- A. A drug shall be exempt from the requirements of §1163.A.2 with respect to the alkaloids, atropine, hyoscine or hyoscyamine, contained in the drug, if the alkaloid is contained therein as constituent of belladonna, hyoscyamus, scopola, stramonium, or other plant material, or any preparation thereof, which was used as an ingredient of the drug, and no practical and accurate method of analysis exists for the quantitative determination of each such alkaloid in the ingredient. This exemption shall be on the condition that the label of the drug shall state the quantity or proportion of total alkaloids contained therein as constituents of the ingredient.
Authority Note
AUTHORITY NOTE: Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as amended.
Historical Note
HISTORICAL NOTE: Adopted by the Department of Health and Human Resources, Office of Preventive and Public Health Services, September 1968.