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

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

2658instruc..htm

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

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Draft Guidance for Registration and Listing forms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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