LSBME AGAIN RECOGNIZED BY THE LORNA BREEN FOUNDATION

The LSBME has been re-recognized as a Wellbeing First Champion for 2024 by ALL IN: Wellbeing First for Healthcare. As a Wellbeing First Champion, LSBME has verified that licensure/renewal applications are free from intrusive and stigmatizing language around mental health care and treatment. This means that health professionals licensed by the LSBME can seek the care they need without fear of losing their license.

pursuant to LSA-R.S. 42:19(A), that the Louisiana State Board of Medical Examiners (the "Board"), within the Louisiana Department of Health, State of Louisiana, shall convene a Regular Call meeting of the Respiratory Therapy Advisory Committee starting at 12:00 P.M., Tuesday, April 15, 2025, at the offices of the Board, 630 Camp Street, New Orleans, Louisiana. Pursuant to La. R.S. 42:17.3 and Act 408 of the 2022 Regular Session, the Respiratory Therapy Advisory Committee will participate via live-streaming video and teleconference for the public session and via non-streaming video and teleconference during the executive session. Members of the public may view the video meeting at the anchor location at 630 Camp Street, New Orleans, Louisiana, or remotely. To view the meeting via YouTube, please go to the website at 

, and from the home page, click on “Advisory Committees” and then “Respiratory Therapy” where a YouTube link to the meeting will be posted at the appointed time of the meeting. Individuals who wish to make a public comment before or during the meeting, may do so by emailing: 

. Public comments comprised of videos and/or audio content must be limited to no more than 3 minutes length and the email size must be less than 10 megabytes. Both requirements must be met, or the content will be refused by our system. All comments received prior to or during the meeting will be identified and acknowledged during the meeting and maintained in the meeting minutes. Members of the public may give verbal comment on any agenda item when the matter comes up for discussion. Individuals wishing to make verbal comment must email 

with the subject line “ZOOM LINK REQUEST” to request a link to the videoconference, identifying themselves by name and relevant affiliation, if any, and the agenda item about which they wish to make verbal comment. This request should be made as far in advance of the meeting as possible so that the request can be processed. The committee will make reasonable efforts to accommodate requests made while the meeting is in progress but cannot guarantee that such requests can be honored. The committee reserves the right to limit or prohibit participation in order to maintain orderly conduct of the meeting in accordance with La. R.S. 42:17(C). Members of the public who choose to view the video meeting at the anchor location may give verbal comment by notifying the presiding officer at the anchor location. The agenda of such meeting shall be as annexed hereto. Note: Regular Meeting held and noticed pursuant to La. Rev. Stat. §42:17A (1), (2), (4), (5) and (10), R.S. 42:17.3 and Act 408 of the 2022 Regular Session. Further, agenda items may be taken out of order and/or in executive session pursuant to R.S 42:17A. La. R.S. 42:17A states “A public body may hold an executive session pursuant to La. R.S. 42:16 for one or more of the following reasons: (1) Discussion of the character, professional competence, or physical or mental health of a person, provided that such person is notified in writing at least twenty-four hours, exclusive of Saturdays, Sundays, and legal holidays, before the scheduled time contained in the notice of the meeting at which such executive session is to take place and that such person may require that such discussion be held at an open meeting.….In cases of extraordinary emergency, written notice to such person shall not be required; however, the public body shall give such notice as it deems appropriate and circumstances permit; (2) Strategy sessions or negotiations with respect to collective bargaining, prospective litigation after formal written demand, or litigation when an open meeting would have a detrimental effect on the bargaining or litigating position of the public body;….(4) Investigative proceedings regarding allegations of misconduct; (5) Cases of extraordinary emergency, which shall be limited to natural disaster, threat of epidemic, civil disturbances, suppression of insurrections, the repelling of invasions, or other matters of similar magnitude; and,….(10) Or any other matters now provided for or as may be provided for by the legislature.”

LOUISIANASTATE BOARD OF MEDICAL EXAMINERS

Respiratory Therapy Advisory Committee Meeting

The LSBME has received information that the State of Michigan may soon withdraw from the Interstate Medical Licensure Compact (IMLC) with immediate effect

If you are currently practicing in the State of Michigan under an IMLC license

, you should contact the Michigan Board of Medicine to determine the status of your credentials and authority to continue to practice in that state.

