[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: 21CFR201.5]
[Page 11.12]
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 A General Labeling Provisions
Sec. 201.5 Drugs; adequate directions for use.
Adequate directions for use means directions under which the layman
can use a drug safely and for the purposes for which it is intended.
(Section 201.128 defines ``intended use.'') Directions for use may be
inadequate because, among other reasons, of omission, in whole or in
part, or incorrect specification of:
(a) Statements of all conditions, purposes, or uses for which such
drug is intended, including conditions, purposes, or uses for which it
is prescribed, recommended, or suggested in its oral, written, printed,
or graphic advertising, and conditions, purposes, or
[[Page 12]]
uses for which the drug is commonly used; except that such statements
shall not refer to conditions, uses, or purposes for which the drug can
be safely used only under the supervision of a practitioner licensed by
law and for which it is advertised solely to such practitioner.
(b) Quantity of dose, including usual quantities for each of the
uses for which it is intended and usual quantities for persons of
different ages and different physical conditions.
(c) Frequency of administration or application.
(d) Duration of administration or application.
(e) Time of administration or application (in relation to time of
meals, time of onset of symptoms, or other time factors).
(f) Route or method of administration or application.
(g) Preparation for use, i.e., shaking, dilution, adjustment of
temperature, or, other manipulation or process.
[41 FR 6908, Feb. 13, 1976]
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