Rules and Regulations of the State of Georgia
 

JavaScript Is Not Enabled alert

You need to have JavaScript enabled in your browser to utilise the full functionality of this website.

How to enable JavaScript in your browser






firefox Mozilla Firefox

  1. In the address bar, type about:config and press Enter.
  2. Click "I'll be careful, I promise" if a warning message appears.
  3. In the search box, search for javascript.enabled
  4. Toggle the "javascript.enabled" preference (right-click and select "Toggle" or double-click the preference) to change the value from "false" to "true".
  5. Click on the "Reload current page" button of the web browser to refresh the page.
  • 1. In the address bar, type about:config and press Enter.
  • 2. Click "I'll be careful, I promise" if a warning message appears.
  • 3. In the search box, search for javascript.enabled
  • 4. Toggle the "javascript.enabled" preference (right-click and select "Toggle" or double-click the preference) to change the value from "false" to "true".
  • 5. Click on the "Reload current page" button of the web browser to refresh the page.




ie Internet Explorer

  1. On web browser menu click "Tools" icon and select "Internet Options".
  2. In the "Internet Options" window select the "Security" tab.
  3. On the "Security" tab click on the "Custom level..." button.
  4. When the "Security Settings - Internet Zone" dialog window opens, look for the "Scripting" section.
  5. In the "Active Scripting" item select "Enable".
  6. When the "Warning!" window pops out asking "Are you sure you want to change the settings for this zone?" select "Yes".
  7. In the "Internet Options" window click on the "OK" button to close it.
  8. Click on the "Refresh" button of the web browser to refresh the page.
  • 1. ie9 01
  • 2. ie9 02
  • 3. ie9 03
  • 4. ie9 04
  • 5. ie9 05
  • 6. ie9 06
  • 7. ie9 07
  • 8. ie9 08
 Internet Explorer < 9
  1. On web browser menu click "Tools" and select "Internet Options"
  2. In the "Internet Options" window select the "Security" tab.
  3. On the "Security" tab click on the "Custom level..." button.
  4. When the "Security Settings - Internet Zone" dialog window opens, look for the "Scripting" section.
  5. In the "Active Scripting" item select "Enable".
  6. When the "Warning!" window pops out asking "Are you sure you want to change the settings for this zone?" select "Yes".
  7. In the "Internet Options" window click on the "OK" button to close it.
  8. Click on the "Refresh" button of the web browser to refresh the page.
  • 1. ie 01
  • 2. ie 02
  • 3. ie 03
  • 4. ie 04
  • 5. ie 05
  • 6. ie 06
  • 7. ie 07
  • 8. ie 08




chrome Google Chrome

  1. On the web browser menu click on the "Customize and control Google Chrome" and select "Settings".
  2. In the "Settings" section click on the "Show advanced settings..."
  3. Under the the "Privacy" click on the "Content settings...".
  4. When the dialog window opens, look for the "JavaScript" section and select "Allow all sites to run JavaScript (recommended)".
  5. Click on the "OK" button to close it.
  6. Close the "Settings" tab.
  7. Click on the "Reload this page" button of the web browser to refresh the page.
  • 1. chrome 01
  • 2. chrome 02
  • 3. chrome 03
  • 4. chrome 04
  • 5. chrome 05
  • 6. chrome 06
  • 7. chrome 07




opera Opera

  • 1. a) Click on "Menu", hover mouse on the "Settings" then hover mouse on the "Quick preferences" and mark the "Enable Javascript" checkbox.
  • 1. b) If "Menu bar" is shown click on the "Tools", hover mouse on the "Quick preferences" and mark the "Enable Javascript" checkbox.
1. a) opera10 a 1. b) opera10 b




safari Apple Safari

