Terms Used In Louisiana Revised Statutes > Title 37 > Chapter 54 - Drug and Device Distributors

• Acquittal:
  1. Judgement that a criminal defendant has not been proved guilty beyond a reasonable doubt.
  2. A verdict of "not guilty."
   
• Appellate: About appeals; an appellate court has the power to review the judgement of another lower court or tribunal.
• Applicant: means a person who applies for licensure as a legend drug or legend device distributor. See Louisiana Revised Statutes 37:3462
• Board: means the Louisiana Board of Drug and Device Distributors. See Louisiana Revised Statutes 37:3462
• Bureau: means the Louisiana Bureau of Criminal Identification and Information of the office of state police within the Department of Public Safety and Corrections. See Louisiana Revised Statutes 37:3462
• 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. See Louisiana Revised Statutes 37:3462
• Damages: Money paid by defendants to successful plaintiffs in civil cases to compensate the plaintiffs for their injuries.
• Defendant: In a civil suit, the person complained against; in a criminal case, the person accused of the crime.
• Designated responsible party: means a natural person designated by the applicant or licensee as responsible for facility operations of the applicant or licensee facility. See Louisiana Revised Statutes 37:3462
• Distribution: means the sale or facilitation of delivery of legend drugs or legend devices to a person 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 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
• FBI: means the Federal Bureau of Investigation of the United States Department of Justice. See Louisiana Revised Statutes 37:3462
• Fiscal year: The fiscal year is the accounting period for the government. For the federal government, this begins on October 1 and ends on September 30. The fiscal year is designated by the calendar year in which it ends; for example, fiscal year 2006 begins on October 1, 2005 and ends on September 30, 2006.
• 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
• Licensure: means any license, permit, or registration that the board is authorized by law to issue. See Louisiana Revised Statutes 37:3462
• Manufacturer: means any of the following:

              (a) A person who manufactures legend drugs or legend devices and includes a labeler or distributor. See Louisiana Revised Statutes 37:3462

• Obligation: An order placed, contract awarded, service received, or similar transaction during a given period that will require payments during the same or a future period.
• Oversight: Committee review of the activities of a Federal agency or program.
• Owner: means a natural person who owns greater than a ten percent interest in the distributor. See Louisiana Revised Statutes 37:3462
• 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. See Louisiana Revised Statutes 37:3462
• Pleadings: Written statements of the parties in a civil case of their positions. In the federal courts, the principal pleadings are the complaint and the answer.
• Prescription drug: means a drug for human use which, because of its toxicity or other potentiality for harmful effects, the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or a drug which is limited by a United States Food and Drug Administration new drug application to use under the professional supervision of a practitioner licensed by law to administer such drug. See Louisiana Revised Statutes 37:3462
• product: as used in this Chapter , does not include any of the following:

              (a) Blood or blood components intended for transfusion. See Louisiana Revised Statutes 37:3462

• Transaction: means the transfer of a product between persons in which a change of ownership occurs, but does not include a transaction that is exempted from the definition by rules of the board or federal law. See Louisiana Revised Statutes 37:3462
• Transaction history: means a statement, in paper or electronic form, that includes the transaction information for each prior transaction going back to the manufacturer of the product. See Louisiana Revised Statutes 37:3462
• Transaction information: means :

              (a) The proprietary or established name or names of the product. See Louisiana Revised Statutes 37:3462

• Transaction statement: means a statement, in paper or electronic form, that the entity transferring ownership in a transaction meets all of the following conditions:

              (a) Is authorized as required under the federal Drug Supply Chain Security Act. See Louisiana Revised Statutes 37:3462

• Trial: A hearing that takes place when the defendant pleads "not guilty" and witnesses are required to come to court to give evidence.
• Wholesale distribution: means the distribution of legend drugs or legend devices to a person other than the consumer or patient except as exempted in the standards of the federal Drug Supply Chain Security Act as the act pertains to wholesale distribution. See Louisiana Revised Statutes 37:3462
• Wholesale distributor: means any person engaged in wholesale distribution. See Louisiana Revised Statutes 37:3462
• Writ: A formal written command, issued from the court, requiring the performance of a specific act.