UPDATED MEETING TIME AND PUBLIC PARTICIPATION INFORMATION: December 4, 2024: Meeting of the Pharmacy Compounding Advisory Committee - 12/04/2024

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<li> <a href="/advisory-committees/advisory-committee-calendar" title="Advisory Committee Calendar"> Advisory Committee Calendar </a> </li> </ol> </section> <main> <article id="main-content" class="article main-content container-fluid" role="article"> <header class="row content-header" role="heading" aria-level="1"> <section id="block-entityviewcontent-6" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <p class="content-type-label text-center">Advisory Committee Meeting | In Person</p> <h1 class="text-center content-title"> <div class="field field--name-field-event-title field--type-string field--label-above"> <div class="field--label">Event Title</div> <div class="field--item">UPDATED MEETING TIME AND PUBLIC PARTICIPATION INFORMATION: December 4, 2024: Meeting of the Pharmacy Compounding Advisory Committee</div> </div> <span class="font-family-sans"> <dd class="cell-2_1"> December 4, 2024</dd> </span> </h1> <div class="lcds-statusbar text-center"> <span class="label label-default"></span> </div> <div class="lcds-toolbar lcds-toolbar--social"> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Fadvisory-committees%2Fadvisory-committee-calendar%2Fupdated-meeting-time-and-public-participation-information-december-4-2024-meeting-pharmacy" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li class="lcds-share__item"> <a 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href="mailto:?subject=UPDATED%20MEETING%20TIME%20AND%20PUBLIC%20PARTICIPATION%20INFORMATION%3A%20December%204%2C%202024%3A%20Meeting%20of%20the%20Pharmacy%20Compounding%20Advisory%20Committee%20-%2012%2F04%2F2024&body=https://www.fda.gov%2Fadvisory-committees%2Fadvisory-committee-calendar%2Fupdated-meeting-time-and-public-participation-information-december-4-2024-meeting-pharmacy" class="lcds-share__btn lcds-share--default__btn-mail"><span class="fa icon-envelope" aria-hidden="true"></span>Email</a> </li> <li class=" lcds-share__item hidden-xs"> <a href="javascript:window.print();" title="Print this page" class="lcds-share__btn lcds-share--default__btn-print"><span class="fa icon-print" aria-hidden="true"></span>Print</a> </li> </ul> <div class="form-group"> </div> </div> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <aside> <h2>On This Page</h2> <ul> <li> <a href="#event-information">Meeting Information</a> </li> <li> <a href="#event-materials">Event Materials</a> </li> </ul> </aside> <hr> <div class="row inset-column" id="event-information"> <div class="col-xs-12 col-md-8"> <dl class="lcds-description-list--event"> <dt class="cell-1_1">Date:</dt> <dd class="cell-2_1"> December 4, 2024</dd> <dt class="cell-1_2">Time:</dt> <dd class="cell-2_2"> 8:00 a.m. - 3:00 p.m. ET </dd> </dl> </div> <div class="col-xs-12 col-md-6"> <dl class="lcds-description-list--grid"> <dt class="cell-1_1">Location:</dt> <dd class="cell-2_1"> <div class="field field--name-field-event-location field--type-entity-reference field--label-above"> <div class="field--label">Event Location</div> <div class="field--items"> <div class="field--item"> FDA Headquarters<br/> FDA headquarters in White Oak, MD<br/> <p class="address" translate="no"><span class="address-line1">10903 New Hampshire Ave</span><br> <span class="locality">Silver Spring</span>, <span class="administrative-area">MD</span> <span class="postal-code">20903</span><br> <span class="country">United States</span></p><br/> </div> </div> </div> </dd> </dl> </div> </div> <hr> <h3>What is an advisory committee?</h3> <p>Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. Please see, "<a href="/consumers/consumer-updates/advisory-committees-give-fda-critical-advice-and-public-voice">Advisory Committees Give FDA Critical Advice and the Public a Voice</a>," for more information.</p> <p><p><div class="callout"> </p> <p>YouTube Broadcast of the Meeting: Pharmacy Compounding Advisory Committee (PCAC) Live Video</p> <p><a href="https://youtube.com/live/E7MlK4p7O7c">YouTube live video link</a></p> <p> </div> </p> <p><strong>Updated Information (as of 11/8/2024):</strong></p> <p>The meeting end time has changed from 3:00 p.m. to <strong>3:50 p.m. Eastern Time</strong>.</p> <p>Additionally, the public participation information has changed as follows:</p> <ul> <li>The date for individuals interested in making formal oral presentations to notify the contact person changed from November 8, 2024 to <strong>November 13, 2024</strong>.</li> <li>The date that the contact person will notify interested persons regarding their request to speak changed from November 12, 2024 to <strong>November 14, 2024</strong>.