For those of you in the OTC monograph world (not OTC products that require an approved NDA or ANDA application for marketing), this draft guidance document, titled Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program (here), will provide you with the how, what, and when information about facility fees for dosage-form manufacturers and contract manufacturers, as well as requirements for the submission of Tier 1 and Tier 2 over-the-counter monograph requests (OMOR) .
The document also describes who is required to pay, the timeline for payments, and what happens if you fail to pay the fees and your firm appears on the arrears list as a result. It also provides advice on which facilities are exempt from manufacturing fees, and notes that there is no waiver-of-fees provision under the statute for the OMUFA program.
This document is a must read for OTC firms and those seeking an OTC monograph request. Don’t get caught short and miss a payment deadline; about 500 firms were put on the arrears list a year ago for failure to pay fees. FY 2022 facility fees were due on June 1, 2022. The arrears list for FY 2022 (here) comprises thirty-seven pages of firms as of September 2022. Fees went up in FY 2022, primarily because the number of fee-liable facilities registered with the FDA decreased considerably the year after the fees went into effect (see here).
So, get that checkbook out or delist all of your covered OTC products and your facility or the Agency will consider all of your products misbranded and all of your OMOR incomplete (or any such requests will be denied or canceled if they have already been submitted).
