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<DIV><FONT face=Calibri>Looking for some guidance, especially from
hospitals/facilities disposing of Pharmaceutical waste in the State of
Florida.</FONT></DIV>
<DIV><FONT face=Calibri></FONT> </DIV>
<DIV><FONT face=Calibri>Per the copy of the email below the Florida Dept. of
Health Drugs, Devices and Cosmetics Division requires that all Prescription
Pharmaceuticals leaving the hospital/Facility be inventoried, etc. My
question to this agency was does that apply to Hazardous Waste Pharmaceuticals
generated in numerous areas of the hospital (OR, ER ICU, Patient Rooms,
Med Rooms, etc) and include but are not limited to : Partially used Vials,
ampoules, Syringes with needles, IV Bags, pills (Potentially some that may be
contaminated with blood also).</FONT></DIV>
<DIV><FONT face=Calibri></FONT> </DIV>
<DIV><FONT face=Calibri>I am not interpreting their regulations but have
attached the response below.</FONT></DIV>
<DIV><FONT face=Calibri></FONT> </DIV>
<DIV><FONT face=Calibri></FONT> </DIV>
<DIV><FONT face=Calibri>I am asking for guidance from any facility out there who
inventories every Hazardous or Non Hazardous Prescription Pharmaceutical before
its placed into a black, yellow, white or whatever color your facility is
using to dispose of your non-viable pharmaceutical waste.</FONT></DIV>
<DIV> </DIV>
<DIV><FONT face=Calibri>I would appreciate any assistance so I can share with
other facilities around the state</FONT><FONT face=Calibri>.</FONT></DIV>
<DIV><FONT face=Calibri></FONT> </DIV>
<DIV><FONT face=Calibri></FONT> </DIV>
<DIV><FONT face=Calibri></FONT> </DIV>
<DIV><FONT face=Calibri></FONT> </DIV>
<DIV><FONT face=Calibri>
<DIV dir=ltr align=left><SPAN class=881450219-29102009><FONT color=#000080
face=Calibri>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><FONT color=#000000>Dear Mr.
Stewart:</FONT></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><FONT
color=#000000></FONT></SPAN> </P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><FONT color=#000000>Thank you for
contacting the Florida Department of Health regarding compliance with Florida's
prescription drug distribution laws and regulations. </FONT></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><FONT
color=#000000></FONT></SPAN> </P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><FONT color=#000000>You have raised
several issues in your email. <SPAN> </SPAN>First and foremost, I am not an
attorney and cannot provide you with legal advice. <SPAN> </SPAN>Please be
aware that any efforts to assist you with navigating the Department's laws and
rules does not constitute Department action and, thus, is not a defense against
any present or future violations found by the Florida Department of Health.
<SPAN> </SPAN>May I direct you to the rule that currently addresses
<FONT color=#ff0000><STRONG>records that are required to be maintained by
pharmacies prior to the prescription drugs leaving the premise</STRONG></FONT>,
which is Chapter 64F-12.012, Florida Administrative Code, subsection (2)(d)
Records of Drugs, Cosmetics and Devices, provided below.</FONT></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><FONT
color=#000000></FONT></SPAN> </P>
<P style="MARGIN: 0in 0in 0pt 0.5in" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><FONT color=#000000>(2) Any person
engaged in the manufacture of prescription drugs, the wholesale distribution of
prescription drugs, or otherwise receiving or distributing prescription drugs
must maintain records as follows:</FONT></SPAN></P>
<P style="MARGIN: 0in 0in 0pt 0.5in" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><FONT color=#000000>(d) Records to
document the distribution of prescription drugs required by Section 499.0121(6),
F.S., and this rule are to be created during the transaction (i.e., at the time
of order, receipt, processing, picking or shipping) and not retroactively
created. <SPAN> </SPAN><FONT color=#ff0000>A pharmacy</FONT> or other
person authorized to possess prescription drugs that <STRONG><FONT
color=#ff0000>transfers prescription drugs to an establishment
performing</FONT></STRONG> reverse distribution services or </FONT><FONT
color=#ff0000><STRONG>destruction activities must prepare or have prepared an
inventory or other record of the prescription drugs so transferred prior to the
prescription drugs leaving the premises. In addition to the name, address, and
license number of the sender and the name, address, and license number of the
