[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.105]

[Page 51-53]
 
                        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. 201.105  Veterinary drugs.

    A drug subject to the requirements of section 503(f)(1) of the act 
shall be exempt from section 502(f)(1) of the act 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 drugs that are to be used only by 
or on the prescription or other order of a licensed veterinarian; or

[[Page 52]]

    (ii) In the possession of a retail, hospital, or clinic pharmacy, or 
other person authorized under State law to dispense veterinary 
prescription drugs, who is regularly and lawfully engaged in dispensing 
drugs that are to be used only by or on the prescription or other order 
of a licensed veterinarian; or
    (iii) In the possession of a licensed veterinarian for use in the 
course of his professional practice; and
    (2) To be dispensed in accordance with section 503(f) of the act.
    (b) The label of the drug bears:
    (1) The statement ``Caution: Federal law restricts this drug to use 
by or on the order of a licensed veterinarian''; 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(e) of the act; 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;

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 
paragraphs (b) (2), (3), and (5) of this section may be contained in 
other labeling on or within the package from which it is to be so 
dispensed, and 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.
    (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 veterinarians 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 512 of the act, the 
labeling bearing such information is the labeling authorized by the 
approved new animal drug application or required as a condition for the 
certification or the exemption from certification requirements 
applicable to preparations of antibiotic drugs: Provided, however, That 
the information required by paragraph (c)(1) of this section may be 
omitted from the dispensing package if, but only if, the article is a 
drug for which directions, hazards, warnings, and use information are 
commonly known to veterinarians licensed by law to administer the drug. 
Upon written request, stating reasonable grounds therefore, the 
Commissioner will offer an opinion on a proposal to omit such 
information from the dispensing package under this proviso.
    (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

[[Page 53]]

use of the drug (other than dose information required by paragraph 
(b)(2) of this section and Sec. 201.100(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, and including information relevant to 
compliance with the new animal drug provisions of the act, under which 
veterinarians 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 512 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 512, 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;


Provided, however, That the information required by paragraphs (d) (1) 
and (2) of this section is not required on the so-called reminder-piece 
labeling which calls attention to the name of the drug but does not 
include indications or dosage recommendations for use of the drug.
    (e) All labeling, except labels and cartons, bearing information for 
use of the drug also bears the date of the issuance or the date of the 
latest revision of such labeling.
    (f) A prescription drug intended for both human and veterinary use 
shall comply with paragraphs (e) and (f) of this section and 
Sec. 201.100.

[40 FR 13998, Mar. 27, 1975, as amended at 42 FR 15674, Mar. 22, 1977; 
57 FR 54300, Nov. 18, 1992]