40 C.F.R. § 439.31
Special definitions.
Cite as 40 C.F.R. § 439.31 (2026)
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]