FDA Announces Significant Milestone in Compounding Program to Protect Public Health Through Collaboration with States
On October 26, 2020, the FDA announced the availability for signature of the standard Memorandum of Understanding (MOU) Addressing Certain Distributions of Compounded Human Drug Products between state boards of pharmacy or other state agencies and the FDA. The purpose of this memorandum is to protect public health through collaboration with individual states. This goal would be accomplished through improved communication, maximization of both federal and state resources, and expanded information sharing between the FDA and various state agencies regarding compounded human drug products distributed interstate.
If the Iowa Board of Pharmacy signs the MOU, the Board must report certain information pertaining to the distribution of compounded human drug products by pharmacies located in Iowa to the FDA. In turn, the FDA would agree to not enforce the 5% interstate distribution limit imposed by 503A of the Food Drug and Cosmetic Act.
If the Board does not sign the MOU, pharmacies and physicians would be limited to dispensing and distributing compounded human drug products to no more than 5% of their total prescription orders interstate. This limit is not applicable to the interstate distribution of veterinarian drug products, biological products, or drugs compounded by outsourcing facilities.
The Board is soliciting comments from the public regarding the MOU before making a decision to sign. Please submit your comments through the Google Form.
Comments are being accepted through March 12, 2021.
For additional information regarding the MOU, please visit the FDA website or view the full text of the MOU at https://www.fda.gov/media/143283/download.