Rules and Regulations of the State of Georgia
 

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  1. In the address bar, type about:config and press Enter.
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  4. Toggle the "javascript.enabled" preference (right-click and select "Toggle" or double-click the preference) to change the value from "false" to "true".
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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.




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="480-11?urlRedirected=yes&amp;data=admin&amp;lookingfor=480-11" id="form1"> <input type="hidden" name="__VIEWSTATE" id="__VIEWSTATE" value="/wEPDwUKLTY5ODkwOTM2Nw8WAh4Ec3BhbQIKFgJmD2QWAgIFDw8WAh4EVGV4dAUFMyArIDdkZGTgv6vzYqDWHs3k9jAH0p+Uze2uEw==" /> <input type="hidden" name="__VIEWSTATEGENERATOR" id="__VIEWSTATEGENERATOR" value="EEBB6393" /> <input type="hidden" name="__EVENTVALIDATION" id="__EVENTVALIDATION" value="/wEWCALqztXcBwLniKOhBALV5cpNAoa5iIEFAoznisYGAsrv5u0MAsrv4u0MAsrv3u0MUike9k0r3FJQ6vxvA6RXy7QAme0=" /> <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 480-11</li> </ul> </div> </div><div id="doc" class="container"> <div id="doc-content" class="content"> <h1><nllchapter>Chapter 480-11 PHARMACEUTICAL COMPOUNDING</nllchapter></h1> <h2><a href="/GAC/480-11-.01" name="480-11-.01" title="480-11-.01">Rule 480-11-.01 Definitions</a></h2> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Administer" or "administration" means the provision of a unit dose and/or doses of medication to an individual patient as a result of the order of an authorized practitioner of the healing arts.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Barrier Isolator" means an isolator specifically designed for compounding pharmaceutical ingredients or preparations in an aseptic environment.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Biological safety cabinet" means a ventilated cabinet for personnel, product, and environmental protection having an open front with inward airflow for personnel protection, downward HEPA filtered laminar airflow for product protection, and HEPA<U>-</U>filtered exhausted air for environmental protection.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(4)">(4)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Board of Pharmacy" or "Board" means the Georgia State Board of Pharmacy.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(5)">(5)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Class 100 Environment" or "ISO Class 5" means an atmospheric environment which contains fewer than 100 particles 0.5 microns or larger in diameter per cubic meter of air.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(6)">(6)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Compounding" means the preparation, mixing, assembling, packaging, or labeling of a drug or de vice as the result of a practitioner's prescription drug order or initiative based on the relationship between the practitioner, patient, and pharmacist in the course of professional practice or for the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or dispensing. Compounding also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine and regularly observed prescribing patterns. Compounding does not include mixing, reconstituting, or similar acts that are performed in accordance with the directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(7)">(7)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Component" means any ingredient intended for use in the compounding of a drug preparation, including those that may not appear in such preparation.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(8)">(8)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Cytotoxic" means a pharmaceutical that has the capability of killing living cells.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(9)">(9)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Deliver" or "delivery" means the actual, constructive, or attempted transfer of a drug or device from one person to another, whether or not for a consideration.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(10)">(10)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Device" means an instrument, apparatus, contrivance, or other similar or related article, including any component part or accessory, which is required under federal law to bear the label,"Caution: federal or state law requires dispensing by or on the order of a physician" or "Rx Only."</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(11)">(11)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Dispense" or "dispensing" means the preparation and delivery of a drug or device to a patient, patient's caregiver, or patient's agent pursuant to a lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to, or use by a 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="480-11-.01(12)">(12)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Distribute" means the delivery of a drug or device other than by administering or 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="480-11-.01(13)">(13)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Drug" means: <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(13)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Articles recognized as drugs in any official compendium, or supplement thereto, designated from time to time by the Board for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(13)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(13)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Articles, other than food, intended to affect the structure or any function of the body of humans or animals; 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="480-11-.01(13)(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Articles intended for use as a component of any articles specified in subparagraph (a), (b), or (c) of this paragraph but does not include devices.</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="480-11-.01(14)">(14)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Drug regimen review includes but is not limited to the following activities: <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(14)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Evaluation of any prescription drug order and patient record for: <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(14)(a)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Known allergies;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(14)(a)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Rational therapy-contraindications;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(14)(a)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Reasonable dose and route of administration; 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="480-11-.01(14)(a)4.">4.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Reasonable directions for use.</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="480-11-.01(14)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Evaluation of any prescription drug order and patient record for duplication of therapy;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(14)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Evaluation of any prescription drug order and patient record for the following interactions: <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(14)(c)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Drug-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="480-11-.01(14)(c)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Drug-food;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(14)(c)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Drug-disease; 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="480-11-.01(14)(c)4.">4.