The CARES Act of 2020 replaced FDA’s old rulemaking process for over-the-counter (OTC) drug monographs with a faster administrative order process. It also created OMUFA — the Over-the-Counter Monograph Drug User Fee program — which requires many OTC monograph drug facilities to pay an annual fee, and it created a paid OTC Monograph Order Request (OMOR) process for anyone seeking to change or add to a monograph.
What is an OTC monograph?
A monograph is FDA’s rulebook for a category of over-the-counter drugs. It sets out which active ingredients, doses, and labeling are allowed without each manufacturer needing a separate drug approval.
If your product fits within its monograph, you can market it without an individual FDA approval for that product.
What did the CARES Act change?
Section 3851 of the CARES Act (2020) replaced the old three-phase rulemaking process for updating OTC monographs with an administrative order process. FDA can now issue administrative orders — on its own initiative or in response to an industry request — to update what a monograph allows.
This was meant to let FDA move faster on both safety issues and beneficial innovations than the old rulemaking process allowed.
What is OMUFA, and who has to pay?
OMUFA is the OTC Monograph Drug User Fee program, created by the CARES Act and modeled on the prescription drug user fee program. Facilities that manufacture OTC monograph drugs generally owe an annual facility fee.
Missing that fee is not a minor paperwork problem — FDA can treat the product as misbranded.
What is an OMOR?
An OTC Monograph Order Request, or OMOR, is how industry asks FDA to change or add to a monograph — for example, adding a new active ingredient or indication. OMORs carry their own fee, separate from the annual OMUFA facility fee, and FDA has agreed to specific review timelines for them.
What should an OTC brand do now?
First, confirm whether your facility owes the annual OMUFA fee and pay it on time — this is an annual, recurring obligation, not a one-time filing.
Second, if you want to change or add to a monograph, budget for the OMOR process and its fee and timeline before you plan a launch around it.
Third, keep your labeling aligned with the current version of your monograph, since monograph terms can change through the administrative order process faster than under the old rulemaking system.
Frequently Asked Questions
Does OTC monograph reform apply to my product?
If you manufacture or market an over-the-counter drug regulated under an FDA monograph — sunscreen, antacids, hand sanitizer, pain relief, and many others — yes.
How often is the OMUFA fee due?
Annually. It applies per facility, so a company operating multiple facilities that manufacture OTC monograph drugs owes the fee for each one.
What happens if I don’t pay the OMUFA fee?
FDA can deem the associated products misbranded, which creates enforcement risk independent of whether the product itself meets its monograph.
Is filing an OMOR the same as getting FDA approval for my specific product?
No. An OMOR changes or adds to the monograph itself. Once a monograph permits an ingredient or indication, products that conform to the monograph don’t need individual product approval.
Who typically files OMORs — FDA or industry?
Both. FDA-initiated requests are typically aimed at finalizing GRASE (generally recognized as safe and effective) status across a monograph, while industry-initiated OMORs are typically about adding a new ingredient, indication, or other change a company wants.
Video Transcript
Sell an over-the-counter drug under an FDA monograph? The rules for changing those monographs are completely different now.
In 2020, the CARES Act overhauled how OTC monograph drugs are regulated.
A monograph is the FDA’s rulebook that says which active ingredients, doses, and labeling are allowed without a separate drug approval.
The old system updated these through slow rulemaking. Now the FDA uses faster administrative orders, and industry helps pay through user fees.
Why does this matter? This is the OMUFA program, the Over-the-Counter Monograph Drug User Fee program.
If you make OTC monograph drugs, you likely owe an annual facility fee. Miss it and your products can be deemed misbranded.
To change or add a monograph ingredient, you now file an OTC Monograph Order Request, called an OMOR, which carries its own fee.
So what should you do? First, confirm whether your facility owes the annual OMUFA fee, and pay it on time.
Second, if you want a monograph change, plan for the OMOR process and its costs.
Third, keep your labeling aligned with the current monograph.
Need help navigating OTC monograph reform? Contact us today.
Talk to an FDA Compliance Attorney
Talk to an FDA compliance attorney before a problem becomes a recall, a hold, or a lost contract. Contact Capote Law Firm today.
- Related: Is Your OTC Brand Actually FDA Compliant?
- Related: OTC Drug Brands: Are You Keeping Up With FDA Regulatory Changes?
This content is provided for educational purposes only and does not constitute legal advice. For guidance specific to your product and facility, please contact Capote Law Firm.