Rules and Regulations of the State of Georgia
 

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  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.
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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.
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.
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<xmp>.</xmp> <form name="form1" method="post" action="480-10?urlRedirected=yes&amp;data=admin&amp;lookingfor=480-10" id="form1"> <input type="hidden" name="__VIEWSTATE" id="__VIEWSTATE" value="/wEPDwUKLTY5ODkwOTM2Nw8WAh4Ec3BhbQIJFgJmD2QWAgIFDw8WAh4EVGV4dAUFMiArIDdkZGRn9c3PB+KlEb6GPlBGTqJ+VN4aDQ==" /> <input type="hidden" name="__VIEWSTATEGENERATOR" id="__VIEWSTATEGENERATOR" value="EEBB6393" /> <input type="hidden" name="__EVENTVALIDATION" id="__EVENTVALIDATION" value="/wEWCALPgbPWBgLniKOhBALV5cpNAoa5iIEFAoznisYGAsrv5u0MAsrv4u0MAsrv3u0MsK3RkDYzKJI/mxd9TZf8AyDcsRE=" /> <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 480-10</li> </ul> </div> </div><div id="doc" class="container"> <div id="doc-content" class="content"> <h1><nllchapter>Chapter 480-10 RETAIL PHARMACY REGULATIONS</nllchapter></h1> <h2><a href="/GAC/480-10-.01" name="480-10-.01" title="480-10-.01">Rule 480-10-.01 Controlled Substances and Dangerous Drugs: Inspection, Retention of Records and Security</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="480-10-.01(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Every retail pharmacy, possessing or having possessed any controlled substances and/or dangerous drugs, within a period of two years, and/or possessing any record related to the same, which is required to be kept by O.C.G.A. T. Ch. 16-13, shall exercise diligent care in protecting such controlled substances and/or dangerous drugs and/or records related to the same from loss or theft. <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="480-10-.01(1)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Every licensed retail pharmacy shall ensure that all controlled substances and/or dangerous drugs are purchased from and/or returned to firms holding a current permit issued by the Georgia State Board of Pharmacy (Board). This requirement can be met by a pharmacy maintaining a copy of such firms' current Georgia Board permit.</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="480-10-.01(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> All controlled substances and/or dangerous drugs shall be kept in the prescription department, accessible only to an authorized person, except where contained in a collection receptacle compliant with state and federal law and 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="480-10-.01(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The Georgia Drugs and Narcotics Agency (GDNA) shall have the authority to conduct inspections of any place or premises used by any such licensed retail pharmacy in relation to such controlled substances and/or dangerous drugs and/or any records pertaining to their acquisition, dispensing, disposal, or loss.</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="480-10-.01(4)">(4)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The GDNA shall have the authority to examine, copy, or remove all such records, and to examine, copy, remove, or inventory all such controlled substances and/or dangerous drugs. <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="480-10-.01(4)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> It shall be the responsibility to such person possessing such controlled substances and/or dangerous drugs and/or records to make the same available for such inspection, copying, examination, or inventorying by said GDNA.</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="480-10-.01(4)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> At the conclusion of an inspection, the GDNA personnel examining said drugs and/or records shall have the responsibility of providing to such retail pharmacy a copy of an inspection report on which any deficiencies or violations are made along with any recommendations, if any, concerning the satisfactory storage, keeping, handling and security of controlled substances and/or dangerous drugs.</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="480-10-.01(5)">(5)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Any person possessing controlled substances and/or dangerous drugs and/or records may request that such an inspection be made, and upon receipt of such written request, the GDNA Director shall make, or cause to be made, without reasonable delay, an inspection in compliance with said request.</td> </tr> </table> <h2><a href="/GAC/480-10-.02" name="480-10-.02" title="480-10-.02">Rule 480-10-.02 Prescription Department, Requirement, Supervision, Hours Closed</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="480-10-.02(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> For the purpose of this rule, the following definitions shall apply: <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="480-10-.02(1)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Direct supervision" shall mean that a pharmacist is physically present, providing care at the address listed on the pharmacy license, and is in the prescription department, consultation room, vaccination room, or areas where over-the-counter drugs, devices, or durable medical equipment are displayed. The supervising pharmacist is professionally responsible and accountable for all activities performed by authorized pharmacy personnel and is available to provide assistance and direction to authorized pharmacy personnel. This shall not require a pharmacist to maintain a direct line of sight to authorized pharmacy personnel. The supervising pharmacist shall provide a final check of prepared products and document final checks before any prescription drug is 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="480-10-.02(1)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Pharmacy care" shall mean those services related to the interpretation, evaluation, or dispensing of prescription drug orders, the participation in drug and device selection, drug administration, and drug regimen reviews, and the provision of patient counseling related thereto.</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="480-10-.02(1)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Preparation" shall mean the functions of preparing a prescription to be dispensed, including product selection, data entry into a pharmacy dispensing system, and any other functions required to have the prescription ready to be verified, checked, and dispensed by a pharmacist or pharmacy intern working under the direct supervision of a 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="480-10-.02(1)(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Pharmacy" shall mean all areas of a facility when the prescription department is not closed or locked separately from the facility or only the area of the prescription department in those facilities where the prescription department is locked and separated.</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="480-10-.02(1)(e)">(e)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Prescription Department" shall mean an area set aside for the preparation and dispensing of prescription drugs. In a facility offering other departments and types of merchandise not requiring a pharmacist to be open for business, this term shall apply only to the area in which prescriptions are prepared and 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="480-10-.02(1)(f)">(f)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Vaccination room" is an area adjacent to the pharmacy where vaccinations are 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="480-10-.02(1)(g)">(g)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Consultation room" is an area adjacent to the pharmacy where patient or customer consultations are done, and more in-depth pharmacy care may be provided.