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Adverse drug reactions.</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="480-11-.01(14)(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Evaluation of any prescription drug order and patient record for proper utilization, including over utilization or under utilization, and optimum therapeutic outcomes.</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="480-11-.01(15)">(15)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Enteral" means within or by way of the intestine.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(16)">(16)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "FDA" means the United States Food and Drug Administration.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(17)">(17)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "GDNA" means the Georgia Drugs and Narcotics Agency.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(18)">(18)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Labeling" means the process of preparing and affixing a label to any drug container exclusive, however, of the labeling by a manufacturer, packer, or distributor of a nonprescription drug or commercially packaged legend drug or device. Any such label shall include all information required by federal and state law or 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="480-11-.01(19)">(19)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Nonprescription drug" means a drug which may be sold without a prescription drug order and which is labeled for use by the consumer in accordance with the requirements of the laws and rules of this state and/or the federal government.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(20)">(20)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Parenteral" means an injectable sterile preparation of drugs for administration by any other means than through the gastrointestinal tract.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(21)">(21)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Patient counseling" means the oral communication by the pharmacist of information, as defined in the law and the rules of the Board, to the patient, patient's caregiver, or patient's agent, in order to improve therapy by ensuring proper use of drugs and devices.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(22)">(22)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Pharmaceutical" means a compound to be used as a medicinal 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="480-11-.01(23)">(23)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Pharmacist" means an individual currently licensed by this state to engage in the practice of pharmacy. This recognizes a pharmacist as a learned professional who is authorized to provide patient services and pharmacy care.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(24)">(24)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Pharmacist in charge" means a pharmacist currently licensed in this state who accepts responsibility for the operation of a pharmacy in conformance with all laws and rules pertinent to the practice of pharmacy and the distribution of drugs and who is personally in full and actual charge of such pharmacy and personnel.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(25)">(25)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Pharmacy" means any place licensed in accordance with the laws and rules of this state wherein the possessing, displaying, compounding, dispensing, or selling of drugs may be conducted, including any and all portions of the building or structure leased, used, or controlled by the licensee in the conduct of the business or profession licensed by the Board at the address for which the license was issued.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(26)">(26)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Practitioner" or "practitioner of the healing arts" means a physician, dentist, podiatrist, or veterinarian and shall include any other person licensed under the laws of this state to use, mix, prepare, dispense, prescribe, and administer drugs in connection with medical treatment to the extent provided by the laws of this state.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(27)">(27)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Prescription drug order" means a lawful order of a practitioner for a drug or device for a specific 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="480-11-.01(28)">(28)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Prospective drug use review" means a review of the patient's drug therapy and prescription drug order, as defined in the law and the rules of the Board, prior to dispensing the drug as part of a drug regimen review.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(29)">(29)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Sterile pharmaceutical" means any dosage form devoid of viable microorganisms, or any other contaminant including, but not limited to, parenterals, injectables, and ophthalmics.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(30)">(30)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "Sterile Preparations" are those as defined by USP 797.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.01(31)">(31)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "USP-NF" means the United States Pharmacopeia and National Formulary.</td> </tr> </table> <h2><a href="/GAC/480-11-.02" name="480-11-.02" title="480-11-.02">Rule 480-11-.02 Compounded Drug Preparations</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="480-11-.02(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Compounded drug preparations -Pharmacist/Patient/Prescriber Relationship. <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(1)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Based on the existence of a pharmacist/patient/prescriber relationship and the presentation of a valid prescription drug order or in anticipation of a prescription drug order based on routine, regularly observed prescribing patterns, pharmacists may compound, for an individual patient, drug preparations that are not commercially available in the marketplace or commercially available in the place as outlined by the restrictions under 12(b). Dispensing of pharmaceutical products shall be consistent with the provisions of O.C.G.A. T. 16, Ch. 13 and T. 26, Ch. 4 relating to the issuance of prescriptions and the dispensing of drugs.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(1)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Pharmacists shall receive, store, or use pharmaceuticals that have been manufactured or repackaged in a FDA-registered facility. Pharmacists shall also receive, store, or use pharmaceuticals in compounding preparations that meet official compendia requirements. If neither of these requirements can be met, pharmacists shall use their professional judgment to procure alternatives.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(1)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Pharmacists may compound pharmaceuticals prior to receiving a valid prescription drug order based on a history of receiving valid prescription drug orders within an established pharmacist/patient/prescriber relationship, and provided that they maintain the prescriptions on file for all such preparations compounded at the pharmacy. Preparations compounded in anticipation of a valid prescription drug order shall be properly labeled to include the name of the compounded pharmaceutical, date of compounding, and beyond-use date. The distribution of compounded preparations, for office use by a practitioner, shall not exceed 5% of production of compounded preparation in a calendar year by that pharmacy. Amounts produced greater than 5% shall be considered manufacturing and will require separate licensure as a manufacturer. Pharmacists must maintain a separate compounding log for each compounded preparation that includes the quantity and amount of each pharmaceutical that is compounded. Pharmacists shall label all compounded preparations that are dispensed pursuant to a prescription in accordance with the provisions of O.C.G.A. T. 16, Ch. 13 and O.C.G.A. T. 26, Chs. 3 and 4, and Board rules and regulations, and shall include on the labeling an appropriate beyond-use date as determined by the pharmacist in compliance with USP-NF standards for pharmacy compounding.