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<title>FW: Sample prescription drugs</title>
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<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>I’m not sure about the <st1:State
w:st="on"><st1:place w:st="on">Florida</st1:place></st1:State> 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></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'><o:p> </o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>I hope this helps. <o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'><o:p> </o:p></span></font></p>
<div>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>Best regards,</span></font><font
color=navy><span style='color:navy'><o:p></o:p></span></font></p>
<p class=MsoNormal><font size=3 color=navy face="Times New Roman"><span
style='font-size:12.0pt;color:navy'> <o:p></o:p></span></font></p>
<p class=MsoNormal><font size=3 color=navy face="Times New Roman"><span
style='font-size:12.0pt;color:navy'> <o:p></o:p></span></font></p>
<p class=MsoNormal><st1:PersonName w:st="on"><font size=2 color=navy
face=Arial><span style='font-size:10.0pt;font-family:Arial;color:navy'>Charlotte
A. Smith</span></font></st1:PersonName><font size=2 color=navy face=Arial><span
style='font-size:10.0pt;font-family:Arial;color:navy'>, R. Ph., M.S., HEM</span></font><font
color=navy><span style='color:navy'><o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>President</span></font><font color=navy><span
style='color:navy'><o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>PharmEcology Associates, LLC</span></font><font
color=navy><span style='color:navy'><o:p></o:p></span></font></p>
<p class=MsoNormal><st1:Street w:st="on"><st1:address w:st="on"><font size=2
color=navy face=Arial><span style='font-size:10.0pt;font-family:Arial;
color:navy'>12229 W. North Ave., Suite 2</span></font></st1:address></st1:Street><font
color=navy><span style='color:navy'><o:p></o:p></span></font></p>
<p class=MsoNormal><st1:place w:st="on"><st1:City w:st="on"><font size=2
color=navy face=Arial><span style='font-size:10.0pt;font-family:Arial;
color:navy'>Wauwatosa</span></font></st1:City><font size=2 color=navy
face=Arial><span style='font-size:10.0pt;font-family:Arial;color:navy'>, <st1:State
w:st="on">WI</st1:State> <st1:PostalCode w:st="on">53226</st1:PostalCode></span></font></st1:place><font
color=navy><span style='color:navy'><o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>414-292-3959</span></font><font
color=navy><span style='color:navy'><o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>414-915-4026 (cell)</span></font><font
color=navy><span style='color:navy'><o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'><a href="mailto:csmith@pharmecology.com">csmith@pharmecology.com</a></span></font><font
color=navy><span style='color:navy'><o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>www.pharmecology.com</span></font><o:p></o:p></p>
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<p class=MsoNormal><b><font size=2 face=Tahoma><span style='font-size:10.0pt;
font-family:Tahoma;font-weight:bold'>From:</span></font></b><font size=2
face=Tahoma><span style='font-size:10.0pt;font-family:Tahoma'>
pharmwaste-bounces@lists.dep.state.fl.us
[mailto:pharmwaste-bounces@lists.dep.state.fl.us] <b><span style='font-weight:
bold'>On Behalf Of </span></b>Tenace, Laurie<br>
<b><span style='font-weight:bold'>Sent:</span></b> Tuesday, October 14, 2008
1:52 PM<br>
<b><span style='font-weight:bold'>To:</span></b>
pharmwaste@lists.dep.state.fl.us<br>
<b><span style='font-weight:bold'>Cc:</span></b> ayoungblut@cvmspc.com<br>
<b><span style='font-weight:bold'>Subject:</span></b> [Pharmwaste] FW: Sample
prescription drugs</span></font><o:p></o:p></p>
</div>
<p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size:
12.0pt'><o:p> </o:p></span></font></p>
<div>
<div>
<p class=MsoNormal><font size=2 color="#1f497d" face=Calibri><span
style='font-size:11.0pt;font-family:Calibri;color:#1F497D'>Can anyone help this
person?<u5:p></u5:p></span></font><o:p></o:p></p>
<p class=MsoNormal><font size=2 color="#1f497d" face=Calibri><span
style='font-size:11.0pt;font-family:Calibri;color:#1F497D'><u5:p> </u5:p></span></font><o:p></o:p></p>
<p class=MsoNormal><font size=2 color="#1f497d" face=Calibri><span
style='font-size:11.0pt;font-family:Calibri;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.”
