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 |
09-10-2021 | 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 |
CDER / Office of Compliance / Office of Compounding Quality and Compliance F. Gail Bormel, Director |
06-29-2021 | 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 |
03-18-2021 | Indefinite |