COMPLIANCE POLICY GUIDE (CPG)
CPG Sec. 454.100 OTC Ear Drop Preparations May 1987
- Docket Number:
- None found
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and Research
It has been our policy <> that the only acceptable claim for over-the-counter distribution of ear drops is for the loosening of wax. The inclusion of a local anesthetic agent in an ear drop whose primary function is to soften wax is irrational and may mask an acute infection.
REGULATORY ACTION GUIDANCE:
The following represents criteria for recommending legal action to the *Division of Drug Labeling Compliance, HFD-310*:
Any ear drop preparation offered for over-the-counter distribution that contains a local anesthetic
Any ear drop preparation offered for over-the-counter distribution with claims offering the product for conditions other than "for the loosening of wax."
Some of these preparations may be suitable for marketing as prescription drugs.
*Material between asterisks is new or revised*
<> Indicates material has been deleted
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: None found.