Cal. Code Regs. tit. 16 § 1708.3

Current through Register 2024 Notice Reg. No. 39, September 27, 2024
Section 1708.3 - Radioactive Drugs

A radioactive drug is any substance defined as a drug in Section 201(g)(1) of the Federal Food, Drug and Cosmetic Act or a radioactive biological product as defined in 21 CFR 600.3(ee) which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any such drug or biological product which is intended to be made radioactive. This definition includes non-radioactive reagent kits and nuclide generators which are intended to be used in the preparation of any such substance but does not include drugs such as carbon-containing compounds, potassium-containing compounds or potassium-containing salts which contain trace quantities of naturally occurring radionuclides.

Cal. Code Regs. Tit. 16, § 1708.3

1. New section filed 1-20-76; effective thirtieth day thereafter (Register 76, No. 4).
2. Amendment filed 4-22-85; effective thirtieth day thereafter (Register 85, No. 17).
3. Change without regulatory effect amending NOTE filed 9-11-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 37).

Note: Authority cited: Section 4005, Business and Professions Code. Reference: Section 4025, Business and Professions Code.

1. New section filed 1-20-76; effective thirtieth day thereafter (Register 76, No. 4).
2. Amendment filed 4-22-85; effective thirtieth day thereafter (Register 85, No. 17).
3. Change without regulatory effect amending Note filed 9-11-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 37).