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Effluent Guidelines

Pharmaceutical Manufacturing Effluent Guidelines

""EPA promulgated the Pharmaceutical Manufacturing Effluent Guidelines and Standards (40 CFR Part 439) in 1976 and amended the regulation in 1983, 1998 and 2003. The Effluent Guidelines are incorporated into NPDES permits for direct dischargersHelpdirect dischargerA point source that discharges pollutants to waters of the United States, such as streams, lakes, or oceans., and permits or other control mechanisms for indirect dischargersHelpindirect dischargerA facility that discharges pollutants to a publicly owned treatment works (municipal sewage treatment plant). (see Pretreatment Program).

Facilities Covered

The regulation applies to facilities organized into five subcategories:
  1. Fermentation Products
  2. Extraction Products
  3. Chemical Synthesis Products
  4. Mixing/Compounding and Formulation
  5. Research

Guidance and Analytical Methods Documents

Rulemaking History

2003 Amendment

1998 Amendment

Major revision of BPT, BAT, NSPS, PSES, and PSNS for Subparts A-D

1983 Amendment

  • Final Rule (October 27, 1983)
    BAT, NSPS, PSES, PSNS; revised BPT

1976 Initial Rulemaking

Additional Information

For additional information regarding Pharmaceutical Manufacturing Effluent Guidelines, please contact Meghan Hessenauer ( or 202-566-1040.