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id="page-title">The Compounding Corner</h1> </div> </div> </div> <div id="page"> <div id="main-wrapper"> <div id="main"> <div id="content" class="column" role="main"> <a id="main-content"></a> <div id="content-area"> <div class="panel-2col-stacked clearfix panel-display" > <div class="panel-col-top panel-panel"> <div class="inside"><div class="panel-pane pane-views-panes pane-ethosce-slideshow-panel-pane-1" > <div class="pane-content"> <div class="view view-ethosce-slideshow view-id-ethosce_slideshow view-display-id-panel_pane_1 view-dom-id-6f9ead24d9a46c1c97e72004d9e85345"> <div class="view-content"> <div class="skin-default"> <div id="views_slideshow_cycle_main_ethosce_slideshow-panel_pane_1_1" class="views_slideshow_cycle_main views_slideshow_main"><div id="views_slideshow_cycle_teaser_section_ethosce_slideshow-panel_pane_1_1" class="views-slideshow-cycle-main-frame views_slideshow_cycle_teaser_section"> <div id="views_slideshow_cycle_div_ethosce_slideshow-panel_pane_1_1_0" class="views-slideshow-cycle-main-frame-row views_slideshow_cycle_slide views_slideshow_slide views-row-1 views-row-first views-row-odd" aria-labelledby='views_slideshow_pager_field_item_bottom_ethosce_slideshow-panel_pane_1_1_0'> <div class="views-slideshow-cycle-main-frame-row-item views-row views-row-0 views-row-odd views-row-first"> <div class="views-field views-field-edit-node"> <span class="field-content"></span> </div> <div class="views-field views-field-nothing"> <span class="field-content"><div class="clear-block"> <a href=https://education.aaaai.org/compounding-corner/compoundingcorner><img typeof="foaf:Image" src="https://education.aaaai.org/sites/default/files/styles/slideshow_group_image/public/slideshow/2023-05/CompoundCrnr-650x250-v2.jpg?itok=R4EKg96r" width="1200" height="462" alt="" /></a> </div></span> </div> <div class="views-field views-field-counter"> <span class="field-content"> </span> </div></div> </div> </div> </div> </div> </div> </div> </div> </div> <div class="panel-pane pane-custom pane-6" > <h3 class="pane-title">Welcome!</h3> <div class="pane-content"> <p>USP has finalized the Chapter 797 standards for sterile compounding, including standards specifically for physician in-office compounding of allergen extracts in allergy practices, with an implementation date of November 1, 2023. The purpose of the standards is to ensure safe treatment of an allergy clinic's patients. <br /> <br />The Compounding Corner has been established to prepare physicians, practice managers, and clinic staff at allergy practices to achieve and maintain compliance ahead of the updated implementation date. Ensure your practice is ready by browsing our resources and working through our training module below. View the final language from the allergenic extracts section <a href="https://education.aaaai.org/sites/default/files/media/2023-05/Section%2021%20Allergen%20Extracts.pdf" target="_blank">here</a>.</p><p>The contents of this page are currently under review. We welcome your feedback at <a href="mailto:practicemanagement@aaaai.org">practicemanagement@aaaai.org</a>. </p> </div> </div> <div class="panel-pane pane-views-panes pane-ethosce-courses-blocks-enduring-courses" > <h3 class="pane-title">AAAAI Training Module</h3> <div class="pane-content"> <div class="view view-ethosce-courses-blocks view-id-ethosce_courses_blocks view-display-id-enduring_courses group-live-courses view-dom-id-ccf0ce2de6d3773f0625c34a5189d186"> <div class="view-content"> <table class="views-table cols-4 footable fooicon-expanded-minus fooicon-collapsed-plus" id="footable"> <thead> <tr> <th data-type="html" data-breakpoints=""class="views-field views-field-title" > <a href="/compounding-corner/compoundingcorner?sort_by=field_course_date_value&sort_order=DESC&order=title&sort=asc" title="sort by Activity Title" class="active">Activity Title</a> </th> <th data-type="html" data-breakpoints="xs"class="views-field views-field-course-credit-types" > Credit </th> <th data-type="html" data-breakpoints="xs"class="views-field