La. Admin. Code tit. 49 § I-1161

Current through Register Vol. 50, No. 9, September 20, 2024
Section 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.

La. Admin. Code tit. 49, § I-1161

Adopted by the Department of Health and Human Resources, Office of Preventive and Public Health Services, September 1968.
AUTHORITY NOTE: Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as amended.