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Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution

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OMB: 0910-0045

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DRLS Instructions <body stylesrc="toc.htm" bgcolor="white" link="blue" vlink="blue">  <div class=Section1> <p align=center style='text-align:center'><strong><span style='font-family: Arial;color:blue'>Table of Contents</span></strong><o:p></o:p></p> <table class=MsoNormalTable border=0 cellspacing=0 cellpadding=0 width="95%" style='width:95.0%;mso-cellspacing:0in;mso-padding-alt:0in 0in 0in 0in' height=423> <tr style='mso-yfti-irow:0;mso-yfti-firstrow:yes;height:12.6pt'> <td width=203 colspan=2 style='width:121.8pt;padding:0in 0in 0in 0in; height:12.6pt'> <ul type=disc> <li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-list:l4 level1 lfo1;tab-stops:list .5in'><span style='font-family:Arial'><a href="registration_listing.htm" target="frmain">Regulatory Guidance Drug Registration and Listing</a></span></li> </ul> </td> </tr> <tr style='mso-yfti-irow:1;height:12.6pt'> <td width=203 colspan=2 style='width:121.8pt;padding:0in 0in 0in 0in; height:12.6pt'> <ul type=disc> <li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-list:l11 level1 lfo2;tab-stops:list .5in'><span style='font-family:Arial'><a href="http://www.fda.gov/cder/guidance/4316dft.htm" target="frmain">Draft Guidance for Registration and Listing forms</a></span></li> </ul> </td> </tr> <tr style='mso-yfti-irow:2;height:12.6pt'> <td width=203 colspan=2 style='width:121.8pt;padding:0in 0in 0in 0in; height:12.6pt'> <ul type=disc> <li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-list:l2 level1 lfo3;tab-stops:list .5in'><span style='font-family:Arial;color:blue'><a href="introduc.htm" target=frmain>Introduction </a></span></li> <li class=MsoNormal><u><span style='font-family:Arial;mso-bidi-font-family:"Times New Roman"'><a href="summaryreg.htm" target="frmain">Summary of Registration and Listing requirements</a> <o:p></o:p> </span></u></li> </ul> </td> </tr> <tr style='mso-yfti-irow:3;height:12.6pt'> <td width=203 colspan=2 style='width:121.8pt;padding:0in 0in 0in 0in; height:12.6pt'> <ul type=disc> <li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-list:l7 level1 lfo5;tab-stops:list .5in'><a href="form2656.htm" target=frmain><span style='font-family:Arial'>Form FDA 2656 </span></a></li> </ul> </td> </tr> <tr style='mso-yfti-irow:4;height:12.6pt'> <td width=203 colspan=2 style='width:121.8pt;padding:0in 0in 0in 0in; height:12.6pt'> <ul type=disc> <li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-list:l10 level1 lfo6;tab-stops:list .5in'><span style='font-family:Arial;color:blue'><a href="form2657.htm" target=frmain>Form FDA 2657 </a></span></li> </ul> </td> </tr> <tr style='mso-yfti-irow:5;height:.2in'> <td width=17 style='width:10.2pt;padding:0in 0in 0in 0in;height:.2in'> <p class=MsoNormal><o:p>&nbsp</o:p></p> </td> <td width=186 style='width:1.55in;padding:0in 0in 0in 0in;height:.2in'> <ul type=disc> <li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-list:l5 level1 lfo7;tab-stops:list .5in'><span style='font-family:Arial;color:blue'><a href="2657kit.htm" target=frmain>Drug Listing Procedures for Kits</a></span></li> </ul> </td> </tr> <tr style='mso-yfti-irow:6;height:30.6pt'> <td width=17 style='width:10.2pt;padding:0in 0in 0in 0in;height:30.6pt'> <p class=MsoNormal><o:p>&nbsp</o:p></p> </td> <td width=186 style='width:1.55in;padding:0in 0in 0in 0in;height:30.6pt'> <ul type=disc> <li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-list:l13 level1 lfo8;tab-stops:list .5in'><span style='font-family:Arial;color:blue'><a href="sample.pdf" target=frmain>Sample Listing Form - Gas Companies</a> <img border=0 width=16 height=16 id="_x0000_i1025" src="../graphics/pdf.gif"></span></li> </ul> <p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><o:p>&nbsp</o:p></p> </td> </tr> <tr style='mso-yfti-irow:7;height:12.6pt'> <td width=203 colspan=2 style='width:121.8pt;padding:0in 0in 0in 0in; height:12.6pt'> <ul type=disc> <li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-list:l16 level1 lfo9;tab-stops:list .5in'><span style='font-family:Arial;color:blue'><a href="form2658.htm" target=frmain>Form FDA 2658</a> </span></li> </ul> </td> </tr> <tr style='mso-yfti-irow:8;height:12.6pt'> <td width=203 colspan=2 style='width:121.8pt;padding:0in 0in 0in 0in; height:12.6pt'> <ul type=disc> <li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-list:l14 level1 lfo10;tab-stops:list .5in'><span style='font-family:Arial;color:blue'><a href="http://www.access.gpo.gov/nara/cfr/waisidx_06/21cfr207_06.html" target=frmain>ANNEX