[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: 21CFR310.547]

[Page 48-49]
 
                        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. 310.547  Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or prevention of malaria.

    (a) Quinine and quinine salts have been used OTC for the treatment 
and/or prevention of malaria, a serious and potentially life-threatening 
disease. Quinine is no longer the drug of choice for the treatment and/
or prevention of most types of malaria. In addition, there are serious 
and complicating aspects of the disease itself and some potentially 
serious and life-threatening risks associated with the use of quinine at 
doses employed for the treatment of malaria. There is a lack of adequate 
data to establish general recognition of the safety of quinine drug 
products for OTC use in the treatment and/or prevention of malaria. 
Therefore, quinine or quinine salts cannot be safely and effectively 
used for the treatment and/or prevention of malaria except under the 
care and supervision of a doctor.
    (b) Any OTC drug product containing quinine or quinine salts that is 
labeled, represented, or promoted for the treatment and/or prevention of 
malaria is regarded as a new drug within the meaning of section 201(p) 
of the act, for which an approved application or abbreviated 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 or 
abbreviated 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 for the 
treatment and/or

[[Page 49]]

prevention of malaria 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 April 20, 1998, 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.

[63 FR 13528, Mar. 20, 1998]