Disposal may result from production waste such as out of specification lots, returned or expired product, and user disposal of empty or partly used product and packaging.  Pharmaceutical waste and returned or expired product will be disposed of by the manufacturer at a licensed incineration facility or expired or rejected drug product may be destroyed by shredding and rinsing followed by wastewater treatment.  At U.S. hospitals or clinics empty or partially empty packages will be disposed according to hospital procedures.  From home use, empty or partially empty containers will typically be disposed of by a community’s solid waste management system which may include landfills, incineration and recycling, while minimal quantities of unused drug may be disposed of in the sewer system.

 

Precautions taken at the sites of manufacture of the bulk drug product and its final formulation are expected to minimize occupational exposures and environmental release.

 

The Center for Drug Evaluation and Research has concluded that the product can be manufacturer, used and disposed of without any expected adverse environmental effects.  Adverse effects are not anticipated upon endangered or threatened species or upon property listed in or eligible for listing in the National Register of Historic Places.

 

 

10/26/95                                (Signature)

DATE                                PREPARED BY

                                Nancy B. Sager

                                Environmental Scientist

                                Center for Drug Evaluation and Research

 

10/26/95                                (Signature)

                                CONCURRED

                                Roger L. Williams, M.D.

                                Center for Drug Evaluation and Research

 

Attachment:                                Environmental Assessment

 

 

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