2013 Louisiana Laws
Revised Statutes
TITLE 37 - Professions and Occupations
RS 37:3462 - Definitions

§3462. Definitions

As used in this Chapter:

(1) "Applicant" means a person who applies for licensure as a wholesale drug distributor.

(2) "Board" means the Louisiana Board of Wholesale Drug Distributors.

(3) "Bureau" means the Louisiana Bureau of Criminal Identification and Information of the office of state police within the Department of Public Safety and Corrections.

(4) "Criminal history record information" means information collected by state and federal criminal justice agencies on persons consisting of identifiable descriptions and notations of arrests, detentions, indictments, bills of information, or any formal criminal charges, and any disposition arising therefrom, including sentencing, criminal correctional supervision, and release, but does not include intelligence for investigatory purposes, nor does it include any identification information which does not indicate involvement of the person in the criminal justice system.

(5) "FBI" means the Federal Bureau of Investigation of the United States Department of Justice.

(6) "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.

(7) "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".

(8) "Legend drug pedigree" means a written document or electronic file recording each wholesale distribution of a legend drug.

(9) "Licensure" means any license that the board is authorized by law to issue.

(10) "Manufacturer" means any of the following:

(a) A person who manufactures legend drugs and includes a labeler or primary distributor.

(b) A person who prepares legend drugs in dosage form by mixing, compounding, encapsulating, entableting, or by other processes.

(c) A person who manufactures, assembles, processes, or modifies legend devices.

(11) "Owner" means a natural person who owns greater than a ten percent interest in the wholesale drug distributor.

(12) "Person" means a natural or juridical person, including a proprietorship, partnership, corporation, limited liability company, trust, business firm, association, franchise arrangement, combination of any of these entities, or any other legal entity.

(13) "Responsible party" means a natural person designated by the applicant or licensee as responsible for facility operations of the applicant or licensee.

(14) "Third-party logistics provider" means a person that contracts with a manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of the manufacturer, but does not take title to the legend drug or legend device or have responsibility to direct the sale or disposition of the legend drug or legend device.

(15) "Wholesale drug distribution" means the distribution or sale of legend drugs or legend devices to other than the consumer or patient, including but not limited to distribution by manufacturers, repackagers, own label distributors, jobbers, third-party logistics providers, retail pharmacy warehouses, pharmacies, brokers, agents, and wholesale drug distributors.

(16) "Wholesale drug distributor" means any person who sells or distributes legend drugs or legend devices to other than the consumer or patient, including but not limited to manufacturers, repackagers, own label distributors, jobbers, third-party logistics providers, retail pharmacy warehouses, brokers, agents, and pharmacies.

Acts 1988, No. 852, §1; Acts 2008, No. 597, §1.