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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  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.
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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.
  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.
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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.
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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.
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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.
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<xmp>.</xmp> <form name="form1" method="post" action="480-25?urlRedirected=yes&amp;data=admin&amp;lookingfor=480-25" id="form1"> <input type="hidden" name="__VIEWSTATE" id="__VIEWSTATE" value="/wEPDwUKLTY5ODkwOTM2Nw8WAh4Ec3BhbQIOFgJmD2QWAgIFDw8WAh4EVGV4dAUFOCArIDZkZGQl7RWiSAg1pTfLNzD244jr6QFmoA==" /> <input type="hidden" name="__VIEWSTATEGENERATOR" id="__VIEWSTATEGENERATOR" value="EEBB6393" /> <input type="hidden" name="__EVENTVALIDATION" id="__EVENTVALIDATION" value="/wEWCAKulbeYCwLniKOhBALV5cpNAoa5iIEFAoznisYGAsrv5u0MAsrv4u0MAsrv3u0MamgceXqDCq5LHcpK4BtR9iI2p7E=" /> <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 480-25</li> </ul> </div> </div><div id="doc" class="container"> <div id="doc-content" class="content"> <h1><nllchapter>Chapter 480-25 NUCLEAR PHARMACIES AND PHARMACISTS</nllchapter></h1> <h2><a href="/GAC/480-25-.01" name="480-25-.01" title="480-25-.01">Rule 480-25-.01 Definitions</a></h2> <P>Unless a different meaning is required by the context, the following terms as used in these rules and regulations shall have the meaning hereinafter respectively ascribed to them:</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="480-25-.01(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Authentication of product history" means, but is not limited to, identifying the purchasing source, the ultimate fate, and any intermediate handling of any component of a radiopharmaceutical.</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="480-25-.01(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Board" means the State 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="480-25-.01(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Compounding of radiopharmaceuticals" means the addition of a radioactive substance to nonradioactive substances or the use of a radioactive substance in preparation for single or multidose dispensation upon the prescription order of a physician who is licensed to use radioactive materials. Compounding of radiopharmaceuticals may include: loading and eluting of radionuclide generators; using manufactured reagents; preparing reagent kits; a liquoting reagents; formulation and quality assurance testing of radiochemicals for use as radiopharmaceuticals, and radiolabeling of compounds or products, including biological products, for use as radiopharmaceuticals.</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="480-25-.01(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Department" means the Department of Natural Resources.</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="480-25-.01(e)">(e)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Governing Body" or "Management" means the board of directors, trustees, partnership, corporation, association, person or group of persons who maintain and control the operation of the nuclear pharmacy, and who are legally responsible for its operation.</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="480-25-.01(f)">(f)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Internal Test Assessment" means, but is not limited to conducting those tests of a quality assurance necessary to ensure the integrity of the test.</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="480-25-.01(g)">(g)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Licensed Nuclear Pharmacist" means an authorization granted by the Board to a pharmacist to practice as a nuclear pharmacist.</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="480-25-.01(h)">(h)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Manufacturing of radiopharmaceuticals" means the preparation, derivation, or production of a product to which a radioactive substance is or will be added to provide a radiopharmaceutical for sale, resale, redistribution, or reconstitution.</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="480-25-.01(i)">(i)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Nuclear pharmacist" means a pharmacist who compounds and dispenses radiopharmaceuticals in the course of his/her pharmacy 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="480-25-.01(j)">(j)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Nuclear Pharmacy" means a pharmacy providing radiopharmaceutical 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="480-25-.01(k)">(k)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Nuclear Pharmacy Permit" means an authorization granted by the Board to the governing body of a facility to operate a nuclear 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="480-25-.01(l)">(l)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Pharmacist" means an individual who is currently licensed to practice pharmacy under the provisions of O.C.G.A. Title 26, Chapter 4, Article 3.</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="480-25-.01(m)">(m)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Pharmacy Intern" means an individual who is currently licensed to practice as a pharmacy intern under the provisions of O.C.G.A. Title 26, Chapter 4, Article 3.</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="480-25-.01(n)">(n)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Physician" means an individual who is currently licensed to practice medicine under the provisions of O.C.G.A. Title 43, Chapter 34.