Requests that the FDA reclassify azelaic acid, at concentrations up to and including 15%, from prescription-only status to over-the-counter availability in the United States. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-8162

Requests that the FDA reclassify azelaic acid, at concentrations up to and including 15%, from prescription-only status to over-the-counter availability in the United States.

Documents

Comments

Key Dates

Comment Period OpensJul 24, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Acknowledgement Letter from FDA DMB to Melanie Morales	Jul 24, 2026	--

Keywords

CDER

Citizen Petition

reclassify azelaic acid

at concentrations up to and including 15%

from

prescription-only status to over-the-counter

availability in the United States

OPEN

Data from Regulations.gov