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Case Studies

FDA Recall and


U.S. Marshal’s Seizure
problem disposition (EPA, DOT, FDA) this
A pharmaceutical manufacturer was necessitated the use of different types
forced to close its doors due to a of destruction methods, including
FDA Class II recall. The U.S. Marshals secure landfills and incineration
Service then seized the inventory. Two facilities.
dozen trailer loads of double-stacked The bulk of the material was destroyed
pallets remaining in storage required via controlled and witnessed
destruction. destruction and subsequent secure
solution landfill. The remainder of the waste
Because the company’s doors were (materials high in RCRA metals
closed for over two years prior to this and EPA listed wastes) was also
disposal project, a technical contact appropriately destroyed.
was not available to answer questions Strong places safety first. Incinerators
regarding inventory and unlabeled were selected in consideration of
products. Determinations had to be OSHA’s strict guidelines for destruction
PHARMACEUTICAL SERVICES
TM
made on questionable inventory while of powders, so that employees were
the disposal and disposition effort was protected from inhaling contents
in process. during destruction. A direct feed unit
Who We Are was the proper choice; use of a “pit-
Some of the product contained trace
amounts of EPA-regulated metals type” municipal incinerator would
Strong Pharmaceutical Services, a division
and additional chemicals. Once these have exposed employees to possible
of Strong Environmental, Inc. (a Stericycle
materials were declared ‘waste,’ powder inhalation.
company), is the leading provider of destruction
services to the pharmaceutical industry. Our EPA regulations governed disposal
methodology. SUCCESSFUL CONCLUSION
experienced professionals manage and ensure
By partnering with SEI, the U.S.
the appropriate witnessed destruction of
CAREFUL CONSIDERATION Marshals Service achieved multi-
DEA controlled substances, as well as proper agency compliance while maintaining
Once all pharmaceutical materials
disposition of RCRA hazardous and non- cost-effectiveness and responsive
were characterized, Strong technicians
hazardous finished goods and manufacturing service.
carefully segregated them. Due to
wastes. When we take control of waste
the three different entities regulating
materials at your shipping dock, they become continued

our full responsibility.

Strong Pharmaceutical Services: Secure


Pharmaceutical Destruction Solutions

6264 Crooked Creek Road


Norcross, GA 30092
770.409.1500 800.778.7664
Solutions@StrongServices.com

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Copyright © 2009 Stericycle, Inc. All rights reserved.
Case Studies

Not all pharmaceutical waste is EPA non-hazardous.


In this case vials, some marked only with a trade
name, were carefully evaluated and properly
classified as an EPA regulated waste due to
Chromium and Epinephrine content.

US Marshals kept product under supervised lock and


key for two years.

This project required the inspection of almost


ONE MILLION containers.

w w w. Strong Pharma.com Copyright © 2009 Stericycle, Inc. All rights reserved.