Pharmacy Compounding Advisory Committee’s (PCAC) Review Of Methylcobalamin
Recently, McGuff Compound Pharmacy Services informed you that the FDA’s PCAC is requesting information on Methylcobalamin for review and inclusion on the 503A bulk drug substances list. They greatly appreciate the information they received, which aided them in meeting the FDA’s initial response deadline. However, now is not the time to let our guards down! We must make our final effort push to meet the FDA’s second deadline of February 23rd and provide, “…any additional information that FDA should consider in its evaluation that may help to clarify the role of the nominated methylcobalamin bulk substance in compound drug products in current clinical practice…”
McGuff is again requesting your assistance to ensure compounded Methylcobalamin preparations remain available for your patients. Share with them any of the following:
· Personal anecdotal experiences you may have using Methylcobalamin in your practice.
· Your patients’ experiences with the use of Methylcobalamin—let you patients know their access to this important compounded drug is in jeopardy!
· Scientific literature supporting Methylcobalamin uses.
· Statements or guidelines from professional medical societies regarding Methylcobalamin uses.
Be aware that your response or your patient’s may be referenced in their statements to FDA’s PCAC.
We must act! Methylcobalamin is too important for our patients! The FDA’s PCAC must be persuaded of its medical therapeutic value. We will not have another chance to fight for this cause. We must do everything possible to ensure Methylcobalamin continues to be available for your patients and your practice!
Please forward any information to firstname.lastname@example.org under the subject heading of, “Methylcobalamin, PCAC Review Information.” If preferred, you may also fax the requested information to 877-444-1155.