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Pharmaceutical Industry Source Reduction Assessment

DTSC is preparing the first assessment of the California pharmaceutical industry’s efforts to reduce hazardous waste under the Hazardous Waste Source Reduction and Management Review Act of 1989 (SB 14). SB 14 requires DTSC to select two categories of generators by Standard Industrial Classification (SIC) code every two years for source reduction planning assessment. Selection of an industry is based on the consideration of several factors including the amount of waste generated, opportunity for source reduction measures and organizational interests focused on emerging issues. One of the industries selected in 2005 was the pharmaceutical industry. The pharmaceutical industry includes the manufacture, extraction, processing, purification, and packaging of chemical materials to be used as medications for humans or animals. Each of these production steps may generate air emissions, liquid effluents, and solid wastes. This assessment report focuses on the hazardous wastes generated by this industry. In late 2005, DTSC requested the California industries operating under SIC codes 2833 (medicinals and botanicals), 2834 (pharmaceutical preparations), 2835 (diagnostic substances) and 2836 (biological products, except diagnostic) to submit SB 14 documents for a technical and completeness review. Based on the submitted documentation from twenty-eight (28) California facilities, a profile for each individual facility will be generated. Each profile will contain individual facility site information, identify their major waste streams reduction accomplishments from 1999 to 2002 and their present projections for further reducing these major waste streams from 2003 to 2006.

SIC Chart for Pharmaceutical Industry Waste Streams

Based on the preliminary review of this industry’s 2002 source reduction (SB 14) documents, it is evident that the largest hazardous waste quantity generated by the pharmaceutical industry are solvents reported under California Waste Code (CWC) 212, 211, and 214 (refer to the chart). More detailed analysis will be given in our assessment report, which is scheduled for release in early 2007. Notable SB 14 source reduction measures include waste segregation, inventory control and employee training.

Major Waste Streams Generated by California Pharmaceutical Industries in 2002 * e.g., Conventional drug delivery waste solids, pharmaceutical tablets, powders and packaging, transdermal drug delivery wastes, pharmaceutical patches, liner and roll stock, pharmaceutical process wastes, nicotine containing wastes generated from processes, off-specification pharmaceuticals. This waste was only generated by SIC 2834 (pharmaceutical preparations).

The product-specific production techniques and cleaning/maintenance approaches take years to develop and receive final FDA approval. Changing these procedures requires supplemental FDA approval. This process can add a significant delay in the implementation of source reduction practices. Some source reduction opportunities exist when developing new products.

References and Related Publications