</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="480-10-.02(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Except for pharmacy benefit manager retail pharmacies, the owner, manager or proprietor of each pharmacy shall designate an area, room or rooms, which shall be known as the "Prescription Department," and which is primarily devoted to activities related to prescriptions, including preparation and 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="480-10-.02(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A licensed pharmacist shall be in charge of each pharmacy. His or her name shall be upon the application for the license of the pharmacy; he or she shall be the pharmacist in charge of and have supervision of not more than one pharmacy at one time; and he or she shall be responsible and accountable for the conduction of business related to prescriptions within and access to said retail pharmacy. <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="480-10-.02(3)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> This regulation is not intended to prohibit any pharmacist from engaging in the practice of pharmacy at more than one pharmacy, if conducted in compliance with the other provisions of this rule and 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="480-10-.02(3)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> This regulation does not prohibit a pharmacist from being in charge of one separately licensed Home Health Care Pharmacy, as defined by Board Rule 480-21, and/or one Nursing Home Pharmacy, and/or one Long Term Health Care Facility Pharmacy, as both are defined in Board Rule 480-24, in addition to being in charge of a retail pharmacy, licensed under Rule 480-10, as long as each pharmacy is operated under the same ownership and is located under the same roof, provided that there is a physical separation of the two pharmacies and separate inventories are maintained for the two pharmacies.</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="480-10-.02(4)">(4)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Except for pharmacy benefit manager retail pharmacies, a Licensed Pharmacist shall be present and on duty in a licensed retail pharmacy as follows: <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="480-10-.02(4)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Entire business establishments which are licensed under O.C.G.A. § <a href="https://links.casemakerlegal.com/states/ga/books/Code_of_Georgia/browse?ci=25&amp;id=gasos&amp;codesec=26-4-110&amp;title=26#" target="_newtab">26-4-110</a> as a pharmacy shall have a pharmacist on duty at all times the pharmacy is open for business as follows: <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="480-10-.02(4)(a)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Such times when the pharmacist is absent from the pharmacy cannot exceed three (3) hours daily, or more than one and one half (11/2) hours at any one time. If a pharmacist is absent less than five minutes from the prescription department, this absence is not considered an "absence" within the meaning of this rule and will not require a posted notice, provided that the prescription department's security is not compromised.</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="480-10-.02(4)(a)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> In the absence of a pharmacist from the pharmacy, the area designated as the prescription department shall be closed and locked in such a manner as to prevent unauthorized entry; 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="480-10-.02(4)(a)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Whenever the pharmacist is absent from the pharmacy, a sign shall be prominently displayed on the entrance to the prescription department announcing "Prescription Department Closed" and such sign shall be clear and legible with letters not less than three (3) inches in size.</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="480-10-.02(4)(a)4.">4.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The pharmacist on duty shall be responsible and accountable for the direct supervision of all personnel working in the pharmacy or prescription department. Pharmacy technicians and pharmacy interns/externs can continue preparation of a prescription when the pharmacist is in the immunization or consultation room or is providing pharmacy care services.</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="480-10-.02(4)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> If a pharmacy is located in a general merchandising establishment, or if the owner of a business licensed as a pharmacy so chooses, a portion of the space in the business establishment may be set aside and permanently enclosed or otherwise secured; only the permanently enclosed area shall be subject to provisions of this rule and shall be licensed as a pharmacy; <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="480-10-.02(4)(b)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> In such cases, the area to be licensed or registered as a pharmacy shall be permanently enclosed with a partition built from the floor to the ceiling or in a manner which meets security guidelines submitted to and approved by the Board and upon inspection by the GDNA;</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="480-10-.02(4)(b)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> In the absence of a pharmacist from the Prescription Department, consultation room, vaccination room, and area where over-the-counter drugs, devices, and durable medical equipment are displayed, the area designated as the Prescription Department shall be closed and locked in such a manner as to prevent unauthorized entry; 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="480-10-.02(4)(b)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Whenever the pharmacist is absent from the Prescription Department, consultation room, vaccination room, and area where over-the-counter drugs, devices, and durable medical equipment are displayed, a sign shall be prominently displayed on the entrance to the Prescription Department announcing "Prescription Department Closed" and such sign shall be clear and legible with letters not less than three (3) inches in size.</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="480-10-.02(4)(b)4.">4.</a></td> <td valign="top" style="text-align:left" class="leftalign"> If a pharmacist is absent less than five minutes from the prescription department, this absence is not considered an "absence" within the meaning of this rule and will not require a posted notice, provided that the prescription department's security is not compromised. No prescription shall be dispensed in the absence of a licensed pharmacist. The pharmacist on duty shall be responsible and accountable for the direct supervision of all personnel working in the pharmacy or prescription department. Pharmacy technicians and pharmacy interns/externs can continue preparation of a prescription when the pharmacist is in the immunization or consultation room or is providing pharmacy care services.</td> </tr> </table> </td> </tr> </table> </td> </tr> </table> <h2><a href="/GAC/480-10-.03" name="480-10-.03" title="480-10-.03">Rule 480-10-.03 Location of Dangerous Drugs (Legend Drugs), Controlled Substances, and Poisons</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="480-10-.03(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> All drugs or devices which bear, or are required to bear, upon the package, the words "Caution, Federal Law Prohibits Dispensing Without Prescription","Rx Only", or words of like import, shall be stored within the prescription department of the pharmacy possessing such drugs or devices; 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="480-10-.03(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> All dangerous drugs (legend drugs), controlled substances, or poisons shall be kept in the prescription department, and shall be kept from the public in a secure manner.</td> </tr> </table> <h2><a href="/GAC/480-10-.04" name="480-10-.04" title="480-10-.04">Rule 480-10-.04 Sufficient Space in Prescription Department</a></h2> <P>There shall be provided within the prescription department of each pharmacy sufficient shelf, drawer, counter or cabinet space for the neat and orderly storage of all drugs, equipment, publications and other items kept therein. In addition, there shall be such clear floor space within each prescription department as to permit pharmacists, interns/externs, and/or technicians employed therein, to adequately, safely, and accurately fulfill their duties, related to prescriptions and drugs. The minimum floor space of a retail pharmacy shall be 150 square feet.</P> <h2><a href="/GAC/480-10-.05" name="480-10-.05" title="480-10-.05">Rule 480-10-.05 Refrigeration</a></h2> <P>There shall be provided within each prescription department adequate facilities for the proper storage of drugs or devices which require refrigeration, and such drugs or devices shall be stored therein in such manner as to preserve their therapeutic activity.