Further to the May 2021 stakeholder phone call, regarding single ingredient high dose Vitamin D submissions, the single ingredient high dose Vitamin D monograph was finalized and posted on Friday, July 23, 2021. Applicants can now submit single ingredient high dose Vitamin D submissions via Class I, using the Web PLA version 4 form. Other versions of the PLA form cannot be permitted.
The increase in Vitamin D was released as a single ingredient monograph due to the risks associated with higher dose of Vitamin D and to avoid the risk of combining high dose Vitamin D with different ingredients. This was also done to increase awareness to Health Care Practitioners and consumers that higher doses of Vitamin D are available without a prescription.
For submissions that do not fall within the scope of the single ingredient high dose Vitamin D monograph will continue to be Class III submissions and this monograph cannot be combined with any other monographs as Class II submissions. Therefore, the only options available for high dose vitamin D products is to either submit via Class I or as a Class III.
