La. Admin. Code tit. 49 § I-1185

Current through Register Vol. 50, No. 11, November 20, 2024

Section I-1185 - Labeling-Exemption from Requirements, Conditions or Exemption [Formerly 49:4.0440]

A. The label of a drug shall be exempt from compliance with the requirements of §1163. A.2 if the container is so small that the label when extended over the area available for label space is of insufficient size so that all words, statements, and other information required by or under authority of the Act to appear on the label of such drug, cannot be so placed on the label as to comply with the requirements of R.S. 40:617 (A)(4) and regulations §1143 and its subparagraphs promulgated thereunder. This exemption shall be on the condition that if the statement on the label of the quantity of the contents is omitted as authorized by §1141 under R.S. 40:617 (A)(3) and this omission will allow sufficient space to include the information required by §1163. A.2 even though the statement is not so conspicuous as to render it likely to be read by the ordinary individual under customary conditions of purchase, then the statement of the quantity of contents shall be omitted and the information required by 4.07 (2) shall be stated as prominently as is practicable.

La. Admin. Code tit. 49, § I-1185

Adopted by the Department of Lfealth 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.