The pharmaceutical manufacturing sector 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.

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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

• 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
  • 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)

• Waste:

  • Process-Based Self-Assessment Tool for the Organic Chemical Industry

Policies and Guidance

• Industrial Process Refrigeration Compliance Guidance