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 §§ 201.1 and 600.3(t) of this chapter.

Solid oral dosage form means capsules, tablets, or similar drug products intended for oral use.