By Ed Callaway

Epinephrine, nicotine and a host of other pharmaceuticals are considered hazardous waste when they are discarded.  Traditionally, pharmaceutical companies have helped hospitals and pharmacies get around this problem through the use of a "reverse distribution" system.  When unused pharmaceuticals approach their expiration date (or will not be used for some other reason), the manufacturer has agreed to take the drugs back.  Theoretically, the manufacturer would then determine whether the drugs could be recycled, used in charity work overseas, or otherwise put to use; or if they need to be discarded.  When the decision to discard the drugs is made, then and only then do they become a waste -- and subject to hazardous waste regulation.
 
EPA has noticed over the years, however, that the theory hasn't worked out: the manufacturers always discard the returned drugs.  There isn't a real decision being made when the drugs come back to the manufacturer.  If that's the case, EPA points out that the pharmaceuticals really should be considered a waste at the pharmacy, and storage, shipment and disposal should be governed by hazardous waste laws.  This would mean that hospitals and pharmacies across the country have a new environmental compliance issue to track, complete with its own annual reporting forms, shipping manifests, storage standards and records, fees, and other potential "gotchas."
 
Word among the regulators is that EPA plans to address the issue by declaring that while the pharmaceuticals should be considered a waste when they won't be used at the facility (not after their return to the manufacturer), they can be managed as "universal waste."  Universal wastes are subject to less stringent regulation than most other hazardous wastes, and are generally cheaper and easier to manage.  EPA's proposed rule is expected by the end of 2008.