</li> <li>The start times for oral presentations from the public has changed from approximately 9:35 a.m., 10:50 a.m., and 1:40 p.m. to <strong>10:00 a.m., 11:25 a.m., and 2:30 p.m.</strong> Eastern Time.</li> </ul> <p>Lastly, the location information has been updated to the following: FDA White Oak Campus, 10903 New Hampshire Ave., <strong>Bldg. 2, Room 2047</strong>, Silver Spring, MD 20993-0002. <strong>Room 2047 will have limited seating for the public. Overflow seating will be available in Bldg. 2, Room 2058</strong>.</p> <p>All other information remains the same.</p> <hr /> <p><strong>Center:</strong> Center for Drug Evaluation and Research</p> <p><strong>Location:</strong> The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. The public will also have the option to participate, and the advisory committee meeting will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform.</p> <h2>Agenda</h2> <p>The Committee will discuss the following bulk drug substances being considered for inclusion on the 503A Bulks List: AOD-9604-related bulk drug substances (AOD-9604 acetate, and AOD-9604 (free base)), CJC-1295-related bulk drug substances (CJC-1295 (free base), CJC-1295 acetate, CJC-1295 with drug affinity complex (DAC) (free base), CJC-1295 DAC acetate, and CJC-1295 DAC trifluoroacetate)), and Thymosin alpha-1-related bulk drug substances (Thymosin alpha-1 acetate, and Thymosin alpha-1 (free base)). The chart below identifies the use(s) FDA reviewed for each of the bulk drug substances being discussed at this advisory committee meeting. For nominated bulk drug substances, the nominators of these substances will be invited to make a short presentation supporting the nomination.</p> <table border="1" cellpadding="0" cellspacing="0" class="table table-responsive table-bordered table-striped" summary="Bulk Drug Substances" width="100%"> <tbody> <tr> <th>Bulk Drug Substance</th> <th>Uses Evaluated</th> </tr> <tr> <td>AOD-9604 (free base)<br /> AOD-9604 Acetate</td> <td>Obesity.</td> </tr> <tr> <td>CJC-1295 (free base)<br /> CJC-1295 Acetate<br /> CJC-1295 DAC (free base)<br /> CJC-1295 DAC Acetate<br /> CJC-1295 DAC Trifluoroacetate</td> <td>Growth hormone deficiency.</td> </tr> <tr> <td rowspan="12">Thymosin alpha-1(free base)<br /> Thymosin alpha-1 Acetate</td> <td>Hepatitis B.</td> </tr> <tr> <td>Hepatitis C.</td> </tr> <tr> <td>Human immunodeficiency virus (HIV).</td> </tr> <tr> <td>Coronavirus disease 2019 (COVID-19).</td> </tr> <tr> <td>Depressed response to vaccinations; adjuvant to flu vaccines.</td> </tr> <tr> <td>Malignant melanoma.</td> </tr> <tr> <td>Hepatocellular carcinoma (HCC).</td> </tr> <tr> <td>Non-small cell lung cancer (NSCLC).</td> </tr> <tr> <td>Sepsis.</td> </tr> <tr> <td>Infections after hematopoietic stem cell transplantation (HSCT).</td> </tr> <tr> <td>Chronic obstructive pulmonary disease (COPD).</td> </tr> <tr> <td>Myalgic encephalomyelitis and chronic fatigue syndrome (ME/CFS).</td> </tr> </tbody> </table> <h2>Meeting Materials</h2> <p>FDA intends to make background material and the link to the live webcast available to the public no later than two (2) business days before the meeting in the Event Materials section of this web page. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting and on FDA’s website at the time of the advisory committee meeting. The online presentation of materials will include slide presentations with audio and video components in a manner that most closely resembles an in-person advisory committee meeting.</p> <h2>Public Participation Information</h2> <p>Interested persons may present data, information, or views, orally or in writing, on issues pending before the Committee.</p> <p>FDA is establishing a docket for public comment on this meeting. The docket number is <strong>FDA-2024-N-4777</strong>. The docket will close on December 3, 2024. Submit either electronic or written comments on this public meeting by December 3, 2024. Please note that late, untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 3, 2024. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.</p> <p>Comments received on or before November 19, 2024 will be provided to the Committee. Comments received after that date but by December 3, 2024 will be taken into consideration by FDA. In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate.</p> <p>You may submit comments as follows:</p> <h2>Electronic Submissions</h2> <p>Submit electronic comments in the following way:</p> <ul> <li>Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.</li> <br /> <li>If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).</li> </ul> <h2>Written/Paper Submissions</h2> <p>Submit written/paper submissions as follows:</p> <ul> <li>Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.