§439.41. Special definitions.
40 C.F.R. § 439.41
For the purpose of this subpart:
Mixing, compounding, and formulating operations means processes that put pharmaceutical products in dosage forms.
Product means any pharmaceutical product manufactured by blending, mixing, compounding, and formulating pharmaceutical ingredients. The term includes pharmaceutical preparations for both human and veterinary use such as ampules, tablets, capsules, vials, ointments, medicinal powders, solutions, and suspensions.
Notes, amendments, and revision history
Amendments
[68 FR 12274, 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 12274, Mar. 13, 2003]