[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.100]
[Page 66-68]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 201 LABELING--Table of Contents
Subpart D Exemptions From Adequate Directions for Use
Sec. 201.100 Prescription drugs for human use.
A drug subject to the requirements of section 503(b)(1) of the act
shall be exempt from section 502(f)(1) if all the following conditions
are met:
(a) The drug is:
(1)(i) In the possession of a person (or his agents or employees)
regularly and lawfully engaged in the manufacture, transportation,
storage, or wholesale distribution of prescription drugs; or
(ii) In the possession of a retail, hospital, or clinic pharmacy, or
a public health agency, regularly and lawfully engaged in dispensing
prescription drugs; or
(iii) In the possession of a practitioner licensed by law to
administer or prescribe such drugs; and
(2) It is to be dispensed in accordance with section 503(b)
(b) The label of the drug bears:
(1) The statement ``Rx only'' and
(2) The recommended or usual dosage and
(3) The route of administration, if it is not for oral use; and
(4) The quantity or proportion of each active ingredient, as well as
the information required by section 502 (d) and (e); and
(5) If it is for other than oral use, the names of all inactive
ingredients, except that:
(i) Flavorings and perfumes may be designated as such without naming
their components.
(ii) Color additives may be designated as coloring without naming
specific color components unless the naming of such components is
required by a color additive regulation prescribed in subchapter A of
this chapter.
(iii) Trace amounts of harmless substances added solely for
individual product identification need not be named. If it is intended
for administration by parenteral injection, the quantity or proportion
of all inactive ingredients, except that ingredients added to adjust the
pH or to make the drug isotonic may be declared by name and a statement
of their effect; and if the vehicle is water for injection it need not
be named.
(6) An identifying lot or control number from which it is possible
to determine the complete manufacturing history of the package of the
drug.
(7) A statement directed to the pharmacist specifying the type of
container to be used in dispensing the drug product to maintain its
identity, strength, quality, and purity. Where there are standards and
test procedures for determining that the container meets the
requirements for specified types of containers as defined in an official
compendium, such terms may be used. For example, ``Dispense in tight,
light-resistant container as defined in the National Formulary''. Where
standards and test procedures for determining the types of containers to
be used in dispensing the drug product are not included in an official
compendium, the
[[Page 67]]
specific container or types of containers known to be adequate to
maintain the identity, strength, quality, and purity of the drug
products shall be described. For example, ``Dispense in containers which
(statement of specifications which clearly enable the dispensing
pharmacist to select an adequate container)'': Provided, however, That
in the case of containers too small or otherwise unable to accommodate a
label with sufficient space to bear all such information, but which are
packaged within an outer container from which they are removed for
dispensing or use, the information required by paragraph (b) (2), (3),
(5), and (7) of this section may be contained in other labeling on or
within the package from which it is to be dispensed; the information
referred to in paragraph (b)(1) of this section may be placed on such
outer container only; and the information required by paragraph (b)(6)
of this section may be on the crimp of the dispensing tube. The
information required by this paragraph (b)(7) is not required for
prescription drug products packaged in unit-dose, unit-of-use, on other
packaging format in which the manufacturer's original package is
designed and intended to be dispensed to patients without repackaging.
(c)(1) Labeling on or within the package from which the drug is to
be dispensed bears adequate information for its use, including
indications, effects, dosages, routes, methods, and frequency and
duration of administration, and any relevant hazards, contraindications,
side effects, and precautions under which practitioners licensed by law
to administer the drug can use the drug safely and for the purposes for
which it is intended, including all purposes for which it is advertised
or represented; and
(2) If the article is subject to section 505 of the act, the
labeling bearing such information is the labeling authorized by the
approved new drug application or required as a condition for the
certification or the exemption from certification requirements
applicable to preparations of insulin or antibiotic drugs.
(d) Any labeling, as defined in section 201(m) of the act, whether
or not it is on or within a package from which the drug is to be
dispensed, distributed by or on behalf of the manufacturer, packer, or
distributor of the drug, that furnishes or purports to furnish
information for use or which prescribes, recommends, or suggests a
dosage for the use of the drug (other than dose information required by
paragraph (b)(2) of this section and Sec. 201.105(b)(2) contains:
(1) Adequate information for such use, including indications,
effects, dosages, routes, methods, and frequency and duration of
administration and any relevant warnings, hazards, contraindications,
side effects, and precautions, under which practitioners licensed by law
to administer the drug can use the drug safely and for the purposes for
which it is intended, including all conditions for which it is
advertised or represented; and if the article is subject to section 505
of the act, the parts of the labeling providing such information are the
same in language and emphasis as labeling approved or permitted, under
the provisions of section 505, and any other parts of the labeling are
consistent with and not contrary to such approved or permitted labeling;
and
(2) The same information concerning the ingredients of the drug as
appears on the label and labeling on or within the package from which
the drug is to be dispensed.
(3) The information required, and in the format specified, by
Sec. Sec. 201.56, 201.57, and 201.80.
(e) All labeling described in paragraph (d) of this section bears
conspicuously the name and place of business of the manufacturer,
packer, or distributor, as required for the label of the drug under
Sec. 201.1.
(f) Reminder labeling which calls attention to the name of the drug
product but does not include indications or dosage recommendations for
use of the drug product is exempted from the provisions of paragraph (d)
of this section. This reminder labeling shall contain only the
proprietary name of the drug product, if any; the established name of
the drug product, if any; the established name of each active ingredient
in the drug product; and, optionally, information relating to
quantitative ingredient statements, dosage form, quantity of package
contents, price,
[[Page 68]]
the name and address of the manufacturer, packer, or distributor or
other written, printed, or graphic matter containing no representation
or suggestion relating to the drug product. If the Commissioner finds
that there is evidence of significant incidence of fatalities or serious
injury associated with the use of a particular prescription drug, he may
withdraw this exemption by so notifying the manufacturer, packer, or
distributor of the drug by letter. Reminder labeling, other than price
lists and catalogs solely intended to convey price information
including, but not limited to, those subject to the requirements of
Sec. 200.200 of this chapter, is not permitted for a prescription drug
product whose labeling contains a boxed warning relating to a serious
hazard associated with the use of the drug product. Reminder labeling
which is intended to provide consumers with information concerning the
price charged for a prescription for a particular drug product shall
meet all of the conditions contained in Sec. 200.200 of this chapter.
Reminder labeling, other than that subject to the requirements of Sec.
200.200 of this chapter, is not permitted for a drug for which an
announcement has been published pursuant to a review of the labeling
claims for the drug by the National Academy of Sciences/National
Research Council (NAS/NRC), Drug Efficacy Study Group, and for which no
claim has been evaluated as higher than ``possibly effective.'' If the
Commissioner finds the circumstances are such that reminder labeling may
be misleading to prescribers of drugs subject to NAS/NRC evaluation,
such reminder labeling will not be allowed and the manufacturer, packer,
or distributor will be notified either in the publication of the
conclusions on the effectiveness of the drug or by letter.
[40 FR 13998, Mar. 27, 1975, as amended at 40 FR 58799, Dec. 18, 1975;
42 FR 15674, Mar. 22, 1977; 43 FR 37989, Aug. 25, 1978; 44 FR 20659,
Apr. 6, 1979; 44 FR 37467, June 26, 1979; 45 FR 25777, Apr. 15, 1980; 63
FR 26698, May 13, 1998; 64 FR 400, Jan. 5, 1999; 67 FR 4906, Feb. 1,
2002; 71 FR 3996, Jan. 24, 2006]
Back to Top
© 2007 Betterchem Corp.
|
