United States · Food and Drug Administration · Over-the-counter
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
1 requirements
Application fee
-
A prescription drug approved under a new drug application can be moved to nonprescription status. The company can ask through a supplement to its approved application or a petition. The agency must find that the drug is safe and effective for self-medication as directed in the proposed labeling. Approved prescription drugs that could be used safely without a prescription.
1. Send a supplement or petition; 2. Review of self-medication data and labeling; 3. Decision.
Outcome: Approval of nonprescription labeling and status.
Legal basis: 21 CFR 310.200(b)
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).
Official step durations
From the official approvals data of this market, all products of this pathway type and segment
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 |
|---|---|
| No fees published. |
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), Over-the-counter monograph order, 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 (3 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.