FDA Pharmacy Compounding Advisory Committee voted to approve the compounding of DMPS

FDA Pharmacy Compounding Advisory Committee voted to approve the compounding of DMPS

We are very pleased to announce that the FDA Pharmacy Compounding Advisory Committee on June 23, 2016 voted 8-3 to approve the compounding of DMPS, going against the FDA staff recommendation. The Committee favored having an effective intravenous IV chelator, understanding that DMPS is needed to save lives.

We would like to thank Dr. Paul Anderson for his terrific job in giving the presentation to the Committee. He was instrumental in presenting the lifesaving benefit of having DMPS readily available. Additionally, Ron McGuff presented comments to the committee and provided technical answers to questions.

The committee rarely has returned a vote in opposition to the FDA’s wishes. This vote allows us to have some hope that there will be additional reversals in the future.

One key point to keep in the back of your mind is that the Committee is an advisory group to the FDA and the FDA is not required to accept its recommendations. We will see how this plays out in the future, but for now… it is time to celebrate!

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