La. Admin. Code tit. 49 § I-1135

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

Section I-1135 - Quantity of Contents, Where Minimum Quantity Not Expressed [Formerly 49:4.0170]

A. Where the statement does not express the minimum quantity, variations shall be permitted:

1. when caused by ordinary and customary exposure, after the drug is introduced into commerce, to conditions which normally occur in good distribution practice and which unavoidably result in change of weight or measure;

2. when caused by unavoidable deviations in weighing, measuring or counting the contents of individual packages, which occur in good packing practices. However, under this provision variations shall not be permitted to such an extent that the average of the quantities in the package comprising a shipment or other delivery of the drug or device is below the quantity stated; and no unreasonable shortage in any package shall be permitted, even though overages in other packages in the same shipment or delivery compensate for such shortage.

La. Admin. Code tit. 49, § I-1135

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.