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The Louisina Board of Wholesale Drug Distributors regulates licensing for the following title: Wholesale Distributor of Legend Drugs or Devices (or Wholesale Drug Distributor).
Application for licensure as a wholesale distributor of legend drugs or devices is required in accordance with Louisiana Revised Statutes 37:3461-3482, in compliance with the Federal Prescription Drug Marketing Act of 1987, and Board promulgated rules in the Louisiana Administrative Code 46:XCI.101-108 if your company engages in the wholesale distribution of legend drugs and/or devices including:
Manufacturing in the state of Louisiana, or
Shipping in or into the state of Louisiana, or
Selling or offering to sell in or into the state of Louisiana, or
Brokering, giving away, or transferring in or into the state of Louisiana, legend drugs or devices whether by passage of title, physical movement, or both.
A legend drug or device is a drug or device intended for human use which can only be dispensed by prescription or on the order of a licensed practitioner and that’s labeling contains the legend:
“Caution: Federal law prohibits dispensing without a prescription.”, or
“Except the sale by or on order of a physician or appropriate licensed practitioner.”, or
EVERY LEGEND DRUG OR DEVICE DISTRIBUTOR WHO ENGAGES IN THE WHOLESALE DISTRIBUTION OF THESE DRUGS OR DEVICES IN OR INTO THE STATE OF LOUISIANA TO PERSONS OTHER THAN CONSUMERS OR PATIENTS MUST REGISTER WITH THIS BOARD TO DO SO AND MUST RENEW SUCH LICENSE ANNUALLY.