[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR310.534]

[Page 32-33]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 310_NEW DRUGS--Table of Contents
 
        Subpart E_Requirements for Specific New Drugs or Devices
 
Sec. 310.534  Drug products containing active ingredients offered
over-the-counter (OTC) for human use as oral wound healing agents.

    (a) Allantoin, carbamide peroxide in anhydrous glycerin, water 
soluble chlorophyllins, and hydrogen peroxide in aqueous solution have 
been present in oral mucosal injury drug products

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for use as oral wound healing agents. Oral wound healing agents have 
been marketed as aids in the healing of minor oral wounds by means other 
than cleansing and irrigating, or by serving as a protectant. Allantoin, 
carbamide peroxide in anhydrous glycerin, water soluble chlorophyllins, 
and hydrogen peroxide in aqueous solution are safe for use as oral wound 
healing agents, but there are inadequate data to establish general 
recognition of the effectiveness of these ingredients as oral wound 
healing agents.
    (b) Any OTC drug product that is labeled, represented, or promoted 
for use as an oral wound healing agent is regarded as a new drug within 
the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic 
Act, for which an approved new drug application under section 505 of the 
act and part 314 of this chapter is required for marketing. In the 
absence of an approved new drug application, such product is also 
misbranded under section 502 of the act.
    (c) Clinical investigations designed to obtain evidence that any 
drug product labeled, represented, or promoted for OTC use as an oral 
wound healing agent is safe and effective for the purpose intended must 
comply with the requirements and procedures governing the use of 
investigational new drugs set forth in part 312 of this chapter.
    (d) After the effective date of the final regulation, any OTC drug 
product that is labeled, represented, or promoted for use as an oral 
wound healing agent may not be initially introduced or initially 
delivered for introduction into interstate commerce unless it is the 
subject of an approved new drug application.

[51 FR 26114, July 18, 1986, as amended at 55 FR 11579, Mar. 29, 1990]