[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: 21CFR330.1]

[Page 201-204]
 
                        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 
 
                      Subpart A_General Provisions
 
Sec.  330.1  General conditions for general recognition as safe, effective and 


not misbranded.

    An over-the-counter (OTC) drug listed in this subchapter is 
generally recognized as safe and effective and is not misbranded if it 
meets each of the conditions contained in this part and each of the 
conditions contained in any applicable monograph. Any product which 
fails to conform to each of the conditions contained in this part and in 
an applicable monograph is liable to regulatory action.
    (a) The product is manufactured in compliance with current good 
manufacturing practices, as established by parts 210 and 211 of this 
chapter.
    (b) The establishment(s) in which the drug product is manufactured 
is registered, and the drug product is listed, in compliance with part 
207 of this chapter. It is requested but not required that the number 
assigned to the product pursuant to part 207 of this chapter appear on 
all drug labels and in all drug labeling. If this number is used, it 
shall be placed in the manner set forth in part 207 of this chapter.
    (c)(1) The product is labeled in compliance with chapter V of the 
Federal Food, Drug, and Cosmetic Act (the act) and subchapter C et seq. 
of this chapter, including the format and content requirements in Sec.  
201.66 of this chapter. An OTC drug product that is not in compliance 
with chapter V and subchapter C, including Sec.  201.66 of this chapter, 
is subject to regulatory action. For purposes of Sec.  201.61(b) of this 
chapter, the statement of identity of the product shall be the term or 
phrase used in the applicable OTC drug monograph established in this 
part.
    (2) The ``Uses'' section of the label and labeling of the product 
shall contain the labeling describing the ``Indications'' that have been 
established in an applicable OTC drug monograph or alternative truthful 
and nonmisleading statements describing only those indications for use 
that have been established in an applicable monograph, subject to the 
provisions of section 502 of the act relating to misbranding and the 
prohibition in section 301(d) of the act against the introduction or 
delivery for introduction into interstate commerce of unapproved new 
drugs in violation of section 505(a) of the act. Any other labeling 
under this subchapter and subchapter C et seq. of this chapter shall be 
stated in the exact language where exact language has been established

[[Page 202]]

and identified by quotation marks in an applicable OTC drug monograph or 
by regulation (e.g., Sec.  201.63 of this chapter), except as provided 
in paragraphs (i) and (j) of this section.
    (d) The advertising for the product prescribes, recommends, or 
suggests its use only under the conditions stated in the labeling.
    (e) The product contains only suitable inactive ingredients which 
are safe in the amounts administered and do not interfere with the 
effectiveness of the preparation or with suitable tests or assays to 
determine if the product meets its professed standards of identity, 
strength, quality, and purity. Color additives may be used only in 
accordance with section 721 of the act and subchapter A of this chapter.
    (f) The product container and container components meet the 
requirements of Sec.  211.94 of this chapter.
    (g) The labeling for all drugs contains the general warning: ``Keep 
out of reach of children.'' [highlighted in bold type]. The labeling of 
drugs shall also state as follows: For drugs used by oral 
administration, ``In case of overdose, get medical help or contact a 
Poison Control Center right away''; for drugs used topically, rectally, 
or vaginally and not intended for oral ingestion, ``If swallowed, get 
medical help or contact a Poison Control Center right away''; and for 
drugs used topically and intended for oral use, ``If more than used 
for'' (insert intended use, e.g., pain) ``is accidentally swallowed, get 
medical help or contact a Poison Control Center right away.'' The Food 
and Drug Administration will grant an exemption from these general 
warnings where appropriate upon petition, which shall be maintained in a 
permanent file for public review by the Division of Dockets Management, 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852.
    (h) Where no maximum daily dosage limit for an active ingredient is 
established in this part, it is used in a product at a level that does 
not exceed the amount reasonably required to achieve its intended 
effect.
    (i) The following terms may be used interchangeably in the labeling 
of OTC drug products, provided such use does not alter the meaning of 
the labeling that has been established and identified in an applicable 
monograph or by regulation. The following terms shall not be used to 
change in any way the title, headings, and subheadings required under 
Sec.  201.66(c)(1) through (c)(9) of this chapter:
    (1) ``Abdominal'' or ``stomach'' (in context only).
    (2) ``Administer'' or ``give''.
    (3) ``Aggravate(s)'' or ``make(s) worse''.
    (4) ``Application of this product'' or ``applying''.
    (5) ``Are uncertain'' or ``do not know''.
    (6) ``Ask'' or ``consult'' or ``contact''.
    (7) ``Asking'' or ``consulting''.
    (8) ``Assistance'' or ``help'' or ``aid''.
    (9) ``Associated with'' or ``due to'' or ``caused by''.
    (10) ``Avoid contact with eyes'' or ``do not get into eyes''.
    (11) ``Avoid inhaling'' or ``do not inhale''.
    (12) ``Before a doctor is consulted'' or ``without first consulting 
your doctor'' or ``consult your doctor before''.
    (13) ``Beverages'' or ``drinks''.
    (14) ``Clean'' or ``cleanse''.
    (15) ``Consulting'' or ``advising''.
    (16) ``Continue(s)'' or ``persist(s)'' or ``is persistent'' or 
``do(es) not go away'' or ``last(s)''.
    (17) ``Daily'' or ``every day''.
    (18) ``Develop(s)'' or ``begin(s)'' or ``occur(s)''.
    (19) ``Difficulty'' or ``trouble''.
    (20) ``Difficulty in urination'' or ``trouble urinating''.
    (21) ``Discard'' or ``throw away''.
    (22) ``Discontinue'' or ``stop'' or ``quit''.
    (23) ``Doctor'' or ``physician''.
    (24) ``Drowsiness'' or ``the drowsiness effect''.
    (25) ``Drowsiness may occur'' or ``you may get drowsy''.
    (26) ``Enlargement of the'' or ``an enlarged''.
    (27) ``Especially in children'' or especially children''.
    (28) ``Exceed'' or ``use more than'' or ``go beyond''.
    (29) ``Exceed recommended dosage'' or ``use more than directed''.
    (30) ``Excessive'' or ``too much''.
    (31) ``Excitability may occur'' or ``you may get excited''.

