An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

In this section: Historical Status of OTC Rulemakings

Rulemaking History for OTC Oral Insect Repellent Drug Products

Final Monograph (21 CFR 310.529):
Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect repellents

FDA Archive-It webpage:

Rulemaking History for OTC Oral Insect Repellent Drug Products

Search for Federal Register documents:

GPO Federal Register Database (1994 to present)
HeinOnline provides online access to Federal Registers from 1936-forward

Insect Repellent Drug Products

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	1/5/1982	47FR424
Proposed Rules	Date	FR Citation
Proposed Rule	6/10/1983	48FR26986
Correction	7/15/1983	48FR32361
Final Rule	Date	FR Citation
Final Rule	6/17/1985	50FR25170

Top