The International Academy of Compounding Pharmacists (IACP) on behalf of our more than 4,000 compounding pharmacists and the patients and providers they serve, is sharing the information from FDA regarding a request for nomination to the Pharmacy Compounding Advisory Committee.
IACP has worked diligently along with the DQSA Coalition members and Members of Congress to send Congressional letters, letters from the Coalition, obtain numerous statements from Congress, and obtain Appropriations Report Language urging FDA to implement the DQSA in manner that is consistent with Congressional intent by allowing stakeholder input in the form of voting positions on the PCAC.
Throughout all of these efforts, IACP has expressed strong concern with the only compounding pharmacist on the PCAC being designated as a non-voting position and has urged FDA to include stakeholders that provide and depend on compounded medications as these stakeholders thoroughly understand patients' need for access to these vital compounded medications.
Most recently, during the Congressional Hearing held by the House Energy and Commerce Committee where IACP Vice President, Shawn Hodges, testified, IACP submitted written testimony expressing many concerns with FDA's implementation of the DQSA, including concerns with the structure and process of the PCAC. During that hearing, Members of Congress, urged Commissioner Gottlieb to move forward with including stakeholders as voting members of the PCAC.
As FDA moves forward in soliciting nominations, IACP strongly encourages FDA to follow the will of Congress and allow compounding pharmacists to serve on the PCAC as voting members.
More Information about Serving on the PCAC
Information about becoming a member on an FDA advisory committee can also be
obtained by visiting FDA's website by using the following link:
Process for Submitting Nomination to Serve on the PCAC
Please note that anyone can submit an application to join PCAC by submitting nominations for membership electronically here:
or by mail to:
Advisory Committee Oversight and Management Staff
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 32, Rm. 5103
Silver Spring, MD 20993-0002
Process for Seeking IACP Recommendation or Nominations:
If you want a Letter of Recommendation from IACP or for IACP to officially submit your application, please let us know if you would like to serve on the PCAC by emailing [email protected]. The IACP Legislative Committee and Board of Directors will be considering nominations over the coming weeks.
Please stay tuned as IACP develops a Request to Serve process for the PCAC and releases it in the coming weeks where you will be able to submit your interest in serving on the PCAC.
Timeframe
Please note that FDA has stated within the guidance that first consideration for membership will be given to those that submit nominations in 60 days.
Nominations submitted after this timeframe will be considered for future PCAC vacancies.
|
