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Pharmaceutical and Medicine Manufacturing Sector (NAICS 3254)

Pharmaceutical manufacturing is part of the manufacturing sector (NAICS 31 - 33). It consists of establishments primarily engaged in one or more of the following:

  • manufacturing biological and medical products;
  • processing botanical drugs and herbs; 
  • isolating active medical principles from botanical drugs and herbs;
  • manufacturing pharmaceutical products intended for internal and external consumption in such forms as tablets, capsules, ointments, powders and solutions.

Laws and Regulations

Air:

  • Greenhouse Gas Reporting Program
  • Essential Uses of CFCs for Metered-Dose Inhalers
  • National Emissions Standards for Hazardous Air Pollutants (NESHAP): Pharmaceutical Production Industry
  • Stationary Refrigeration and Air-Conditioning

General:

  • Inorganic Chemical Manufacturing Statutory and Regulatory Summaries (191 pp, 1080 K, About PDF)

Waste:

  • Management of Hazardous Waste Pharmaceuticals

Water:

  • Effluent Guidelines: Pharmaceutical Manufacturing

Compliance

Air:

  • Compliance Assistance Tool for Clean Air Act Regulations: Subpart GGG of 40 CFR NESHAPS for Source Category Pharmaceutical Production (260 pp, 6900 K, About PDF)
  • Compliance Assistance Tool for Pharmaceutical Production, Pesticide Active Ingredient Production, and Miscellaneous Organic Chemical Manufacturing NESHAP: Comparison of Regulatory Requirements and Case Study Compliance Illustrations for Nondedicated Equipment (PDF) (85 pp, 1505 K, About PDF)

Waste:

  • Process-Based Self-Assessment Tool for the Organic Chemical Industry (404 pp, 2700 K, About PDF)

Policies and Guidance

  • Industrial Process Refrigeration Compliance Guidance

Additional federal and state regulations not listed here may apply. Find your state environmental agency.

Partnership Programs

  • Safer Choice Labeling: labeling program for variety of chemical-based products.
  • Green Chemistry
  • The Lean and Chemicals Toolkit: strategies and techniques for chemical manufacturing, management, and use.
Contact Us to ask a question, provide feedback, or report a problem.
Last updated on September 2, 2021
United States Environmental Protection Agency

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