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<title>FW: Sample prescription drugs</title>
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<p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";
color:#1F497D'>Laura, Charlotte, All,<o:p></o:p></span></p>
<p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";
color:#1F497D'><o:p> </o:p></span></p>
<p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";
color:#1F497D'>One would think that a manufacturer would not distribute samples
of a product that is considered a RCRA hazardous waste when discarded, but it
does happen. Example: Jantoven (Warfarin Sodium), EPA Waste Code = P001.<o:p></o:p></span></p>
<div>
<p class=MsoNormal style='mso-margin-top-alt:5.0pt;margin-right:0in;margin-bottom:
5.0pt;margin-left:0in'><span style='color:#1F497D'><o:p> </o:p></span></p>
<p class=MsoNormal><span style='font-size:10.0pt;color:black'>Jeff Hollar</span><span
style='color:#1F497D'><o:p></o:p></span></p>
<p class=MsoNormal><span style='font-size:10.0pt;color:black'>President</span><span
style='color:#1F497D'><o:p></o:p></span></p>
<p class=MsoNormal><span style='color:#1F497D'> <o:p></o:p></span></p>
<p class=MsoNormal><b><span style='color:blue'>PharmWaste Technologies, Inc.</span></b><span
style='color:#1F497D'><o:p></o:p></span></p>
<p class=MsoNormal><span style='font-size:10.0pt;color:black'>4164 NW Urbandale
Dr., Suite A</span><span style='color:#1F497D'><o:p></o:p></span></p>
<p class=MsoNormal><span style='font-size:10.0pt;color:black'>Urbandale, IA
50322</span><span style='color:#1F497D'><o:p></o:p></span></p>
<p class=MsoNormal><span style='font-size:10.0pt;color:black'>(P) 515-276-5302
Ext. 316</span><span style='color:#1F497D'><o:p></o:p></span></p>
<p class=MsoNormal><span style='font-size:10.0pt;color:black'>(F) 480-393-5564</span><span
style='color:#1F497D'><o:p></o:p></span></p>
<p class=MsoNormal><span style='font-size:10.0pt;color:black'>(E) <a
href="mailto:Jhollar@Pwaste.com">Jhollar@Pwaste.com</a></span><span
style='color:#1F497D'><o:p></o:p></span></p>
<p class=MsoNormal><span style='color:#1F497D'> <o:p></o:p></span></p>
</div>
<p class=MsoNormal><span style='font-size:8.0pt;color:black'>The unauthorized
disclosure or interception of e-mail is a federal crime. See 18 U.S.C. SEC
2517(4). This e-mail is intended for the use of those whom it is addressed and may
contain information that is privileged, confidential, and exempt from
disclosure under the law. If you have received this e-mail in error, do not
distribute or copy it. Please return it immediately to the sender with
attachments, if any, and notify the sender by telephone.</span><span
style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p></o:p></span></p>
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<div style='border:none;border-top:solid #B5C4DF 1.0pt;padding:3.0pt 0in 0in 0in'>
<p class=MsoNormal><b><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif"'>From:</span></b><span
style='font-size:10.0pt;font-family:"Tahoma","sans-serif"'> Charlotte A. Smith
[mailto:csmith@pharmecology.com] <br>
<b>Sent:</b> Tuesday, October 14, 2008 7:35 PM<br>
<b>To:</b> Tenace, Laurie; pharmwaste@lists.dep.state.fl.us<br>
<b>Cc:</b> ayoungblut@cvmspc.com<br>
<b>Subject:</b> RE: [Pharmwaste] FW: Sample prescription drugs<o:p></o:p></span></p>
</div>
</div>
<p class=MsoNormal><o:p> </o:p></p>
<p class=MsoNormal><span style='font-size:10.0pt;font-family:"Arial","sans-serif";
color:navy'>I’m not sure about the Florida statute, but the FDA
Prescription Drug Marketing Act prohibits manufacturers’ representatives
from picking up samples once they have been distributed. I believe the rep can assist
the clinic in packaging them up for return to the manufacturer, but
realistically, that doesn’t happen. It’s important to remember that
any clinic that generates pharmaceutical waste of any type has the
responsibility of determining if the waste drugs are RCRA hazardous waste.