If you are currently practicing in the State of Louisiana under a IMLC license with a Letter of Qualification from Michigan as your home state, 

the Louisiana State Board of Medical Examiners will extend your authorization to practice for 

, unless a different agreement between the Interstate Medical Licensure Compact Commission and the State of Michigan is reached, or a court order is issued

regarding Michigan’s participation in the IMLC.

The LSBME will update this notice if additional information becomes available.

Michigan may soon withdraw from the IMLC

Michigan may soon withdraw from Interstate Medical Licensure Compact (IMLC) 

, pursuant to LSA-R.S. 42:19(A), that the Louisiana State Board of Medical Examiners (the "Board"), within the Louisiana Department of Health, State of Louisiana, shall convene a Regular Call meeting of the Respiratory Therapy Advisory Committee starting at 12:00 P.M., Tuesday, March 18, 2025, at the offices of the Board, 630 Camp Street, New Orleans, Louisiana. Pursuant to La. R.S. 42:17.3 and Act 408 of the 2022 Regular Session, the Respiratory Therapy Advisory Committee will participate via live-streaming video and teleconference for the public session and via non-streaming video and teleconference during the executive session. 

Members of the public may view the video meeting at the anchor location at 630 Camp Street, New Orleans, Louisiana, or remotely. 

To view the meeting via YouTube, please go to the website at 

, and from the home page, click on “Advisory Committees” and then “Respiratory Therapy” where a YouTube link to the meeting will be posted at the appointed time of the meeting. 

Individuals who wish to make a public comment before or during the meeting, may do so by emailing: 

. Public comments comprised of videos and/or audio content must be limited to no more than 3 minutes length and the email size must be less than 10 megabytes. Both requirements must be met, or the content will be refused by our system. All comments received prior to or during the meeting will be identified and acknowledged during the meeting and maintained in the meeting minutes. 

Members of the public may give verbal comment on any agenda item when the matter comes up for discussion. Individuals wishing to make verbal comment must email 

 with the subject line “ZOOM LINK REQUEST” to request a link to the videoconference, identifying themselves by name and relevant affiliation, if any, and the agenda item about which they wish to make verbal comment. This request should be made as far in advance of the meeting as possible so that the request can be processed. The committee will make reasonable efforts to accommodate requests made while the meeting is in progress but cannot guarantee that such requests can be honored. The committee reserves the right to limit or prohibit participation in order to maintain orderly conduct of the meeting in accordance with La. R.S. 42:17(C). Members of the public who choose to view the video meeting at the anchor location may give verbal comment by notifying the presiding officer at the anchor location. 

The agenda of such meeting shall be as annexed hereto. 

Note: Regular Meeting held and noticed pursuant to La. Rev. Stat. §42:17A (1), (2), (4), (5) and (10), R.S. 42:17.3 and Act 408 of the 2022 Regular Session. Further, agenda items may be taken out of order and/or in executive session pursuant to R.S 42:17A. La. R.S. 42:17A states “A public body may hold an executive session pursuant to La. R.S. 42:16 for one or more of the following reasons: (1) Discussion of the character, professional competence, or physical or mental health of a person, provided that such person is notified in writing at least twenty-four hours, exclusive of Saturdays, Sundays, and legal holidays, before the scheduled time contained in the notice of the meeting at which such executive session is to take place and that such person may require that such discussion be held at an open meeting.….In cases of extraordinary emergency, written notice to such person shall not be required; however, the public body shall give such notice as it deems appropriate and circumstances permit; (2) Strategy sessions or negotiations with respect to collective bargaining, prospective litigation after formal written demand, or litigation when an open meeting would have a detrimental effect on the bargaining or litigating position of the public body;….(4) Investigative proceedings regarding allegations of misconduct; (5) Cases of extraordinary emergency, which shall be limited to natural disaster, threat of epidemic, civil disturbances, suppression of insurrections, the repelling of invasions, or other matters of similar magnitude; and,….(10) Or any other matters now provided for or as may be provided for by the legislature.”

, pursuant to LSA-R.S. 42:19(A), that the Louisiana State Board of Medical Examiners (the "Board"), within the Louisiana Department of Health, State of Louisiana, shall convene a Regular Call meeting of the Physician Assistant Advisory Committee starting at 3:00 P.M., Thursday, February 20, 2025, at the offices of the Board, 630 Camp Street, New Orleans, Louisiana. Pursuant to La. R.S. 42:17.3 and Act 408 of the 2022 Regular Session, the Physician Assistant Advisory Committee will participate via live-streaming video and teleconference for the public session and via non-streaming video and teleconference during the executive session.

