[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR310.542]

[Page 36]
 
                        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. 310.542  Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hyperphosphatemia.

    (a) Hyperphosphatemia is a condition in which an abnormally high 
plasma level of phosphate occurs in the blood. This condition in not 
amenable to self-diagnosis or self-treatment. Treatment of this 
condition should be restricted to the supervision of a physician. For 
this reason, any drug product containing ingredients offered for OTC use 
in the treatment of hyperphosphatemia cannot be considered generally 
recognized as safe and effective.
    (b) Any drug product that is labeled, represented, or promoted for 
OTC use in the treatment of hyperphosphatemia 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 labeled, represented, or promoted for use in the treatment 
of hyperphosphatemia is safe and effective for the purpose intended must 
comply with the requirements and procedures governing use of 
investigational new drugs set forth in part 312 of this chapter.
    (d) After November 12, 1990, 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.

[55 FR 19858, May 11, 1990]