§ 201.18 Drugs; significance of control numbers.

FederalRegulations

Ask Donna

How this section applies to your facts.

Title 21 CFR: Food and Drugs › Chapter I › Part 201 › Subpart A › § 201.18: § 201.18 Drugs; significance of control numbers.

This text was captured on Aug 14, 2026. It is a snapshot, not a live feed, so check the official code before relying on it.

Text

The lot number on the label of a drug should be capable of yielding the complete manufacturing history of the package. An incorrect lot number may be regarded as causing the article to be misbranded.

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.

A word about cookies

We need a few to keep you signed in and the library working. The rest help us see which pages people use and where they get stuck. They stay off unless you say yes.

§ 201.18 Drugs; significance of control numbers. · 21 C.F.R. § 201.18 (2026) | Frix