</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="480-25-.01(o)">(o)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Radiopharmaceutical" means radioactive drugs and chemical products used for diagnostic and therapeutic purposes and includes the terms radioactive pharmaceuticals, radioisotopes, and radioactive tracers.</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="480-25-.01(p)">(p)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Radiopharmaceutical quality assurance" means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on radiopharmaceuticals and their component materials and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.</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="480-25-.01(q)">(q)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Radiopharmaceutical service" means, but is not limited to, the compounding, dispensing, labeling, and delivering of radiopharmaceuticals; the participation in radiopharmaceutical selection and radiopharmaceutical utilization review; the maintenance of radiopharmaceutical quality assurance; and the responsibility for advising, where necessary or where regulated, of therapeutic values, hazards, and use of radiopharmaceuticals; and the offering or performing of those acts, services, operations, or transactions necessary in the conduct, operation, management, and control of a nuclear 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="480-25-.01(r)">(r)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Unit dose transport container" (a/k/a "lead pig") means a lead lined container designed to transport doses of radiopharmaceutical agents and prevent the emission of radiation or radioactive materials during the process. The terms "unit dose transport container" and "lead pig" may be used interchangeably.</td> </tr> </table> <h2><a href="/GAC/480-25-.02" name="480-25-.02" title="480-25-.02">Rule 480-25-.02 Applicability of Regulations</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="480-25-.02(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> All persons who manufacture, possess, transport, or otherwise handle pharmaceuticals or radioactive materials intended for radiopharmaceutical use prior to their arrival at a nuclear pharmacy shall comply with the requirements of the Department's Rules and Regulations for Radioactive Materials, and the requirements of the Rules and Regulations of the Board.</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="480-25-.02(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The requirements of these Rules and Regulations are in addition to, and not in substitution of, other applicable Rules and Regulations by the Department for radioactive materials and applicable Rules and Regulations promulgated by the Board for pharmacists and pharmacies.</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="480-25-.02(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Nothing in these Rules and Regulations shall be construed as requiring a licensed physician to obtain a separate license as a nuclear pharmacist, when his/her use of radiopharmaceuticals is limited to the diagnosis and treatment of his/her own patients.</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="480-25-.02(4)">(4)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Nothing in these Rules and Regulations shall be construed so as to require a licensed clinical laboratory which is also licensed by the Department to handle radioactive materials to obtain the services of a nuclear pharmacist, or to have a nuclear pharmacy license, unless the laboratory is engaged in the commercial sale or resale of radiopharmaceuticals.</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="480-25-.02(5)">(5)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Nothing in these Rules and Regulations shall be construed to require a department of nuclear medicine which is located in a hospital of 250 beds or less, which has a board certified radiologist in the practice of nuclear medicine, and which is licensed by the Department to handle radioactive materials to obtain the services of a nuclear pharmacist or to have a nuclear pharmacy license.</td> </tr> </table> <h2><a href="/GAC/480-25-.03" name="480-25-.03" title="480-25-.03">Rule 480-25-.03 Licensure of Nuclear Pharmacists</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="480-25-.03(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Except as provided for in Rule <a title="480-25-.02" href="480-25-.02">480-25-.02</a>, all acts of compounding and dispensing radiopharmaceuticals in the State of Georgia shall be performed by persons licensed as nuclear pharmacists; provided, however, that licensed pharmacists and licensed pharmacy interns/externs under the direct supervision and control of a nuclear pharmacist may compound and dispense radiopharmaceuticals without being separately licensed as nuclear pharmacists.</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="480-25-.03(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> An applicant for a license as a nuclear pharmacist shall: <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="480-25-.03(2)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Be a currently licensed pharmacist in the State of Georgia, 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="480-25-.03(2)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Submit to the Board a completed application and the appropriate fee, on forms to be provided by the Board, and an affidavit of training and experience which indicates that the applicant: <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="480-25-.03(2)(b)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Meets the minimum requirements to use radioactive materials as required by the Department's Rules and Regulations for Radioactive Materials, and either <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="480-25-.03(2)(b)1.