21 CFR § 206.1Chapter I

§ 206.1 Scope.

Primary source

Verbatim text below is from the Electronic Code of Federal Regulations (eCFR), a public-domain U.S. government work. Always verify the current version with the eCFR before relying on it for any legal matter.

Full Text

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.

eCFR data current as of: June 10, 2026

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.