[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR310.540]

[Page 35]
 
                        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.  310.540  Drug products containing active ingredients offered over-the-

counter (OTC) for use as stomach acidifiers.

    (a) Betaine hydrochloride, glutamic acid hydrochloride, diluted 
hydrochloric acid, and pepsin have been present as ingredients in over-
the-counter (OTC) drug products for use as stomach acidifiers. Because 
of the lack of adequate data to establish the effectiveness of these or 
any other ingredients for use in treating achlorhydria and 
hypochlorhydria, and because such conditions are asymptomatic, any OTC 
drug product containing ingredients offered for use as a stomach 
acidifier cannot be considered generally recognized as safe and 
effective.
    (b) Any OTC drug product that is labeled, represented, or promoted 
for use as a stomach acidifier 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 as a stomach acidifier 
for OTC use 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 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.

[53 FR 31271, Aug. 17, 1988]