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