(i)">(i)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Is certified as a nuclear pharmacist by the Board of Pharmaceutical Specialties of the American Pharmaceutical Association; 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="480-25-.03(2)(b)1.(ii)">(ii)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Has completed a minimum of 200 contact hours of didactic instruction in nuclear pharmacy from an accredited college of pharmacy, and, completed a minimum of 500 hours of clinical nuclear pharmacy training: <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="480-25-.03(2)(b)1.(ii)(I)">(I)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Under the direct supervision of a licensed nuclear pharmacist in a licensed nuclear pharmacy providing nuclear pharmacy service; 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="480-25-.03(2)(b)1.(ii)(II)">(II)</a></td> <td valign="top" style="text-align:left" class="leftalign"> In a certified nuclear pharmacy residency program approved by the American Society of Hospital Pharmacists or the Board; 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="480-25-.03(2)(b)1.(ii)(III)">(III)</a></td> <td valign="top" style="text-align:left" class="leftalign"> In a structured nuclear pharmacy training program of an accredited college of pharmacy.</td> </tr> </table> </td> </tr> </table> </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="480-25-.03(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Pharmacists engaged in the practice of nuclear pharmacy in the State of Georgia prior to March 18, 1983 shall be exempt from the requirements listed in subsection (2)(b)1. (i) and (2)(b)1. (ii).</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="480-25-.03(4)">(4)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A license as a nuclear pharmacist may be issued to any pharmacist who makes application to the Board, together with a required fee, and meets the requirements of these Rules and Regulations. The Board may refuse to issue a license for any of the grounds set forth in O.C.G.A. Section <a href="https://links.casemakerlegal.com/states/ga/books/Code_of_Georgia/browse?ci=25&amp;id=gasos&amp;codesec=26-4-60&amp;title=26#" target="_newtab">26-4-60</a>, and may also refuse to issue a license to an applicant who makes any false statement in the application or cheats in any manner upon any examination administered pursuant to these Rules and 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="480-25-.03(5)">(5)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Licenses shall be renewed biennially on odd numbered years by application to the Board for renewal.</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="480-25-.03(6)">(6)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The Board may limit, suspend, or revoke licenses issued under the provisions of these Rules and Regulations, or impose any other reasonable sanctions upon holders of such licenses upon violation of these Rules and Regulations or violation of O.C.G.A. Section <a href="https://links.casemakerlegal.com/states/ga/books/Code_of_Georgia/browse?ci=25&amp;id=gasos&amp;codesec=26-4-60&amp;title=26#" target="_newtab">26-4-60</a>.</td> </tr> </table> <h2><a href="/GAC/480-25-.04" name="480-25-.04" title="480-25-.04">Rule 480-25-.04 Licensure of Nuclear Pharmacies</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="480-25-.04(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> No nuclear pharmacy shall be operated in the State of Georgia without a valid permit.</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="480-25-.04(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The governing body of the facility shall submit a completed application with the required fee to the Board for a permit using forms provided by the Board.</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="480-25-.04(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Separate applications and permits are required for nuclear pharmacies maintained on separate premises, even though they are owned or operated by the same person(s), business or corporation; and may be doing business under the same trade 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="480-25-.04(4)">(4)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Permits are not transferable or assignable.</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="480-25-.04(5)">(5)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The applicant shall comply with additional application requirements as may be required by the Board.</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="480-25-.04(6)">(6)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Following inspection and evidence of compliance with these Rules and Regulations, the Board may issue a nuclear pharmacy permit to the applicant(s). The Board may refuse to issue a permit to any applicant for any of the grounds set forth in O.C.G.A. Section <a href="https://links.casemakerlegal.com/states/ga/books/Code_of_Georgia/browse?ci=25&amp;id=gasos&amp;codesec=26-4-113&amp;title=26#" target="_newtab">26-4-113</a>, and may also refuse to issue or revoke a permit if an applicant makes any false statements in the application.</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="480-25-.04(7)">(7)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Permits shall be renewed biennially on even numbered years by application to the Board for renewal.</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="480-25-.04(8)">(8)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The Board may limit, suspend, or revoke permits issued under the provisions of these Rules and Regulations, or impose any other reasonable sanctions upon holders of such permits upon violation of these Rules and Regulations or violation of O.C.G.A. Section <a href="https://links.casemakerlegal.com/states/ga/books/Code_of_Georgia/browse?ci=25&amp;id=gasos&amp;codesec=26-4-113&amp;title=26#" target="_newtab">26-4-113</a>.