  1. On the web browser menu click on the "Edit" and select "Preferences".
  2. In the "Preferences" window select the "Security" tab.
  3. In the "Security" tab section "Web content" mark the "Enable JavaScript" checkbox.
  4. Click on the "Reload the current page" button of the web browser to refresh the page.
  • 1. safari 01
  • 2. safari 02
  • 3. safari 03
  • 4. safari 04
<xmp>.</xmp> <form name="form1" method="post" action="480-21?urlRedirected=yes&amp;data=admin&amp;lookingfor=480-21" id="form1"> <input type="hidden" name="__VIEWSTATE" id="__VIEWSTATE" value="/wEPDwUKLTY5ODkwOTM2Nw8WAh4Ec3BhbQIKFgJmD2QWAgIFDw8WAh4EVGV4dAUFNiArIDRkZGT5KRg2/P81T+PP7bxEy6NImYdskQ==" /> <input type="hidden" name="__VIEWSTATEGENERATOR" id="__VIEWSTATEGENERATOR" value="EEBB6393" /> <input type="hidden" name="__EVENTVALIDATION" id="__EVENTVALIDATION" value="/wEWCALZ3fuwBgLniKOhBALV5cpNAoa5iIEFAoznisYGAsrv5u0MAsrv4u0MAsrv3u0MFTD3ZcZFJrY3mZ7ElCtM8GvxdJA=" /> <div class='popup'> <div class='cnt223'> <div style="margin-bottom:6px;"> <img alt="Rules and Regulations of the State of Georgia" src="/images/new.gif"/> </div> <div class="header"> Terms and Conditions of Agreement for Access to Rules and Regulations of the State of Georgia Website </div> <div class="scroll"> <p>(Note: certain features of this site have been disabled for the general public to prevent digital piracy. If you are an entitled government entity pursuant the Georgia Administrative Procedures Act, <a target="_new" href="http://links.casemakerlegal.com/states/GA/books/Code_of_Georgia/browse?ci=25id=gasos&amp;codesec=50-13-7&amp;title=50&amp;#50-13-7(d)">O.C.G.A.§ 50-13-7(d)</a> contact the State of Georgia's Administrative Procedures Division at 678-364-3785 to enable these features for your location.)</p> <p>To access this website, you must agree to the following: </p> <p> These terms of use are a contract between you and/or your employer (if any), and Lawriter, LLC. </p> <p> You agree that you will not copy, print, or download anything from this website for any commercial use. </p> <p> You agree not to use any web crawler, scraper, or other robot or automated program or device to obtain data from the website.</p> <p> You agree that you will not sell, will not license, and will not otherwise make available in exchange for anything of value, anything that you download, print, or copy from this site.</p> <p> You agree that you will not copy, print, or download any portion of the regulations posted on this site exceeding a single chapter of regulations for sale, license, or other transfer to a third party, except that you may quote a reasonable portion of the regulations in the course of rendering professional advice.</p> <p> If you violate this agreement, or if you access or use this website in violation of this agreement, you agree that Lawriter will suffer damages of at least $20,000. </p> <p> THIS WEBSITE AND ITS CONTENT ARE PROVIDED "AS IS." THE STATE OF GEORGIA AND LAWRITER EXPRESSLY DISCLAIM ALL WARRANTIES, INCLUDING THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT AND ARE NOT LIABLE TO ANY PERSON FOR ANY ERRORS IN INACCURACIES CONTAINED IN THIS WEBSITE. </p> <p> If you accept these terms enter the information below and click “I AGREE”.</p> </div> <table border="0" style="width: 810px"> <tr> </tr> <tr> <td style="vertical-align: text-top; width: 243px;"> Full Name:</td> <td style="width: 532px; vertical-align:super;"> <input name="firstName" type="text" id="firstName" class="txt" /> <span id="lbl_fname"><font color="Red"></font></span> </td> </tr> <tr><td style="width: 243px"> Human verification: <b> <span id="lblStopSpam">6 + 4</span>&nbsp;= </b></td><td style="width: 532px"> <input name="captcha" type="text" id="captcha" class="txt" /> <span id="lbl_captcha"><font color="Red"></font></span> &nbsp; <input name="sum" type="hidden" id="sum" value="10" /> </td></tr> </table> <input type="submit" name="Button1" value="I AGREE" id="Button1" disabled="disabled" /> <span id="alrtmsg"><font color="Red"></font></span> <input name="v1" type="hidden" id="v1" /> <input name="v2" type="hidden" id="v2" /> <input name="v3" type="hidden" id="v3" /> <p>Privacy Policy: the above information is for internal use only as related to this agreement and will not be sold or distributed.</p> </div> </div> </form> <html> <head runat="server"> <title>GA - GAC</title> <link href="_files/main.css" media="all" rel="Stylesheet" type="text/css" /> <link href="_files/treeview_old.css" media="all" rel="Stylesheet" type="text/css" /> <link href="/_files/popup.css" media="all" rel="stylesheet" type="text/css" /> <script type="text/javascript" src="/_files/treeview.js"></script> <script type="text/javascript" src="/_files/jquery-1.8.0.min.js"></script> <script type="text/javascript" src="/_files/jquery-1.10.2.js"></script> <script type="text/javascript" src="/_files/popup.js"></script> <script type="text/javascript" src="http://code.jquery.com/jquery-1.8.2.js"></script> <script type="text/javascript" src="https://ajax.googleapis.com/ajax/libs/jquery/1.8/jquery.min.js" /> <script type="text/javascript" src="/_files/jquery.popup.js"></script> <script type="text/javascript" src="/_files/jquery.popup.min.js"></script> <script type="text/javascript" src="/_files/ValidateForm.js"></script> <script src="https://code.jquery.com/jquery-1.11.3.js"></script> <link href="/_files/enablejs.css" rel="Stylesheet" type="text/css" /> <link href="/_files/forJavascript.css" rel="Stylesheet" type="text/css" /> <style type="text/css"> .collapse{background-image:url('/images/expcoll_right.png');} .expand{background-image:url('/images/expcoll_down.png');} </style> <script type="text/javascript"> $(document).ready(function(){ $("#History-parent").click(function(){ $("#History-Childs").toggle(); if ($('#History-parent img').hasClass('expand')) { $('#History-parent img').addClass('collapse'); $('#History-parent img').removeClass('expand'); $('#History-parent