1. Regulations
  2. title 40
  3. chapter I-i31
  4. part 439
  5. subpart C
  6. § 439.31

View all text of Subpart C [§ 439.30 - § 439.37]

§ 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]

AUTHORITY: 33 U.S.C. 1311, 1314, 1316, 1317, 1318, 1342 and 1361.

SOURCE: 48 FR 49821, Oct. 27, 1983, unless otherwise noted.

CITE AS: 40 CFR 439.31