</td> </tr> </table> <h2><a href="/GAC/480-25-.05" name="480-25-.05" title="480-25-.05">Rule 480-25-.05 Inspections</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="480-25-.05(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Any nuclear pharmacy shall be open during all business hours for observation and examination by properly identified representatives of the Board and the Department.</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="480-25-.05(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> All nuclear pharmacies shall be inspected by the Board prior to licensure and may be inspected at the discretion of the Board or the Department to determine whether it continues to meet these requirements.</td> </tr> </table> <h2><a href="/GAC/480-25-.06" name="480-25-.06" title="480-25-.06">Rule 480-25-.06 Nuclear Pharmacy General Requirements</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="480-25-.06(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> In addition to complying with these Rules and Regulations, nuclear pharmacies shall comply with the Rules and Regulations of the Board and with all applicable Federal and State laws and regulations pertaining to nonradioactive drugs and pharmaceuticals.</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="480-25-.06(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The pharmacist in charge at a nuclear pharmacy shall be a licensed nuclear pharmacist. All personnel performing tasks in the preparation and distribution of radiopharmaceuticals shall be under the direct supervision of a licensed nuclear pharmacist. All acts of compounding and dispensing of radiopharmaceuticals shall be performed by the nuclear pharmacist or by a pharmacist or pharmacy intern, under the direct supervision and control of a nuclear pharmacist. A nuclear pharmacist shall be responsible for all operations of the nuclear pharmacy and shall be in personal attendance at all times when the acts of compounding and dispensing are performed and the pharmacy is open for business.</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="480-25-.06(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Nuclear pharmacies shall only dispense radiopharmaceuticals which comply with acceptable professional standards of radiopharmaceutical quality assurance.</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="480-25-.06(4)">(4)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Radiopharmaceuticals are to be dispensed only upon prescription drug order by a practitioner who is authorized by the Department to possess, use, and administer radioactive materials.</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="480-25-.06(5)">(5)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A nuclear pharmacist may transfer to authorized persons radioactive materials not intended for drug use, in accordance with the Department Rules and Regulations for Radioactive Materials. A nuclear pharmacy may also furnish radioactive materials for use to practitioners, for individual patient use in accordance with subsection (4) of this regulation.</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="480-25-.06(6)">(6)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The amount of radioactivity dispensed in each individual preparation shall be determined by the nuclear pharmacist through radiometric methods immediately prior to dispensing.</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="480-25-.06(7)">(7)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Nuclear pharmacies may redistribute Federal Food and Drug Administration approved radiopharmaceuticals if the pharmacy does not possess the radiopharmaceuticals in any manner or violate the product packaging. Such redistribution may only be made to another nuclear pharmacy or other authorized person or institution.</td> </tr> </table> <h2><a href="/GAC/480-25-.07" name="480-25-.07" title="480-25-.07">Rule 480-25-.07 Space Requirements</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="480-25-.07(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Nuclear pharmacies shall have adequate space, commensurate with the scope of service required and provided and meet the minimal space requirements of all pharmacies in the State.</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="480-25-.07(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Nuclear pharmacies shall have a minimum area, secured from unauthorized personnel, which comprise at least 600 square feet designed for the compounding and dispensing and quality assurance of radiopharmaceuticals.</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="480-25-.07(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The foregoing nuclear pharmacy areas shall be exclusive from other pharmacy areas such as those for nonradioactive drugs and office space.</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="480-25-.07(4)">(4)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Detailed floor plans shall be submitted to the Board before the permit is granted.</td> </tr> </table> <h2><a href="/GAC/480-25-.08" name="480-25-.08" title="480-25-.08">Rule 480-25-.08 Equipment</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="480-25-.08(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> In addition to other articles and equipment required by the Board for all pharmacies in the State, the nuclear pharmacy shall have: <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="480-25-.08(1)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> dose calibrator;</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="480-25-.08(1)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> vertical laminar flow hood;</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="480-25-.08(1)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> single or multiple channel scintillation analyzer;</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="480-25-.08(1)(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> microscope and hemocytometer;</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="480-25-.08(1)(e)">(e)</a></td> <td