Compounding Pharmacy and Loss of Interstate Dispensing

Compounding Pharmacy and Loss of Interstate Dispensing

Through everyone’s action on the “Ask Your U.S. Congressional Representatives to Sign onto Representative Stewart and Representative Cuellar’s letter to the FDA on Compounding Pharmacies,” we were able to increase the number of United States Congressmen signatures on the letter from 19 to 61! This was an amazing undertaking and on behalf of McGuff Compounding Pharmacy Services, Inc., I would like to personally thank each and every one of you who participated. The letter has since been sent to the FDA on June 20, 2016.

Currently, the largest impediment to your receiving compounded drugs is the Memorandum of Understanding (MOU). The way MOU impacts physicians and patients is that if the current draft MOU is enacted without change it will SEVERLEY limit, if not completely remove, physician and patient access to compounded drugs.

“How is this possible?” you ask. The FDA’s regulation (FDA’s interpretation of the law passed by Congress) combines the definition of dispense and distribute into one word “Distribute”. FDA says “Distribute” shall be all drugs that leave the compounding pharmacy’s facility. When this definition is used to replace “dispense” and “distribute” in 503A law then the regulation takes on an entirely new meaning than what was intended by Congress. This is another FDA failure to implement a regulation that meets the intent of Congress

If the FDA moves forward with the draft MOU, physicians and patients will go without the vital compounded drugs they rely upon to obtain the highest level of patient care. We, at McGuff Compounding Pharmacy Services, once again ask for your help in sending a letter to your Congressmen about the impact this will have on you. Please go to the following link:

It takes less than 5 minutes to complete your letter.

On behalf of McGuff Compounding Pharmacy Services, Inc., I would like to personally thank you for your continued support. If you have any questions at all, please feel free to let us know as we are here for you!

Austin McGuff

McGuff was named a Top Workplace of 2014 by the Orange County Register