[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR358.703]

[Page 298-299]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--Continued
 
PART 358--MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents
 
    Subpart H--Drug Products for the Control of Dandruff, Seborrheic 
                        Dermatitis, and Psoriasis
 
Sec. 358.703  Definitions.

    As used in this subpart:
    (a) Coal tar. The tar used for medicinal purposes that is obtained 
as a byproduct during the destructive distillation of bituminous coal at 
temperatures in the range of 900  deg.C to 1,100  deg.C. It may be 
further processed using either extraction with alcohol and suitable 
dispersing agents and maceration times or fractional distillation with 
or without the use of suitable organic solvents.
    (b) Dandruff. A condition involving an increased rate of shedding of 
dead epidermal cells of the scalp.
    (c) Psoriasis. A condition of the scalp or body characterized by 
irritation, itching, redness, and extreme excess shedding of dead 
epidermal cells.
    (d) Seborrheic dermatitis. A condition of the scalp or body 
characterized by irritation, itching, redness, and excess shedding of 
dead epidermal cells.
    (e) Selenium sulfide, micronized. Selenium sulfide that has been 
finely ground and that has a median particle size of approximately 5 
micrometers (m), with not more than 0.1 percent of the 
particles greater than 15 m and

[[Page 299]]

not more than 0.1 percent of the particles less than 0.5 m.

[56 FR 63568, Dec. 4, 1991, as amended at 59 FR 4001, Jan. 28, 1994]