valign="top" style="text-align:left" class="leftalign"> adequate glassware, utensils, and 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="480-25-.08(1)(f)">(f)</a></td> <td valign="top" style="text-align:left" class="leftalign"> calculator;</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="480-25-.08(1)(g)">(g)</a></td> <td valign="top" style="text-align:left" class="leftalign"> laboratory incubator;</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="480-25-.08(1)(h)">(h)</a></td> <td valign="top" style="text-align:left" class="leftalign"> water or oil bath;</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="480-25-.08(1)(i)">(i)</a></td> <td valign="top" style="text-align:left" class="leftalign"> aluminum ion test kit; 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="480-25-.08(1)(j)">(j)</a></td> <td valign="top" style="text-align:left" class="leftalign"> adequate apparatus and supplies for performing chromatography.</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="480-25-.08(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Nuclear pharmacies shall also have equipment required for the safe handling and storage of radioactive materials, as required by the Department's Rules and Regulations for radioactive materials.</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="480-25-.08(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Each nuclear pharmacy shall utilize unit dose transport containers, a/k/a lead pigs, <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="480-25-.08(3)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Unit dose transport containers, a/k/a lead pigs, for radioactive doses shall include: <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="480-25-.08(3)(a)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign">an effective tamper-evident seal;</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="480-25-.08(3)(a)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign">an effective mechanism to avoid radioactive contamination; 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="480-25-.08(3)(a)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign">an effective system to prevent contamination of the transport container with blood, bodily fluids, or other biohazardous substances.</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="480-25-.08(3)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> No nuclear pharmacist or nuclear pharmacy shall re-use a unit dose transport container or lead pig that has been contaminated with blood, bodily fluids, or other hazardous 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="480-25-.08(3)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Any unit dose transport container or lead pig returned to a nuclear pharmacy with the tamper-evident seal broken and containing an exposed unit dose syringe shall be considered contaminated.</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="480-25-.08(3)(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Section 3 of this Rule shall not apply to: <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="480-25-.08(3)(d)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign">an individual prescriber preparing radiopharmaceuticals for administration to his or her own patients;</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="480-25-.08(3)(d)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign">transfer of radioactive material, not intended for use as a drug, to other legally authorized persons; 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="480-25-.08(3)(d)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign">the occasional transfer of bulk radiopharmaceuticals to other authorized entities or persons to meet shortages.</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="480-25-.08(3)(e)">(e)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Biohazardous prevention systems containing a barrier that if used properly eliminates or substantially reduces the potential for contamination of the unit dose transport container, or lead pig, would meet the requirements of these regulations. Improper use of such system resulting in ineffective sanitation of the unit dose transport container, or lead pig, would require that such containers be effectively sanitized prior to subsequent use or discarding of that container.</td> </tr> </table> </td> </tr> </table> <h2><a href="/GAC/480-25-.09" name="480-25-.09" title="480-25-.09">Rule 480-25-.09 Labeling</a></h2> <P>All radiopharmaceuticals dispensed from a nuclear pharmacy shall be dispensed in appropriate containers and labeled in accordance with the following:</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="480-25-.09(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The immediate inner container shall be labeled with: <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="480-25-.09(a)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> the identifying prescription number; 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="480-25-.09(a)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> the name of the radioactive drug.</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="480-25-.09(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> In addition to any labeling standards established by law the immediate outer container shall be labeled with: <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="480-25-.09(b)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> the name of the radionuclide;</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="480-25-.09(b)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> the chemical form;</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="480-25-.09(b)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign"> the amount of radioactive material contained, in millicuries (mCi) or microcuries (uCi);</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="480-25-.09(b)4.">4.