img').attr('src', '/images/expcoll_right.png'); } else { $('#History-parent img').removeClass('collapse'); $('#History-parent img').addClass('expand'); $('#History-parent img').attr('src', '/images/expcoll_down.png'); } }); $("#History-Childs").hide(); var tocnode=document.getElementById('toc-children'); if (tocnode != null) { if(tocnode.childNodes.length != 0) { document.getElementById("doc-content").style.width="72%"; document.getElementById("toc").style.width="21%"; document.getElementById("toc").style.padding="10px"; } else { document.getElementById('toc').style.display="none"; } } }); function fnsetRDVal(id) { if (id=="y") { document.getElementById("y").value="yes" document.getElementById("n").value="" } else { document.getElementById("n").value="no" document.getElementById("y").value="" } } </script> <script type="text/javascript"> function TermsCon() { var overlay = $('<div id="overlay"></div>'); overlay.show(); overlay.appendTo(document.body); $('.popup2').show(); $('#btnAgree').click(function () { $('.popup2').hide(); $("#overlay").hide(); overlay.appendTo(document.body).remove(); }); $("#btnprint").click(function () { var contents = $("#popupterms").html(); var frame1 = $('<iframe />'); frame1[0].name = "frame1"; frame1.css({ "position": "absolute", "top": "-1000000px" }); $("body").append(frame1); var frameDoc = frame1[0].contentWindow ? frame1[0].contentWindow : frame1[0].contentDocument.document ? frame1[0].contentDocument.document : frame1[0].contentDocument; frameDoc.document.open(); //Create a new HTML document. frameDoc.document.write('<html><head>'); frameDoc.document.write('</head><body>'); //Append the external CSS file. frameDoc.document.write('<link href="_files/popup.css" rel="stylesheet" type="text/css" />'); //Append the DIV contents. frameDoc.document.write(contents); frameDoc.document.write('</body></html>'); frameDoc.document.close(); setTimeout(function () { window.frames["frame1"].focus(); window.frames["frame1"].print(); frame1.remove(); }, 500); }); // alert("Because you do not agree to the Terms and Conditions for Access, you must cease accessing and/or using this website and destroy all material obtained from this website without your agreement."); // $('.popup2').show(); } </script> </head> <body> <div class="popup2"> <div class='cnt2231' id="popupterms"> <div style="margin-bottom: 6px;"> <img alt="Rules and Regulations of the State of Georgia" src="/images/new.gif" /> </div> <div class="header"> Terms and Conditions of Agreement for Access to Rules and Regulations of the State of Georgia Website </div> <div class="scroll" style="height:100%;"> <p>(Note: certain features of this site have been disabled for the general public to prevent digital piracy. If you are an entitled government entity pursuant the Georgia Administrative Procedures Act, <a target="_new" href="http://links.casemakerlegal.com/states/GA/books/Code_of_Georgia/browse?ci=25id=gasos&amp;codesec=50-13-7&amp;title=50&amp;#50-13-7(d)">O.C.G.A.§ 50-13-7(d)</a> contact the State of Georgia's Administrative Procedures Division at 678-364-3785 to enable these features for your location.)</p> <p>To access this website, you must agree to the following: </p> <p> These terms of use are a contract between you and/or your employer (if any), and Lawriter, LLC. </p> <p> You agree not to use any web crawler, scraper, or other robot or automated program or device to obtain data from the website. </p> <p> You agree that you will not sell or license anything that you download, print, or copy from this website.</p> <p> THIS WEBSITE AND ITS CONTENT ARE PROVIDED "AS IS." THE STATE OF GEORGIA AND LAWRITER EXPRESSLY DISCLAIM ALL WARRANTIES, INCLUDING THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT AND ARE NOT LIABLE TO ANY PERSON FOR ANY ERRORS IN INACCURACIES CONTAINED IN THIS WEBSITE. </p> <p> By accessing and/or using this website, you agree to the terms and conditions above. If you do not agree to the terms and conditions above, you must cease accessing and/or using this website and destroy all material obtained from this website without your agreement. </p> </div> </div> <div class="modal-footer"> <input type="button" name="btnAgree" value="Close" id="btnAgree" class="btn-blue noprint" /> <input type="button" name="btnprint" value="Print" id="btnprint" class="btn-blue noprint" /> </div> </div> </div> <div id="main" class="noprint"> <!--class="noprint"--> <div id="header" class="noprint"> <div class="container"> <div class="terms"> NOTICE OF TERMS OF USE OF THIS WEBSITE. By accessing and/or using this website, you agree to the following <a onclick="javascript:TermsCon();" style="text-decoration: underline">terms and conditions.</a> </div> <div class="content"> <div id="logo"> <!--<a href="../" title="Home"><img alt="Rules and Regulations of the State of Georgia" src="/images/garr_logo.gif" /></a>--> <!--<span id="georgia"><a href="/">Rules and Regulations of the State of Georgia</a></span>--> <a href="../" title="Home"><img alt="Rules and Regulations of the State of Georgia" src="/images/ga_rulesreg.gif" /></a> </div> <div id="links"> <a href="../home.aspx" class="constant" title="home">Home</a> | <a href="../gac/" class="constant" title="home">Browse</a> | <a href="../help.aspx" class="constant" title="help">Help</a> | <a href="http://sos.ga.gov/index.php/General/rules_and_regulations" target="_blank" onclick="void(0);" class="constant" title="Georgia SOS">Go to Georgia SOS</a> </div> </div> </div> <div class="sidebar"> <div id="full-text-search"> <form class="searchform" action="../search.aspx" method="get" onsubmit="javascript:return fncheckqts();"> <span class="searchHierarchy" style="margin-right:10px;" > <em class="mnemonic">H</em>ierarchy Search:&nbsp; <input onclick="fnsetRDVal(id);" id="y" checked="checked" type="radio" name="hierarchysearch" value="yes" />&nbsp;Y <input onclick="fnsetRDVal(id);" id="n" type="radio" name="hierarchysearch" value="" />&nbsp;N </span> <input id="query" name="query" class="searchfield" value="Search GA R&R...." onfocus="if (this.value == 'Search GA R&R....') {this.value = '';}" onblur="if (this.value == '') {this.value = 'Search GA R&R....';}" type="text" /> <input class="searchbutton" value="Go" type="submit" /> <input type="hidden" name="searchvalue" value="Chapter 480-21 RETAIL PHARMACIES PROVIDING HOME HEALTH CARE SERVICES" /> <input type="hidden" id="msg" value="REPLACE_MESSAGE" /> <input type="hidden" name="from" value="gac" /> </form> </div> <!