While most samples would not be listed drugs, since it is newer drugs that are
sampled and the regulations have not been updated, it is possible that the
samples could exhibit one of the characteristics of hazardous waste. It is not
therefore appropriate for businesses to use the landfill option without
reviewing their drugs first. It is also not a best management practice. Clinics
should check with their regulated medical waste vendors and see if disposal of
non-hazardous pharmaceutical waste by incineration is an option for them. If
they do have RCRA hazardous waste, they will need a hazardous waste vendor
also. <o:p></o:p></span></p>
<p class=MsoNormal><span style='font-size:10.0pt;font-family:"Arial","sans-serif";
color:navy'><o:p> </o:p></span></p>
<p class=MsoNormal><span style='font-size:10.0pt;font-family:"Arial","sans-serif";
color:navy'>I hope this helps. <o:p></o:p></span></p>
<p class=MsoNormal><span style='font-size:10.0pt;font-family:"Arial","sans-serif";
color:navy'><o:p> </o:p></span></p>
<div>
<p class=MsoNormal><span style='font-size:10.0pt;font-family:"Arial","sans-serif";
color:navy'>Best regards,</span><span style='color:navy'><o:p></o:p></span></p>
<p class=MsoNormal><span style='color:navy'> <o:p></o:p></span></p>
<p class=MsoNormal><span style='color:navy'> <o:p></o:p></span></p>
<p class=MsoNormal><span style='font-size:10.0pt;font-family:"Arial","sans-serif";
color:navy'>Charlotte A. Smith, R. Ph., M.S., HEM</span><span style='color:
navy'><o:p></o:p></span></p>
<p class=MsoNormal><span style='font-size:10.0pt;font-family:"Arial","sans-serif";
color:navy'>President</span><span style='color:navy'><o:p></o:p></span></p>
<p class=MsoNormal><span style='font-size:10.0pt;font-family:"Arial","sans-serif";
color:navy'>PharmEcology Associates, LLC</span><span style='color:navy'><o:p></o:p></span></p>
<p class=MsoNormal><span style='font-size:10.0pt;font-family:"Arial","sans-serif";
color:navy'>12229 W. North Ave., Suite 2</span><span style='color:navy'><o:p></o:p></span></p>
<p class=MsoNormal><span style='font-size:10.0pt;font-family:"Arial","sans-serif";
color:navy'>Wauwatosa, WI 53226</span><span style='color:navy'><o:p></o:p></span></p>
<p class=MsoNormal><span style='font-size:10.0pt;font-family:"Arial","sans-serif";
color:navy'>414-292-3959</span><span style='color:navy'><o:p></o:p></span></p>
<p class=MsoNormal><span style='font-size:10.0pt;font-family:"Arial","sans-serif";
color:navy'>414-915-4026 (cell)</span><span style='color:navy'><o:p></o:p></span></p>
<p class=MsoNormal><span style='font-size:10.0pt;font-family:"Arial","sans-serif";
color:navy'><a href="mailto:csmith@pharmecology.com">csmith@pharmecology.com</a></span><span
style='color:navy'><o:p></o:p></span></p>
<p class=MsoNormal><span style='font-size:10.0pt;font-family:"Arial","sans-serif";
color:navy'>www.pharmecology.com</span><o:p></o:p></p>
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<hr size=2 width="100%" align=center>
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<p class=MsoNormal><b><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif"'>From:</span></b><span
style='font-size:10.0pt;font-family:"Tahoma","sans-serif"'>
pharmwaste-bounces@lists.dep.state.fl.us
[mailto:pharmwaste-bounces@lists.dep.state.fl.us] <b>On Behalf Of </b>Tenace,
Laurie<br>
<b>Sent:</b> Tuesday, October 14, 2008 1:52 PM<br>
<b>To:</b> pharmwaste@lists.dep.state.fl.us<br>
<b>Cc:</b> ayoungblut@cvmspc.com<br>
<b>Subject:</b> [Pharmwaste] FW: Sample prescription drugs</span><o:p></o:p></p>
</div>
<p class=MsoNormal><o:p> </o:p></p>
<div>
<div>
<p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";
color:#1F497D'>Can anyone help this person?</span><o:p></o:p></p>
<p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";
color:#1F497D'> </span><o:p></o:p></p>
<p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";
color:#1F497D'>This question comes up a lot for me. A Florida Statute says,
“All out-of-date drug samples must be returned to the manufacturer or
distributor of that drug sample.” (Ch. 499.028(9), F.S.) However every
drug rep I’ve asked (just while waiting to see doctors at various times)
has never heard this and insists that they do not take back samples. </span><o:p></o:p></p>
<p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";
color:#1F497D'> </span><o:p></o:p></p>
<p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";
color:#1F497D'>Thanks!</span><o:p></o:p></p>
<p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";
color:#1F497D'>Laurie</span><o:p></o:p></p>
