Effluent Guidelines for Pharmaceutical Manufacturing

This regulation limits the discharge of pollutants into navigable waters of the United States and into wastewater treatment plants by existing and new pharmaceutical manufacturing facilities.

The rule benefits the environment by removing a total of 13.9 million pounds per year of nonconventional and 16.0 million pounds per year of organic pollutants including volatile organic compounds.

Final Rule

Amendments

• Corrections published in the Federal Register | Print version (PDF, 48kb, 2 pages) (May 2004)
• Partial withdrawal of a direct final rule published in the Federal Register (June 11, 2003)
  • Fact sheet
• Direct final rule published in the Federal Register (March 13, 2003)
  • Fact sheet
• Correction published in the Federal Register | Print version (PDF, 20kb, 2 pages) (September 2, 1999)
• Correction published in the Federal Register | Print version (PDF, 9kb, 1 page) (March 16, 1999)
• Correction published in the Federal Register | Print version (PDF, 33kb, 4 pages) (March 4, 1999)

Final rule published September 1998

• Fact sheet about the final rule
• Final rule published in the Federal Register | Print version (PDF, 443kb, 51 pages) (September 21, 1998)

  Support Documents

  • Technical development document
  • Economic analysis
  • Analytical methods for the determination of pollutants in pharmaceutical manufacturing wastewater (PDF, 135kb, 34 pages)
  • Notice of data availability published in the Federal Register (August 8, 1997)
  • Proposed rule published in the Federal Register (May 2, 1995)

Other resources

Biennial plan and schedule to consider developing and revising effluent guidelines

Effluent guidelines home page

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