EA Review #1, NDA 20-358

Page 4

d.      Expected Locations of Use (Drug Product)

          The use of the drug product will be in hospitals and homes.

          Adequate

e.       Disposal Locations:

          The Wellcome Foundation Limited (UK)

          Expired or rejected drug substance will be directed to a landfill site, licensed by the Essex Waste           Regulation Authority, license number 72/79.  Alternatively, rejected drug substances will be           directed to an off-site, high-temperature incineration facility, licensed by Her Majesty’s           Inspectorate of Pollution (HMIP).

          DEFICIENT

          Burroughs Wellcome Co. (USA)

          Expired or rejected drug product will be disposed of by shredding, washing the shredded           material, and disposing of shredded material at the Pitt County Landfill or by on-site           incineration.  Wastewater from washing the shredded material 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.

          Alternatively, the material may be destroyed by on-site high-temperature incineration operating           under North Carolina Division of Solid Waste Permit No. 74-03-I.

          Adequate

f.       Description of type of environments present at or adjacent to production and disposal sites.

          Adequate