</P> <h2><a href="/GAC/480-10-.06" name="480-10-.06" title="480-10-.06">Rule 480-10-.06 Licensure, Applications, and Display of License and Renewal Certificate</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="480-10-.06(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Licensure and Applications <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="480-10-.06(1)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Every retail pharmacy must be licensed by the Board in accordance with the laws and regulations of this State. As used in these rules, a "retail pharmacy" shall mean all pharmacies, except hospital, clinic, prison, and specialty pharmacies, located in this state where pharmacy is practiced as defined in O.C.G.A. §§ <a href="https://links.casemakerlegal.com/states/ga/books/Code_of_Georgia/browse?ci=25&amp;id=gasos&amp;codesec=26-4-4&amp;title=26#" target="_newtab">26-4-4</a> and <a href="https://links.casemakerlegal.com/states/ga/books/Code_of_Georgia/browse?ci=25&amp;id=gasos&amp;codesec=26-4-5&amp;title=26#" target="_newtab">26-4-5</a>, and shall mean every pharmacy benefit manager, as defined in O.C.G.A. § 26-4-110.1, providing services or benefits in this State that constitute the practice of pharmacy as defined in O.C.G.A. § <a href="https://links.casemakerlegal.com/states/ga/books/Code_of_Georgia/browse?ci=25&amp;id=gasos&amp;codesec=26-4-4&amp;title=26#" target="_newtab">26-4-4</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="480-10-.06(1)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> All retail pharmacies shall renew biennially by June 30th of the odd-numbered years with the Georgia State Board of Pharmacy; certificates of registration shall be issued only to those retail pharmacies who comply with this rule.</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="480-10-.06(1)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Certificates of registration shall be issued only to those retail pharmacies who meet the following requirements: <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="480-10-.06(1)(c)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Submission of an application with the following information: <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="480-10-.06(1)(c)1.i.">i.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The name, full business address, and telephone number of the licensee;</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="480-10-.06(1)(c)1.ii.">ii.</a></td> <td valign="top" style="text-align:left" class="leftalign"> All trade or business names used by the licensee;</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="480-10-.06(1)(c)1.iii.">iii.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Address, telephone number, and the name of the Pharmacist in Charge;</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="480-10-.06(1)(c)1.iv.">iv.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The type of ownership or operations (i.e., partnership, corporation, or sole proprietorship); 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="480-10-.06(1)(c)1.v.">v.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The name(s) of the owner and/or operator of the licensee, including: <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="480-10-.06(1)(c)1.v.(I)">(I)</a></td> <td valign="top" style="text-align:left" class="leftalign"> If a person, the name of the person;</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="480-10-.06(1)(c)1.v.(II)">(II)</a></td> <td valign="top" style="text-align:left" class="leftalign"> If a partnership, the name of the partnership and the name of each partner;</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="480-10-.06(1)(c)1.v.(III)">(III)</a></td> <td valign="top" style="text-align:left" class="leftalign"> If a sole proprietorship, the full name of the sole proprietorship and the name of the business entity; 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="480-10-.06(1)(c)1.v.(IV)">(IV)</a></td> <td valign="top" style="text-align:left" class="leftalign"> If a corporation, the corporate name, the name and title of each corporate officer and director, the state of incorporation; and the name of the parent company, if any.</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="480-10-.06(1)(c)1.vi.">vi.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Where operations are conducted at more than one location by a single retail pharmacy, each such location shall be licensed by the Board.</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="480-10-.06(1)(c)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Payment of an application fee. Application fees shall not be refundable.</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="480-10-.06(1)(c)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Filing a report from the Director of the Georgia Drugs and Narcotics Agency (GDNA) certifying the applicant possesses the necessary qualifications for a license. </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="480-10-.06(1)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Licenses become null and void upon the sale, transfer or change of mode of operation or location of the 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="480-10-.06(1)(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Licenses are renewed for two year periods and expire on June 30th of each odd numbered year and may be renewed upon the payment of the required fee for each place of business and the filing of an application for renewal. If the application for renewal is not made and the fee paid before September 1st, of the odd numbered year, the license shall lapse and shall not be renewed except by application for a new license.</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="480-10-.06(1)(e)">(e)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Changes in any information in this rule shall be submitted to the Board prior to such change.</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="480-10-.06(1)(f)">(f)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The Board will consider the following factors in determining eligibility for licensure of applicants in charge of the facility who are applying for a retail pharmacy license: <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="480-10-.06(1)(f)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Any convictions of the applicant under any Federal, State, or local laws relating to drug samples, wholesale or retail drug distribution, or distribution of 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="480-10-.06(1)(f)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Any felony convictions of the applicant under Federal, State, or local laws;</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="480-10-.06(1)(f)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The furnishing by the applicant of false or fraudulent material in any application made in connection with drug manufacturing or distribution;</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="480-10-.06(1)(f)4.">4.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Suspension or revocation by Federal, State, or local government of any pharmacist, pharmacy or other health care license currently or previously held by the applicant;</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="480-10-.06(1)(f)5.">5.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Compliance with licensing requirements under previously granted licenses, if any;</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="480-10-.06(1)(f)6.">6.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Compliance with requirements to maintain and/or make available to the State Licensing Authority or to Federal, State, or local law enforcement officials, those records required to be maintained by retail pharmacies; 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="480-10-.06(1)(f)7.">7.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Other factors or qualifications the Board considers relevant to and consistent with the public health and safety.</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="480-10-.06(1)(g)">(g)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The Board reserves the right to deny a license to an applicant if it determines that the granting of such a license would not be in the best interest of the public.</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="480-10-.06(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The pharmacist's wall certificate issued by the Georgia State Board of Pharmacy (Board), along with the current renewal license of each full-time Pharmacist, employed at the pharmacy, shall be displayed in a conspicuous place, near the prescription department where such pharmacist is actively engaged in the practice of Pharmacy; <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="480-10-.06(2)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> While employed in a pharmacy on a full-time basis, if a pharmacist has not yet received their Board issued Pharmacist Wall Certificate, in its place such pharmacist shall post a copy of their current Board issued pocket license card;</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="480-10-.06(2)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Any pharmacist employed on a part-time basis at a pharmacy shall post a copy of their current Board issued pocket license instead of posting their Pharmacist Wall Certificate; 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="480-10-.06(2)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Any pharmacist employed as a relief or "prn" pharmacist need not post any type of Board issued license, but such pharmacist must maintain and present upon request their current Board issued pocket license.