METHYLCOBALAMIN UPDATE

Dear Patients and Prescribers, 

 

Your comments matter! More than 1,000 public comments in favor of compounded methylcobalamin were heard and counted!

 

A huge thank you to everyone who advocated for the importance of methylcobalamin access through compounding pharmacies like Lee Silsby.

 

Today, June 9, 2021, FDA’s Pharmacy Compounding Advisory Committee (PCAC) ruled in favor of methycobalamin's inclusion on the 503a's bulk drug list and rejected FDA’s argument that all compounded methylcobalamin should be banned in the United States.

 

Several prescribers, pharmacists and researchers presented testimony to the Committee regarding the risks and benefits of compounded methylcobalamin, including B12 injections. This outcome would not have been possible without the collection of valuable clinical data presented by these experts or the patient testimonies submitted to the Committee! 

 

Nine out of 14 committee members voted YES to compounded methylcobalamin, and every one of them cited the “overwhelming” public comments in favor of methylcobalamin’s effectiveness and safety. Each of these YES votes cited the importance of patient access, and many expressed great compassion for children with ASD and their parents and caregivers.

 

The Lee Silsby Compounding Pharmacy team is proud to advocate alongside you and support your needs with high quality compounded methylcobalamin drugs. 

 

Thank you! Our work is important because of you!


To review all public comments regarding today’s PCAC meeting, to go: https://www.regulations.gov/document/FDA-2021-N-0357-0001/comment

All the best,

The Lee Silsby Family