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Notes

§439.31. Special definitions.

40 C.F.R. § 439.31

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.
Notes, amendments, and revision history

Amendments

[68 FR 12273, Mar. 13, 2003]

Authority

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

Source

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

Amendments

[68 FR 12273, Mar. 13, 2003]