21 CFR § 206.1 - Scope.

---
identifier: "/us/cfr/t21/s206.1"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 206.1 - Scope."
title_number: 21
title_name: "Food and Drugs"
section_number: "206.1"
section_name: "Scope."
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"
---


# 206.1 Scope.

This part applies to all solid oral dosage form human drug products, including prescription drug products, over-the-counter drug products, biological drug products, and homeopathic drug products, unless otherwise exempted under § 206.7.