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  5. Compounding MOUs
  1. FDA Memoranda of Understanding

Compounding MOUs

The three compounding MOUs listed on this webpage are suspended. While suspended, FDA does not expect the parties that have signed the compounding MOU to carry out the activities described in the MOU. For more information, please see FDA’s webpage called Memorandum of Understanding Addressing Certain Distributions of Compounded Drugs.

MOU No. Purpose Parties FDA Lead Center or
Office/Contact		 Effective Date Expiration
Date		 Last Revision
Date
225-21-012 This MOU describes the responsibilities of the Kentucky Board of Pharmacy in investigating and responding to complaints related to drug products compounded in Kentucky and distributed outside Kentucky and in addressing the interstate distribution of inordinate amounts of compounded human drug products. Kentucky Board of Pharmacy/ Jill Rhodes, Board President

CDER / Office of Compliance / Office of Compounding Quality and Compliance
 

F. Gail Bormel, Director
compounding@fda.hhs.gov

 2021-09-10 Indefinite  
225-21-014 This MOU describes the responsibilities of the Colorado Board of Pharmacy in investigating and responding to complaints related to drug products compounded in Colorado and distributed outside Colorado and in addressing the interstate distribution of inordinate amounts of compounded human drug products.

Colorado Board of Pharmacy

Patricia Evacko
Board Chair

CDER / Office of Compliance / Office of Compounding Quality and Compliance

F. Gail Bormel, Director
compounding@fda.hhs.gov

 2021-06-29 Indefinite  
225-21-008 This MOU establishes an agreement with the New Hampshire Office of Professional Licensure and Certification regarding the distribution of inordinate amounts of compounded human drug products interstate and the appropriate investigation by the New Hampshire Office of Professional Licensure and Certification of complaints relating to human drug products compounded in New Hampshire and distributed outside the state. New Hampshire Office of Professional Licensure and Certification (OPLC)

CDER / Office of Compliance / Office of Compounding Quality and Compliance

F. Gail Bormel, Director
compounding@fda.hhs.gov

 2021-03-18 Indefinite  

 



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