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. Submitted by the Environmental Protection Agency