La. Admin. Code tit. 49 § I-1195
Current through Register Vol. 50, No. 11, November 20, 2024
Section I-1195 - Labeling Exemption, Drugs to be Processed, Labeled or Repackaed [Formerly 49:4.0540]A. A drug or device which is to be processed, labeled or repacked, in substantial quantities in accordance with regular trade practice, at an establishment other than were originally processed or packed, shall be exempt, except as provided by §1196 and §1197, from compliance with the labeling and packaging requirements of R.S. 40:616 (5) R.S. 40:617 (A) (3), (5), (6) and (7) and §1187 of these regulations, during transit from the original establishment to the labeling, processing, or repacking plant, and the time of holding in such establishment if:1. the person responsible for the transit of the drug or device in commerce is the operator of the establishment where the drug or device is to be processed, labeled or repacked; or2. in case such person is not the operator, the shipment or delivery of the drug or device is made under a written agreement, signed by and containing the post office addresses of the person responsible for the shipment or delivery and the operator of the processing, labeling or repacking plant, and also containing specifications for the processing, labeling, or repacking, as the case may be, of the drug or device, which if followed will ensure that the drug or device will not be adulterated or misbranded within the meaning of the Act upon completion of the processing, labeling, or repacking. Each party to the agreement shall keep a copy of the agreement until all the shipment or delivery subject to its terms have been removed from the processing, labeling, or repacking plant; and provided that copies of the agreement shall be made available for inspection at any reasonable hour by any officer or agent of the department who requests them. La. Admin. Code tit. 49, § I-1195
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.