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.

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Guidance Document

• Permit Guidance Document for Pharmaceuticals Manufacturing

Final Rule

Amendments

• Corrections published in the Federal Register (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 (September 02, 1999)
• Correction published in the Federal Register (March 16, 1999)
• Correction published in the Federal Register (March 04, 1999)

Final rule published September 1998

• Final rule published in the Federal Register (September 21, 1998)
  • Fact sheet about the final rule

Support Documents

• Technical development document
• Economic analysis
• Analytical Methods Guidance for the Pharmaceutical Manufacturing Point Source Category (PDF) (34 pp, 131 K; August 1999, EPA 821-B-99-003)
• Analytical methods for the determination of pollutants in pharmaceutical manufacturing wastewater (PDF) (283 K, 99 pp; July 1998, EPA 821-B-98-016)
• Notice of data availability published in the Federal Register (August 8, 1997)
• Proposed rule published in the Federal Register (May 2, 1995)