--<div id="full-text-search"> <form id="search" action="../search.aspx" method="get" onsubmit="javascript:return fncheckqts();"> <span class="searchHierarchy" style="margin-right:10px;" > <em class="mnemonic">H</em>ierarchy Search:&nbsp; <input onclick="fnsetRDVal(id);" id="y" checked="checked" type="radio" name="hierarchysearch" value="yes" />&nbsp;Y <input onclick="fnsetRDVal(id);" id="n" type="radio" name="hierarchysearch" value="" />&nbsp;N </span> <label for="query" accesskey="s"> <em class="mnemonic">S</em>earch GA R&R: </label><input type="hidden" name="from" value="gac" /> <input id="query" name="query" type="text" /> <input class="submit" value="Go" type="submit" /> <input type="hidden" id="msg" value="REPLACE_MESSAGE" /> <input type="hidden" name="searchlevel" value="REPLACE_SEARCHLEVEL" /> <input type="hidden" name="searchvalue" value="Chapter 480-21 RETAIL PHARMACIES PROVIDING HOME HEALTH CARE SERVICES" /> </form> </div>--> <div id="searchcitation"> <form class="searchform" action="../search.aspx" method="get" onsubmit="javascript:return fnchecks();"> <div> <input id="section" name="section" class="searchfield" value="Go to Citation...." onfocus="if (this.value == 'Go to Citation....') {this.value = '';}" onblur="if (this.value == '') {this.value = 'Go to Citation....';}" type="text" /> <input class="searchbutton" value="Go" type="submit" /> <input type="hidden" name="from" value="gac" /> </div> </form> </div> </div> <HTML xmlns:xs="http://www.w3.org/2001/XMLSchema" xmlns:msxsl="urn:schemas-microsoft-com:xslt" xmlns:nll="uuid:{D3B28627-934D-41bc-8B7A-0549A8802FE4}"> <HEAD> <META http-equiv="Content-Type" content="text/html; charset=UTF-16"> </HEAD> <div id="infobar"><a href="javascript:;" accesskey="r" Name="Route" title="Route" class="quickkey"><em class="mnemonic">R</em>oute </a>:<div class="searchtips" style="float:right;margin-right:10px;color: rgb(47, 79, 79);"> <a style="text-decoration:none;color: rgb(47, 79, 79);" title="search tips" name="searchtip" href="../help.aspx#searching" target="_blank"><em class="mnemonic">S</em>earch tips</a></div><ul class="breadcrumb"> <li><a href="/GAC" name="GAC" title="GAC">GA R&amp;R</a></li> <li>&raquo; <a href="/GAC/480" title="480">Department 480</a></li> <li>&raquo; Chapter 480-21</li> </ul> </div> </div><div id="doc" class="container"> <div id="doc-content" class="content"> <h1><nllchapter>Chapter 480-21 RETAIL PHARMACIES PROVIDING HOME HEALTH CARE SERVICES</nllchapter></h1> <h2><a href="/GAC/480-21-.01" name="480-21-.01" title="480-21-.01">Rule 480-21-.01 Definitions</a></h2> <P>For the purpose of these rules and regulations, the following definitions apply:</P> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.01(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Retail Pharmacy Providing Home Health Care Services. A retail pharmacy providing home health care services is defined as a licensed retail pharmacy that routinely prepares and dispenses compounded, sterile parenteral products to outpatients.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.01(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Outpatient. An outpatient is defined as a patient in the home environment or an institutionalized patient that is receiving compounded, sterile parenteral products from a pharmacy outside the institution.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.01(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Compounded, Sterile Parenteral Products. Compounded, sterile parenteral products are defined as those parenteral drug products that require preparation by the pharmacist and which must be sterile, stable, and effective when dispensed for patient use.</td> </tr> </table> <h2><a href="/GAC/480-21-.02" name="480-21-.02" title="480-21-.02">Rule 480-21-.02 Registration</a></h2> <P>All retail pharmacies providing home health care services must have a current retail pharmacy permit. Therefore, they must comply with all retail pharmacy laws and regulations as well as the special regulations contained in these rules.</P> <h2><a href="/GAC/480-21-.03" name="480-21-.03" title="480-21-.03">Rule 480-21-.03 Personnel</a></h2> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.03(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Pharmacist-in-Charge. The pharmacist-in-charge at each retail pharmacy providing home health care services shall be knowledgeable in the specialized functions of preparing and dispensing compounded, sterile parenteral products, including the principles of aseptic technique and quality assurance. This knowledge is may be obtained through residency training programs, continuing education programs, or experience in an IV admixture facility. The pharmacist-in-charge shall be responsible for the purchasing, storage, compounding, repackaging, dispensing, and distribution of all drugs and pharmaceuticals. The pharmacist-in-charge shall also be responsible for the development and continuing review of all policies and procedures, training manuals, and the quality assurance programs. The pharmacist-in-charge may be assisted by additional pharmacists adequately trained in this area of practice.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.03(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Supportive Personnel. The pharmacist-in-charge may be assisted by supportive personnel. These personnel shall have specialized training in this field, and shall work under the direct supervision of a licensed pharmacist. The training provided to these personnel shall be described in writing in a training manual. The duties and responsibilities of these personnel must be consistent with their training and experience.