[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR206.3]

[Page 120]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 206_IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE--Table of Contents
 
Sec.  206.3  Definitions.

    The following definitions apply to this part:
    The act means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
301 et seq.).
    Debossed means imprinted with a mark below the dosage form surface.
    Drug product means a finished dosage form, e.g., a tablet or capsule 
that contains a drug substance, generally, but not necessarily, in 
association with one or more other ingredients.
    Embossed means imprinted with a mark raised above the dosage form 
surface.
    Engraved means imprinted with a code that is cut into the dosage 
form surface after it has been completed.
    Imprinted means marked with an identification code by means of 
embossing, debossing, engraving, or printing with ink.
    Manufacturer means the manufacturer as described in Sec. Sec.  201.1 
and 600.3(t) of this chapter.
    Solid oral dosage form means capsules, tablets, or similar drug 
products intended for oral use.