</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="480-10-.06(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Any letter(s) from the Board which have granted a licensee any exception(s) and/or exemption(s) from this, or any other rule, must be posted and/or displayed next to the current Board of Pharmacy renewal permit; 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="480-10-.06(4)">(4)</a></td> <td valign="top" style="text-align:left" class="leftalign"> No pharmacist or intern/extern shall display his or her license in any pharmacy where he or she is not employed or engaged in the practice of pharmacy, and shall not knowingly permit any other person to use his or her license for the purpose of misleading anyone to believe that such person is the holder or recipient of said license or intern certificate.</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="480-10-.06(5)">(5)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Every pharmacy benefit manager providing services or benefits in this state which constitutes the practice of pharmacy as defined in Code Section <a href="https://links.casemakerlegal.com/states/ga/books/Code_of_Georgia/browse?ci=25&amp;id=gasos&amp;codesec=26-4-4&amp;title=26#" target="_newtab">26-4-4</a> shall be licensed as a retail pharmacy in this state and shall comply with the provisions of 26-4-110 as required under 26-4-110.1(b).</td> </tr> </table> <h2><a href="/GAC/480-10-.07" name="480-10-.07" title="480-10-.07">Rule 480-10-.07 Sanitation</a></h2> <P>No Pharmacy shall operate a prescription department which is under unclean, unsanitary, overcrowded, or unhealthy conditions, or under any condition which endangers the health, safety or welfare of the public.</P> <h2><a href="/GAC/480-10-.08" name="480-10-.08" title="480-10-.08">Rule 480-10-.08 Storage of Equipment</a></h2> <P>The required equipment of a pharmacy shall be in a clean condition and shall be stored in a clean and sanitary manner. When not in use, vessels shall be inverted upon a clean towel or suspended upon a rack.</P> <h2><a href="/GAC/480-10-.09" name="480-10-.09" title="480-10-.09">Rule 480-10-.09 Oral Prescription Drug Orders</a></h2> <P>Only a licensed pharmacist or a licensed pharmacy intern/extern, acting under the direct personal supervision of a licensed pharmacist, may accept an oral prescription drug order of any nature, and upon so accepting such prescription drug orders, the pharmacist or intern/extern shall immediately reduce the same to writing.</P> <h2><a href="/GAC/480-10-.10" name="480-10-.10" title="480-10-.10">Rule 480-10-.10 Prescription Drug Order Copies</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="480-10-.10(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Only a licensed pharmacist or a licensed pharmacy intern/extern, acting under the direct supervision of a licensed pharmacist, may prepare, receive, read, or transfer a copy of a prescription drug order to any person, and then only to a licensed pharmacist or licensed pharmacy intern/extern, acting under the direct supervision of a licensed pharmacist, who is authorized to receive and give such information as follows: <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="480-10-.10(1)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> When a copy of prescription drug order is received manually, meaning without the use of a computer or other electronic means, the person receiving such copy shall immediately reduce the information to writing by creating a hard-copy prescription drug order which, besides the required prescription data, should include at a minimum the following information; <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="480-10-.10(1)(a)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The name of the pharmacist or pharmacy intern/extern who received the prescription drug order;</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="480-10-.10(1)(a)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The name of the transferring pharmacy and its telephone number along with the name of the pharmacist or pharmacy intern/extern who provided the information for the prescription drug order copy;</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="480-10-.10(1)(a)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The date the prescription drug order copy was received.</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="480-10-.10(1)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> When a prescription drug order copy is sent and handled manually, meaning without the use of a computer or other electronic means, the person giving such copy shall record immediately upon his or her hard copy prescription drug order the following information: <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="480-10-.10(1)(b)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> That a copy of the prescription has been given and the prescription drug order is null and void, with the word "VOID" being marked on its face;</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="480-10-.10(1)(b)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The name of the pharmacy, and telephone number, where the prescription drug order was transferred;</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="480-10-.10(1)(b)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The name of the pharmacist, or pharmacy intern/extern who received the transferred prescription drug order information; 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="480-10-.10(1)(b)4.">4.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The date on which the prescription drug order was transferred.</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="480-10-.10(1)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> When a prescription drug order copy is either sent or received by aid of a computer, or other electronic means, the pharmacist or pharmacy intern/extern should use the procedures for prescription drug order transfers detailed in Rule <a title="480-27-.07" href="480-27-.07">480-27-.07</a>.</td> </tr> </table> </td> </tr> </table> <h2><a href="/GAC/480-10-.11" name="480-10-.11" title="480-10-.11">Rule 480-10-.11 Outdated, Deteriorated Drugs</a></h2> <P>The Pharmacist in Charge of each Pharmacy shall cause examination of the stock of the prescription department, of that Pharmacy, by persons qualified to do so, and shall cause to be removed from stock all out-dated and deteriorated drugs, and such shall be done at regular intervals of not more than six months duration, and under no circumstances will any Pharmacy or Pharmacist permit any drug or device to be dispensed which bears a date of expiration which has been reached, or any drug or device which is in a deteriorated condition.</P> <h2><a href="/GAC/480-10-.12" name="480-10-.12" title="480-10-.12">Rule 480-10-.12 Minimum Equipment for Prescription Departments</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="480-10-.12(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> No pharmacy licensed in accordance with O.C.G.A. T. 26, Ch. 4, shall engage in the practice of filling, compounding or dispensing prescriptions unless it shall possess the following items: <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="480-10-.12(1)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Copies of and/or computer or electronic access to current reference materials appropriate to the individual pharmacy practice. These reference materials shall be authoritative on at least the topics of drug interactions; patient counseling; compounding and pharmaceutical calculations; and generic substitution.</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="480-10-.12(1)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The telephone number of a poison control center. This number shall be conspicuously posted within the prescription 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="480-10-.12(1)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Current copies of and/or computer or electronic access to 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="480-10-.12(1)(c)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Georgia Pharmacy Practice Act, O.C.G.A. T. 26, Ch. 4;</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="480-10-.12(1)(c)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Georgia Controlled Substances Act &amp; Dangerous Drug Act, O.C.G.A. T. 16, Ch. 13; 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="480-10-.12(1)(c)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Official Rules of the Georgia State Board of Pharmacy.