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(1)(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> All compounded preparations labeled in accordance with Board rules and regulations regarding pharmaceutical compounding shall be deemed to meet the labeling requirements of O.C.G.A. T. 16, Ch. 13, and T. 26, Chs. 3 and 4.</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="480-11-.02(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Compounded drug preparations - Pharmacist for Distribution to Practitioner <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(2)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Only a pharmacy licensed or registered by the Board may distribute compounded preparations to practitioners licensed in this state for administration to their patients in the course of their professional practice, either personally or by an authorized person under their direct and immediate 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="480-11-.02(2)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A practitioner shall make a request to the pharmacy for a compounded preparation in the same manner as ordering products from a wholesale pharmaceutical distributor or manufacturer and not by using a 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="480-11-.02(2)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A pharmacy receiving an order from a practitioner for a compounded preparation shall maintain such order with its compounding records as required in Rule <a title="480-11-.08" href="480-11-.08">480-11-.08</a> and other rules and regulations of the Board.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(2)(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Pharmacists shall label all compounded preparations distributed to practitioners for administration to their patients with 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="480-11-.02(2)(d)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> "By purchase order, Not by 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="480-11-.02(2)(d)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> "For Office Use Administration Only - Not for resale",</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(2)(d)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The name of the active ingredients and strengths contained in the compounded preparation,</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(2)(d)4.">4.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The lot number or identification of the compounded preparation,</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(2)(d)5.">5.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The pharmacy's name, address and telephone number,</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(2)(d)6.">6.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The initials of the pharmacist verifying the finished compounded preparation and the date verified,</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(2)(d)7.">7.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The quantity, amount, size, or weight of the compounded preparation in the container,</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(2)(d)8.">8.</a></td> <td valign="top" style="text-align:left" class="leftalign"> An appropriate beyond-use (expiration) date of the compounded preparation as determined by the pharmacist in compliance with Board rule and USP-NF standards for pharmacy compounding, 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="480-11-.02(2)(d)9.">9.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Appropriate ancillary instructions such as storage instructions or cautionary statements, and where appropriate, hazardous drug warning labels.</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="480-11-.02(2)(e)">(e)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Pharmacists shall enter into a written agreement with a practitioner for the practitioner's use of the compounded preparation before providing any compounded preparation to the practitioner. The written agreement shall provide 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="480-11-.02(2)(e)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The name and address of the practitioner, license number and contact 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="480-11-.02(2)(e)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> An agreement by the practitioner that the compounded preparation may only be administered to the patient and may not be dispensed to the patient or sold to any other person or entity.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(2)(e)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign"> An agreement by the practitioner to include on the patient's chart, or medication administration record the lot number and beyond-use date of the compounded preparation administered to the patient.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(2)(e)4.">4.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The procedures for a patient to report an adverse reaction or to submit a complaint about a compounded preparation.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(2)(e)5.">5.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The procedure to be used when the pharmacy has to recall a batch of compounded preparation.</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="480-11-.02(2)(f)">(f)</a></td> <td valign="top" style="text-align:left" class="leftalign"> When pharmacists are compounding sterile preparations to be provided to practitioners for use in patient care or when pharmacists are altering or repackaging such products for practitioners to use in patient care in the practitioner's office, the sterile compounding shall be conducted as allowed by applicable federal law and Board rules and shall be in compliance with USP-NF standards for sterile compounding.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(2)(g)">(g)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Sterile compounded preparations may be dispensed to practitioners in quantities no more than 100 individual dosage containers and must have a beyond-use date no more than one week.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(2)(h)">(h)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Pharmacist may not compound Schedule II, III, IV or V controlled substances, as defined in Article 2 of Chapter 13 of Title 16 without a patient specific 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="480-11-.02(2)(i)">(i)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Prior to any pharmacy engaging in the practice of compounding preparations for use in the practitioner's office, the pharmacy must notify the Georgia Drugs and Narcotic Agency ("GDNA") of its practice, and must maintain on file the written acknowledgement of receipt of the notice from 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="480-11-.02(2)(j)">(j)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Nothing in this paragraph shall be construed to apply to pharmacies owned or operated by institutions or to pharmacists or practitioners employed by an institution or its affiliated entities; provided, however, pharmacies owned or operated by institutions and pharmacists and practitioners within or employed by institutions or affiliated entities shall remain subject to the other rules and regulations of the Board governing the compounding of pharmaceuticals.