NCPA win: PCAC adds methylcobalamin to bulk list
By a 9-5 vote on Wednesday, PCAC members recommended that the FDA keep methylcobalamin on the 503A Bulk List, voting against FDA’s recommendation. Before the meeting NCPA submitted comments in favor of the inclusion. We were represented at the meeting NCPA member A.J. Day, a member of the Compounding Committee, who highlighted the importance of the availability of methylcobalamin for patients with Autism Spectrum Disorder. FDA is not obligated to PCAC’s advice, but they do consider the input.
Source: ncpa.org