CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 4]

[CITE: 21CFR206.3]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER C - DRUGS: GENERAL

PART 206 -- IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE

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

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