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 1977, 1983, 1986 and 1998. The Effluent Guidelines are incorporated into NPDES permits for direct dischargers, and permits or other control mechanisms for indirect dischargers (see Pretreatment Program).

Facilities Covered

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

Federal Register Notices

  • Partial Withdrawal of Direct Final Rule (PDF)(2 pp, 163 K) (June 11, 2003)
  • Direct Final Rule (PDF)(10 pp, 206 K) (March 13, 2003)
  • Final Rule (PDF)(50 pp, 554 K) (September 21, 1998)
    Major revision of BPT, BAT, NSPS, PSES, and PSNS for Subparts A-D
  • Final Rule: December 16, 1986 (51 FR 45094)
  • Final Rule: October 27, 1983 (48 FR 49808)
  • Final Rule: February 4, 1977 (42 FR 6813)
  • Final Rule: November 17, 1976 (41 FR 50676)
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