[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: 21CFR330.13]

[Page 218-219]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--Continued
 
PART 330--OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED--Table of Contents
 
                  Subpart B--Administrative Procedures
 
Sec. 330.13  Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC drug review.

    (a) Before the publication in the Federal Register of an applicable 
proposed monograph, an OTC drug product that contains: (1) An active 
ingredient limited, on or after May 11, 1972, to prescription use for 
the indication and route of administration under consideration by an OTC 
advisory review panel, and not thereafter exempted from such limitation 
pursuant to Sec. 310.200 of this chapter, or
    (2) An active ingredient at a dosage level higher than that 
available in an OTC drug product on December 4, 1975, shall be regarded 
as a new drug within the meaning of section 201(p) of the act for which 
an approved new drug application is required.
    (b)(1) An OTC drug product that contains: (i) An active ingredient 
limited, on or after May 11, 1972, to prescription use for the 
indication and route of administration under consideration by an OTC 
advisory review panel, and not thereafter exempted from such limitation 
pursuant to Sec. 310.200 of this chapter, or
    (ii) An active ingredient at a dosage level higher than that 
available in an OTC drug product on December 4, 1975, which ingredient 
and/or dosage level is classified by the panel in category I (conditions 
subject to Sec. 330.10(a)(6)(i)) shall be regarded as a new drug within 
the meaning of section 201(p) of the act for which an approved new drug 
application is required if marketed for OTC use prior to the date of 
publication in the Federal Register of a proposed monograph.
    (2) An OTC drug product covered by paragraph (b)(1) of this section 
which is marketed after the date of publication in the Federal Register 
of a proposed monograph but prior to the effective date of a final 
monograph shall be subject to the risk that the Commissioner may not 
accept the panel's recommendation and may instead adopt a different 
position that may require relabeling, recall, or other regulatory 
action. The Commissioner may state such position at any time by notice 
in the Federal Register, either separately or as part of another 
document; appropriate regulatory action will commence immediately and 
will not await publication of a final monograph. Marketing of such a 
product with a formulation or labeling not in accord with a proposed 
monograph or tentative final monograph also may result in regulatory 
action against the product, the marketer, or both.
    (c) An OTC drug product that contains: (1) An active ingredient 
limited, on or after May 11, 1972, to prescription use for the 
indication and route of administration under consideration by an OTC 
advisory review panel, and not thereafter exempted from such limitation 
pursuant to Sec. 310.200 of this chapter, or
    (2) An active ingredient at a dosage level higher than that 
available in any OTC drug product on December 4, 1975, which ingredient 
and/or dosage level is classified by the panel in category II 
(conditions subject to Sec. 330.10(a)(6)(ii)), may be marketed only 
after:
    (i) The Center for Drug Evaluation and Research or the Commissioner 
tentatively determines that the ingredient is generally recognized as 
safe and effective, and the Commissioner states by notice in the Federal 
Register (separately or as part of another document) that marketing 
under specified conditions will be permitted;
    (ii) The ingredient is determined by the Commissioner to be 
generally recognized as safe and effective and is included in the 
appropriate published OTC drug final monograph; or
    (iii) A new drug application for the product has been approved.
    (d) An OTC drug product that contains: (1) An active ingredient 
limited, on or after May 11, 1972, to prescription use for the 
indication and route of administration under consideration by an

[[Page 219]]

OTC advisory review panel, and not thereafter exempted from such 
limitation pursuant to Sec. 310.200 of this chapter, or
    (2) An active ingredient at a dosage level higher than that 
available in any OTC drug product on December 4, 1975, which ingredient 
and/or dosage level is classified by the panel in category III 
(conditions subject to Sec. 330.10(a)(6)(iii)), may be marketed only 
after:
    (i) The Center for Drug Evaluation and Research or the Commissioner 
tentatively determines that the ingredient is generally recognized as 
safe and effective, and the Commissioner states by notice in the Federal 
Register (separately or as part of another document) that marketing 
under specified conditions will be permitted;
    (ii) The ingredient is determined by the Commissioner to be 
generally recognized as safe and effective and is included in the 
appropriate published OTC drug final monograph; or
    (iii) A new drug application for the product has been approved.

[41 FR 32582, Aug. 4, 1976, as amended at 47 FR 17739, Apr. 23, 1982; 50 
FR 8996, Mar. 6, 1985; 55 FR 11581, Mar. 29, 1990]