Members of the public may view the video meeting at the anchor location at 630 Camp Street, New Orleans, Louisiana, or remotely.

, and from the home page, click on “Advisory Committees” and then “Physician Assistant” where a YouTube link to the meeting will be posted at the appointed time of the meeting.

. Public comments comprised of videos and/or audio content must be limited to no more than 3 minutes length and the email size must be less than 10 megabytes. Both requirements must be met, or the content will be refused by our system. All comments received prior to or during the meeting will be identified and acknowledged during the meeting and maintained in the meeting minutes.

 with the subject line “ZOOM LINK REQUEST” to request a link to the videoconference, identifying themselves by name and relevant affiliation, if any, and the agenda item about which they wish to make verbal comment. This request should be made as far in advance of the meeting as possible so that the request can be processed. The committee will make reasonable efforts to accommodate requests made while the meeting is in progress but cannot guarantee that such requests can be honored. The committee reserves the right to limit or prohibit participation in order to maintain orderly conduct of the meeting in accordance with La. R.S. 42:17(C). Members of the public who choose to view the video meeting at the anchor location may give verbal comment by notifying the presiding officer at the anchor location.

The agenda of such meeting shall be as annexed hereto.

Note: Regular Meeting held and noticed pursuant to La. Rev. Stat. §42:17A(1), (2), (4), (5) and (10), R.S. 42:17.3 and Act 408 of the 2022 Regular Session. Further, agenda items may be taken out of order and/or in executive session pursuant to R.S 42:17A. La. R.S. 42:17A states “A public body may hold an executive session pursuant to La. R.S. 42:16 for one or more of the following reasons: (1) Discussion of the character, professional competence, or physical or mental health of a person, provided that such person is notified in writing at least twenty-four hours, exclusive of Saturdays, Sundays, and legal holidays, before the scheduled time contained in the notice of the meeting at which such executive session is to take place and that such person may require that such discussion be held at an open meeting.….In cases of extraordinary emergency, written notice to such person shall not be required; however, the public body shall give such notice as it deems appropriate and circumstances permit; (2) Strategy sessions or negotiations with respect to collective bargaining, prospective litigation after formal written demand, or litigation when an open meeting would have a detrimental effect on the bargaining or litigating position of the public body;….(4) Investigative proceedings regarding allegations of misconduct; (5) Cases of extraordinary emergency, which shall be limited to natural disaster, threat of epidemic, civil disturbances, suppression of insurrections, the repelling of invasions, or other matters of similar magnitude; and,….(10) Or any other matters now provided for or as may be provided for by the legislature.”

Physician Assistant Advisory Committee Meeting

, pursuant to LSA-R.S. 42:19(A), that the Louisiana State Board of Medical Examiners (the "Board"), within the Louisiana Department of Health, State of Louisiana, shall convene a Regular Call meeting of the Respiratory Therapy Advisory Committee starting at 12:00 P.M., Tuesday, February 18, 2025, at the offices of the Board, 630 Camp Street, New Orleans, Louisiana. Pursuant to La. R.S. 42:17.3 and Act 408 of the 2022 Regular Session, the Respiratory Therapy Advisory Committee will participate via live-streaming video and teleconference for the public session and via non-streaming video and teleconference during the executive session.

, and from the home page, click on “Advisory Committees” and then “Respiratory Therapy” where a YouTube link to the meeting will be posted at the appointed time of the meeting.

See LSBME's Statement of Position regarding Public Immunizations

Public Immunizations Statement of Position

Public Immunizations SOP

, pursuant to LSA-R.S. 42:19(A), that the Louisiana State Board of Medical Examiners (the "Board"), within the Louisiana Department of Health, State of Louisiana, shall convene a Regular Call meeting of the Clinical Laboratory Personnel Advisory Committee starting at 3:00 P.M., Wednesday, February 12, 2025, at the offices of the Board, 630 Camp Street, New Orleans, Louisiana. Pursuant to La. R.S. 42:17.3 and Act 408 of the 2022 Regular Session, the Respiratory Therapy Advisory Committee will participate via live-streaming video and teleconference for the public session and via non-streaming video and teleconference during the executive session.

, and from the home page, click on “Advisory Committees” and then “Clinical Laboratory Personnel” where a YouTube link to the meeting will be posted at the appointed time of the meeting.