(<st1:country-region w:st="on"><st1:place w:st="on">Ch.</st1:place></st1:country-region>
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. <u5:p></u5:p></span></font><o:p></o:p></p>
<p class=MsoNormal><font size=2 color="#1f497d" face=Calibri><span
style='font-size:11.0pt;font-family:Calibri;color:#1F497D'><u5:p> </u5:p></span></font><o:p></o:p></p>
<p class=MsoNormal><font size=2 color="#1f497d" face=Calibri><span
style='font-size:11.0pt;font-family:Calibri;color:#1F497D'>Thanks!<u5:p></u5:p></span></font><o:p></o:p></p>
<p class=MsoNormal><font size=2 color="#1f497d" face=Calibri><span
style='font-size:11.0pt;font-family:Calibri;color:#1F497D'>Laurie<u5:p></u5:p></span></font><o:p></o:p></p>
<p class=MsoNormal><font size=2 color="#1f497d" face=Calibri><span
style='font-size:11.0pt;font-family:Calibri;color:#1F497D'><u5:p> </u5:p></span></font><o:p></o:p></p>
<p class=MsoNormal><font size=2 color="#1f497d" face="Times New Roman"><span
style='font-size:10.0pt;color:#1F497D'>Laurie J. Tenace<br>
Environmental Specialist<br>
Florida Department of Environmental Protection<br>
<st1:place w:st="on"><st1:City w:st="on">2600</st1:City> Blair Stone Road, <st1:State
w:st="on">MS</st1:State></st1:place> 4555<br>
<st1:place w:st="on"><st1:City w:st="on">Tallahassee</st1:City>, <st1:State
w:st="on">Florida</st1:State> <st1:PostalCode w:st="on">32399-2400</st1:PostalCode></st1:place><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: <st1:State w:st="on"><st1:place w:st="on">Florida</st1:place></st1:State>
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>
<br>
</span></font><o:p></o:p></p>
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<u5:p></u5:p>
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<p class=MsoNormal style='margin-bottom:12.0pt'><font size=3
face="Times New Roman"><span style='font-size:12.0pt'><o:p> </o:p></span></font></p>
</div>
<div>
<p class=MsoNormal><em><i><font size=2 face=Arial><span style='font-size:10.0pt;
font-family:Arial'>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. <eXclaimer:HTML_ONLY>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>.</eXclaimer:HTML_ONLY>
Thank you in advance for completing the survey.</span></font></i></em><font
size=1 face="Courier New"><span style='font-size:9.0pt;font-family:"Courier New"'><o:p></o:p></span></font></p>
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<p class=MsoNormal><b><font size=2 face=Tahoma><span style='font-size:10.0pt;
font-family:Tahoma;font-weight:bold'>From:</span></font></b><font size=2
face=Tahoma><span style='font-size:10.0pt;font-family:Tahoma'> Angie Youngblut
[mailto:AYoungblut@cvmspc.com] <br>
<b><span style='font-weight:bold'>Sent:</span></b> Tuesday, October 14, 2008
2:39 PM<br>
<b><span style='font-weight:bold'>To:</span></b>
pharmwaste@lists.dep.state.fl.us<br>
<b><span style='font-weight:bold'>Subject:</span></b> FW: Sample prescription
drugs<u5:p></u5:p></span></font><o:p></o:p></p>
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<p class=MsoNormal><u5:p><font size=3 face="Times New Roman"><span
style='font-size:12.0pt'> <o:p></o:p></span></font></u5:p></p>
<p><font size=2 face="Comic Sans MS"><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></font><u5:p></u5:p><o:p></o:p></p>
<p><font size=2 face="Comic Sans MS"><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></font><u5:p></u5:p><o:p></o:p></p>
<p><font size=2 face="Comic Sans MS"><span style='font-size:10.0pt;font-family:
"Comic Sans MS"'>Is there any clear guideline federally or in <st1:State w:st="on"><st1:place
w:st="on">Iowa</st1:place></st1:State> that I have missed?</span></font> <u5:p></u5:p><o:p></o:p></p>
<p><font size=3 color=teal face="Franklin Gothic Medium"><span
style='font-size:12.0pt;font-family:"Franklin Gothic Medium";color:teal'>Angie
Youngblut RN, BS</span></font> <br>
<font size=2 color=teal face="Franklin Gothic Medium"><span style='font-size:
10.0pt;font-family:"Franklin Gothic Medium";color:teal'>Clinical <st1:place
w:st="on"><st1:PlaceName w:st="on">Practice Manager</st1:PlaceName><font
size=3 color=black face="Times New Roman"><span style='font-size:12.0pt;
font-family:"Times New Roman";color:windowtext'> <br>
</span></font><st1:PlaceName w:st="on">Cedar</st1:PlaceName> <st1:PlaceType
w:st="on">Valley</st1:PlaceType></st1:place> Medical Specialists, P.C.</span></font>
<br>
<font size=2 color=teal face="Franklin Gothic Medium"><span style='font-size:
10.0pt;font-family:"Franklin Gothic Medium";color:teal'>4150 <st1:address
w:st="on"><st1:Street w:st="on">Kimball Avenue</st1:Street><font size=3
color=black face="Times New Roman"><span style='font-size:12.0pt;font-family:
"Times New Roman";color:windowtext'> <br>
</span></font><st1:City w:st="on">Waterloo</st1:City>, <st1:State w:st="on">Iowa</st1:State>
<st1:PostalCode w:st="on">50701</st1:PostalCode></st1:address></span></font> <br>
<font size=2 color=teal face="Franklin Gothic Medium"><span style='font-size:
10.0pt;font-family:"Franklin Gothic Medium";color:teal'>Phone 319-235-5390</span></font>
<br>
<font size=2 color=teal face="Franklin Gothic Medium"><span style='font-size:
10.0pt;font-family:"Franklin Gothic Medium";color:teal'>Fax 319-287-9249</span></font>
<br>
<font size=2 color=teal face="Franklin Gothic Medium"><span style='font-size:
10.0pt;font-family:"Franklin Gothic Medium";color:teal'>ayoungblut@cvmspc.com</span></font>
<u5:p></u5:p><o:p></o:p></p>
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