EPA Guidance Document: Pharmaceutical Manufacturing Point Source Category (40 CFR Part 439)

Pharmaceutical manufacturers use many different raw materials and manufacturing processes to create a wide range of products with therapeutic value. Pharmaceutical products are produced by a number of processes. These include the following: chemical synthesis, fermentation, extraction from naturally occurring plant or animal substances, mixing, compounding, and formulating operations, or by refining a technical grade product.

The regulations establish different requirements depending on whether a manufacturing operation is an existing source or a new source. The pharmaceutical manufacturing industry regularly may make equipment and process changes to existing manufacturing processes. Consequently, permitting authorities should carefully review EPA regulations before deciding whether a particular source of discharge is an existing source or a new source.

The definition of new source for direct dischargers is at 40 CFR 122.2 and the new source definition for indirect dischargers is at 40 CFR 403.3. Direct discharging pharmaceutical new sources have to meet more stringent BOD5 and TSS standards than existing sources. In the case of indirect facilities, PSES and PSNS are identical.

The pharmaceutical guidelines and standards regulation applies generally, but not exclusively, to process wastewater discharges resulting from the manufacture of pharmaceutical products and from pharmaceutical research reported within three specified U.S. Department of Commerce Bureau of the Census Standard Industrial Classification system (SIC) groups and to the manufacture of certain pharmaceutical products not reported under the three SIC codes. The regulation does not apply to dischargers from the manufacture of pharmaceutical products included in eight other SIC subgroups and three other identified pharmaceutical products. Which pharmaceutical product process wastewaters are, and are not, subject to this regulation is explained in further detail at 40 CFR 439.0. The currently applicable regulations may be found in any edition of the CFR dated July, 1999 or later.