</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="480-11-.02(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Pharmacists must maintain documentation of proof that the beyond-use date on compounded pharmaceuticals is valid.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(4)">(4)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Pharmacists shall personally perform or personally supervise the compounding process, which shall include a final verification check for accuracy and conformity to the formula of the product being prepared, correct ingredients and calculations, accurate and precise measurements, appropriate conditions and procedures, and appearance of the final product.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(5)">(5)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Pharmacists shall ensure compliance with USP-NF standards for both sterile and non-sterile compounding.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(6)">(6)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Pharmacists may use prescription bulk substances in compounding when such bulk substances: <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(6)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Comply with the standards of an applicable USP-NF monograph, if such monograph exists, including the testing requirements, and the Board rules on pharmaceutical compounding; or are substances that are components of pharmaceuticals approved by the FDA for use in the United States; or otherwise approved by the FDA;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(6)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Are manufactured by an establishment that is registered by the FDA; 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="480-11-.02(6)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Are distributed by a wholesale distributor licensed by the Board and registered by the FDA to distribute bulk substances if the pharmacist can establish purity and safety by reasonable means, such as lot analysis, manufacturer reputation, or reliability of the source.</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="480-11-.02(7)">(7)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Pharmacists shall maintain records of all compounded pharmaceutical products. Pharmacist shall maintain a complete compounding formula listing all procedures, necessary equipment, necessary environmental considerations, and other factors in detail when such instructions are necessary to replicate a compounded product or where the compounding is difficult or complex and must be done by a certain process in order to ensure the integrity of the finished product. <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(7)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> This record-keeping requirement does not apply when FDA-approved and labeled sterile injectable drug products, produced by registered pharmaceutical manufacturers, are reconstituted under conditions as allowed by USP 797, and each such sterile drug product must be administered within 24 hours of being reconstituted.</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="480-11-.02(8)">(8)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Pharmacists engaged in the compounding of pharmaceuticals shall operate in conformance with Georgia laws and regulations. Non-sterile compounded preparations shall be subject to USP 795. All sterile compounded preparations shall be subject to USP 797.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(9)">(9)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Radiopharmaceuticals. If radiopharmaceuticals are being compounded, conditions set forth in the Board's rules for nuclear pharmacists and pharmacies must be followed.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(10)">(10)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Special precaution preparations. If drug preparations with special precautions for contamination are involved in a compounding operation, appropriate measures, including either the dedication of equipment for such operations or the meticulous cleaning of contaminated equipment prior to its return to inventory, must be utilized in order to prevent cross-contamination.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(11)">(11)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Cytotoxic drugs. In addition to the minimum requirements for a pharmacy established by rules of the Board, the following requirements are necessary for those pharmacies that prepare cytotoxic drugs to insure the protection of the personnel involved. <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(11)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> All cytotoxic drugs should be compounded in a vertical flow, Class II, biological safety cabinet or an appropriate barrier isolator. Other preparations should not be compounded in this cabinet.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(11)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Personnel compounding cytotoxic drugs shall wear protective apparel as outlined in the National Institute of Occupation Hazards (NIOSH.) in addition to appropriate compounding attire as described in USP 797.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(11)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Appropriate safety and containment techniques for compounding cytotoxic drugs shall be used in conjunction with the aseptic techniques required for preparing sterile preparations.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(11)(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Disposal of cytotoxic waste shall comply with all applicable local, state, and federal requirements.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(11)(e)">(e)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Written procedures for handling both major and minor spills of cytotoxic agents must be developed and must be included in the policy and procedure manual.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(11)(f)">(f)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Prepared doses of cytotoxic drugs must be dispensed, labeled with proper precautions inside and outside, and delivered in a manner to minimize the risk of accidental rupture of the primary container.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(11)(g)">(g)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Disposal of cytotoxic and/or hazardous wastes. The pharmacist-in-charge is responsible for assuring that there is a system for the disposal of cytotoxic and/or infectious waste in a manner so as not to endanger the public health.</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="480-11-.02(12)">(12)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Pharmacists shall not engage in 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="480-11-.02(12)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The compounding for human use of a pharmaceutical product that has been withdrawn or removed from the market by the FDA because such drug product or a component of such drug product has been found to be unsafe.