[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.300]

[Page 58-59]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
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 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

[[Page 59]]

are therefore subject to the same comment as applies to those intended 
for oral administration.