LAC 49:I.1161 – Habit Forming Drugs, Labeling Exemptions [Formerly 49:4.0300]

A. A drug shall not be considered to be misbranded by reason of failure of its label to bear the statement "Warning—May Be Habit Forming—"
1. If 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; or
2. If the only substance or derivative subject to R.S. 40:617 (A)(5) contained in such drug is chlorobutanol, which is present solely as a preservative and in a quantity not more than 0.5 percent by weight, and such drug is for parenteral use only; or
3. If the only substance or derivative subject to R.S. 40:617 (A)(5) contained in such drug is chlorobutanol, which is present as an analgesic or as an analgesic and a preservative in a quantity not more than 3.0 percent, and such drug contains one or more other active ingredients and is for parenteral use only.

AUTHORITY NOTE: Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as amended.

HISTORICAL NOTE: Adopted by the Department of Health and Human Resources, Office of Preventive and Public Health Services, September 1968.