Bupropion hydrochloride is indicated for the treatment of depression. It has been marketed as an Immediate-Release Tablet since 1989.  The sustained-release tablet formulation has demonstrated reduced seizure rates when compared to the immediate-release formulation.  The estimated patient population is one million people per year.

 

4.c                Describe location(s) where the product(s) are to be

 

(1)                 Produced

 

The drug substance and drug product will be manufactured at Burroughs Wellcome Co., Corner of US13/NC11 and Hwy. US 264, Greenville, NC, 27835-1887 (USA).

 

(2)                 Used

 

WELLBUTRIN (bupropion hydrochloride) is intended for use in patients with depression.  This product will be used in hospitals and homes (out-patient care) throughout the United States (US).

 

(3)                 Disposed

 

Disposal of expired or rejected drug products will be accomplished through on-site waste management procedures which minimize threats to human health or the environment.  Material is destroyed either by shredded and rinsing followed by wastewater treatment, or by incineration.

 

The shredder facility combines shredding of the material through a Milpac shredder with a water wash of the shredded material.  Wastewater from the wash operation is discharged to an on-site biological pretreatment facility and then discharged to the Greenville Utilities Publicly Owned Treatment Works under Pretreatment Permit BW01-98.  Solids generated during the shredding process are disposed of off-site at the Bertie County Regional Landfill under local County ordinances.

 

Alternatively, the material may be destroyed by an on-site controlled air incinerator which operates at temperatures ranging from 1200° in the primary chamber to 1850° in the secondary chamber.  The incinerator operates under N.C. Division of Solid Waste Permit No. 74-03-I.  Inert material such as glass and foil wrap remains with the ash residue which is managed according to specified permit conditions, cardboard packaging is destroyed and remains mostly as ash material, and volatile emissions form PVC packaging are released into the secondary chamber and converted to water, carbon dioxide, and hydrogen chloride.  The gases are further treated in a flux force collision scrubber which removes particulate and hydrogen chloride contaminants.  The incinerator and ancillary equipment (scrubber and waste feed components) have all been designed to meet Federal and State air emission standards for particulate, hydrogen chloride, and metal compounds.

 

 

 

 

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