United States · Food and Drug Administration · Over-the-counter
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
1 requirements
Application fee
$614,608
FY2027
Nonprescription drugs that meet a monograph can be sold without an individual approval. The agency sets or changes monograph conditions through administrative orders, on its own initiative or at the request of a company. A drug that meets the order is treated as generally recognized as safe and effective. Nonprescription active ingredients and uses that can be covered by a monograph.
The order request fee, tier 1 is $614,608 for FY2027.
1. Order request (OMOR); 2. Proposed order; 3. Public comment (45 days); 4. Final order.
Outcome: A final administrative order that sets the monograph conditions.
Legal basis: Section 505G of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355h)
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 45 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Order request fee, Tier 1Application · FY2027 | $614,608 |
| Order request fee, Tier 2Application · FY2027 | $122,921 |
| Monograph drug facility (yearly)Establishment · FY2027 | $47,891 |
Other routes in United States: New drug application (full, new active ingredient), New drug application relying on other data (505(b)(2)), Abbreviated new drug application (generic), Prescription to nonprescription switch, Breakthrough therapy designation, Fast track designation, Accelerated approval, Priority review, Orphan drug designation, National priority voucher (pilot), Emergency use authorization, Expanded access (compassionate use), Pediatric study requirements. See all routes on the United States page or explore them in the .
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (6 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.