Clinical Laboratory Personnel Advisory Committee Meeting

the meeting will be posted at the appointed time of the meeting.

 make a public comment before or during the meeting, may do so by

requirements must be met, or the content will be refused by our system. All comments received prior to or during the meeting will be identified and acknowledged during the meeting and maintained in the meeting minutes.

Members of the public may give verbal comment on any agenda item when the matter comes up for discussion.

Occupational Therapy Advisory Committee Meeting

Genetic Counselor Advisory Committee Meeting

 pursuant to LSA-R.S. 42:19(A), that the Louisiana State Board of Medical Examiners (the "Board"), within the Louisiana Department of Health, State of Louisiana, shall convene a Regular Call meeting of the Respiratory Therapy Advisory Committee starting at 12:00 P.M., Tuesday, January 21, 2025, at the offices of the Board, 630 Camp Street, New Orleans, Louisiana. Pursuant to La.  R.S.  42:17.3 and Act 408 of the 2022 Regular Session, the Respiratory Therapy Advisory Committee will participate via live-streaming video and teleconference for the public session and via non-streaming video and teleconference during the executive session.

 and from the home page, click on “Advisory Committees” and then “Respiratory Therapy” where a YouTube link to the meeting will be posted at the appointed time of the meeting.

Public comments comprised of videos and/or audio content must be limited to no more than 3 minutes length and the email size must be less than 10 megabytes. Both requirements must be met, or the content will be refused by our system. All comments received prior to or during the meeting will be identified and acknowledged during the meeting and maintained in the meeting minutes.

Members of the public may give verbal comment on any agenda item when the matter comes up for discussion.  Individuals  wishing  to  make  verbal  comment  must  email  

 with the subject line “ZOOM LINK REQUEST” to request a link to the videoconference, identifying themselves by name and relevant affiliation, if any, and the agenda item about which they wish to make verbal comment. This request should be made as far in advance of the meeting as possible so that the request can be processed. The committee will make reasonable efforts to accommodate requests made while the meeting is in progress but cannot guarantee that such requests can be honored. The committee reserves the right to limit or prohibit participation in order to maintain orderly conduct of the meeting in accordance with La. R.S. 42:17(C).

Members of the public who choose to view the video meeting at the anchor location may give verbal comment by notifying the presiding officer at the anchor location.

 Regular Meeting held and noticed pursuant to La. Rev. Stat. §42:17A (1), (2), (4), (5) and (10), R.S. 42:17.3 and Act 408 of the 2022 Regular Session. Further, agenda items may be taken out of order and/or in executive session pursuant to R.S 42:17A. La. R.S. 42:17A states “A public body may hold an executive session pursuant to La. R.S. 42:16 for one or more of the following reasons: (1) Discussion of the character, professional competence, or physical or mental health of a person, provided that such person is notified in writing at least twenty-four hours, exclusive of Saturdays, Sundays, and legal holidays, before the scheduled time contained in the notice of the meeting at which such executive session is to take place and that such person may require that such discussion be held at an open meeting.….In cases of extraordinary emergency, written notice to such person shall not be required; however, the public body shall give such notice as it deems appropriate and circumstances permit; (2) Strategy sessions or negotiations with respect to collective bargaining, prospective litigation after formal written demand, or litigation when an open meeting would have a detrimental effect on the bargaining or litigating position of the public body;….(4) Investigative proceedings regarding allegations of misconduct; (5) Cases of extraordinary emergency, which shall be limited to natural disaster, threat of epidemic, civil disturbances, suppression of insurrections, the repelling of invasions, or other matters of similar magnitude; and,….(10) Or any other matters now provided for or as may be provided for by the legislature.”

of Medical Examiners (the "Board"), within the Louisiana Department of Health, State of Louisiana, shall convene

            R.S. 42:17.3                   and                                  Act   408      of              the      2022 Regular Session,     

 and from the home page, click on “Advisory Committees” and then “Polysomnography ” where a

will be posted at the appointed time of the meeting.

Public comments comprised of videos and/or audio content must be limited

to no more than 3 minutes length and the email size must be less than 10 megabytes.

meeting will be identified and acknowledged during the meeting and maintained in the meeting minutes.

Note: Regular Meeting held and noticed pursuant to La. Rev. Stat. §42:17A(1), (2), (4), (5) and (10), R.S. 42:17.3 and Act 408 of the 2022 Regular Session. Further, agenda items may be taken out of order and/or in executive session pursuant to R.S 42:17A. La. R.S. 42:17A states “A public body may hold an executive session pursuant to La. 

