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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 />