[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR310.530]

[Page 31]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 310--NEW DRUGS--Table of Contents
 
        Subpart E--Requirements for Specific New Drugs or Devices
 
Sec. 310.530  Topically applied hormone-containing drug products for over-the-counter (OTC) human use.

    (a) The term ``hormone'' is used broadly to describe a chemical 
substance formed in some organ of the body, such as the adrenal glands 
or the pituitary, and carried to another organ or tissue, where it has a 
specific effect. Hormones include, for example, estrogens, progestins, 
androgens, anabolic steroids, and adrenal corticosteroids, and synthetic 
analogs. Estrogens, progesterone, pregnenolone, and pregnenolone acetate 
have been present as ingredients in OTC drug products marketed for 
topical use as hormone creams. However, there is a lack of adequate data 
to establish effectiveness for any OTC drug use of these ingredients. 
Therefore, with the exception of those hormones identified in paragraph 
(e) of this section, any OTC drug product containing an ingredient 
offered for use as a topically applied hormone cannot be considered 
generally recognized as safe and effective for its intended use. The 
intended use of the product may be inferred from the product's labeling, 
promotional material, advertising, and any other relevant factor. The 
use of the word ``hormone'' in the text of the labeling or in the 
ingredient statement is an implied drug claim. The claim implied by the 
use of this term is that the product will have a therapeutic or some 
other physiological effect on the body. Therefore, reference to a 
product as a ``hormone cream'' or any statement in the labeling 
indicating that ``hormones'' are present in the product, or any 
statement that features or emphasizes the presence of a hormone 
ingredient in the product, will be considered to be a therapeutic claim 
for the product, or a claim that the product will affect the structure 
or function of the body, and will consequently cause the product to be a 
drug.
    (b) Any OTC drug product that is labeled, represented, or promoted 
as a topically applied hormone-containing product for drug use, with the 
exception of those hormones identified in paragraph (e) of this section, 
is regarded as a new drug within the meaning of section 201(p) of the 
act, for which an approved application or abbreviated application under 
section 505 of the act and part 314 of this chapter is required for 
marketing. In the absence of an approved new drug application or 
abbreviated new drug application, such product is also misbranded under 
section 502 of the act.
    (c) Clinical investigations designed to obtain evidence that any 
drug product labeled, represented, or promoted for OTC use as a 
topically applied hormone-containing drug product is safe and effective 
for the purpose intended must comply with the requirements and 
procedures governing the use of investigational new drugs set forth in 
part 312 of this chapter.
    (d) After March 9, 1994, any such OTC drug product initially 
introduced or initially delivered for introduction into interstate 
commerce that is not in compliance with this section is subject to 
regulatory action.
    (e) This section does not apply to hydrocortisone and hydrocortisone 
acetate labeled, represented, or promoted for OTC topical use in 
accordance with part 348 of this chapter.

[58 FR 47610, Sept. 9, 1993]