[Pharmwaste] 1. RE: Question (Grasso, Cheri)

[Terry Kilgore]

The question Cheri raises is very important for the RCRA and DOT  response and from the DEA side of the question. You have different RCRA regulations for  retail, commercial, distributor and manufacturer than you do for a household waste. The regulations are more structured and stringent for the "commercial & business" entities than for the common household wether pharmaceutical or non-pharmaceutical. This is also true of the DEA concerning pharmaceuticals and DEA listed chemicals. Households are not regulated by DEA, for waste pharmaceuticals that were dispensed to that individual with a legitimate prescription. There is a caveat  based on the DEA controlled and listed chemicals being in the hands of the legitimate recipient , otherwise you are illegally in possession of of controlled drugs or listed chemicals. The drugs have left the DEA's closed loop of distribution when given to the end user by the doctor or by the pharmacist and cannot be returned to a DEA registrant.

The statement that go to the state level first because they can be more stringent is not necessarily true  either. The DEA recently corrected a state concerning the state regulations posted on the state's web site, saying that it was ok for non-registrant LTC facilities to return drugs to a DEA registered reverse distributor as long as you filed the DEA form 41 to the state.  This is not correct because the federal regulations say that a registrant can only receive controlled substance from another registrant and most LTCs are non-registrant. LTC = Long Term Care

Their are some states (ex. CA) that would classify all pharmaceuticals as hazardous waste but if shipped out of the state the hazardous status reverts to the EPA & DOT  regulations.  There are al levels of state regs from no regs use the Federal regs to extremely stricter state regs like California..

It is a very interwoven and confusing regulatory stew that is constantly changing on all levels from local to federal and each entity is not concerned with the others regulations. We as facilitators from different disciplines must be cognizant of  this complexity and what is required on the different levels. Since most can't be the GURU on every regulatory body and all states and territories, we have to develop the resource team to fill our weaknesses. 


Terry Kilgore
	SPS Program Manager
	Strong Pharmaceutical Services, 
	a division of Strong Environmental Inc., a Stericycle company
	770.409.1500 x141
	770.409.1449 fax
	TKilgore at StrongServices.com





Strong Pharmaceutical Services, a division of Strong Environmental, is the leading provider of destruction services to the pharmaceutical industry. Our experienced professionals manage and ensure the appropriate witnessed destruction of DEA controlled substances, as well as proper disposition of RCRA hazardous and non-hazardous finished goods and manufacturing wastes. When we take control of waste materials at your shipping dock, they become our full responsibility.






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