21 CFR § 206.3 - Definitions.

---
identifier: "/us/cfr/t21/s206.3"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 206.3 - Definitions."
title_number: 21
title_name: "Food and Drugs"
section_number: "206.3"
section_name: "Definitions."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "DRUGS: GENERAL"
part_number: "206"
part_name: "IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 355, 371; 42 U.S.C. 262."
regulatory_source: "58 FR 47958, Sept. 13, 1993, unless otherwise noted."
cfr_part: "206"
---


# 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.