### Question
What is the definition of radioactive drug?


### Answer
The definition of **radioactive drug** is as follows in *21 CFR § 310.3*:

> any substance defined as a drug in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any nonradioactive reagent kit ornuclide generator which is intended to be used in the preparation of any such substance but does not include drugs such as carbon-containing compounds or potassium-containing salts which contain trace quantities of naturally occurring radionuclides. 

#### Citation:
  - *21 CFR § 310.3*
  - Heading: **PART 300—GENERAL > PART 310—NEW DRUGS > Subpart A—General Provisions > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES—Continued**