[[Page 203]]

    (32) ``Experience'' or ``feel''.
    (33) ``For relief of'' or ``relieves''.
    (34) ``For temporary reduction of'' or ``temporarily reduces''.
    (35) ``For the temporary relief of'' or ``temporarily relieves''.
    (36) ``For the treatment of'' or ``treats''.
    (37) ``Frequently'' or ``often''.
    (38) ``Give to'' or ``use in''.
    (39) ``Immediately'' or ``right away'' or ``directly''.
    (40) ``Immediately'' or ``as soon as''.
    (41) ``Immediately following'' or ``right after''.
    (42) ``Improve(s)'' or ``get(s) better'' or ``make(s) better''.
    (43) ``Increased'' or ``more''.
    (44) ``Increase your risk of'' or ``cause''.
    (45) ``Indication(s)'' or ``Use(s)''.
    (46) ``Inhalation'' or ``puff''.
    (47) ``In persons who'' or ``if you'' or ``if the child''.
    (48) ``Instill'' or ``put''.
    (49) ``Is (are) accompanied by'' or ``you also have'' (in context 
only) or ``(optional: that) occur(s) with''.
    (50) ``Longer'' or ``more''.
    (51) ``Lung'' or ``pulmonary''.
    (52) ``Medication(s)'' or ``medicine(s)'' or ``drug(s)''.
    (53) ``Nervousness, dizziness, or sleeplessness occurs'' or ``you 
get nervous, dizzy, or sleepless''.
    (54) ``Not to exceed'' or ``do not exceed'' or ``not more than''.
    (55) ``Obtain(s)'' or ``get(s)''.
    (56) ``Passages'' or ``passageways'' or ``tubes''.
    (57) ``Perforation of'' or ``hole in''.
    (58) ``Persistent'' or ``that does not go away'' or ``that 
continues'' or ``that lasts''.
    (59) ``Per day'' or ``daily''.
    (60) ``Presently'' or ``now''.
    (61) ``Produce(s)'' or ``cause(s)''.
    (62) ``Prompt(ly)'' or ``quick(ly)'' or ``right away''.
    (63) ``Reduce'' or ``minimize''.
    (64) ``Referred to as'' or ``of''.
    (65) ``Sensation'' or ``feeling''.
    (66) ``Solution'' or ``liquid''.
    (67) ``Specifically'' or ``definitely''.
    (68) ``Take'' or ``use'' or ``give''.
    (69) ``Tend(s) to recur'' or ``reoccur(s)'' or ``return(s)'' or 
``come(s) back''.
    (70) ``To avoid contamination'' or ``avoid contamination'' or ``do 
not contaminate''.
    (71) ``To help'' or ``helps''.
    (72) ``Unless directed by a doctor'' or ``except under the advice of 
a doctor'' or ``unless told to do so by a doctor''.
    (73) ``Use caution'' or ``be careful''.
    (74) ``Usually'' or ``generally'' (in context only).
    (75) ``You'' (``Your'') or ``the child'' (``the child's'').
    (76) ``You also have'' or ``occurs with''.
    (77) ``When practical'' or ``if possible''.
    (78) ``Whether'' or ``if''.
    (79) ``Worsen(s)'' or ``get(s) worse'' or ``make(s) worse''.
    (j) The following connecting terms may be deleted from the labeling 
of OTC drug products, provided such deletion does not alter the meaning 
of the labeling that has been established and identified in an 
applicable monograph or by regulation. The following terms shall not be 
used to change in any way the specific title, headings, and subheadings 
required under Sec.  201.66(c)(1) through (c)(9) of this chapter:
    (l) ``And''.
    (2) ``As may occur with''.
    (3) ``Associated'' or ``to be associated''.
    (4) ``Consult a doctor''.
    (5) ``Discontinue use''.
    (6) ``Drug Interaction Precaution''.
    (7) ``Due to''.
    (8) ``Except under the advice and supervision of a physician''.
    (9) ``If this occurs''.
    (10) ``In case of''.
    (11) ``Notice''.
    (12) ``Or''.
    (13) ``Occurring with''.
    (14) ``Or as directed by a doctor''.
    (15) ``Such as''.
    (16) ``Such as occurs with''.
    (17) ``Tends to''.
    (18) ``This product''.
    (19) ``Unless directed by a doctor''.
    (20) ``While taking this product'' or ``before taking this 
product''.

[[Page 204]]

    (21) ``Within''.

[39 FR 11741, Mar. 29, 1974, as amended at 40 FR 11718, Mar. 13, 1975; 
40 FR 13496, Mar. 27, 1975; 42 FR 15674, Mar. 22, 1977; 46 FR 8459, Jan. 
27, 1981; 50 FR 8996, Mar. 6, 1985; 51 FR 16266, May 1, 1986; 55 FR 
11581, Mar. 29, 1990; 59 FR 4000, Jan. 28, 1994; 59 FR 14365, Mar. 28, 
1994; 64 FR 13294, Mar. 17, 1999; 68 FR 24879, May 9, 2003]