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(12)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The compounding of any pharmaceutical products that are essentially copies of commercially available pharmaceutical products. However, this prohibition shall not include: <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(12)(b)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The compounding of any commercially available product when there is a change in the product ordered by the prescriber for an individual 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="480-11-.02(12)(b)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The compounding of a commercially available manufactured pharmaceutical during times when the product is not available from the manufacturer or wholesale distributor,</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(12)(b)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The compounding of a commercially manufactured pharmaceutical that appears on the drug shortages list, 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="480-11-.02(12)(b)4.">4.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The mixing of two or more commercially available products of which the end product is a commercially available product.</td> </tr> </table> </td> </tr> </table> </td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.02(13)">(13)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Practitioners who may lawfully compound pharmaceuticals for administering or dispensing to their own patients pursuant to O.C.G.A. Section <a href="https://links.casemakerlegal.com/states/ga/books/Code_of_Georgia/browse?ci=25&amp;id=gasos&amp;codesec=26-4-130&amp;title=26#" target="_newtab">26-4-130</a> shall comply with all the provisions of this rule and other applicable Board laws, rules and regulations.</td> </tr> </table> <h2><a href="/GAC/480-11-.03" name="480-11-.03" title="480-11-.03">Rule 480-11-.03 Organization and Personnel</a></h2> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.03(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The pharmacist has the responsibility and authority to inspect and approve or reject all components, drug preparations containers, closures, in-process materials, and labeling; and the authority to prepare and review all compounding records to assure that no errors have occurred in the compounding process. The pharmacist is also responsible for the proper maintenance, cleanliness, and use of all equipment used in prescription compounding practice.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.03(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Pharmacists who engage in drug compounding, and any other pharmacy personnel, supervised by pharmacists, who assist in drug compounding, shall be competent and proficient in compounding procedures and shall maintain that proficiency through current awareness and training and documentation of that training. Every pharmacist who engages in drug compounding and any other pharmacy staff member who assists in compounding, must be aware of and familiar with all details of these good compounding practices. Records of documentation of training for all personnel must be maintained for a minimum of five (5) years.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.03(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> All pharmacy personnel engaged in the compounding of drugs shall wear clean clothing appropriate to the operation being performed. Protective apparel, such as coats/jackets, aprons, gowns, hand or arm coverings, or masks shall be worn as necessary to protect personnel from chemical exposure and drug preparations from contamination.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.03(4)">(4)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Only personnel authorized by the responsible pharmacist shall be in the immediate vicinity of the drug compounding operation. Any person known at any time (either by medical examination or pharmacist determination) to have an apparent illness or open lesions that may adversely affect the safety or quality of a drug preparation being compounded shall be excluded from direct contact with components, drug preparation containers, closures, in-process materials, and drug preparations until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of the preparations being compounded. All personnel who assist the pharmacist in compounding procedures shall be instructed to report to the pharmacist any health conditions that may have an adverse effect on drug preparations.</td> </tr> </table> <h2><a href="/GAC/480-11-.04" name="480-11-.04" title="480-11-.04">Rule 480-11-.04 Facilities and Equipment</a></h2> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Facilities. <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(1)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Pharmacies engaging in compounding shall have an adequate area for the orderly compounding of prescriptions, including the placement of equipment and materials. The drug compounding area for sterile preparations shall be separate and distinct from the area used for the compounding of non-sterile drug preparations. The area(s) used for compounding of drugs shall be maintained in a good state of repair.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(1)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Bulk drugs and other chemicals or materials used in the compounding of prescription drug orders must be stored in adequately labeled containers in a clean, dry area or, if required, under proper refrigeration.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(1)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Adequate lighting and ventilation shall be provided in all drug-compounding areas. Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute to contamination of any compounded drug preparation. Adequate washing facilities, easily accessible to the compounding area(s) of the pharmacy shall be provided. These facilities shall include, but not be limited to, hot and cold water, soap or detergent, and air dryers or single-use towels.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(1)(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Sewage, trash, and other refuse in and from the pharmacy and immediate drug compounding area(s) shall be disposed of in a safe and sanitary manner.</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="480-11-.04(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Equipment. <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(2)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Equipment used in the compounding of drug preparation shall be of appropriate design, appropriate capacity, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance. Equipment used in the compounding of drug preparations shall be of suitable composition so that surfaces that contact components, in-process materials, or drug preparations shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug preparation beyond that desired.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(2)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Equipment and utensils used for compounding shall be cleaned and sanitized immediately prior to use to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug preparation beyond that desired. In the case of equipment, utensils, and containers/closures used in the compounding of sterile drug preparations, cleaning, sterilization, and maintenance procedures as set forth in Board Rules.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(2)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Equipment and utensils used for compounding drugs must be stored in a manner to protect them from contamination. Immediately prior to the initiation of compounding operations, they must be inspected by the pharmacist and determined to be suitable for use.