Compliance with these regulations, as applicable, must be ensured in addition to compliance with the standards described in this chapter.