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.03(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Secretarial Personnel. Secretarial and clerical support shall be provided as required to assist with record keeping and other administrative duties.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.03(4)">(4)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Staffing. A licensed pharmacist shall be accessible at all times at each such licensed facility to respond to patients' and other health professionals questions and needs.</td> </tr> </table> <h2><a href="/GAC/480-21-.04" name="480-21-.04" title="480-21-.04">Rule 480-21-.04 Physical Requirements</a></h2> <P>The physical requirements are:</P> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.04(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Space. Each retail pharmacy providing home health care services shall have a designated area for preparing compounded, sterile parenteral products. This area shall be physically separate from other areas and should be designed to avoid unnecessary traffic and airflow disturbances. The minimum space shall be 150 square feet. It shall be used only for the preparation of specialty products. It shall be of sufficient size to accommodate a laminar airflow hood and to provide for the proper storage of drugs and supplies under appropriate conditions of temperature, light, moisture, sanitation, ventilation, and security.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.04(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Equipment. <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.04(b)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Laminar Airflow Hood; or Class 100 Clean Room;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.04(b)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Infusion Pumps, if appropriate;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.04(b)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Sink, in working condition, with hot and cold running water, which is convenient to the compounding area for the purpose of hand scrubs prior to compounding;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.04(b)4.">4.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Equipment for light/dark field examination;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.04(b)5.">5.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Appropriate disposal containers for used needles, syringes, etc., and if applicable, cytotoxic waste from the preparation of chemotherapy agents;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.04(b)6.">6.</a></td> <td valign="top" style="text-align:left" class="leftalign"> A Class II, vertical flow biological safety cabinet, if chemotherapy agents are routinely prepared;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.04(b)7.">7.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Refrigerator/Freezer with a thermometer and in working condition.</td> </tr> </table> </td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.04(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Supplies. <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.04(c)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Disposable needles, syringes and other supplies needed for aseptic admixture;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.04(c)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Disinfectant cleaning solutions;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.04(c)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Handwashing agent with bactericidal action;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.04(c)4.">4.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Disposable, lint free paper towels;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.04(c)5.">5.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Appropriate filters and filtration equipment;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.04(c)6.">6.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Disposable masks and sterile, disposable gloves;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.04(c)7.">7.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Gowns, if chemotherapy agents are routinely prepared;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.04(c)8.">8.</a></td> <td valign="top" style="text-align:left" class="leftalign"> An oncology drug spill kit, if chemotherapy agents are routinely prepared.</td> </tr> </table> </td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.04(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> References. In addition to references required of a retail pharmacy, current edition of an established reference on IV stability and incompatibility, such as, HANDBOOK ON INJECTABLE DRUGS, or KING'S GUIDE TO PARENTERAL ADMIXTURES.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.04(e)">(e)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Variances. <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.04(e)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The pharmacist-in-charge may submit to the Georgia State Board of Pharmacy a written request for a variance to these provisions relating to minimum equipment requirements. Stated reasons for application for variances must be included in the submitted request. A variance shall be granted by the Board only when, in the judgement of the Board, there are sound reasons for doing so that relate to the necessary or efficient delivery of health care. After consideration by the Board, the requestor will be notified in writing of the Board's decision.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.04(e)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> If approved, said letter(s) will serve as the proof of the Board's approval for variances indicted in the letter, and must be posted next to the inspection report.