</li> <br /> <li>For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”</li> </ul> <p><strong>Instructions:</strong> All submissions received must include the Docket No. <strong>FDA-2024-N-4777</strong> for “Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments--Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List.” Received comments, those filed in a timely manner, will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.</p> <ul> <li>Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify the information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: <a href="https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.</li> </ul> <p><strong>Docket:</strong> For access to the docket to read background documents or the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.</p> <h2>Oral Presentations</h2> <p>Oral presentations from the public will be scheduled following FDA presentations. FDA has allotted approximately 1 hour for open public hearing presentations, which will be split to allow for public remarks on each substance. The sessions will begin at approximately 9:35 a.m., 10:50 a.m., and 1:40 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, whether they would like to present online or in-person, and an indication of the approximate time requested to make their presentation on or before November 8, 2024.</p> <p>Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. FDA may also extend the time scheduled for open public hearing presentations depending on interest. Similarly, room for interested persons to participate in-person may be limited. If the number of registrants requesting to speak in-person during the open public hearing is greater than can be reasonably accommodated in the venue for the in-person portion of the advisory committee meeting, FDA may conduct a lottery to determine the speakers who will be invited to participate in-person. The contact person will notify interested persons regarding their request to speak by November 12, 2024.</p> <h2>Webcast Information</h2> <p>CDER plans to provide a free of charge, live webcast of the upcoming advisory committee meeting. If there are instances where the webcast transmission is not successful, staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available no later than two (2) business days before the meeting in the Event Materials section of this web page.</p> <p>CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.</p> <h2>Contact Information</h2> <ul> <li>Takyiah Stevenson, PharmD<br /> Center for Drug Evaluation and Research<br /> Food and Drug Administration<br /> 10903 New Hampshire Avenue<br /> WO31-2417<br /> Silver Spring, MD  20993-0002<br /> Phone: 240-402-2507<br /> Email: <a href="mailto:PCAC@fda.hhs.gov">PCAC@fda.hhs.gov</a></li> </ul> <ul> <li>FDA Advisory Committee Information Line<br /> 1-800-741-8138 (301-443-0572 in the Washington DC area)<br /> Please call the Information Line for up-to-date information on this meeting.</li> <br /> <li>For press inquiries, please contact the Office of Media Affairs at <em><a href="mailto:fdaoma@fda.hhs.gov">fdaoma@fda.hhs.gov</a> or 301–796–4540.</em></li> </ul> <div class="inset-column"> <table class="Table" style="width:7.5in; border:solid #dddddd 1px" width="720"> <thead> <tr> <td style="border-bottom:2px solid #dddddd; width:51%; padding:8px 30px 8px 8px; border-top:none; border-right:1px solid #dddddd; border-left:1px solid #dddddd" valign="bottom"> <p><em><strong>FDA Briefing Information for the December 4, 2024 Meeting of the Pharmacy Compounding Advisory Committee</strong> </em></p> <ol> <li><em><a href="https://www.fda.gov/media/183583/download">Introduction</a></em></li> <li><em>Substances Nominated for Inclusion on the 503A Bulks List (in order of discussion at the meeting) </em> <ol> <li><em><a href="https://www.fda.gov/media/183819/download">CJC-1295-related bulk drug substances</a></em></li> <li><em><a href="https://www.fda.gov/media/183584/download">AOD-9604-related bulk drug substances</a></em></li> <li><em><a href="https://www.fda.gov/media/183820/download">Thymosin alpha-1-related bulk drug substances</a></em></li> </ol> <em> </em></li> </ol> </td> </tr> </thead> </table> </div> </p> <hr> <div class=""> <p>A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s website or call the committee’s Designated Federal Officer (see Contact Information) to learn about possible modifications before coming to the meeting.</p> <p>Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact the committee’s Designated Federal Officer (see Contact Information) at least 7 days in advance of the meeting.</p> <p>Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: <a href="/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings">Common Questions and Answers about FDA Advisory Committee Meetings</a>.