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9455 .1991(02) <br />OFFICE OF SOLID WASTE AND EMERGENCY RESPONSE <br />MAY 161991 <br />Mark J. Schulz <br />President <br />Pharmaceutical Services, Inc. <br />Browning-Ferris Industries <br />757 N. Eldridge <br />Houston, Texas 77079 <br />Dear Mr. Schulz: <br />This responds to your February 22,1991 letter to David Bussard requesting a <br />determination regarding the regulatory status of pharmaceutical products that <br />are returned by the dispensers of these products to the manufacturers, <br />wholesalers, or to a third -party service company that will facilitate the <br />processing, crediting, and, if needed, appropriate disposal of the returned <br />products. Currently, such products are returned directly to the manufacturer <br />or wholesaler, who credits the dispenser for the products and determines <br />whether the products are to be reused, reclaimed, or appropriately disposed. <br />BFI Pharmaceutical Services, Inc. (BFI-Pharm) intends to provide this reverse <br />distribution service to the pharmaceutical industry. <br />As I understand your letter, pharmaceutical products maybe returned for many <br />reasons, including, among others: 1) an oversupply at the dispenser, 2) <br />expiration of the recommended shelf life, 3) a recall has been initiated by <br />the manufacturer, 4) the product was received as a result of a shipping <br />error, and 5) the product has been damaged. You state that, in general the <br />dispensers of the pharmaceutical products do not know whether the returned <br />products will be reused, reclaimed, sold overseas, or disposed (i.e, they are <br />not able to determine whether these materials are solid wastes). Because the <br />dispensers receive credit for the returned products (either because the <br />products actually have real value to manufacturer or because such credits are <br />part of a competitive marketing approach), the products have a monetary value <br />to the dispensers and they would not normally assume such materials to be <br />wastes. <br />Under our current regulati <br />ons, such returned products are not considered <br />solid wastes until a determination is made to discard these materials. T`he <br />returned products themselves (being "commercial chemical products" under our <br />classification system) are considered more product -like than waste -like <br />(until a determination is made to dispose of them) because recycling by <br />use/reuse is generally a viable option. If the underlying assumption is that <br />the returned products will be recycled, until the manufacturer or wholesaler <br />determines otherwise (assuming that this determination is beyond the ability <br />of the dispenser), then those products managed within the reverse <br />distribution system are not solid wastes until the manufacturer or wholesaler <br />makes the determination to dispose of them. This view is based on our <br />understanding that the system is established as a means to facilitate the <br />recycling of reusable pharmaceutical products, rather than a <br />