La. Admin. Code tit. 49 § I-1188
Current through Register Vol. 50, No. 11, November 20, 2024
Section I-1188 - Labeling-Inadequate Directions [Formerly 49:4.0470]A. Directions for use may be deemed to be inadequate by reason, (among other reasons) of omission in whole or in part, or incorrect specification of: 1. directions for use in all conditions for which the drug or device is prescribed, recommended, or suggested in its labeling, or in advertising regarding it which is disseminated or sponsored by, or on behalf of, its manufacturer or packer, or in such other conditions, if any there be, for which such drug or device is commonly and effectively used; or2. quantity of dose (including quantities for persons of different ages and different physical conditions); or3. frequency and duration of administration or application; or4. time of administration or application (in relation to time of meals, time of onset of symptoms, or other time factor); or5. route or method of administration or application; or6. preparation for use (shaking, dilution, adjustment of temperature, or other manipulation or process).La. Admin. Code tit. 49, § I-1188
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.