</p> <p>FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at <a href="/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings">Public Conduct During FDA Advisory Committee Meetings</a> for procedures on public conduct during advisory committee meetings.</p> <p>Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).</p> </div> <hr> <div class="inset-column" id="event-materials"> <h2>Event Materials</h2> <div class="lcds-datatable lcds-datatable--event-materials"> <table class="table table-bordered"> <thead> <tr> <th class="min-mobile" scope="col" width="20%">Title</th> <th class="min-mobile" scope="col" width="30%">File Type/Size</th> <th class="min-mobile" scope="col" width="15%">Source Organization</th> </tr> </thead> <tbody> <tr> <td><a href="/media/183583/download">December 4, 2024 Meeting of the Pharmacy Compounding Advisory Committee- FDA Briefing Document- Introduction</a></td> <td>pdf (226.26 KB) </td> <td></td> </tr> <tr> <td><a href="/media/183584/download">December 4, 2024 Meeting of the Pharmacy Compounding Advisory Committee- FDA Briefing Document for AOD-9604 Related Bulk Drug Substances</a></td> <td>pdf (2.78 MB) </td> <td></td> </tr> <tr> <td><a href="/media/183641/download">December 4, 2024 Meeting of the Pharmacy Compounding Advisory Committee-, Padma Gulur, MD 18 U.S.C. 208(b)(3) Waiver</a></td> <td>pdf (381.54 KB) </td> <td></td> </tr> <tr> <td><a href="/media/183642/download">December 4, 2024 Meeting of the Pharmacy Compounding Advisory Committee-, Padma Gulur, MD Disclosure Document</a></td> <td>pdf (174.26 KB) </td> <td></td> </tr> <tr> <td><a href="/media/183643/download">December 4, 2024 Meeting of the Pharmacy Compounding Advisory Committee-, Kathleen Gura, PharmD, BCNSP 18 U.S.C. 208(b)(3) Waiver</a></td> <td>pdf (390.07 KB) </td> <td></td> </tr> <tr> <td><a href="/media/183644/download">December 4, 2024 Meeting of the Pharmacy Compounding Advisory Committee-, Kathleen Gura, PharmD, BCNSP MD Disclosure Document</a></td> <td>pdf (452.69 KB) </td> <td></td> </tr> <tr> <td><a href="/media/183645/download">December 4, 2024 Meeting of the Pharmacy Compounding Advisory Committee-, Janet Lee, MD 18 U.S.C. 208(b)(3) Waiver</a></td> <td>pdf (467.11 KB) </td> <td></td> </tr> <tr> <td><a href="/media/183646/download">December 4, 2024 Meeting of the Pharmacy Compounding Advisory Committee-, Janet Lee, MD Disclosure Document</a></td> <td>pdf (172.26 KB) </td> <td></td> </tr> <tr> <td><a href="/media/183819/download">December 4, 2024 Meeting of the Pharmacy Compounding Advisory Committee- FDA Briefing Document for CJC-1295 Related Bulk Drug Substances</a></td> <td>pdf (2.21 MB) </td> <td></td> </tr> <tr> <td><a href="/media/183820/download">December 4, 2024 Meeting of the Pharmacy Compounding Advisory Committee- FDA Briefing Document for Thymosin Alpha-1 Related Bulk Drug Substances</a></td> <td>pdf (6.37 MB) </td> <td></td> </tr> <tr> <td><a href="/media/183891/download">December 4, 2024 Meeting of the Pharmacy Compounding Advisory Committee- FDA Presentations- AM</a></td> <td>pdf (3.20 MB) </td> <td></td> </tr> <tr> <td><a href="/media/183892/download">December 4, 2024 Meeting of the Pharmacy Compounding Advisory Committee- FDA Presentations- PM</a></td> <td>pdf (521.68 KB) </td> <td></td> </tr> <tr> <td><a href="/media/183946/download">December 4, 2024 Meeting of the Pharmacy Compounding Advisory Committee- Webcast Information</a></td> <td>pdf (146.83 KB) </td> <td></td> </tr> <tr> <td><a href="/media/183961/download">December 4, 2024 Meeting of the Pharmacy Compounding Advisory Committee - Committee Roster</a></td> <td>pdf (165.09 KB) </td> <td></td> </tr> <tr> <td><a href="/media/184042/download">December 4, 2024 Meeting of the Pharmacy Compounding Advisory Committee- Final Meeting Roster</a></td> <td>pdf (180.16 KB) </td> <td></td> </tr> <tr> <td><a href="/media/184043/download">December 4, 2024 Meeting of the Pharmacy Compounding Advisory Committee- Final Questions</a></td> <td>pdf (116.20 KB) </td> <td></td> </tr> <tr> <td><a href="/media/184044/download">December 4, 2024 Meeting of the Pharmacy Compounding Advisory Committee- Final Agenda</a></td> <td>pdf (170.26 KB) </td> <td></td> </tr> </tbody> </table> </div> </div> <hr>   </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top"> <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Content current as of:</h2> <p class="lcds-description-list__item-text"><time datetime="2025-01-02T00:00:00Z">01/02/2025</time> </p> </div> </li> <li role="menuitem" class="lcds-description-list__item"> <div> <h2 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UPDATED MEETING TIME AND PUBLIC PARTICIPATION INFORMATION: December 4, 2024: Meeting of the Pharmacy Compounding Advisory Committee - 12/04/2024 | FDA