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:
Water:
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:
Policies and 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.