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Compounding: Regulatory Policy Information

Friday, May 29, 2020   (0 Comments)
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I am pleased to invite a representative of your organization to participate in a virtual listening session with the FDA regarding drug compounding. FDA has regularly held listening sessions with groups of interested stakeholders to discuss FDA’s efforts to implement the compounding provisions of the Drug Quality and Security Act since the Act was signed into law in November, 2013.  
 
Since our last meetings, we have issued numerous draft and final policy documents on drug compounding and related topics and are continuing our implementation efforts.  (See https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm166743.htm.)  
 
Because we continue to receive positive feedback concerning prior sessions, we have decided to hold a series of similar meetings again this year. We will hold listening sessions with: pharmacy, consumer and industry organizations; hospital organizations; medical and insurer organizations; and outsourcing facilities registered under section 503B.
 
Please plan on joining us for the listening session for medical and insurer organizations on June 23, 2020, 10:00AM-12:00PM Eastern Time. Due to the COVID-19 public health emergency we will be holding this year’s sessions virtually.
 
Prior to the sessions, we will share recommended discussion topics that are of particular interest to the Agency. They are not intended to limit conversation. We value hearing stakeholder perspectives on all topics related to compounding.
 
To allow sufficient time for discussion we will not begin the sessions with formal spoken statements from participants, but we welcome the submission of written statements which you may provide in advance of, or following, the session.
 
In addition, if your statement or comments during the listening session address topics that are relevant to open FDA dockets (e.g., for draft guidance’s), we strongly recommend that you submit comments or other information to the relevant docket(s).
 
Please respond by close of business on June 4, 2020 to Janis Fleischer, Professional Affairs and Stakeholder Engagement, Janis.Fleischer@fda.hhs.gov, or 240-402-2579 concerning your attendance.  Please provide the names and titles of the representatives from your organization who will attend the meeting.  To facilitate discussion, please limit participants to no more than three representatives from your organization.
 
Information to access the virtual listening and informational sessions will be provided prior to the meeting.
 
We hope you will be able to join us.
Janis Fleischer, MBA
Center for Drug Evaluation and Research
Professional Affairs and Stakeholder Engagement
U.S. Food and Drug Administration




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