 42:16 for one or more of the following reasons: (1) Discussion of the character, professional competence, or physical or mental health of a person, provided that such person is notified in writing at least twenty-four hours, exclusive of Saturdays, Sundays, and legal holidays, before the scheduled time contained in the notice of the meeting at which such executive session is to take place and that such person may require that such discussion be held at an open meeting.….In cases of extraordinary emergency, written notice to such person shall not be required; however, the public body shall give such notice as it deems appropriate and circumstances permit; (2) Strategy sessions or negotiations with respect to collective bargaining, prospective litigation after formal written demand, or litigation when an open meeting would have a detrimental effect on the bargaining or litigating position of the public body;….(4) Investigative proceedings regarding allegations of misconduct; (5) Cases of extraordinary emergency, which shall be limited to natural disaster, threat of epidemic, civil disturbances, suppression of insurrections, the repelling of invasions, or other matters of similar magnitude; and,….(10) Or any other matters now provided for or as may be provided for by the legislature.”

Polysomnography Advisory Committee Meeting

 and from the home page, click on “Advisory Committees” and then “Occupational Therapy ” where a YouTube link to the meeting will be posted at the appointed time of the meeting.

This request should be made as far in advance of the meeting as possible so that the request can be processed. 

The committee will make reasonable efforts to accommodate requests made while the meeting is in progress but cannot guarantee that such requests can be honored. The committee reserves the right to limit or prohibit participation in order to maintain orderly conduct of the meeting in accordance with La. R.S. 42:17(C).

Members of the public who choose to view the video meeting at the anchor

 pursuant to LSA-R.S. 42:19(A), that the Louisiana State Board of Medical Examiners (the "Board"), within the Louisiana Department of Health, State of Louisiana, shall convene a Regular Call meeting of the Physician Assistant Advisory Committee starting at 11:00 A.M., Tuesday, November 26, 2024, at the offices of the Board, 630 Camp Street, New Orleans, Louisiana. Pursuant to La.  R.S.  42:17.3 and Act 408 of the 2022 Regular Session, the Physician Assistant Advisory Committee will participate via live-streaming video and teleconference for the public session and via non-streaming video and teleconference during the executive session.

 and from the home page, click on “Advisory Committees” and then “Physician Assistant” where a YouTube link to the meeting will be posted at the appointed time of the meeting.

  Public comments comprised of videos and/or audio content must be limited to no more than 3 minutes length and the email size must be less than 10 megabytes. Both requirements must be met, or the content will be refused by our system. All comments received prior to or during the meeting will be identified and acknowledged during the meeting and maintained in the meeting minutes.

Members of the public may give verbal comment on any agenda item when the matter comes up for discussion.  Individuals  wishing  to  make  verbal  comment  must  email  

 with the subject line “ZOOM LINK REQUEST” to request a link to the videoconference, identifying themselves by name and relevant affiliation, if any, and the agenda item about which they wish to make verbal comment. This request should be made as far in advance of the meeting as possible so that the request can be processed. The committee will make reasonable efforts to accommodate requests made while the meeting is in progress but cannot guarantee that such requests can be honored. The committee reserves the right to limit or prohibit participation in order to maintain orderly conduct of the meeting in accordance with La. R.S. 42:17(C).  Members of the public who choose to view the video meeting at the anchor location may give verbal comment by notifying the presiding officer at the anchor location.

 Regular Meeting held and noticed pursuant to La. Rev. Stat. §42:17A(1), (2), (4), (5) and (10), R.S. 42:17.3 and Act 408 of the 2022 Regular Session. Further, agenda items may be taken out of order and/or in executive session pursuant to R.S 42:17A. La. R.S. 42:17A states “A public body may hold an executive session pursuant to La. 

, pursuant to LSA-R.S. 42:19(A), that the Louisiana State Board of Medical Examiners (the "Board"), within the Louisiana Department of Health, State of Louisiana, shall convene a Regular Call meeting of the Clinical Laboratory Personnel Advisory Committee starting at 2:00 P.M., Friday, November 22, 2024, at the offices of the Board, 630 Camp Street, New Orleans, Louisiana. Pursuant to La.  R.S.  42:17.3  and  Act  408  of  the  2022  Regular  Session,  the Clinical Laboratory Personnel  Advisory Committee will participate via live-streaming video and teleconference for the public session and via non-streaming video and teleconference during the executive session. Members of the public may view the video meeting at the anchor location at 630 Camp Street, New Orleans, Louisiana, or remotely.