</td> </tr> </table> </td> </tr> </table> <h2><a href="/GAC/480-21-.05" name="480-21-.05" title="480-21-.05">Rule 480-21-.05 Drug Distribution and Control</a></h2> <P>Regulations are:</P> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> General. A drug distribution system is the entirety of that mechanism by which a physician's prescription drug order is executed, from the time the drug is ordered and received in the pharmacy, to the time the prescribed drug is dispensed to the patient. </td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Purchasing. All drugs and pharmaceutical products purchased and dispensed by a retail pharmacy providing home health care services shall meet national standards of quality (USP-NF standards) and shall be clearly and accurately labeled by the manufacturer or distributor as to contents.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Policy and Procedure Manual. A policy and procedure manual shall be prepared and maintained at each retail pharmacy providing home health care services and be available for inspection by agents of the Georgia Drugs and Narcotics Agency. The policy and procedure manual shall set forth in detail the objectives and operational guidelines of the pharmacy. The manual shall be reviewed and revised at a minimum on an annual basis. A copy shall be provided to the Board of Pharmacy when applying for a permit or engaging in this specialized area of practice.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Prescription Drug Order. The pharmacist or pharmacy intern/extern acting under the direct supervision of a licensed pharmacist must receive a written or verbal prescription drug order from a physician before dispensing any compounded, sterile parenteral product or other drug. Prescriptions drug orders may be filed by patient, assigned consecutive numbers, or any other system that assures a complete, retrievable and accurate record. A new prescription drug order is required every six (6) months if the physician does not specify a course of therapy. These prescriptions drug orders shall, at a minimum, contain the following: <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(d)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Patient's full name;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(d)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Patient address for a controlled substance;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(d)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Drug name, strength, and dispensing quantity;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(d)4.">4.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Patient directions for use;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(d)5.">5.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Date of issuance;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(d)6.">6.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Prescriber's signature;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(d)7.">7.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Prescriber's address and drug enforcement administration identification code, if applicable;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(d)8.">8.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Refill instructions.</td> </tr> </table> </td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(e)">(e)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Patient Profile. A pharmacy generated patient profile that may be separate from the prescription file must be maintained for each patient. The patient profile shall be maintained under the control of the pharmacist-in-charge for a period of two years after the last dispensing activity. The patient profile shall contain, at a minimum: <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(e)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Patient's full name;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(e)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Age;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(e)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Weight;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(e)4.">4.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Sex;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(e)5.">5.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Compounded, sterile parenteral products dispensed;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(e)6.">6.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Date dispensed;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(e)7.">7.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Drug content and quantity;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(e)8.">8.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Patient directions;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(e)9.">9.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Prescription serial number;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(e)10.">10.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Identification of dispensing pharmacist(s);</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(e)11.">11.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Other drugs patient is receiving;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(e)12.">12.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Patient's drug sensitivities and allergies to drugs and foods;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(e)13.">13.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Primary diagnosis of the patient.