views-field-sell-price" > <a href="/compounding-corner/compoundingcorner?sort_by=field_course_date_value&sort_order=DESC&order=sell_price&sort=asc" title="sort by Cost" class="active">Cost</a> </th> <th data-type="html" data-breakpoints="xs"class="views-field views-field-field-course-date" > <a href="/compounding-corner/compoundingcorner?sort_by=field_course_date_value&sort_order=DESC&order=field_course_date&sort=asc" title="sort by Start and Expiration Dates" class="active">Start and Expiration Dates</a> </th> </tr> </thead> <tbody> <tr class="odd views-row-first"> <td class="views-field views-field-title" > <a href="/compounding-corner/node/30339">Allergen Extract Compounding Quiz 2024/2025</a> </td> <td class="views-field views-field-course-credit-types" > <div class="item-list"><ul><li class="first last"><div class="item-list"><ul class="course-credit-list"><li class="first last">0.00 Attendance</li> </ul></div></li> </ul></div> </td> <td class="views-field views-field-sell-price" > <span class="uc-price">$25.00</span> </td> <td class="views-field views-field-field-course-date" > <span class="date-display-range"><span class="date-display-start" property="dc:date" datatype="xsd:dateTime" content="2024-08-01T00:00:00-05:00">08/01/2024 - 12:00am</span> to <span class="date-display-end" property="dc:date" datatype="xsd:dateTime" content="2025-07-31T23:59:00-05:00">07/31/2025 - 11:59pm</span></span> </td> </tr> <tr class="even views-row-last"> <td class="views-field views-field-title" > <a href="/compounding-corner/node/29830">Preparing Allergen Immunotherapy Extracts</a> </td> <td class="views-field views-field-course-credit-types" > <div class="item-list"><ul><li class="first last"><div class="item-list"><ul class="course-credit-list"><li class="first last">0.00 Attendance</li> </ul></div></li> </ul></div> </td> <td class="views-field views-field-sell-price" > <span class="uc-price">$0.00</span> </td> <td class="views-field views-field-field-course-date" > <span class="date-display-range"><span class="date-display-start" property="dc:date" datatype="xsd:dateTime" content="2023-09-18T00:00:00-05:00">09/18/2023 - 12:00am</span> to <span class="date-display-end" property="dc:date" datatype="xsd:dateTime" content="2025-06-30T23:59:00-05:00">06/30/2025 - 11:59pm</span></span> </td> </tr> </tbody> </table> </div> </div> </div> </div> </div> </div> <div class="center-wrapper"> <div class="panel-col-first panel-panel"> <div class="inside"><div class="panel-pane pane-custom pane-3" > <h3 class="pane-title">Guides to Compliance</h3> <div class="pane-content"> <h4>Facility</h4><p><span class="file"><img class="file-icon" alt="PDF icon" title="application/pdf" src="/modules/file/icons/application-pdf.png" /> <a href="https://education.aaaai.org/sites/default/files/media/2023-11/AECA%20or%20PEC%20Hood%20-%20which%20will%20you%20choose.pdf" type="application/pdf; length=908290">AECA or PEC Hood.pdf</a></span></p><p><span class="file"><img class="file-icon" alt="PDF icon" title="application/pdf" src="/modules/file/icons/application-pdf.png" /> <a href="https://education.aaaai.org/sites/default/files/AECA%20Cleaning%20Procedure_0.pdf" type="application/pdf; length=141492">AECA Cleaning Procedure</a></span></p><p><span class="file"><img class="file-icon" alt="PDF icon" title="application/pdf" src="/modules/file/icons/application-pdf.png" /> <a href="https://education.aaaai.org/sites/default/files/PEC%20or%20Hood%20Cleaning%20Procedure_0.pdf" type="application/pdf; length=140387">PEC ("Hood") Cleaning Procedure</a></span></p><p><span class="file"><img class="file-icon" alt="File" title="application/vnd.openxmlformats-officedocument.wordprocessingml.document" src="/modules/file/icons/x-office-document.png" /> <a href="https://education.aaaai.org/sites/default/files/Refrigerator%20Temperature%20Log.docx" type="application/vnd.openxmlformats-officedocument.wordprocessingml.document; length=56104">Refrigerator Temperature Log</a></span></p><h4>Personnel Training and Competency</h4><p><span class="file"><img class="file-icon" alt="PDF