Compliance Assistance

The pharmaceutical manufacturing sector consists of establishments primarily engaged in one or more of the following:

1. Manufacturing biological and medical products;
2. Processing botanical drugs and herbs;
3. Isolating active medical principles from botanical drugs and herbs;
4. Manufacturing pharmaceutical products intended for internal and external consumptio0n in such forms as tablets, capsules, ointments, powders and solutions. The sector is now classified under the 2007 North American Industry Classification System (NAICS) as 3254.

Additional Compliance Assistance Resources

Regulations that apply to these industries may have changed since the document publication dates; additional research on rule changes may be necessary.

• State-Specific Regulatory Information
• Inorganic Chemical Manufacturing Statutory and Regulatory Summaries - (12/1/97) (PDF) (191 pp, 1MB)
• Pharmaceutical Manufacturing Statutory and Regulatory Summaries - (12/1/97) (PDF) (136 pp, 817MB)
• Compliance Assistance Tool for Clean Air Act Regulations: Subpart GGG of 40 CFR NESHAPS for Source Category Pharmaceutical Production - (8/1/02) (PDF) (260 pp, 7MB)
• Compliance Guidance for Industrial Process Refrigeration Leak Repairs Regulations Under Section 608 Clean Air Act - (10/31/95) (PDF) (59 pp, 238K)

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