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e-CFR data is current as of September 24, 2020

Title 40Chapter ISubchapter NPart 439Subpart D → §439.41


Title 40: Protection of Environment
PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY
Subpart D—Mixing/Compounding and Formulation


§439.41   Special definitions.

For the purpose of this subpart:

(a) Mixing, compounding, and formulating operations means processes that put pharmaceutical products in dosage forms.

(b) 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.

[68 FR 12274, Mar. 13, 2003]

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