icon" title="application/pdf" src="/modules/file/icons/application-pdf.png" /> <a href="https://education.aaaai.org/sites/default/files/media/2023-07/Hand%20Hygiene%20and%20Garbing%202023.pdf" type="application/pdf; length=174174">Hand Hygiene and Garbing 2023</a></span></p><p><span class="file"><img class="file-icon" alt="PDF icon" title="application/pdf" src="/modules/file/icons/application-pdf.png" /> <a href="https://education.aaaai.org/sites/default/files/media/2023-07/Gloved%20Fingertip%20and%20Thumb%20Sampling%202023.pdf" type="application/pdf; length=239223">Gloved Fingertip and Thumb Sampling 2023</a></span></p><p><span class="file"><img class="file-icon" alt="PDF icon" title="application/pdf" src="/modules/file/icons/application-pdf.png" /> <a href="https://education.aaaai.org/sites/default/files/media/2023-07/Media%20Fill%20Testing%202023.pdf" type="application/pdf; length=182471">Media Fill Testing 2023</a></span></p><p><span class="file"><img class="file-icon" alt="File" title="application/vnd.openxmlformats-officedocument.wordprocessingml.document" src="/modules/file/icons/x-office-document.png" /> <a href="https://education.aaaai.org/sites/default/files/Personnel%20Training%20Form_1.docx" type="application/vnd.openxmlformats-officedocument.wordprocessingml.document; length=17224">Personnel Training Log</a></span></p><h4>Documentation</h4><p><span class="file"><img class="file-icon" alt="PDF icon" title="application/pdf" src="/modules/file/icons/application-pdf.png" /> <a href="https://education.aaaai.org/sites/default/files/media/2023-06/Documentation%20Requirements%20for%20Allergen%20Extract%20Compounding.pdf" type="application/pdf; length=903375">Documentation Requirements for Allergen Extract Compounding</a></span></p><p><span class="file"><img class="file-icon" alt="PDF icon" title="application/pdf" src="/modules/file/icons/application-pdf.png" /> <a href="https://education.aaaai.org/sites/default/files/media/2023-11/Compliant%20allergen%20extract%20vial%20label.pdf" type="application/pdf; length=916662">Compliant allergen extract vial label.pdf</a></span></p><p><span class="file"><img class="file-icon" alt="File" title="application/vnd.openxmlformats-officedocument.spreadsheetml.sheet" src="/modules/file/icons/x-office-spreadsheet.png" /> <a href="https://education.aaaai.org/sites/default/files/media/2023-12/Sample%20-%20Allergy%20Injection%20Compunding%20Spreadsheet%2012.2023.xlsx" type="application/vnd.openxmlformats-officedocument.spreadsheetml.sheet; length=15406">Sample - Allergy Injection Compounding Spreadsheet 12.2023.xlsx</a></span></p><p><span class="file"><img class="file-icon" alt="File" title="application/vnd.openxmlformats-officedocument.wordprocessingml.document" src="/modules/file/icons/x-office-document.png" /> <a href="https://education.aaaai.org/sites/default/files/media/2023-10/Sample%20-%20Standard%20Operating%20Procedure%20for%20Preparation%20of%20Allergy%20Immunotherapy%20Extracts%20%28AIT%29.docx" type="application/vnd.openxmlformats-officedocument.wordprocessingml.document; length=23867">Sample - Standard Operating Procedure for Preparation of Allergy Immunotherapy Extracts (AIT).docx</a></span></p><p><span class="file"><img class="file-icon" alt="PDF icon" title="application/pdf" src="/modules/file/icons/application-pdf.png" /> <a href="https://education.aaaai.org/sites/default/files/media/2023-10/Steps%20to%20Comply%20with%20USP_1.pdf" type="application/pdf; length=410005">Steps to Comply with USP.pdf</a></span></p> </div> </div> </div> </div> <div class="panel-col-last panel-panel"> <div class="inside"><div class="panel-pane pane-custom pane-4" > <h3 class="pane-title">AAAAI Resources on Chapter 797</h3> <div class="pane-content"> <p><span class="file"><img class="file-icon" alt="PDF icon" title="application/pdf" src="/modules/file/icons/application-pdf.png" /> <a href="https://education.aaaai.org/sites/default/files/media/2023-06/Prepping%20for%20Practice-%20AIT%20USP%20and%20Tools%20for%20a%20Successful%20Start.pdf" type="application/pdf; length=1405756">Prepping