[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: 21CFR201.300]
[Page 75-76]
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 G Specific Labeling Requirements for Specific Drug Products
Sec. 201.300 Notice to manufacturers, packers, and distributors of glandular
preparations.
(a) Under date of December 4, 1941, in a notice to manufacturers of
glandular preparations, the Food and Drug Administration expressed the
opinion that preparations of inert glandular materials intended for
medicinal use should, in view of the requirement of
[[Page 76]]
section 201(n) of the Federal Food, Drug, and Cosmetic Act (52 Stat.
1041; 21 U.S.C. 321(n) ), be labeled with a statement of the material
fact that there is no scientific evidence that the articles contain any
therapeutic or physiologically active constituents. Numerous
preparations of such inert glandular materials were subsequently
marketed with disclaimers of the type suggested. The term inert
glandular materials means preparations incapable of exerting an action
or effect of some significant or measurable benefit in one way or
another, i.e., in the diagnosis, cure, mitigation, treatment, or
prevention of disease, or in affecting the structure or any function of
the body.
(b) Manufacturers have heretofore taken advantage of Sec. 201.100
permitting omission of directions for use when the label bears the
prescription legend. Section 201.100(c) requires that the labeling of
the drug, which may include brochures readily available to licensed
practitioners, bear information as to the use of the drug by
practitioners licensed by law to administer it. Obviously, information
adequate for the use of an inert glandular preparation is not available
to practitioners licensed by law.
(c) The Department of Health and Human Services is of the opinion
that inert glandular materials may not be exempted from the requirements
of section 502(f)(1) of the act that they bear adequate directions for
use; and, accordingly, that their labeling must include among other
things, representations as to the conditions for which such articles are
intended to be used or as to the structure or function of the human body
that they are intended to affect. Since any such representations
offering these articles for use as drugs would be false or misleading,
such articles will be considered to be misbranded if they are
distributed for use as drugs.
(d) The amended regulations provide also that in the case of drugs
intended for parenteral administration there shall be no exemption from
the requirement that their labelings bear adequate directions for use.
Such inert glandular materials for parenteral use are therefore subject
to the same comment as applies to those intended for oral
administration.
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