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 dischargersdirect 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 dischargersindirect dischargerA facility that discharges pollutants to a publicly owned treatment works (municipal sewage treatment plant). (see Pretreatment Program).

Facilities Covered

1. Fermentation Products
2. Extraction Products
3. Chemical Synthesis Products
4. Mixing/Compounding and Formulation
5. Research

Guidance and Analytical Methods Documents

• Guidance Document (2006)
  Assists permit writers and pretreatment coordinators in developing appropriate NPDES permits and pretreatment requirements for pharmaceutical facilities
• Approved Analytical Methods for Pharmaceutical Pollutants

Rulemaking History

2003 Amendment

• Partial withdrawal of Direct Final Rule (June 11, 2003)
  Corrections regarding compliance dates
• Direct Final Rule (March 13, 2003)
  Clarification of compliance dates; correction to effluent limitations; additional definitions

1998 Amendment

• Final Rule (September 21, 1998)
• Development Document
  Describes industry processes, pollutants generated, available control and treatment technologies, the technical basis for the final rule, and costs of the rule
• Economic Analysis

1983 Amendment

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

1976 Initial Rulemaking

• Interim Final Rule (November 17, 1976)
  Initial BPT limitations

Additional Information

For additional information regarding Pharmaceutical Manufacturing Effluent Guidelines, please contact Meghan Hessenauer (hessenauer.meghan@epa.gov) or 202-566-1040.