Pharmaceutical Production

eCFR Subpart GGG [ecfr.gov]

This subpart applies to:

1. Manufactures of pharmaceutical product which process, use, or produce HAPs and are located at plant site that is a major source.

"Pharmaceutical product" means any of the following, except for nonreactive solvents, excipient, binder, or filler or any material produced in a chemical manufacturing process units that is subject to subpart F and G of this part:

1. Any material described by SIC code 2833 or 2834;
2. Any material whose manufacturing process is described by NAICS code 325411 or 325412;
3. A finished dosage form of a drug (e.g., tablet, capsule, solution, etc);
4. Any active ingredient or precursor that is produced at a facility whose primary manufacturing operations are described by SIC code 2833 or 2834;
5. At facilities whose primary operations are not described by SIC code 2833 or 2834, any material whos primary use is as an active ingredient or precursor.

*Major Sources of HAPs emit or have the potential to emit:

• ≥ 10 tons/year of any single HAP; or
• ≥ 25 tons/year of total HAPs.
• Area Sources emit less than Major Sources.

Exempt to this Subpart:

1. Research and development facilities

No

NESHAP – 40 CFR Part 63

Subpart F – Organic Hazardous Air Pollutants from the Synthetic Organic Chemical Manufacturing Industry (SOCMI)
Subpart G – Equipment Specific Organic HAPs from SOCMI

eCFR Subpart GGG [ecfr.gov]