</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="480-10-.12(1)(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Equipment (appliances): <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="480-10-.12(1)(d)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Refrigerator in operating condition with a thermometer; 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="480-10-.12(1)(d)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Sink in working condition with both hot and cold running water.</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="480-10-.12(1)(e)">(e)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Weighing and labeling: <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="480-10-.12(1)(e)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Class A Balance, Class I or II Electronic Balance, or as approved in writing 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="480-10-.12(1)(e)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Assortment of weights: metric and apothecary, only if utilizing a Class A Balance;</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="480-10-.12(1)(e)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Appropriate prescription labels consistent with the requirements of the Georgia Drug and Cosmetic Act, O.C.G.A. Title 26, Chapter 3; 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="480-10-.12(1)(e)4.">4.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Appropriate auxiliary labels that should be used in the pharmacist's professional judgment.</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="480-10-.12(1)(f)">(f)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Other 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="480-10-.12(1)(f)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Graduates of assorted sizes;</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="480-10-.12(1)(f)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Two mortars and pestles of assorted sizes;</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="480-10-.12(1)(f)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Two spatulas;</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="480-10-.12(1)(f)4.">4.</a></td> <td valign="top" style="text-align:left" class="leftalign"> One pill counting tray;</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="480-10-.12(1)(f)5.">5.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Ointment slab, tile or ointment paper pad;</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="480-10-.12(1)(f)6.">6.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Stirring rods;</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="480-10-.12(1)(f)7.">7.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Typewriter, word processor or computer with label-printer; 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="480-10-.12(1)(f)8.">8.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Any other equipment necessary for a specialized practice setting where such a specialized practice takes place.</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="480-10-.12(1)(g)">(g)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Adequate supply of drugs most commonly prescribed (ONLY to be on hand after a permit has been issued 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="480-10-.12(1)(h)">(h)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Assorted sizes and types of child-resistant dispensing containers.</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="480-10-.12(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The pharmacist-in-charge of a facility may submit to the Georgia State Board of Pharmacy a typed request for a variance to these provisions relating to minimum equipment requirements. Stated reasons for application for variances must be included in submitted request. A variance may be granted by the Board only when, in the judgment of the Board, there are sound reasons for doing so which relate to the necessary or efficient delivery of health care. <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="480-10-.12(2)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Any variance granted by the Board must be in writing, and this variance must be posted in the pharmacy next to the current Board issued permit/renewal certificate.</td> </tr> </table> </td> </tr> </table> <h2><a href="/GAC/480-10-.13" name="480-10-.13" title="480-10-.13">Rule 480-10-.13 Syringes for Injections</a></h2> <P>Pharmacies shall keep syringes for injections behind the dispensing counter in their prescription departments and in no other place. No person other than a licensed pharmacist or a pharmacy intern/extern, acting under the direct supervision of a licensed pharmacist, shall sell, distribute, exchange, or give, to any person a hypodermic syringe or needle designed or marketed primarily for human use. No hypodermic needle or syringe shall be sold by a pharmacist or pharmacy intern/extern, acting under the direct supervision of a licensed pharmacist, if such person has reasonable cause to believe that it will be used for an unlawful purpose.</P> <h2><a href="/GAC/480-10-.14" name="480-10-.14" title="480-10-.14">Rule 480-10-.14 Destruction of Controlled Substance Drugs and Dangerous Drugs</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="480-10-.14(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> All controlled substances which are outdated or expired must be disposed of in a manner which generates a DEA Form 41 (Drug Destruction Form), a copy of which must be retained by the pharmacy. Such controlled substances can be disposed of by one of 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="480-10-.14(1)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Representatives of the Georgia Drugs and Narcotics Agency (GDNA);</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="480-10-.14(1)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Agents of the U.S. Drug Enforcement Administration (DEA); 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="480-10-.14(1)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A reverse distributor holding a current permit issued by the Georgia State Board of Pharmacy (Board).</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="480-10-.14(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Dangerous drugs which are outdated or expired must be disposed of by a reverse distributor holding a current permit issued by the Georgia State Board of Pharmacy.</td> </tr> </table> <h2><a href="/GAC/480-10-.15" name="480-10-.15" title="480-10-.15">Rule 480-10-.15 Requirements of a Prescription Drug Order</a></h2> <P>A Prescription Drug Order (defined as a "lawful order of a Practitioner for a Drug or Device for a specific patient") shall include, but not be limited to the following information as well as any information required by Rule 480-22:</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="480-10-.15(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Full name and address 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="480-10-.15(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Name, address of the prescribing practitioner and DEA registration number in the case of 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="480-10-.15(3)">(3)</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="480-10-.15(4)">(4)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Name, strength, if needed, dosage form and quantity of drug prescribed;</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="480-10-.15(5)">(5)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Directions for use 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="480-10-.15(6)">(6)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Refills authorized, if any;</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="480-10-.15(7)">(7)</a></td> <td valign="top" style="text-align:left" class="leftalign"> If a written Prescription Drug Order, prescribing practitioner's signature; 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="480-10-.15(8)">(8)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A serial number assigned by the Pharmacist so that Prescription Drug Orders may be filed in a numerical and retrievable sequence.