[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: 21CFR201.56]

[Page 20-21]

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 B--Labeling Requirements for Prescription Drugs and/or Insulin

Sec. 201.56 General requirements on content and format of labeling for human prescription drugs.

Prescription drug labeling described in Sec. 201.100(d) shall
contain the information in the format required by Sec. 201.57 and shall
meet the following general requirements:
(a) The labeling shall contain a summary of the essential scientific
information needed for the safe and effective use of the drug.
(b) The labeling shall be informative and accurate and neither
promotional in tone nor false or misleading in any particular.
(c) The labeling shall be based whenever possible on data derived
from human experience. No implied claims or suggestions of drug use may
be made if there is inadequate evidence of safety or a lack of
substantial evidence of effectiveness. Conclusions based on animal data
but necessary for safe and effective use of the drug in humans shall be
identified as such and included with human data in the appropriate
section of the labeling, headings for which are listed in paragraph (d)
of this section.
(d)(1) The labeling shall contain specific information required
under Sec. 201.57 under the following section headings and in the
following order:

Description.
Clinical Pharmacology.
Indications and Usage.
Contraindications.
Warnings.
Precautions.
Adverse Reactions.
Drug Abuse and Dependence.
Overdosage.
Dosage and Administration.
How Supplied.

(2) The labeling may contain the following additional section
headings if appropriate and if in compliance with Sec. 201.57 (l) and
(m):

Animal Pharmacology and/or Animal Toxicology.
Clinical Studies.
References.

(3) The labeling may omit any section or subsection of the labeling
format if clearly inapplicable.
(4) The labeling may contain a ``Product Title'' section preceding
the ``Description'' section and containing only the information required
by Sec. 201.57(a)(1)(i), (ii), (iii), and (iv) and Sec. 201.100(e). The
information required by Sec. 201.57(a)(1)(i), (ii), (iii), and (iv)
shall appear in the ``Description'' section of the labeling, whether or
not it also appears in a ``Product Title.''
(e) The labeling shall contain the date of the most recent revision
of the labeling, identified as such, placed

[[Page 21]]

prominently immediately after the last section of the labeling.

[44 FR 37462, June 26, 1979]