Louisiana Revised Statutes 37:3474.4 – Order to quarantine a legend drug or legend device
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Terms Used In Louisiana Revised Statutes 37:3474.4
- Board: means the Louisiana Board of Drug and Device Distributors. See Louisiana Revised Statutes 37:3462
- Distributor: means any person engaged in distribution, including but not limited to manufacturers, repackagers, own-label distributors, jobbers, third-party logistics providers, retail pharmacy warehouses, pharmacies, brokers, agents, and wholesale distributors. See Louisiana Revised Statutes 37:3462
- Legend device: means any device intended for use by humans that carries on its label "Rx" "Rx only" a designation for physician use only, or a statement that federal law restricts the device to sale by or on the order of a licensed health care practitioner. See Louisiana Revised Statutes 37:3462
- Legend drug: means any drug intended for use by humans that carries on its label any of the following: "Caution: Federal law prohibits dispensing without a prescription" "Rx" or "Rx Only". See Louisiana Revised Statutes 37:3462
A. If the board finds a reasonable probability that a distributor possesses an adulterated, misbranded, counterfeited, or recalled legend drug or legend device, the board may issue an order to quarantine the legend drug or legend device.
B. Any order issued pursuant to this Section shall subject the distributor to the order with an opportunity for hearing to be held no later than thirty days after issuance of the order on the actions required by the order. If, after the hearing, the board determines that inadequate grounds exist to support the order, the board shall vacate the order.
Acts 2008, No. 597, §1; Acts 2015, No. 443, §1, eff. July 1, 2015.