receiving establishment, the record must include the elements set forth in
paragraph 64F-12.023(3)(a), F.A.C.</STRONG></FONT></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><FONT
color=#000000></FONT></SPAN> </P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><FONT color=#000000>Unfortunately, I
am unable to provide you with the specific answers to your questions, as they
require an opinion from the Department of Health.<SPAN> </SPAN>The process
for seeking a formal opinion from the Department regarding the application of
Florida laws to your specific set of facts is governed by section 120.565,
Florida Statutes, and Rule 28-105, Florida Administrative Code which deals with
petitions for declaratory statements. </FONT></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><FONT
color=#000000></FONT></SPAN> </P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><FONT color=#000000>I hope this
information is beneficial to you. <SPAN> </SPAN></FONT></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><FONT
color=#000000></FONT></SPAN> </P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><FONT
color=#000000>Sincerely,</FONT></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><FONT color=#000000>Gregg
Jones</FONT></SPAN></P>
<P style="MARGIN: 0in 0in 0pt" class=MsoNormal><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"></SPAN><SPAN
style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><FONT color=#000000><FONT
color=#999999 size=1 face="Trebuchet MS">Gregg Jones, RPh</FONT> <BR><FONT
color=#999999 size=1 face="Trebuchet MS">Compliance Manager</FONT> <BR><FONT
color=#999999 size=1 face="Trebuchet MS">Florida Department of Health</FONT>
<BR><FONT color=#999999 size=1 face="Trebuchet MS">MQA Board of Pharmacy/Drugs,
Devices, and Cosmetics</FONT> <BR><FONT color=#999999 size=1
face="Trebuchet MS">4052 Bald Cypress Way, C-04</FONT> <BR><FONT color=#999999
size=1 face="Trebuchet MS">Tallahassee, FL 32399</FONT> <BR><FONT
color=#999999 size=1 face="Trebuchet MS">850-245-4737 - Phone
850-413-6982 - Fax</FONT> <BR><FONT color=#999999 size=1
face="Trebuchet MS">gregg_jones@doh.state.fl.us
www.doh.state.fl.us/mqa/ddc</FONT> </P>
<P><FONT color=#ff0000 size=2
face="Times New Roman"> <B></B></FONT><B> <FONT
color=#ff0000 face="Times New Roman"><I> </I></FONT><I> <FONT color=#ff0000
face=Arial>“For up-to-date information about H1N1 Swine Flu visit
</FONT></I></B><A href="http://www.myyflusafety.com/"><B><I><U><FONT
color=#0000ff face=Arial>www.myyflusafety.com</FONT></U></I></B></A><B><I><FONT
color=#ff0000 face=Arial> or call 877-352-3581”</FONT></I></B>
<UL>
<UL>
<P><B><FONT color=#999999 size=1
face="Trebuchet MS">_____________________________________________________</FONT></B>
<BR><B><FONT color=#c0c0c0 size=1 face="Trebuchet MS">DOH
Mission</FONT></B><I><FONT color=#c0c0c0 size=1 face="Trebuchet MS">:
Promote, protect and improve the health of all people in Florida.</FONT></I>
<BR><B><FONT color=#c0c0c0 size=1 face="Trebuchet MS">DOH Vision:
A</FONT></B><I><FONT color=#c0c0c0 size=1 face="Trebuchet MS"> healthier
future for the people of Florida. </FONT></I><BR><B><FONT color=#c0c0c0
size=1 face="Trebuchet MS">DOH Purpose</FONT></B><I><FONT color=#c0c0c0
size=1 face="Trebuchet MS">: To protect the public through health care
licensure, enforcement and information.</FONT></I> <BR><B><FONT
color=#c0c0c0 size=1 face="Trebuchet MS">DOH Focus:</FONT></B><I><FONT
color=#c0c0c0 size=1 face="Trebuchet MS"> To be the nation's leader in
quality health care regulation.</FONT></I> <BR><FONT color=#999999 size=1
face="Trebuchet MS">*******************************************************************************</FONT>
<BR><FONT color=#999999 size=1 face="Trebuchet MS">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 communications may
therefore be subject to public disclosure.
</FONT></P></UL></UL></FONT></SPAN></FONT></DIV></SPAN><BR></FONT></DIV>
<DIV><FONT face=Calibri></FONT> </DIV>
<DIV><FONT face=Calibri></FONT> </DIV>
<DIV><FONT face=Calibri></FONT> </DIV>
<DIV><FONT face=Calibri>Regards</FONT></DIV>
<DIV><FONT face=Calibri></FONT> </DIV>
<DIV><FONT face=Calibri>Barry E. Stewart<BR>Training Coordinator/ Regional
Project Manager</FONT></DIV>
<DIV><FONT face=Calibri></FONT> </DIV>
<DIV><FONT face=Calibri></FONT> </DIV>
<DIV><FONT face=Calibri>HWS, LLC<BR>418 Cypress Road<BR>Ocala, FL
34472<BR></FONT></DIV>
<DIV><FONT face=Calibri>cell: 772-216-6649</FONT></DIV>
<DIV> </DIV>
<DIV><FONT face=Calibri></FONT> </DIV>
<DIV> </DIV>
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