LAC 49:I.1197 – Voiding of Exemption Under Clause (2) of 4.0540 [Formerly 49:4.0560]

A. Any exemption of a drug or device under §1195.A.2 shall immediately become void:
1. 1. Upon refusal by the person responsible for the shipment or delivery of the drug or device to make available for inspection a copy of the agreement specified in, and required §1195.A.2.
2. 2. Upon refusal by the operator of the establishment where the drug or device is to be labeled, processed, or repacked to make available for inspection a copy of the agreement specified in, and required by §1195.A.2.
3. 3. If the drug or device, or any part thereof, at time of removal from the original establishment is adulterated or misbranded within the meaning of the Act when so removed.

AUTHORITY NOTE: Promulgated in accordance with Louisiana Revised Statutes of 1950, Title 40, as amended.

HISTORICAL NOTE: Adopted by the Department of Health and Human Resources, Office of Preventive and Public Health Services, September 1968.