FDA Withdraw The New OTC Monograph User Fee for FY 2021

January 5, 2021 Update: FDA decided to withdraw their newly published OMUFA fees on December 29, 2020 Federal Register Notice entitled “Fee Rates Under the Over-the-Counter Monograph User Fee Program for Fiscal Year 2021″ till further notice.

In the past March, President Trump had signed a pandemic aid act named “CARES”. This act featured a measure that reshapes and upgrades the manner specific OTC and non-prescription drugs are under regulation in the U.S.

Among the primary aspects of this drug amendment is OMUFA ( OTC Monograph User Fee Act). OMUFA launches new yearly charges for OTC Monograph drug establishments. Contract manufacturer establishments are featured in the act as well. The new charges are aimed at offering FDA extra funds to carry out various OTC monograph actions such as evaluating entries, in a prompt fashion.

The CARES Act also sunsets the Sunscreen Innovation Act and permits the marketing of sunscreen drug products under the 1999 Final Monograph outlined in 21 CFR 352. Among other provisions, this effectively rolls back the proposed changes to labeling and broad-spectrum testing requirements which were part of the proposed rulemaking. The FDA will be required to issue a new order within 18 months (by September 2021) as it relates to sunscreen products, which will have an effective date at least one year thereafter.

What defines an OTC Monograph Drug Establishment/Facility
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FDA, the U.S Food & Drug Administration body, refers to an “OTC Monograph Drug Facility” as a unit that produces or handles the completed dosage shape of an OTC or other non-prescription drug that can be promoted without needing approval (following submission of the drug). This covers completed dosage shapes and production units in official partnerships with the supplier of one or more OTC Monographs.

Furthermore, CMOs (OTC drug manufacturing organizations) are OTC production establishments where the OTC drug is not sold to merchants of any kind or U.S consumers by the owner of the unit or their affiliates.

Based on FDA reports, organizations whose production or handling processes feature only the following are excluded from the definition of OTC Monograph drug units: manufacturing of clinical trial materials, clinical tests, or usage of exterior packaging on packs that consist of various products e.g multipacks, whenever each monograph drug inside the multipack is in a complete packaged shape before getting placed in the external multi packaging.

 Statement of charges

FDA has not released yet the exact facility charges. However, they have disclosed that the charges for such drugs will be estimated on the basis of 2/3rds of the charge of the final facility charge. Unit charges will fall due within 45 days following their publication in the Federal Register.

How to get ready

FDA will estimate costs for a drug facility on the basis of business process criteria chosen in the facility’s registration. Drug facilities registered should check the accuracy of all the criteria in their submissions before the period of FY20-21. Submission starts on October 1st, 2020.

Help with OMUFA & Other OTC Assessment Criteria

If you have doubts on how to classify your establishment or interested in register your OTC product establishment Cosmereg can assist you in each step. For more information about Cares Act just contact us +17273509380 or in**@co******.com.