Code of Federal Regulations (Last Updated: May 6, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter D - Drugs for Human Use |
Part 369 - Interpretative Statements Re Warnings on Drugs and Devices for over-the-Counter Sale |
Subpart B - Warning and Caution Statements for Drugs |
§ 369.22 - Drugs; warning and caution statements specifically required by law.
Latest version.
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PREPARATIONS CONTAINING HABIT-FORMING DERIVATIVES OF SUBSTANCES NAMED IN SECTION 502(d) OF THE ACT. (See §§ 329.1, 329.10, and 329.20 of this chapter.) The statement
“Warning— May be habit forming” is required to appear on the labels of all drugs containing derivatives designated in § 329.1 of this chapter as habit forming, including exempt narcotic preparations described in § 329.20(a) of this chapter and preparations containing one or more derivatives of barbituric acid, unless such drug is not suitable for internal use and is distributed and sold exclusively for such external use as involves no possibility of habit formation.