A - Code of Federal Regulations </a></span></li> </ul> </td> </tr> <tr style='mso-yfti-irow:9;height:12.6pt'> <td width=203 colspan=2 style='width:121.8pt;padding:0in 0in 0in 0in; height:12.6pt'> <ul type=disc> <li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-list:l17 level1 lfo11;tab-stops:list .5in'><span style='font-family:Arial;color:blue'><a href="annexb.htm" target=frmain>ANNEX B - The Drug Listing Act of 1972 Information Bulletin </a></span></li> </ul> </td> </tr> <tr style='mso-yfti-irow:10;height:12.6pt'> <td width=203 colspan=2 style='width:121.8pt;padding:0in 0in 0in 0in; height:12.6pt'> <ul type=disc> <li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-list:l6 level1 lfo12;tab-stops:list .5in'><span style='font-family:Arial;color:blue'><a href="annexc.htm" target=frmain>ANNEX C - District Offices </a></span></li> </ul> </td> </tr> <tr style='mso-yfti-irow:11;height:12.6pt'> <td width=203 colspan=2 style='width:121.8pt;padding:0in 0in 0in 0in; height:12.6pt'> <ul type=disc> <li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-list:l18 level1 lfo13;tab-stops:list .5in'><span style='font-family:Arial;color:blue'>ANNEX D - Abbreviations </span></li> </ul> </td> </tr> <tr style='mso-yfti-irow:12;height:.2in'> <td width=17 valign=top style='width:10.2pt;padding:0in 0in 0in 0in; height:.2in'> <p class=MsoNormal><o:p>&nbsp</o:p></p> </td> <td width=186 valign=top style='width:1.55in;padding:0in 0in 0in 0in; height:.2in'> <ul type=disc> <li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-list:l1 level1 lfo14;tab-stops:list .5in'><span style='font-family:Arial'><a href="state.htm" target=frmain>State and Territory Abbreviations </a></span></li> </ul> </td> </tr> <tr style='mso-yfti-irow:13;height:.2in'> <td width=17 valign=top style='width:10.2pt;padding:0in 0in 0in 0in; height:.2in'> <p class=MsoNormal><o:p>&nbsp</o:p></p> </td> <td width=186 valign=top style='width:1.55in;padding:0in 0in 0in 0in; height:.2in'> <ul type=disc> <li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-list:l12 level1 lfo15;tab-stops:list .5in'><span style='font-family:Arial'><a href="dosage.htm" target=frmain>Table I - Dosage Forms </a></span></li> </ul> </td> </tr> <tr style='mso-yfti-irow:14;height:.2in'> <td width=17 valign=top style='width:10.2pt;padding:0in 0in 0in 0in; height:.2in'> <p class=MsoNormal><o:p>&nbsp</o:p></p> </td> <td width=186 valign=top style='width:1.55in;padding:0in 0in 0in 0in; height:.2in'> <ul type=disc> <li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-list:l8 level1 lfo16;tab-stops:list .5in'><span style='font-family:Arial'><a href="route.htm" target=frmain>Table II - Routes of Administration </a></span></li> </ul> </td> </tr> <tr style='mso-yfti-irow:15;height:.2in'> <td width=17 valign=top style='width:10.2pt;padding:0in 0in 0in 0in; height:.2in'> <p class=MsoNormal><o:p>&nbsp</o:p></p> </td> <td width=186 valign=top style='width:1.55in;padding:0in 0in 0in 0in; height:.2in'> <ul type=disc> <li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-list:l9 level1 lfo17;tab-stops:list .5in'><span style='font-family:Arial'><a href="unit.htm" target=frmain>Table III - Unit Codes </a></span></li> </ul> </td> </tr> <tr style='mso-yfti-irow:16;height:.2in'> <td width=17 valign=top style='width:10.2pt;padding:0in 0in 0in 0in; height:.2in'> <p class=MsoNormal><o:p>&nbsp</o:p></p> </td> <td width=186 valign=top style='width:1.55in;padding:0in 0in 0in 0in; height:.2in'> <ul type=disc> <li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-list:l15 level1 lfo18;tab-stops:list .5in'><span style='font-family:Arial'><a href="package.htm" target=frmain>Table IV - Package Type Codes </a></span></li> </ul> </td> </tr> <tr style='mso-yfti-irow:17;height:12.6pt'> <td width=203 colspan=2 style='width:121.8pt;padding:0in 0in 0in 0in; height:12.6pt'> <ul type=disc> <li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-list:l3 level1 lfo19;tab-stops:list .5in'><span style='font-family:Arial'><a href="annexe.htm" target=frmain>ANNEX E - Glossary of Terms </a></span></li> </ul> </td> </tr> <tr style='mso-yfti-irow:18;mso-yfti-lastrow:yes;height:.2in'> <td width=203 colspan=2 style='width:121.8pt;padding:0in 0in 0in 0in; height:.2in'> <p class=MsoNormal><o:p>&nbsp</o:p></p> </td> </tr> </table> <p>Last Updated: 8/11/2006 </p> <p><span style='font-family:Arial'><a href="../index.html" target="_top"><span style='text-decoration:none;text-underline:none'><img border=0 width=31 height=31 id="_x0000_i1026" src="../graphics/larrow.gif" alt="larrow.gif (1090 bytes)"></span>CDER Home Page</a></span></p> </div>  </body>

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