LAC 49:I.1187 – Drug LabelingDirections, Warnings [Formerly 49:4.0460]

A. The labeling of drugs or devices shall bear:
1. 1. adequate directions for use; and
2. 2. adequate warnings against misuse in connection with pathological conditions or by children where its use may be dangerous to health; or against unsafe dosage, methods, or duration of administration or application, in such manner and form as are necessary for the protection of users.

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.