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(2)(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Automatic, mechanical, electronic, or other types of equipment other than commercial scale manufacturing or testing equipment, may be used in the compounding of drug preparations. If such equipment is used, it shall be routinely inspected, calibrated (if necessary), or checked to ensure proper performance.</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="480-11-.04(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Physical requirements for pharmacies compounding sterile parenteral preparations. <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(3)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A pharmacy compounding or preparing sterile parenteral preparations shall have a designated area for preparing compounded, sterile parenteral preparations as defined in USP 797. This area shall be physically separate from other areas and should be designed to avoid unnecessary traffic and airflow disturbances. It shall be used only for the preparation of sterile parental preparations.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(3)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Equipment and supplies for compounding sterile parenteral preparations. A pharmacy compounding sterile parenteral preparations shall have the following minimum equipment and supplies: <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(3)(b)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Laminar airflow hood (ISO 5) located within a clean room, or barrier isolator as described in USP 797;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(3)(b)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Infusion pumps, if appropriate;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(3)(b)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Sink, in working condition, with hot and cold running water, which is convenient to the compounding area for the purpose of hand scrubs prior to compounding;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(3)(b)4.">4.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Facility for light/dark field examination;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(3)(b)5.">5.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Appropriate disposal containers for used needles, syringes, etc., and if applicable, cytotoxic waste from the preparation of chemotherapy agents;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(3)(b)6.">6.</a></td> <td valign="top" style="text-align:left" class="leftalign"> A Class II, vertical flow biological safety cabinet or appropriate barrier isolator, if chemotherapy agents are routinely prepared;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(3)(b)7.">7.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Refrigerator/freezer in working condition;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(3)(b)8.">8.</a></td> <td valign="top" style="text-align:left" class="leftalign"> 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="480-11-.04(3)(b)9.">9.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Disposable needles, syringes and other supplies needed for aseptic admixture;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(3)(b)10.">10.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Disinfectant cleaning solutions;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(3)(b)11.">11.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Handwashing agent with bactericidal action;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(3)(b)12.">12.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Disposable, lint free towels or an automatic hand dryer;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(3)(b)13.">13.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Appropriate filters and filtration equipment;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(3)(b)14.">14.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Disposable masks and sterile, disposable gloves, gowns, hair and shoe covers and goggles when indicated;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(3)(b)15.">15.</a></td> <td valign="top" style="text-align:left" class="leftalign"> An oncology drug spill kit, if chemotherapy agents are routinely prepared.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(3)(b)16.">16.</a></td> <td valign="top" style="text-align:left" class="leftalign"> For the purpose of emergency or immediate patient care, compounded sterile preparations are exempted from the requirements as outlined in USP 797.</td> </tr> </table> </td> </tr> </table> </td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(4)">(4)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Minimum equipment for pharmacies compounding non-sterile preparations. <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(4)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A compounding pharmacy must have all equipment required of a pharmacy in Chapter 480-10 of the Board Rules.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(4)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Additionally, a compounding pharmacy must have the appropriate equipment for use in compounding as defined in USP Chapters 795 and 797.</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="480-11-.04(5)">(5)</a></td> <td valign="top" style="text-align:left" class="leftalign"> References. In addition to references required of a pharmacy, pharmacies compounding sterile pharmaceuticals shall also have a current edition of or electronic access to an established reference on IV stability and incompatibility, such as, Handbook on Injectable Drugs or King's Guide to Parenteral Admixtures, current Federal requirements for sterile compounding and other reference material including but not limited to: <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(5)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> "USP Pharmacists Pharmacopeia",</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="480-11-.04(6)">(6)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Variances. <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(6)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The pharmacist-in-charge may submit to the Georgia State Board of Pharmacy a typed request for a variance to the provisions relating to minimum equipment requirements. The reasons for the request for a variance must be included in the submitted request. A variance shall be granted by the Board only when, in the judgment of the Board, there are sound reasons for doing so that relate to the necessary or efficient delivery of health care. After consideration by the Board, the requestor will be notified of the Board's decision in writing.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.04(6)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> If approved, said letter(s) will serve as proof of the Board's approval for the variance indicated in the letter, and must be posted next to the inspection report.</td> </tr> </table> </td> </tr> </table> <h2><a href="/GAC/480-11-.05" name="480-11-.05" title="480-11-.05">Rule 480-11-.05 Drug Compounding Controls</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="480-11-.05(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> For compounding of drugs in anticipation of prescription drug orders: <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.05(1)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> There shall be written procedures for the compounding of drug preparations to assure that the finished preparations have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include a listing of the components (ingredients), their amounts (in weight or volume), the order of component mixing, and a description of the compounding process. All equipment and utensils and the container/closure system, relevant to the sterility and stability of the intended use of the drug, shall be listed. These written procedures shall be followed in the execution of the drug compounding procedure. Nothing in these rules shall prohibit or exclude the use of electronic or computer equipment to meet these requirements.