</td> </tr> </table> </td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(f)">(f)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Labeling. Each compounded, sterile parenteral product dispensed to outpatients shall be labeled with the following information with a permanent, non-removable label: <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(f)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Name, address, and telephone number of the retail pharmacy providing home health care services;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(f)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Date and identifying prescription number;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(f)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Patient's full name;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(f)4.">4.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Name of each drug (brand or generic), strength, and amount;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(f)5.">5.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Directions for use to the patient, including infusion rate;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(f)6.">6.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Prescriber's name;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(f)7.">7.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Required precautionary information regarding controlled substances;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(f)8.">8.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Date and time of compounding;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(f)9.">9.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Expiration date and expiration time of the product; and</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(f)10.">10.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Identity of pharmacist compounding and dispensing the product.</td> </tr> </table> </td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(g)">(g)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Records and Reports. The pharmacist-in-charge shall maintain appropriate records and reports as are required to ensure patient's health, safety, and welfare. Such records shall be readily available, maintained for two years, and subject to inspections by the Board of Pharmacy or its agents. These records shall include, as a minimum, the following: <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(g)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Patient profile;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(g)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Prescription record;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(g)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Inventories of the pharmacy;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(g)4.">4.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Biennial controlled substances inventories;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(g)5.">5.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Policy and procedures manual;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(g)6.">6.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Training manuals;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(g)7.">7.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Policies and procedures for cytotoxic waste, if applicable;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(g)8.">8.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Such other records and reports as may be required by law and rules and regulations of the Board of Pharmacy.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.05(g)9.">9.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Delivery Service. The pharmacist-in-charge is responsible for the environmental control of all products shipped or delivered, and must ensure that all drug products are shipped in compliance with O.C.G.A. 26-4-60(a)(11). Therefore, any compounded, sterile parenteral product that is frozen, or requires refrigeration, must be shipped or delivered to a patient in appropriate coolers and stored appropriately in the patient's home.</td> </tr> </table> </td> </tr> </table> <h2><a href="/GAC/480-21-.06" name="480-21-.06" title="480-21-.06">Rule 480-21-.06 Cytotoxic Agents</a></h2> <P>The following additional requirements are necessary for those retail pharmacies providing home health care services that routinely prepare chemotherapy agents to insure the protection of the personnel involved:</P> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.06(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> All chemotherapy agents should be compounded in a vertical flow, Class II, biological safety cabinet. If possible, other products should not be compounded in this cabinet.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.06(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Protective apparel shall be worn by personnel compounding chemotherapy drugs. This shall include disposable masks, gloves, and gowns with tight cuffs.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.06(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Proper aseptic and safety techniques shall be used by personnel compounding chemotherapy agents. This shall include, at a minimum, utilizing syringes and sets with luer-lock fittings, and wrapping alcohol swabs around needle and neck of vials when withdrawing cytotoxic solutions from a vial.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.06(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Appropriate disposal procedures for cytotoxic waste must be developed that comply with applicable state and federal regulations.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.06(e)">(e)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Written policies and procedures for handling both major and minor spills of cytotoxic agents must be developed.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.06(f)">(f)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Prepared doses of chemotherapy must be dispensed and shipped or delivered in a manner to minimize the risk of accidental rupture of the primary container.