</a></td> <td valign="top" style="text-align:left" class="leftalign"> if a liquid, the volume expressed in cubiccentimeters (cc) or milliliters (ml);</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="480-25-.09(b)5.">5.</a></td> <td valign="top" style="text-align:left" class="leftalign"> the requested calibration time and date;</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="480-25-.09(b)6.">6.</a></td> <td valign="top" style="text-align:left" class="leftalign"> the words "For Physician Use Only" in the absence of the name of 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="480-25-.09(b)7.">7.</a></td> <td valign="top" style="text-align:left" class="leftalign"> the name and address of the institution where the radiopharmaceutical will be administered;</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="480-25-.09(b)8.">8.</a></td> <td valign="top" style="text-align:left" class="leftalign"> the expiration date and time of the radioactive drug;</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="480-25-.09(b)9.">9.</a></td> <td valign="top" style="text-align:left" class="leftalign"> auxillary instructions for use, 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="480-25-.09(b)10.">10.</a></td> <td valign="top" style="text-align:left" class="leftalign"> name of the procedure for which drug is intended;</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="480-25-.09(b)11.">11.</a></td> <td valign="top" style="text-align:left" class="leftalign"> name of prescribing practitioner;</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="480-25-.09(b)12.">12.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The standard radiation symbol; 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="480-25-.09(b)13.">13.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The words "<B>Caution - Radioactive Material</B>".</td> </tr> </table> </td> </tr> </table> <h2><a href="/GAC/480-25-.10" name="480-25-.10" title="480-25-.10">Rule 480-25-.10 Library</a></h2> <P>In addition to any reference material required by the Board of all pharmacies in the State, a nuclear pharmacy shall maintain a reference library which shall include the following:</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="480-25-.10(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Current U.S. Pharmacopoeia/National Formulary with supplements or computer or electronic access to same;</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="480-25-.10(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Computer or electronic access to Federal and State Laws and Regulations relating to pharmacy practice in Georgia;</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="480-25-.10(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A minimum of three texts dealing with nuclear 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="480-25-.10(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Current Department of Human Resources Rules and Regulations for Radioactive Materials.</td> </tr> </table> <h2><a href="/GAC/480-25-.11" name="480-25-.11" title="480-25-.11">Rule 480-25-.11 Records</a></h2> <P>The nuclear pharmacy shall maintain acquisition and disposition records as required by the Board of all pharmacies in the State.</P> <h2><a href="/GAC/480-25-.12" name="480-25-.12" title="480-25-.12">Rule 480-25-.12 Enforcement</a></h2> <P>The enforcement and administration of these Rules and Regulations shall be as prescribed in the Georgia Administrative Procedure Act, O.C.G.A., Title 50, Chapter 13, Title 26, Chapter 4, and Title 43, Chapter 1.</P> <h2><a href="/GAC/480-25-.13" name="480-25-.13" title="480-25-.13">Rule 480-25-.13 Severability</a></h2> <P>In the event that any rule, sentence, clause or phrase or any of these rules and regulations may be construed by any court of competent jurisdiction to be invalid, illegal, unconstitutional, or otherwise unenforceable, such determination or adjudication shall in no manner affect the remaining rules or portions thereof and such remaining rules or portions thereof shall remain of full force and effect, as if such rule or portions thereof so determined, declared or adjudged invalid or unconstitutional were not originally a part hereof. It is the intent of the Board of Pharmacy to establish rules and regulations that are constitutional and enforceable so as to safeguard the health and well-being of the people of the State.</P> </div> </div> </HTML> </div> <div id="toc" class="sidebar noprint"> <ul id="toc-children" class="children"><li><a href="/GAC/480-25-.01" name="480-25-.01" title="480-25-.01">Rule 480-25-.01 Definitions</a></li><li><a href="/GAC/480-25-.02" name="480-25-.02" title="480-25-.02">Rule 480-25-.02 Applicability of Regulations</a></li><li><a href="/GAC/480-25-.03" name="480-25-.03" title="480-25-.03">Rule 480-25-.03 Licensure of Nuclear Pharmacists</a></li><li><a href="/GAC/480-25-.04" name="480-25-.04" title="480-25-.04">Rule 480-25-.04 Licensure of Nuclear Pharmacies</a></li><li><a href="/GAC/480-25-.05" name="480-25-.05" title="480-25-.05">Rule 480-25-.05 Inspections</a></li><li><a href="/GAC/480-25-.06" name="480-25-.06" title="480-25-.06">Rule 480-25-.06 Nuclear Pharmacy General Requirements</a></li><li><a href="/GAC/480-25-.07" name="480-25-.07" title="480-25-.07">Rule 480-25-.07 Space Requirements</a></li><li><a href="/GAC/480-25-.08" name="480-25-.08" title="480-25-.08">Rule 480-25-.08 Equipment</a></li><li><a href="/GAC/480-25-.09" name="480-25-.09" title="480-25-.09">Rule 480-25-.09 Labeling</a></li><li><a href="/GAC/480-25-.10" name="480-25-.10" title="480-25-.10">Rule 480-25-.10 Library</a></li><li><a href="/GAC/480-25-.11" name="480-25-.11" title="480-25-.11">Rule 480-25-.11 Records</a></li><li><a href="/GAC/480-25-.12" name="480-25-.12" title="480-25-.12">Rule 480-25-.12 Enforcement</a></li><li><a href="/GAC/480-25-.13" name="480-25-.13" title="480-25-.13">Rule 480-25-.13 Severability</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>