 to make a public comment before or during the meeting, may do so by emailing: 

must be met, or the content will be refused by our system. All comments received prior to or during the meeting

Members of the public may give verbal comment on any agenda item when the matter comes up for discussion.    Individuals    wishing    to    make    verbal    comment    must    email 

, pursuant to LSA-R.S. 42:19(A), that the Louisiana State Board of Medical Examiners (the "Board"), within the Louisiana Department of Health, State of Louisiana, shall convene a Regular Call meeting of the Occupational Therapy Advisory Committee starting at 10:00 a.m., Friday, November 15, 2024, at the offices of the Board, 630 Camp Street, New Orleans, Louisiana. Pursuant to La. R.S. 42:17.3 and Act 408 of the 2022 Regular Session, the Occupational Therapy Advisory Committee will participate via live-streaming video and teleconference for the public session and via non-streaming video and teleconference during the executive session. Members of the public may view the video meeting at the anchor location at 630 Camp Street, New Orleans, Louisiana, or remotely.To view the meeting via YouTube, please go to the website at 

, and from the home page, click on “Advisory Committees” and then “Occupational Therapy ” where a YouTube link to the meeting will be posted at the appointed time of the meeting. Individuals who wish to make a public comment before or during the meeting, may do so by emailing: 

, pursuant to LSA-R.S. 42:19(A), that the Louisiana State Board of Medical Examiners (the "Board"), within the Louisiana Department of Health, State of Louisiana, shall convene a Regular Call meeting of the Clinical Laboratory Personnel Advisory Committee starting at 3:00 P.M., Tuesday, October 12, 2024, at the offices of the Board, 630 Camp Street, New Orleans, Louisiana. Pursuant to La.  R.S.  42:17.3  and  Act  408  of  the  2022  Regular  Session,  the Respiratory Therapy  Advisory Committee will participate via live-streaming video and teleconference for the public session and via non-streaming video and teleconference during the executive session.

meeting will be posted at the appointed time of the meeting.

 make a public comment before or during the meeting, may do so by emailing: 

Members of the public may give verbal comment on any agenda item when the matter comes up for discussion.  

 pursuant to LSA-R.S. 42:19(A), that the Louisiana State Board of Medical Examiners (the "Board"), within the Louisiana Department of Health, State of Louisiana, shall convene a Regular Call meeting of the Respiratory Therapy Advisory Committee starting at 9:00 A.M., Monday, December 2, 2024, at the offices of the Board, 630 Camp Street, New Orleans, Louisiana. Pursuant to La.  R.S.  42:17.3 and Act 408 of the 2022 Regular Session, the Physician Assistant Advisory Committee will participate via live-streaming video and teleconference for the public session and via non-streaming video and teleconference during the executive session.

This Weekly Digest is from the U.S. Food & Drug Administration (FDA).

The FDA Intergovernmental Affairs (IGA) team would like to share announcements and other activities undertaken by the Agency during the week of 

. If you have any questions on the below items, or need assistance with any other FDA-related issues, please reach out to us at 

Intergovernmental Affairs-Weekly Digest for the week of 10/28/2024

The below alert is from the Center for Drug Evaluation and Research, Division of Drug Information.

CDER Alert: Do Not Use Drugs Compounded and Distributed by Fullerton Wellness, LLC

FDA is warning patients and health care professionals not to use drugs compounded and distributed by Fullerton Wellness LLC, Ontario, Calif., and distributed to patients by medical offices and clinics. 

Fullerton Wellness is a facility that compounds drugs intended to be sterile, including semaglutide and tirzepatide injections. 

Based on conditions observed by FDA and information provided by California regulatory authorities, FDA has concerns about the sterility of drugs distributed by Fullerton Wellness. Administration of a non-sterile drug intended to be sterile may result in serious and potentially life-threatening adverse health consequences including infections and sepsis. 

Health care professionals should immediately check their medical supplies, quarantine any drug products from Fullerton Wellness, and not administer them. Patients who have received compounded drugs distributed by Fullerton Wellness should stop using them and contact their health care professional.

FDA is not aware of any adverse reactions associated with the use of compounded drugs from Fullerton Wellness. However, compounders that are not registered with FDA as outsourcing facilities are primarily overseen by state regulators and are not required under federal law to report adverse events to FDA. 

Patients and health care professionals should report any adverse reactions to FDA’s 

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