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Effluent Guidelines
Pharmaceutical Manufacturing Point Source Category
Permit Guidance Document
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On September 21, 1998, EPA promulgated revised regulations for the pharmaceutical industry to control both effluent discharges and air emissions. This guidance document will help permit writers and pretreatment coordinators develop appropriate National Pollutant Discharge Elimination System (NPDES) permits and pretreatment requirements for pharmaceutical facilities with the following types of operations: fermentation, extraction, chemical synthesis, mixing, compounding and formulating and research.
Guidance Document Fact Sheet (January 2006)
For an overview of the NPDES and National Pretreatment Programs, refer to the U.S. EPA NPDES Permit Writer’s Manual (EPA-833-B-96-003) as well as the Industrial User Permitting Guidance Manual (EPA-833/R-89-001). You can download the Permit Writer's Manual from the NPDES publications web page.
Download the entire permit guidance document (PDF) (88 pages, 1.0 MB)
- Cover, Disclaimer, and Executive Summary (PDF) (5 pages, 756 K)
- Table of Contents (PDF) (5 pages, 467 K)
- Part 1: Overview and Scope (PDF) (11 pages, 521 K)
- Part 2: Regulated Pollutants (PDF) (4 pages, 648 K)
- Part 3 (PDF) (11 pages, 512 K)
- What are the Technological Bases for Effluent Limitations Guidelines and Standards for Subparts A, B, C, and D?
- Where Are Facilities Required to Demonstrate Compliance?
- What are the Effluent Limitations Guidelines and Standards for Subparts A, B, C, D, and E?
- Part 4: Developing Permits (PDF) (17 pages, 581 K)
- Part 5: Case Studies (PDF) (35 pages, 675 K)
- Part 6: Help and Glossary (PDF) (7 pages, 481 K)