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<DIV>Hi All,</DIV>
<DIV> </DIV>
<DIV>Someone from EPA suggested that I am misinterpreting one part of the DEA draft rules. </DIV>
<DIV>Because of use of the word "may", he reads the following as actually permitting inventory.</DIV>
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<LI style="MARGIN: 0in 0in 0pt; COLOR: black; mso-margin-bottom-alt: auto; mso-list: l0 level1 lfo1; tab-stops: list .5in" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt">"Controlled substances collected by collectors may not be individually counted or inventoried."<SPAN style="mso-spacerun: yes"> </SPAN></SPAN></LI></UL>
<DIV style="MARGIN: 0in 0in 0pt; COLOR: black; mso-margin-bottom-alt: auto; mso-list: l0 level1 lfo1; tab-stops: list .5in" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><SPAN style="mso-spacerun: yes">Since this may be correct, I am rewording my comment as follows:</SPAN></SPAN></DIV>
<DIV style="MARGIN: 0in 0in 0pt; COLOR: black; mso-margin-bottom-alt: auto; mso-list: l0 level1 lfo1; tab-stops: list .5in" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><SPAN style="mso-spacerun: yes"></SPAN></SPAN> </DIV>
<DIV style="MARGIN: 0in 0in 0pt; COLOR: black; mso-margin-bottom-alt: auto; mso-list: l0 level1 lfo1; tab-stops: list .5in" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><SPAN style="mso-spacerun: yes"></SPAN> The meaning of this rule is not clear. The use of the word “may" leaves it open to interpretation.<SPAN style="mso-spacerun: yes"> </SPAN><o:p></o:p></SPAN></DIV>
<P style="MARGIN: 0in 0in 0pt 0.25in; mso-margin-bottom-alt: auto" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 10pt"><o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt 0.25in; mso-margin-bottom-alt: auto" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 10pt">If what was meant is, "Controlled substances collected by collectors do not have to be individually counted or inventoried." we are very supportive.<o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt 0.25in; mso-margin-bottom-alt: auto" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 10pt">Suggestion:<SPAN style="mso-spacerun: yes"> </SPAN>Clarify the wording.<SPAN style="mso-spacerun: yes"> </SPAN><o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt 0.25in; mso-margin-bottom-alt: auto" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 10pt"><o:p> </o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt 0.25in; mso-margin-bottom-alt: auto" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; COLOR: black; FONT-SIZE: 10pt">If this rule is intended to mean, “must not (or "shall not") be individually counted or inventoried under any circumstances", this will prevent data collection for existing and future research efforts.<SPAN style="mso-spacerun: yes"> </SPAN><BR><BR>Suggestion:<SPAN style="mso-spacerun: yes"> </SPAN>Provide an exemption to</SPAN><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"> this ban on inventorying collected materials under certain circumstances. [We may include specific exemptions as suggested by others.] T<SPAN style="COLOR: black">he ban on any non-law enforcement person from handling controlled substances at any time would also need to be removed to allow for inventory to occur.<o:p></o:p></SPAN></SPAN></P>
<P style="MARGIN: 0in 0in 0pt 0.25in" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><o:p> </o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt 0.25in" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt">Our groups’ inventory efforts are done under the watchful eye of law enforcement and produce data that could prove important to setting new prescribing guidelines designed to prevent so much waste medication from being generated. Medical professionals, mostly pharmacists and pharmacy technicians do the actual counting of doses with the help of a pill counting machine.<SPAN style="mso-spacerun: yes"> </SPAN><o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt 0.25in" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"><o:p> </o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt 0.25in" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt">Ongoing disposal data for residential and LTC sources, obtained from collection events and drop-boxes, would do more than provide a scientific basis for establishing better prescribing guidelines. This data could also be used to verify if new prescribing guidelines are having a measurable effect on the amount of waste produced. <o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt 0.25in" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"> <o:p></o:p></SPAN></P>
<P style="MARGIN: 0in 0in 0pt 0.25in" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt">Providing exceptions to the ban on inventorying adds a minimal risk of diversion while offering a significant means to gather data important for setting policies to reduce the amount of pharmaceutical waste produced.</SPAN></P>
<P style="MARGIN: 0in 0in 0pt 0.25in" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"></SPAN> </P>
<P style="MARGIN: 0in 0in 0pt 0.25in" class=MsoNormal><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt"></SPAN> </P><SPAN style="FONT-FAMILY: Arial; FONT-SIZE: 10pt">
<DIV>
<DIV>Ed Gottlieb</DIV>
<DIV>Chair Coalition for Safe Medication Disposal</DIV>
<DIV>Industrial Pretreatment Coordinator</DIV>
<DIV>Ithaca Area Wastewater Treatment Facility<BR>525 3<SUP><FONT size=3><FONT face="Times New Roman">rd<o:p></o:p></FONT></FONT></SUP> Street</DIV>
<DIV>Ithaca, NY 14850</DIV>
<DIV>(607) 273-8381</DIV>
<DIV>fax: (607) 273-8433</DIV></SPAN></DIV></BODY></HTML>