Draft Guidance for Industry on Enforcement Policy for Over-the-Counter Sunscreen Drug Products Marketed Without an Approved Application; Availability
fda-drug · Food and Drug Administration · Rule · Published 2011-06-17 · 76 FR 35665
Document
Document number
2011-14767
Federal Register citation
76 FR 35665
CFR reference
21 CFR 201
Type
Rule
Action
Notice of availability.
Category
fda-drug
Sub-agency
Food and Drug Administration
Publication date
2011-06-17
HHS docket
Docket No. FDA-2010-D-0509
Abstract
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Enforcement Policy--OTC Sunscreen Drug Products Marketed Without an Approved Application." The draft guidance is intended to inform manufacturers of over-the-counter (OTC) sunscreen products about our enforcement policy for certain OTC sunscreen products marketed without an approved new drug application. The draft guidance describes our intended approach to enforcement for certain OTC sunscreen products prior to an effective final monograph.