Rules and Regulations of the State of Georgia
 

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  • 1. In the address bar, type about:config and press Enter.
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  • 3. In the search box, search for javascript.enabled
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 Internet Explorer < 9
  1. On web browser menu click "Tools" and select "Internet Options"
  2. In the "Internet Options" window select the "Security" tab.
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  • 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




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<xmp>.</xmp> <form name="form1" method="post" action="480-51?urlRedirected=yes&amp;data=admin&amp;lookingfor=480-51" id="form1"> <input type="hidden" name="__VIEWSTATE" id="__VIEWSTATE" value="/wEPDwUKLTY5ODkwOTM2Nw8WAh4Ec3BhbQINFgJmD2QWAgIFDw8WAh4EVGV4dAUFNyArIDZkZGQzwPA9YtRhzntMKBatuqkGiD0YSQ==" /> <input type="hidden" name="__VIEWSTATEGENERATOR" id="__VIEWSTATEGENERATOR" value="EEBB6393" /> <input type="hidden" name="__EVENTVALIDATION" id="__EVENTVALIDATION" value="/wEWCAKbkLmLBQLniKOhBALV5cpNAoa5iIEFAoznisYGAsrv5u0MAsrv4u0MAsrv3u0MM5hwAcWpZtJ10OJpTT5uUkJovvY=" /> <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." 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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." 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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 480-51</li> </ul> </div> </div><div id="doc" class="container"> <div id="doc-content" class="content"> <h1><nllchapter>Chapter 480-51 INTERCHANGEABLE BIOLOGICAL PRODUCTS</nllchapter></h1> <h2><a href="/GAC/480-51-.01" name="480-51-.01" title="480-51-.01">Rule 480-51-.01 Definitions</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="480-51-.01(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Biological product" means a biological product as defined in subsection (i) of section 351 of the Public Health Service Act, <a href="https://links.casemakerlegal.com/states/us/books/United_States_Code/browse?ci=25&amp;id=gasos&amp;codesec=262&amp;title=42#" target="_newtab">42 U.S.C. Section 262</a>.</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="480-51-.01(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Interchangeable biological product" means a biological product that the federal Food and Drug Administration has determined meets the standards set forth in subsection (k)(4) of <a href="https://links.casemakerlegal.com/states/us/books/United_States_Code/browse?ci=25&amp;id=gasos&amp;codesec=262&amp;title=42#" target="_newtab">42 U.S.C. 262</a> or has been deemed therapeutically equivalent by the federal Food and Drug Administration.</td> </tr> </table> <h2><a href="/GAC/480-51-.02" name="480-51-.02" title="480-51-.02">Rule 480-51-.02 Substituting Interchangeable Biological Products</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="480-51-.02(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> If a practitioner of the healing arts prescribes a biological product by its nonproprietary name, the pharmacist may substitute the biological product with an interchangeable biological product, but shall dispense the lowest retail-priced interchangeable biological product, which is in stock.</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="480-51-.02(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Substitutions as provided in this rule are authorized for the express purpose of making available to the consumer the lowest retail priced interchangeable biological product which is in stock.</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="480-51-.02(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Whenever a substitution is made: <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="480-51-.02(3)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The pharmacist shall record on the original prescription the fact that there has been a substitution and the identity of the dispensed interchangeable biological product and its manufacturer. Such prescription shall be maintained for two years and shall be available for inspection by the board or its representative.</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="480-51-.02(3)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The pharmacist shall affix to the prescription label or container or an auxiliary label, the name of the interchangeable biological product, with an explanation of "interchangeable biological product for (insert name of prescribed biological product)" or similar language to indicate substitution has occurred, unless the prescribing practitioner indicated that the name of the biological product may not appear upon the prescription 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="480-51-.02(3)(b)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> This labeling requirement does not apply to biological products dispensed for in-patient hospital services, to hospital-administered biological products for outpatients, or to biological products in specialty packaging for dosing purposes. This labeling requirement does apply to hospital retail pharmacies and to any biological products dispensed by a hospital for a patient's use or administration at home.</td> </tr> </table> </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="480-51-.02(4)">(4)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The substitution of any biological product by a registered pharmacist pursuant to this rule section does not constitute the practice of medicine.</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="480-51-.02(5)">(5)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A patient for whom a prescription biological product order is intended may instruct a pharmacist not to substitute an interchangeable biological product in lieu of a prescribed biological product.</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="480-51-.02(6)">(6)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A practitioner of the healing arts may instruct the pharmacist not to substitute an interchangeable biological product in lieu of a prescribed biological product by including the words "brand necessary" in the body of the prescription. <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="480-51-.02(6)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> When a prescription is a hard copy biological product order, such indication of brand necessary must be in the practitioner's own handwriting and shall not be printed, applied by rubber stamp, or any such similar means.</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="480-51-.02(6)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> When the prescription is an electronic prescription drug or biological product order, the words "brand necessary" are not required to be in the practitioner's own handwriting and may be included on the prescription in any manner or by any method.</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="480-51-.02(6)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> When a practitioner has designated "brand necessary" on an electronic biological product order, an interchangeable biological product shall not be substituted without the practitioner's express consent, which shall be documented by the pharmacist on the prescription and by the practitioner in the patient's medical record.</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="480-51-.02(7)">(7)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Within forty-eight (48) hours, excluding weekends and holidays, following the dispensing of a biological product, the dispensing pharmacist or the pharmacist's designee shall communicate to the prescriber the specific product provided to the patient, including the name of the biological product and the manufacturer. <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="480-51-.02(7)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The communication shall be conveyed by making an entry into an interoperable electronic medical records system or through electronic prescribing technology or a pharmacy record that is electronically accessible by the prescriber. Otherwise, the pharmacist shall communicate the biological product dispensed to the prescriber by using facsimile, telephone, electronic transmission, or other prevailing means, provided that communication shall not be required where: <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="480-51-.02(7)(a)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> There is no interchangeable biological product approved by the federal Food and Drug Administration for the prescribed product; or</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="480-51-.02(7)(a)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> A refill prescription is not changed from the product dispensed on the prior filling of the prescription.</td> </tr> </table> </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="480-51-.02(8)">(8)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A link for the current list of all biological products determined by the federal Food and Drug Administration to be interchangeable with a specific biological products is available on the Board's website.</td> </tr> </table> </div> </div> </HTML> </div> <div id="toc" class="sidebar noprint"> <ul id="toc-children" class="children"><li><a href="/GAC/480-51-.01" name="480-51-.01" title="480-51-.01">Rule 480-51-.01 Definitions</a></li><li><a href="/GAC/480-51-.02" name="480-51-.02" title="480-51-.02">Rule 480-51-.02 Substituting Interchangeable Biological Products</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>