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.05(1)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Components for drug preparation compounding shall be accurately weighed, measured, or subdivided as appropriate. These operations should be checked and rechecked by the compounding pharmacist at each stage of the process to ensure that each weight or measure is correct as stated in the written compounding procedures. If a component is transferred from the original container to another (e.g., a powder is taken from the original container, weighed, placed/stored in an appropriate container), the new container shall be appropriate and shall be identified with the: <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.05(1)(b)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Component name; 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="480-11-.05(1)(b)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Weight or measure.</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="480-11-.05(1)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> To assure the reasonable uniformity and integrity of compounded drug preparations, written procedures shall be established and followed that describe the tests or examinations to be conducted on the preparation compounded (e.g., degree of weight variation among capsules.) Such control procedures shall be established to monitor the output and to validate the performance of those compounding processes that may be responsible for causing variability in the final drug preparation. Such control procedures shall include, but are not limited to, the following (where appropriate): <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.05(1)(c)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Capsule weight variation;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.05(1)(c)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Adequacy of mixing to assure uniformity and homogeneity;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.05(1)(c)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign"> Clarity, completeness, or pH of solutions.</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="480-11-.05(1)(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Appropriate written procedures designed to prevent microbiological contamination of compounded drug preparations purporting to be sterile shall be established and followed. Such procedures shall include validation of any sterilization process.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.05(1)(e)">(e)</a></td> <td valign="top" style="text-align:left" class="leftalign"> All personnel involved in any step of the compounding process shall be clearly identified in the compounding record. The compounding record must document 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="480-11-.05(1)(e)1.">1.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The ingredients and amounts or volumes used including the source, lot numbers and expiration dates;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.05(1)(e)2.">2.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The order of the mixing or preparation of the preparation including the date mixed;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.05(1)(e)3.">3.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The identity of the pharmacist and any staff member involved in each step of the procedure; 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="480-11-.05(1)(e)4.">4.</a></td> <td valign="top" style="text-align:left" class="leftalign"> The pharmacy's lot or identification number and expiration date for the compounded drug/ preparation if applicable.</td> </tr> </table> </td> </tr> </table> </td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.05(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Compounding of drugs for an individual prescription drug order. The pharmacist must document in a readily retrievable manner, 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="480-11-.05(2)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The ingredients and lot numbers used in the compounding;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.05(2)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The amounts (weights or volumes) of each ingredient;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.05(2)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The order of component mixing;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.05(2)(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A description of the compounding process;</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.05(2)(e)">(e)</a></td> <td valign="top" style="text-align:left" class="leftalign"> The name of the responsible pharmacist and all other personnel involved in each step of the compounding; 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="480-11-.05(2)(f)">(f)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Appropriate written procedures designed to prevent microbiological contamination if the compounded prescription is purported to be sterile.</td> </tr> </table> </td> </tr> </table> <h2><a href="/GAC/480-11-.06" name="480-11-.06" title="480-11-.06">Rule 480-11-.06 Labeling and Control of Excess Preparations</a></h2> <P>In the case where a quantity of compounded drug preparation is in excess of that to be initially dispensed is prepared, the excess preparation shall be labeled or documentation referenced with the complete list of ingredients (components), the preparation date, and the assigned beyond-use date based upon the pharmacist's professional judgment, appropriate testing, or published data. It shall also be stored and accounted for under conditions dictated by its composition and stability characteristics (e.g., in a clean, dry place on a shelf or in the refrigerator) to ensure its strength, quality, and purity as outlined in Rule <a title="480-11-.07" href="480-11-.07">480-11-.07</a>.</P> <h2><a href="/GAC/480-11-.07" name="480-11-.07" title="480-11-.07">Rule 480-11-.07 Control of Components and Drug Preparation Containers and Closures</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="480-11-.07(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Components, drug preparation containers, closures, and bagged or boxed components of drug preparation containers and closures used in the compounding of drugs shall be handled and stored in a manner to prevent contamination and to permit unhindered cleaning of the work area (e.g., floors) and inspection.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.07(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Drug preparation containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the compounded drug beyond the desired result. Components, drug preparation containers, and closures for use in the compounding of drug preparations shall be rotated so that the oldest stock is used first. Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the compounded drug preparation. Drug preparation containers and closures shall be clean and, where indicated by the intended use of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.07(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Drug preparation containers and closures intended for the compounding of sterile preparations must be handled, sterilized, processed and stored to remove pyrogenic properties to assure that they are suitable for their intended purpose. Methods of cleaning, sterilizing, and processing to remove pyrogenic properties shall be written and followed for drug preparation containers and closures used in the preparation of sterile pharmaceuticals. These processes shall be performed by pharmacists or under the pharmacist's supervision.