[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR310.537]

[Page 42-43]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--Continued
 
PART 310--NEW DRUGS--Table of Contents
 
        Subpart E--Requirements for Specific New Drugs or Devices
 
Sec. 310.537  Drug products containing active ingredients offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores.

    (a) l-lysine (lysine, lysine hydrochloride), Lactobacillus 
acidophilus, and Lactobacillus bulgaricus have been present in orally 
administered OTC drug products to treat fever blisters and cold sores. 
There is a lack of adequate data to establish general recognition of the 
safety and effectiveness of these or any other orally administered 
ingredients for OTC use to treat or relieve the symptoms or discomfort 
of fever blisters and cold sores. Based on evidence currently available, 
any

[[Page 43]]

OTC drug product for oral administration containing ingredients offered 
for use in treating or relieving the symptoms or discomfort of fever 
blisters and cold sores cannot be generally recognized as safe and 
effective.
    (b) Any OTC drug product for oral administration that is labeled, 
represented, or promoted to treat or relieve the symptoms or discomfort 
of fever blisters and cold sores is regarded as a new drug within the 
meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act 
(the act), for which an approved application under section 505 of the 
act and part 314 of this chapter is required for marketing. In the 
absence of an approved application, such product is also misbranded 
under section 502 of the act.
    (c) Clinical investigations designed to obtain evidence that any 
drug product for oral administration labeled, represented, or promoted 
for OTC use to treat or relieve the symptoms or discomfort of fever 
blisters and cold sores 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 December 30, 1992, any such OTC drug product initially 
introduced or initially delivered for introduction into interstate 
commerce that is not in compliance with this section is subject to 
regulatory action.

[57 FR 29173, June 30, 1992]