</td> </tr> </table> <h2><a href="/GAC/480-21-.07" name="480-21-.07" title="480-21-.07">Rule 480-21-.07 Patient Care Guidelines</a></h2> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.07(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Primary Provider. There shall be a designated practitioner responsible for the patient's medical care. There shall be a clear understanding between the practitioner, the patient, and the pharmacist of the responsibilities of each in the areas of the delivery of care, the monitoring of the patient, and the reimbursement for services. The responsibilities of each person shall be documented in the patient's profile.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.07(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Patient Counseling A pharmacist shall provide to the patient or patient's care-giver any information required for the use of the drugs, supplies and equipment being dispensed. The pharmacist must document the patient's counseling in the pharmacy's patient profile.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.07(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Pharmacist-Patient Relationship. It is imperative that a pharmacist-patient relationship be established and maintained throughout the patient's course of therapy. The patient should be contacted by the pharmacist at least quarterly. This contact shall be documented in the patient's profile.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.07(4)">(4)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Patient Monitoring. The pharmacist should have access to clinical and laboratory data concerning each patient and should monitor each patient's response to his drug therapy. Any unexpected or untoward response should be reported to the prescribing physician. In the absence of the pharmacist monitoring, it shall be documented in the patient's profile, which health care provider has assumed this responsibility.</td> </tr> </table> <h2><a href="/GAC/480-21-.08" name="480-21-.08" title="480-21-.08">Rule 480-21-.08 Quality Control</a></h2> <P>There shall be a documented, ongoing quality control program that monitors personnel performance, equipment, and facilities. The end product shall be examined on a sampling basis as determined by the pharmacist-in-charge to assure that it meets required specifications.</P> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.08(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Hood Certification. All laminar flow hoods shall be certified by Federal Standard 209B for operational efficiency at least every 12 months. Appropriate records shall be maintained.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.08(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Prefilters. Prefilters for the clean air source shall be replaced on a regular basis and these activities shall be documented.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.08(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> End Product Sampling. There shall be written documentation that the end product has been tested on a sampling basis for microbial contamination.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.08(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Bulk Compounding. If bulk compounding of parenteral solutions is performed utilizing nonsterile chemicals, extensive end product testing must be documented prior to the release of the product from quarantine. This process must include testing for sterility and pyrogens.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.08(e)">(e)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Expiration Dates. If the product is assigned a lengthy expiration date (anything exceeding 10 days) there must be in-house data or data in the literature to assure the sterility and stability of the product at the time it is used by the patient.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-21-.08(f)">(f)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Quality Control Audits. There shall be documentation of quality assurance audits at regular, planned intervals.</td> </tr> </table> </div> </div> </HTML> </div> <div id="toc" class="sidebar noprint"> <ul id="toc-children" class="children"><li><a href="/GAC/480-21-.01" name="480-21-.01" title="480-21-.01">Rule 480-21-.01 Definitions</a></li><li><a href="/GAC/480-21-.02" name="480-21-.02" title="480-21-.02">Rule 480-21-.02 Registration</a></li><li><a href="/GAC/480-21-.03" name="480-21-.03" title="480-21-.03">Rule 480-21-.03 Personnel</a></li><li><a href="/GAC/480-21-.04" name="480-21-.04" title="480-21-.04">Rule 480-21-.04 Physical Requirements</a></li><li><a href="/GAC/480-21-.05" name="480-21-.05" title="480-21-.05">Rule 480-21-.05 Drug Distribution and Control</a></li><li><a href="/GAC/480-21-.06" name="480-21-.06" title="480-21-.06">Rule 480-21-.06 Cytotoxic Agents</a></li><li><a href="/GAC/480-21-.07" name="480-21-.07" title="480-21-.07">Rule 480-21-.07 Patient Care Guidelines</a></li><li><a href="/GAC/480-21-.08" name="480-21-.08" title="480-21-.08">Rule 480-21-.08 Quality Control</a></li></ul> </div> </div> <!--content ends here--> <div id="footer" class="noprint"><span class="footer">Copyright &copy; 2019 Lawriter LLC - All rights reserved.</span>| <a href="mailto:support@casemakerlegal.com?subject=Rules and Regulations of the State of Georgia">Email Us</a> | 844-838-0769 | <a href="http://livechat.casemakerlegal.com/client.php?locale=en" target="_blank" onclick="if(navigator.userAgent.toLowerCase().indexOf('opera') != -1 && window.event.preventDefault)window.event.preventDefault();this.newWindow = window.open('http://livechat.casemakerlegal.com/client.php?locale=en&url='+escape(document.location.href)+'&referrer='+escape(document.referrer), 'webim','toolbar=0,scrollbars=0,location=0,status=1,menubar=0,width=640,height=480,resizable=1');this.newWindow.focus();this.newWindow.opener=window;return false;">Live Chat</a> </div> </div> </body> </html>