for Practice: AIT, USP and Tools for a Successful Start</a></span></p><p><a href="https://www.buzzsprout.com/2049216/12860631">Podcast Episode 91: What USP 797 Means for Allergists</a></p><p><a href="https://www.aaaai.org/Professional-Education/Podcasts/Patient-Centered-Care" target="_blank">Podcast Episode: Episode 9: Hot Topics: USP Chapter 797 Standards for Allergen Immunotherapy</a> </p><p><span class="file"><img class="file-icon" alt="PDF icon" title="application/pdf" src="/modules/file/icons/application-pdf.png" /> <a href="https://education.aaaai.org/sites/default/files/media/2023-03/23CompHandout-Garbing-v1-hires.pdf" type="application/pdf; length=145957">Summary of Personnel Requirements</a></span></p><p><span class="file"><img class="file-icon" alt="PDF icon" title="application/pdf" src="/modules/file/icons/application-pdf.png" /> <a href="https://education.aaaai.org/sites/default/files/media/2023-03/Media%20fill%20test%20vendors.pdf" type="application/pdf; length=336133">Media fill test vendors</a></span></p> </div> </div> <div class="panel-pane pane-custom pane-5" > <h3 class="pane-title">Related Resources</h3> <div class="pane-content"> <p><a href="https://www.aaaai.org/Aaaai/media/MediaLibrary/PDF%20Documents/Practice%20and%20Parameters/Allergen-immunotherapy-Jan-2011.pdf" target="_blank">Allergen Immunotherapy Practice Parameter</a></p><p><a href="https://education.aaaai.org/sites/default/files/media/2023-06/Subcutaneous%20Allergen%20Immunotherapy%20Extract%20Preparation%20for%20Aeroallergens%20and%20Venom.pdf" target="_blank">Subcutaneous Allergen Immunotherapy Extract Preparation for Aeroallergens and Venom</a><br />This chapter has been updated to reflect the new USP 797 Guidelines for Pharmaceutical Compounding – Sterile Preparations that go into effect November 1, 2023. Please note: This information is provided as a PRACTICE MANAGEMENT RESOURCE ONLY. This chapter is NOT INTENDED OR AUTHORIZED TO BE USED AS A REQUIREMENT FOR BILLING PURPOSES.</p><p><a href="https://education.aaaai.org/ITRxMixing" target="_blank">A Case-Based Immunotherapy Prescription Mixing Workshop</a> Video of 2019 Annual Meeting Session</p> </div> </div> </div> </div> </div> <div class="panel-col-bottom panel-panel"> <div class="inside"><div class="panel-pane pane-custom pane-1" > <h3 class="pane-title">Frequently Asked Questions</h3> <div class="pane-content"> <p>Have a question that wasn't answered in the training module? Check our list of FAQs below. </p><p style="margin-left:40px"><strong>Q: What in the new standards applies to allergen extract mixing?</strong><br />A: From the USP chapter 797 posted for 2021 update:</p><p style="margin-left:40px">Allergenic extracts: Licensed allergenic extracts are mixed and diluted to prepare prescription sets for administration to patients. A prescription set is a vial or set of vials of premixed licensed allergenic extracts for subcutaneous immunotherapy that have been diluted with an appropriate diluent for an individual patient. Because of certain characteristics of allergenic extracts and allergy practice, preparation of allergenic extract prescription sets is not subject to the requirements in this chapter that are applicable to other sterile CSPs. The standards for compounding allergenic extracts, which are described in 21. </p><p style="margin-left:40px">Compounding Allergenic Extracts, are applicable only when: </p><ul style="margin-left:40px"><li>The compounding process involves transfer via sterile needles and syringes of conventionally manufactured sterile allergen products and appropriate conventionally manufactured sterile added substances; and </li><li>Manipulations are limited to penetrating stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile vials </li></ul><p style="margin-left:40px"><strong>Q: Is a sink necessary in the same room as the dedicated Allergen Extract Compounding Area (AECA) in order to perform the hand washing procedure?