GroundRules
40 CFR 439.41: Special definitions.
Where this section sits in the code
- Title 40—Protection of Environment
- CHAPTER I—ENVIRONMENTAL PROTECTION AGENCY
- SUBCHAPTER N—EFFLUENT GUIDELINES AND STANDARDS
- PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY
- Subpart D—Mixing/Compounding and Formulation
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.
Collected 2026-08-27T02:26:04Z. Source file · JSON