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

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