U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 27, 2025

All TitlesTitle 40Chapter IPart 439 - PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY

GENERAL
§ 439.0 - Applicability.
§ 439.1 - General definitions.
§ 439.2 - General monitoring requirements.
§ 439.3 - General pretreatment standards.
§ 439.4 - General limitation or standard for pH.
Subpart A [§ 439.10 - § 439.17] - Subpart A—Fermentation Products
Subpart B [§ 439.20 - § 439.27] - Subpart B—Extraction Products
Subpart C [§ 439.30 - § 439.37] - Subpart C—Chemical Synthesis Products
Subpart D [§ 439.40 - § 439.47] - Subpart D—Mixing/Compounding and Formulation
Subpart E [§ 439.50 - § 439.52] - Subpart E—Research
Subpart 0 -
Appendix Appendix A - Appendix A to Part 439—Tables
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