U.S. Code of Federal Regulations

Regulations most recently checked for updates: Mar 25, 2023

§ 439.31 - Special definitions.

For the purpose of this subpart:

(a) Chemical synthesis means using one or a series of chemical reactions in the manufacturing process of a specified product.

(b) Product means any pharmaceutical product manufactured by chemical synthesis.

[68 FR 12273, Mar. 13, 2003]