</td> </tr> </table> <h2><a href="/GAC/480-11-.08" name="480-11-.08" title="480-11-.08">Rule 480-11-.08 Records and Reports</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="480-11-.08(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Any procedures or other records required to be maintained in compliance with this chapter shall be retained for the same period of time as required in chapter 480-10 of the Board Rules for the retention of prescription files.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.08(2)">(2)</a></td> <td valign="top" style="text-align:left" class="leftalign"> All records required to be retained under this chapter or copies of such records, shall be readily available for authorized inspection during the retention period at the establishment where the activities described in such records occurred. These records or copies thereof shall be subject to photocopying or other means of reproduction as part of any such inspection.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.08(3)">(3)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Records required under this chapter may be retained either as the original records or as true copies, such as photocopies, microfilm, microfiche, electronic files or other accurate reproductions of the original records. All records or reports must be producible immediately if requested by the Board or an agent of the GDNA or within forty-eight (48) hours if maintained in a central database.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.08(4)">(4)</a></td> <td valign="top" style="text-align:left" class="leftalign"> In addition to standard record and reporting requirements, the following records and reports must be maintained for sterile pharmaceuticals: <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.08(4)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> A policy and procedure manual, including policies and procedures for cytotoxic and/or infectious waste, if applicable; 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="480-11-.08(4)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> Lot numbers and expiration dates of all the components used in compounding sterile prescription drug orders.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.08(4)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> This record-keeping requirement does not apply when FDA approved and labeled sterile injectable drug products, produced by registered pharmaceutical manufacturers, are reconstituted under conditions as allowed by USP 797, and each such sterile drug product must be administered within 24 hours of being reconstituted.</td> </tr> </table> </td> </tr> </table> <h2><a href="/GAC/480-11-.09" name="480-11-.09" title="480-11-.09">Rule 480-11-.09 Quality Assurance Program for Compounding and Preparation of Sterile Pharmaceuticals</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="480-11-.09(1)">(1)</a></td> <td valign="top" style="text-align:left" class="leftalign"> There shall be a documented, ongoing quality assurance control program that monitors personnel performance, equipment, and facilities. Appropriate samples of finished preparations shall be examined to assure that the pharmacy is capable of consistently preparing sterile pharmaceuticals meeting specifications. <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.09(1)(a)">(a)</a></td> <td valign="top" style="text-align:left" class="leftalign"> All clean rooms, ante rooms, barrier isolators and laminar flow hoods shall be certified following procedures such as those outlined in the CETA Certification Guide for Sterile Compounding Facilities (CAG-003-2005) should be performed by a qualified individual no less than every six months whenever the device or room is relocated, altered, or major service to the facility is performed. Appropriate documentation and records shall be maintained.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.09(1)(b)">(b)</a></td> <td valign="top" style="text-align:left" class="leftalign"> There shall be written procedures developed requiring sampling if microbial contamination is suspected.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.09(1)(c)">(c)</a></td> <td valign="top" style="text-align:left" class="leftalign"> If bulk compounding of parenteral solutions is performed using non-sterile chemicals, extensive end preparation testing must be documented prior to the release of the preparation from quarantine. This process must include appropriate tests for particulate matter and testing for pyrogens.</td> </tr> </table> <table border="0" width="100%" cellspacing="4" cellpadding="4"> <tr> <td valign="top" width="1%" style="white-space:nowrap;text-align:left;width:18px;"><a style="white-space:nowrap;" name="480-11-.09(1)(d)">(d)</a></td> <td valign="top" style="text-align:left" class="leftalign"> There shall be documentation of quality assurance audits at regular, planned intervals, including infection control and sterile technique audits.</td> </tr> </table> </td> </tr> </table> <h2><a href="/GAC/480-11-.10" name="480-11-.10" title="480-11-.10">Rule 480-11-.10 Exceptions</a></h2> <P>The requirements of this chapter do no apply to the compounding or mixing of FDA-approved drugs preparations pursuant to the manufacturer's directions for dispensing including but not limited to the reconstitution of oral suspensions, combination of the components of topical preparations, etc.</P> </div> </div> </HTML> </div> <div id="toc" class="sidebar noprint"> <ul id="toc-children" class="children"><li><a href="/GAC/480-11-.01" name="480-11-.01" title="480-11-.01">Rule 480-11-.01 Definitions</a></li><li><a href="/GAC/480-11-.02" name="480-11-.02" title="480-11-.02">Rule 480-11-.02 Compounded Drug Preparations</a></li><li><a href="/GAC/480-11-.03" name="480-11-.03" title="480-11-.03">Rule 480-11-.03 Organization and Personnel</a></li><li><a href="/GAC/480-11-.04" name="480-11-.04" title="480-11-.04">Rule 480-11-.04 Facilities and Equipment</a></li><li><a href="/GAC/480-11-.05" name="480-11-.05" title="480-11-.05">Rule 480-11-.05 Drug Compounding Controls</a></li><li><a href="/GAC/480-11-.06" name="480-11-.06" title="480-11-.06">Rule 480-11-.06 Labeling and Control of Excess Preparations</a></li><li><a href="/GAC/480-11-.07" name="480-11-.07" title="480-11-.07">Rule 480-11-.07 Control of Components and Drug Preparation Containers and Closures</a></li><li><a href="/GAC/480-11-.08" name="480-11-.08" title="480-11-.08">Rule 480-11-.08 Records and Reports</a></li><li><a href="/GAC/480-11-.09" name="480-11-.09" title="480-11-.09">Rule 480-11-.09 Quality Assurance Program for Compounding and Preparation of Sterile Pharmaceuticals</a></li><li><a href="/GAC/480-11-.10" name="480-11-.10" title="480-11-.10">Rule 480-11-.10 Exceptions</a></li></ul> </div> </div> <!--content ends here--> <div id="footer" class="noprint"><span class="footer">Copyright &copy; 2019 Lawriter LLC - All rights reserved.</span>| <a href="mailto:support@casemakerlegal.com?subject=Rules and Regulations of the State of Georgia">Email Us</a> | 844-838-0769 | <a href="http://livechat.casemakerlegal.com/client.php?locale=en" target="_blank" onclick="if(navigator.userAgent.toLowerCase().indexOf('opera') != -1 && window.event.preventDefault)window.event.preventDefault();this.newWindow = window.open('http://livechat.casemakerlegal.com/client.php?locale=en&url='+escape(document.location.href)+'&referrer='+escape(document.referrer), 'webim','toolbar=0,scrollbars=0,location=0,status=1,menubar=0,width=640,height=480,resizable=1');this.newWindow.focus();this.newWindow.opener=window;return false;">Live Chat</a> </div> </div> </body> </html>