</td> </tr> </table> <h2><a href="/GAC/480-10-.16" name="480-10-.16" title="480-10-.16">Rule 480-10-.16 Security System Approval</a></h2> <P>As set forth by O.C.G.A. 26-4-110, the Board may provide in its rules and regulations the manner in which the prescription department of a retail pharmacy may be secured. This requirement will be met in the following manner:</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="480-10-.16(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Any retail pharmacy located in a general merchandising establishment which does not have a prescription department set aside and permanently enclosed with a partition from floor to ceiling as set forth in O.C.G.A. 26-4-110, must submit to the Board in writing a request to approve its particular security system accompanied by a detailed description of that security system. This request must be made prior to a pharmacy receiving its retail pharmacy permit; <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="480-10-.16(1)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Any retail pharmacy located in a general merchandising establishment which chooses to close its prescription department for more than three (3) hours per day, and more than one and one half (1 1/2) hours at any one time, MUST have its prescription department permanently enclosed with a partition from floor to ceiling;</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="480-10-.16(1)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Any retail pharmacy located in a general merchandising establishment in which the prescription department is not permanently enclosed and utilizes ONLY an electronic security system to separate the prescription department from the rest of the business establishment, MAY NOT close for more than three (3) hours per day, nor more than one and one half (1 1/2) hours at any one time. Board approval of a pharmacy's electronic security system, without the presence of a permanent partition, does not exempt a pharmacy from this requirement.</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="480-10-.16(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Each security system description shall be reviewed and either approved or disapproved 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="480-10-.16(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The Board shall notify the pharmacy submitting the security description in writing as to whether or not the Board approves or disapproves the system. In cases in which a system is not approved, the Board may submit suggestions or reasons as to why the system was not acceptable.</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="480-10-.16(4)">(4)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Upon receiving a written approval of a security system, a pharmacy MUST maintain a copy of the Board's approval letter, along with a copy of the security system description, making both available in the pharmacy for inspection by the GDNA. This requirement can be met by posting the approval letter with the last GDNA inspection report.</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="480-10-.16(5)">(5)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Any change in a security system must first be approved in writing by the Board and a copy of the approval maintained by 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="480-10-.16(6)">(6)</a></td> <td valign="top" style="text-align:left" class="leftalign"> In the case of multiple retail pharmacies being operated by a parent corporation, the parent corporation may submit a request for a blanket approval of the same security system to be used by all pharmacies operated by that corporation. A copy of the written Board approval and the system description must be maintained at each pharmacy operated by the corporation. Thereafter, any new pharmacy operated by that corporation may utilize the same security system which was previously approved 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="480-10-.16(7)">(7)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Whenever a corporation or business entity operates multiple pharmacies, each of which has a secured prescription department, whether or not it is an electronically secured or permanently enclosed area, the pharmacist in charge (PIC) shall develop a method, approved by the Board, of allowing authorized access to that area. This method may consist of a Board approved lockbox containing a key, security access code, or other means by which security is maintained. Nothing in this rule is meant to prevent the PIC from having the authority to limit access to such area in regards to non-pharmacy related persons. <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="480-10-.16(7)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Before any such pharmacy can utilize a method of such access, a description of this method, including details of any lockbox to be utilized, must be submitted to the Board for approval. <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="480-10-.16(7)(a)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> A corporation or business entity may choose to utilize the same method of access to secure a key or access code for each pharmacy it operates in the State of Georgia by notifying the Board in writing. A copy of the Board approved method must be attached to the last GDNA inspection report. Any change in such method must be approved by the Board.</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="480-10-.16(7)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Upon approving or disapproving a method, the Board will notify the pharmacy of such in writing. A copy of such approvals must be posted by the pharmacy with the last GDNA inspection report. When a method is not approved, the Board may offer suggestions as to what must be done before the method can be approved.</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="480-10-.16(8)">(8)</a></td> <td valign="top" style="text-align:left" class="leftalign"> All pharmacies licensed on or after January 1, 2006 that utilize a drive-through system for the delivery of drugs, or any currently licensed pharmacy that relocates or has construction or modification of the pharmacy or pharmacy department on or after January 1, 2006 that creates a drive-through or alters an existing drive-through system for delivery of drugs, must submit the construction and security plans for utilization of a pharmacy drive-through to the Board before such construction or modification, and any such drive-through must be approved by the Board and must meet the requirements set forth herein. For purposes of this rule, a pharmacy drive-through is a delivery method by which a patient, or their designated agent, hereafter referred to as "patient", leaves a prescription to be filled or receives a filled prescription drug at the licensed pharmacy location other than by physically being inside the pharmacy. <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="480-10-.16(8)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Any Pharmacy Drive-Through must include a window of transparent material, measuring no less than 2 X 3 feet. The window must be placed in a wall of the prescription department or pharmacy. A pharmacist must be able to observe the patient through the window, whether or not the patient is in a drive-through lane directly next to the window or in a drive-through lane which is one lane over from the window. There shall be no more than two drive-through lanes with the lane farthest from the pharmacy/prescription department drive-through window being no more than twenty-four feet from the window.</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="480-10-.16(8)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Any Pharmacy Drive-Through that utilizes a pneumatic tube system, through which prescription drug orders are received from the patient or prescription drugs are dispensed to the patient, must meet the following standards: <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="480-10-.16(8)(b)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Secured carriers must be utilized in the pneumatic tube system;</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="480-10-.16(8)(b)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Tubes must be constructed in a manner as to prevent access by unauthorized persons;</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="480-10-.16(8)(b)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The tube must originate in the prescription drug area of the pharmacy, be accessible only by a pharmacist or personnel in the pharmacy and must terminate in a secure terminal in the drive-through.</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="480-10-.16(8)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Access to the pneumatic tube system must be constructed in such a way as to provide protection from the natural elements for the patient accessing the prescription.</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="480-10-.16(8)(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Any Pharmacy Drive-Through must be inspected by a GDNA Special Agent prior to utilization. Such Special Agent must file an inspection report with the Board with a recommendation for approval or non-approval.</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="480-10-.16(9)">(9)</a></td> <td valign="top" style="text-align:left" class="leftalign"> All pharmacies licensed prior to January 1, 2006 that utilize drive-throughs that do not comply with subsection 8(a) through (d) shall be grandfathered in.