Melissa Meisel, Associate Editor04.06.21
The passage of the CARES Act last March established a new requirement for OTC Monograph Drug User Fees, according to a report shared from the Independent Beauty Association. The FDA originally published the user fee program on December 29 in a Federal Register Notice "Fee rates under the Over-The-Counter Monograph Drug User Fee Program for Fiscal Year 2021."
After considerable backlash over the obligation of manufacturers that initiated OTC manufacturing to produce hand sanitizer to help meet demand during the pandemic, HHS subsequently withdrew the publication of that version of the OTC User Fee Program.
Update on User Fees
On March 25, 2021 the FDA announced the new user fees.
Manufacturers of Over-The-Counter Drugs in the U.S. are now subject to annual fees. Brands and distributors do not owe fees (unless the business is also manufacturing OTC Drugs). If your facility has an establishment registration with FDA for OTC manufacturing, your organization should look into fee obligations before the due date of May 10 for Fiscal Year 2021.
There are two tiers of pricing based on the type of manufacturer:
These fees cover Fiscal Year 2021 (October 1, 2020 through September 30, 2021). Fees will be due annually and the actual fee amounts may change from one year to the next. This year’s fees are due on May 10, 2021.
The manufacture of combination Cosmetic/OTC Drug products that are subject to this fee program include (but are not limited to): Sunscreens, Anti-Acne Products, Antiperspirants, Skin Protectants, Anti-Dandruff Shampoos, Toothpaste with fluoride.
Exemptions include hand sanitizer manufacturers that first registered with FDA on or after January 27, 2020 solely for purposes of manufacturing hand sanitizer products during the Covid-19 Public Health Emergency do not owe facility fees, and facilities that ceased OTC monograph drug activities, and updated their registration with FDA to that effect prior to December 31, 2019.
After considerable backlash over the obligation of manufacturers that initiated OTC manufacturing to produce hand sanitizer to help meet demand during the pandemic, HHS subsequently withdrew the publication of that version of the OTC User Fee Program.
Update on User Fees
On March 25, 2021 the FDA announced the new user fees.
Manufacturers of Over-The-Counter Drugs in the U.S. are now subject to annual fees. Brands and distributors do not owe fees (unless the business is also manufacturing OTC Drugs). If your facility has an establishment registration with FDA for OTC manufacturing, your organization should look into fee obligations before the due date of May 10 for Fiscal Year 2021.
There are two tiers of pricing based on the type of manufacturer:
- Monograph Drug Facility (MDF): $20,322
- Contract Manufacturing Organization (CMO): $13,548
These fees cover Fiscal Year 2021 (October 1, 2020 through September 30, 2021). Fees will be due annually and the actual fee amounts may change from one year to the next. This year’s fees are due on May 10, 2021.
The manufacture of combination Cosmetic/OTC Drug products that are subject to this fee program include (but are not limited to): Sunscreens, Anti-Acne Products, Antiperspirants, Skin Protectants, Anti-Dandruff Shampoos, Toothpaste with fluoride.
Exemptions include hand sanitizer manufacturers that first registered with FDA on or after January 27, 2020 solely for purposes of manufacturing hand sanitizer products during the Covid-19 Public Health Emergency do not owe facility fees, and facilities that ceased OTC monograph drug activities, and updated their registration with FDA to that effect prior to December 31, 2019.