</strong><br />A: If a sink is present it must be at least one meter from the dedicated AECA. There is no requirement that there be a sink in the AECA. </p><p style="margin-left:40px"><strong>Q: Can a ceiling fan circulate in the room while compounding occurs, or must the room be climate controlled?</strong><br />A: A ceiling fan may not be circulating in the room while compounding occurs, nor may the dedicated Allergen Extract Compounding Area be adjacent to other environmental control challenges. </p><p style="margin-left:40px"><strong>Q: Does a physician always need to be on site during allergen extract mixing?</strong><br />A: Yes, according to the current Allergen Immunotherapy Practice Parameter.</p><p style="margin-left:40px"><strong>Q: Where can I access the required written test?</strong><br />A: A sample written test will be available here in the Compounding Corner in June, 2023.</p><p style="margin-left:40px"><strong>Q: I have carpeting in my compounding area. Do I need to replace my flooring? </strong><br />Yes. Under the existing rules, no area in which compounding is being performed should have carpeting.</p> </div> </div> <div class="panel-pane pane-custom pane-2" > <h3 class="pane-title">Contact Us</h3> <div class="pane-content"> <p><span style="font-size:11pt"><span style="line-height:normal"><span style="font-family:"Calibri",sans-serif"><span style="font-size:12.0pt">Questions should be directed to <a href="mailto:practicemanagement@aaaai.org">practicemanagement@aaaai.org</a></span></span></span></span></p> </div> </div> <div class="panel-pane pane-node-content" > <div class="pane-content"> <article class="node-25866 node node-learning-group node-promoted node-sticky view-mode-full clearfix" about="/compounding-corner/compoundingcorner" typeof="sioc:Item foaf:Document"> <header> <span property="dc:title" content="" class="rdf-meta element-hidden"></span><span property="sioc:num_replies" content="0" datatype="xsd:integer" class="rdf-meta element-hidden"></span> <p class="submitted"> <span property="dc:date dc:created" content="2019-06-14T09:00:33-05:00" datatype="xsd:dateTime" rel="sioc:has_creator">Submitted by <span class="username" xml:lang="" about="/compounding-corner/user/13697" typeof="sioc:UserAccount" property="foaf:name" datatype="">Ellen Price</span> on <time pubdate datetime="2019-06-14T09:00:33-05:00">Fri, 06/14/2019 - 9:00am</time></span> </p> </header> <div class="field field-name-group-group field-type-list-boolean field-label-above"><div class="field-label">Group: </div><div class="field-items"><div class="field-item even"><a href="/compounding-corner/user/login?destination=node/25866">Subscribe to group</a></div></div></div><div class="field field-name-group-access field-type-list-boolean field-label-above"><div class="field-label">Group visibility: </div><div class="field-items"><div class="field-item even">Public - accessible to all site users</div></div></div> </article> </div> </div> </div> </div> </div> </div> </div> <aside class="sidebars"> <section class="region region-sidebar-first column sidebar"> <div id="block-menu-features" class="block block-menu first last odd" role="navigation"> <h3 class="block__title block-title">Features</h3> <div class="content"> <ul class="menu"><li class="menu__item is-leaf first leaf"><a href="/compounding-corner" class="menu__link front">Home</a></li> <li class="menu__item is-leaf leaf"><a href="/compounding-corner/courses" class="menu__link courses">Courses</a></li> <li class="menu__item is-leaf last leaf"><a href="/compounding-corner/discussions" class="menu__link discussions">Discussions</a></li> </ul> </div> </div> </section> </aside> </div> </div> </div> <footer id="footer"> <div id="footer-inner" class="clearfix"> <p><span style="color:#555555; font-family:Verdana,arial,sans-serif; font-size:11px; line-height:16.5px">Medical content developed and reviewed by the leading experts in allergy, asthma and immunology. </span><br /><span style="color:#555555; font-family:Verdana,arial,sans-serif; font-size:11px; line-height:16.5px">© 2023 American Academy of Allergy, Asthma & Immunology. 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