</td> </tr> </table> <h2><a href="/GAC/480-10-.17" name="480-10-.17" title="480-10-.17">Rule 480-10-.17 Return and Reuse of Drugs in a Long Term Care Facility</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="480-10-.17(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Long-term care facility" means an intermediate care home, skilled nursing home, or intermingled home subject to regulation as such by the Department of Human 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="480-10-.17(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Eligible drugs" means unit dosage drugs which have been paid for or reimbursed through the Department of Medical Assistance under O.C.G.A. Title 49, Chapter 4, Article 7.</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="480-10-.17(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Unit dosage drug" means a dangerous drug under O.C.G.A. Title 16, Chapter 13, which is individually packaged by the manufacturer to contain only one dosage unit of the drug and which includes on such individual packaging the brand or generic name, strength, lot number, and expiration date of such 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="480-10-.17(4)">(4)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A pharmacist or pharmacy may receive eligible drugs for credit or reuse from long-term care facilities provided that: <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="480-10-.17(4)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The drugs were originally dispensed by that pharmacist or pharmacy to the facility;</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="480-10-.17(4)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The pharmacist has assurance from a person in responsible charge of the drugs at the facility that the drugs have been stored in accordance with the manufacturer's recommendations and USP standards;</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="480-10-.17(4)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The drugs are still in the manufacturer's packaging with the expiration date and lot number and the integrity of the product and package have been 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="480-10-.17(4)(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The drugs are not expired and have a minimum of six (6) months remaining on the expiration date; 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="480-10-.17(4)(e)">(e)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Under the pharmacist's professional judgment the drugs are appropriate for return and reuse.</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="480-10-.17(5)">(5)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Any pharmacist or pharmacy accepting eligible drugs for return or reuse must adopt written policies and procedures governing such drugs to assure compliance with Section (4) of this Rule. Such procedures and policies shall be established and implemented by the pharmacist-in-charge.</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="480-10-.17(6)">(6)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A pharmacist or pharmacy which has accepted drugs for return in accordance with Section (4) of this Rule, may only re-dispense said drugs for reuse to a resident of a long-term care facility whose drugs are eligible for payment or reimbursement by the Department of Medical Assistance according to O.C.G.A. Title 49, Chapter 4, Article 7.</td> </tr> </table> <h2><a href="/GAC/480-10-.18" name="480-10-.18" title="480-10-.18">Rule 480-10-.18 [Repealed]</a></h2> <h2><a href="/GAC/480-10-.19" name="480-10-.19" title="480-10-.19">Rule 480-10-.19 Use of Automated and or Robotic Pharmacy Systems</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="480-10-.19(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> As used in this rule, the following terms shall mean: <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="480-10-.19(a)(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Automated pharmacy systems" (APS) means a mechanical system that perform operations or activities, other than compounding or administration, relative to storage, packaging, and labeling of medication for the purpose of dispensing of medication to a patient or patient's agent.</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="480-10-.19(a)(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Robotic pharmacy systems" (RPS) means a mechanical system controlled by a computer that performs operations or activities relative to the storage, packaging, and labeling of medication for the purpose of distribution (dispensing) of medication to a patient or a patient's agent.</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="480-10-.19(a)(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Board" shall mean the Georgia State Board of Pharmacy.</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="480-10-.19(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A Georgia licensed retail pharmacy may use automated pharmacy systems or robotic pharmacy systems in the preparation of medication for dispensing provided such systems meet the following requirements: <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="480-10-.19(b)(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The system collects, controls, and maintains all transaction information;</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="480-10-.19(b)(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The system is located within the licensed pharmacy, or if in a general merchandising store, within the pharmacy 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="480-10-.19(b)(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Medication loaded into the system can be visually identified as well as identified by bar code or other such secondary identification system to ensure the proper medication is being placed into and recognized as the correct medication by the system;</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="480-10-.19(b)(4)">(4)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The system has adequate security systems and procedures to prevent unauthorized access to the system;</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="480-10-.19(b)(5)">(5)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The system complies with federal laws and state 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="480-10-.19(b)(6)">(6)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The system maintains patient confidentiality;</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="480-10-.19(b)(7)">(7)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The system provides a visual image or a description of the medication at final verification.</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="480-10-.19(b)(8)">(8)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The system can only be accessed by personal code.</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="480-10-.19(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Each retail pharmacy utilizing an APS or RPS must maintain documentation, as to type of equipment, serial numbers, content, policies and procedures, on-site in the pharmacy for review by an agent 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="480-10-.19(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The filling/stocking of all medications in the APS or RPS shall be performed by licensed pharmacist, licensed pharmacy intern or a registered pharmacy technician under the direct, on-site supervision of a licensed pharmacist. An electronic or hard copy record of medications produced by the system shall be maintained for 2 years, and shall include identification of the person stocking/filling the system, and if a pharmacy intern or registered pharmacy technician, the name of the pharmacist providing the supervision.</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="480-10-.19(e)">(e)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Access to and limits on access to the APS or RPS must comply with state and federal laws and regulations. Proper identification and access control, including electronic passwords, biometric identification, unique credentials or other coded identification, must be authorized by the pharmacist on duty. A record of who was assigned the identifications, credentials or passwords must be maintained for 2 years in order to ascertain who accessed the APS or RPS.</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="480-10-.19(f)">(f)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The pharmacist in charge ("PIC") of the retail pharmacy is responsible for maintaining all records pertaining to the access, usage, audits and maintenance of the systems. These records must be readily accessible and available for inspection upon request by an agent of the Board. In addition, the PIC is responsible for developing and maintaining policies and procedures to assign, discontinue, or change access to the system, insure that access to the medications comply with state and federal regulations, and insure that the system is filled/stocked.