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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 may be 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 regulations,such returned products are not considered <br /> solid wastes until a determination is made to discard these materials. The <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 /> RO 11606 <br />