[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: 21CFR310.200]

[Page 10-11]
 
                        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 C--New Drugs Exempted From Prescription-Dispensing Requirements
 
Sec. 310.200  Prescription-exemption procedure.


    (a) Duration of prescription requirement. Any drug limited to 
prescription use under section 503(b)(1)(C) of the act remains so 
limited until it is exempted as provided in paragraph (b) or (e) of this 
section.
    (b) Prescription-exemption procedure for drugs limited by a new drug 
application. Any drug limited to prescription use under section 
503(b)(1)(C) of the act shall be exempted from prescription-dispensing 
requirements when the Commissioner finds such requirements are not 
necessary for the protection of the public health by reason of the 
drug's toxicity or other potentiality for harmful effect, or the method 
of its use, or the collateral measures necessary to its use, and he 
finds that the drug is safe and effective for use in self-medication as 
directed in proposed labeling. A proposal to exempt a drug from the 
prescription-dispensing requirements of section 503(b)(1)(C) of the act 
may be initiated by the Commissioner or by any interested person. Any 
interested person may file a petition seeking such exemption, which 
petition may be pursuant to part 10 of this chapter, or in the form of a 
supplement to an approved new drug application.
    (c) New drug status of drugs exempted from the prescription 
requirement. A drug exempted from the prescription requirement under the 
provisions of paragraph (b) of this section is a ``new drug'' within the 
meaning of section 201(p) of the act until it has been used to a 
material extent and for a material time under such conditions except as 
provided in paragraph (e) of this section.
    (d) Prescription legend not allowed on exempted drugs. The use of 
the prescription caution statement quoted in section 503(b) (4) of the 
act, in the labeling

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of a drug exempted under the provisions of this section, constitutes 
misbranding. Any other statement or suggestion in the labeling of a drug 
exempted under this section, that such drug is limited to prescription 
use, may constitute misbranding.
    (e) Prescription-exemption procedure of OTC drug review. A drug 
limited to prescription use under section 503(b)(1)(C) of the act may 
also be exempted from prescription-dispensing requirements by the 
procedure set forth in Sec. 330.13 of this chapter.

[39 FR 11680, Mar. 29, 1974, as amended at 41 FR 32582, Aug. 4, 1976; 42 
FR 4714, Jan. 25, 1977; 42 FR 15674, Mar. 22, 1977]