<p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";
color:#1F497D'> </span><o:p></o:p></p>
<p class=MsoNormal style='margin-bottom:12.0pt'><span style='font-size:10.0pt;
color:#1F497D'>Laurie J. Tenace<br>
Environmental Specialist<br>
Florida Department of Environmental Protection<br>
2600 Blair Stone Road, MS 4555<br>
Tallahassee, Florida 32399-2400<br>
PH: (850) 245-8759<br>
FAX: (850) 245-8811<br>
Laurie.Tenace@dep.state.fl.us <br>
<br>
Mercury web pages:<br>
<a href="http://www.dep.state.fl.us/waste/categories/mercury/default.htm">http://www.dep.state.fl.us/waste/categories/mercury/default.htm</a><br>
<br>
Unwanted Medications web pages:<br>
<a href="http://www.dep.state.fl.us/waste/categories/medications/default.htm">http://www.dep.state.fl.us/waste/categories/medications/default.htm</a><br>
<br>
<br>
<br>
<br>
Please Note: Florida has a very broad public records law. Most
written communications to or from state officials regarding state business are
public records available to the public and media upon request. Your
e-mail is communications and may therefore be subject to public disclosure.<br>
<br>
<br>
<br>
</span><o:p></o:p></p>
</div>
<div>
<p class=MsoNormal style='margin-bottom:12.0pt'><o:p> </o:p></p>
</div>
<div>
<p class=MsoNormal><em><span style='font-size:10.0pt;font-family:"Arial","sans-serif"'>The
Department of Environmental Protection values your feedback as a customer. DEP
Secretary Michael W. Sole is committed to continuously assessing and improving
the level and quality of services provided to you. Please take a few minutes to
comment on the quality of service you received. Simply click on <a
href="http://survey.dep.state.fl.us/?refemail=Laurie.Tenace@dep.state.fl.us"
target="_blank">this link to the DEP Customer Survey</a>. Thank you in advance
for completing the survey.</span></em><span style='font-size:9.0pt;font-family:
"Courier New"'><o:p></o:p></span></p>
</div>
<div>
<div>
<div style='border:none;border-top:solid #B5C4DF 1.0pt;padding:3.0pt 0in 0in 0in'>
<p class=MsoNormal><b><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif"'>From:</span></b><span
style='font-size:10.0pt;font-family:"Tahoma","sans-serif"'> Angie Youngblut
[mailto:AYoungblut@cvmspc.com] <br>
<b>Sent:</b> Tuesday, October 14, 2008 2:39 PM<br>
<b>To:</b> pharmwaste@lists.dep.state.fl.us<br>
<b>Subject:</b> FW: Sample prescription drugs</span><o:p></o:p></p>
</div>
</div>
<p class=MsoNormal> <o:p></o:p></p>
<p><span style='font-size:10.0pt;font-family:"Comic Sans MS"'>I have been
trying to get one clear answer- and haven't had much success. I have tried EPA,
DNR, Iowa Board of Pharmacy, local landfill and others. I have expired sample
prescription drugs to dispose of and I don't want to break any regulations,
however I have been told I am a "waste generating facility" and
therefore have different rules. It has been recommended to me to mix them with
undesirable substances and put in regular trash and that they are not
considered hazardous.</span><o:p></o:p></p>
<p><span style='font-size:10.0pt;font-family:"Comic Sans MS"'>I do not have the
option of giving them to a charitable organization because they will only take
them( in the Iowa Drug Repository program) with a year left on the expiration
and our offices keep them until they expire. </span><o:p></o:p></p>
<p><span style='font-size:10.0pt;font-family:"Comic Sans MS"'>Is there any
clear guideline federally or in Iowa that I have missed?</span> <o:p></o:p></p>
<p><span style='font-family:"Franklin Gothic Medium","sans-serif";color:teal'>Angie
Youngblut RN, BS</span> <br>
<span style='font-size:10.0pt;font-family:"Franklin Gothic Medium","sans-serif";
color:teal'>Clinical Practice Manager</span> <br>
<span style='font-size:10.0pt;font-family:"Franklin Gothic Medium","sans-serif";
color:teal'>Cedar Valley Medical Specialists, P.C.</span> <br>
<span style='font-size:10.0pt;font-family:"Franklin Gothic Medium","sans-serif";
color:teal'>4150 Kimball Avenue</span> <br>
<span style='font-size:10.0pt;font-family:"Franklin Gothic Medium","sans-serif";
color:teal'>Waterloo, Iowa 50701</span> <br>
<span style='font-size:10.0pt;font-family:"Franklin Gothic Medium","sans-serif";
color:teal'>Phone 319-235-5390</span> <br>
<span style='font-size:10.0pt;font-family:"Franklin Gothic Medium","sans-serif";
color:teal'>Fax 319-287-9249</span> <br>
<span style='font-size:10.0pt;font-family:"Franklin Gothic Medium","sans-serif";
color:teal'>ayoungblut@cvmspc.com</span> <o:p></o:p></p>
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