</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="480-10-.19(g)">(g)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The pharmacist in charge is responsible to assure that the APS or RPS is in good working order.</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="480-10-.19(h)">(h)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Any pharmacist utilizing the APS or RPS must assure that the system is accurately producing the correct strength, dosage form, and quantity of the drug prescribed while maintaining appropriate record keeping and security safeguards.</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="480-10-.19(i)">(i)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Any retail pharmacy utilizing an APS or RPS in violation of this rule is subject to disciplinary action which may include, but is not limited to, a restriction on the authority to utilize an APS or RPS.</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="480-10-.19(j)">(j)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Nothing herein shall relieve a pharmacist of the professional responsibility to verify the accuracy of the medication being dispensed prior to its being delivered to the patient or the patient's agent</td> </tr> </table> <h2><a href="/GAC/480-10-.20" name="480-10-.20" title="480-10-.20">Rule 480-10-.20 Required Notifications to the Board</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="480-10-.20(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> For purposes of this rule, the following terms shall means as follow: <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="480-10-.20(1)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Board" shall mean the Georgia 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="480-10-.20(1)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Immediate notification" shall mean written notification sent within twenty-four hours of the event;</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="480-10-.20(1)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Significant adverse drug reaction" shall mean any reaction which requires any medical treatment beyond a consultation between Pharmacist/patient, Pharmacist/Prescriber, patient/prescriber or Pharmacist/patient/Prescriber; 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="480-10-.20(1)(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Written notification" shall mean in writing and sent by statutory overnight delivery or by email.</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="480-10-.20(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The following occurrences require immediate notification to the Board at its address of record, unless otherwise provided: <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="480-10-.20(2)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Permanent closing of a licensed pharmacy. Notification shall include the name and contact information for the person responsible for maintaining the pharmacy records after the pharmacy has closed and location of the 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="480-10-.20(2)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Change of ownership or location of a licensed pharmacy. Since a pharmacy license cannot be transferable, unless such change has been previously approved by the Board following the submission of the appropriate applications, the existing pharmacy license is void and there is no continuing authority to operate as a 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="480-10-.20(2)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Change in management of a licensed 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="480-10-.20(2)(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Change of the pharmacist in charge of a licensed pharmacy. When the Board receives notice that a pharmacy no longer has a pharmacist in charge and no replacement pharmacist in charge is named, the pharmacy's license is suspended pending further action 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="480-10-.20(2)(e)">(e)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Any theft or loss of drugs or devices of a licensed pharmacy. This notification must also be made to the Georgia Drugs and Narcotics Agency, and if involving controlled substances, the pharmacy must comply with Rule <a title="480-16-.06" href="480-16-.06">480-16-.06</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="480-10-.20(2)(f)">(f)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Any known conviction of any employee of a licensed pharmacy of any state or federal drug laws, not previously reported.</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="480-10-.20(2)(g)">(g)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Disasters or accidents involving the licensed 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="480-10-.20(2)(h)">(h)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Thefts or break-ins at the licensed 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="480-10-.20(2)(i)">(i)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Theft, destruction, or loss of records of a licensed pharmacy required to be maintained by state or federal law.</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="480-10-.20(2)(j)">(j)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Occurrence at a licensed pharmacy of a significant adverse drug reaction by a customer or person receiving medication dispensed or compounded by the licensed pharmacy.</td> </tr> </table> </td> </tr> </table> <h2><a href="/GAC/480-10-.21" name="480-10-.21" title="480-10-.21">Rule 480-10-.21 Purchase or Receipt of Drugs by a Pharmacy</a></h2> <P>All pharmacies are required to purchase or receive dangerous drugs and/or controlled substances from a firm licensed by this state as a drug wholesaler, distributor or manufacturer.</P> </div> </div> </HTML> </div> <div id="toc" class="sidebar noprint"> <ul id="toc-children" class="children"><li><a href="/GAC/480-10-.01" name="480-10-.01" title="480-10-.01">Rule 480-10-.01 Controlled Substances and Dangerous Drugs: Inspection, Retention of Records and Security</a></li><li><a href="/GAC/480-10-.02" name="480-10-.02" title="480-10-.02">Rule 480-10-.02 Prescription Department, Requirement, Supervision, Hours Closed</a></li><li><a href="/GAC/480-10-.03" name="480-10-.03" title="480-10-.03">Rule 480-10-.03 Location of Dangerous Drugs (Legend Drugs), Controlled Substances, and Poisons</a></li><li><a href="/GAC/480-10-.04" name="480-10-.04" title="480-10-.04">Rule 480-10-.04 Sufficient Space in Prescription Department</a></li><li><a href="/GAC/480-10-.05" name="480-10-.05" title="480-10-.05">Rule 480-10-.05 Refrigeration</a></li><li><a href="/GAC/480-10-.06" name="480-10-.06" title="480-10-.06">Rule 480-10-.06 Licensure, Applications, and Display of License and Renewal Certificate</a></li><li><a href="/GAC/480-10-.07" name="480-10-.07" title="480-10-.07">Rule 480-10-.07 Sanitation</a></li><li><a href="/GAC/480-10-.08" name="480-10-.08" title="480-10-.08">Rule 480-10-.08 Storage of Equipment</a></li><li><a href="/GAC/480-10-.09" name="480-10-.09" title="480-10-.09">Rule 480-10-.09 Oral Prescription Drug Orders</a></li><li><a href="/GAC/480-10-.10" name="480-10-.10" title="480-10-.10">Rule 480-10-.10 Prescription Drug Order Copies</a></li><li><a href="/GAC/480-10-.11" name="480-10-.11" title="480-10-.11">Rule 480-10-.11 Outdated, Deteriorated Drugs</a></li><li><a href="/GAC/480-10-.12" name="480-10-.12" title="480-10-.12">Rule 480-10-.12 Minimum Equipment for Prescription Departments</a></li><li><a href="/GAC/480-10-.13" name="480-10-.13" title="480-10-.13">Rule 480-10-.13 Syringes for Injections</a></li><li><a href="/GAC/480-10-.14" name="480-10-.14" title="480-10-.14">Rule 480-10-.14 Destruction of Controlled Substance Drugs and Dangerous Drugs</a></li><li><a href="/GAC/480-10-.15" name="480-10-.15" title="480-10-.15">Rule 480-10-.15 Requirements of a Prescription Drug Order</a></li><li><a href="/GAC/480-10-.16" name="480-10-.16" title="480-10-.16">Rule 480-10-.16 Security System Approval</a></li><li><a href="/GAC/480-10-.17" name="480-10-.17" title="480-10-.17">Rule 480-10-.17 Return and Reuse of Drugs in a Long Term Care Facility</a></li><li><a href="/GAC/480-10-.18" name="480-10-.18" title="480-10-.18">Rule 480-10-.18 [Repealed]</a></li><li><a href="/GAC/480-10-.19" name="480-10-.19" title="480-10-.19">Rule 480-10-.19 Use of Automated and or Robotic Pharmacy Systems</a></li><li><a href="/GAC/480-10-.20" name="480-10-.20" title="480-10-.20">Rule 480-10-.20 Required Notifications to the Board</a></li><li><a href="/GAC/480-10-.21" name="480-10-.21" title="480-10-.21">Rule 480-10-.21 Purchase or Receipt of Drugs by a Pharmacy</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 && 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