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Terms Used In Louisiana Revised Statutes 37:1250

  • administration: means the direct application of a drug to the body of a patient or research subject by injection, inhalation, ingestion, or any other means. See Louisiana Revised Statutes 37:1164
  • Board: means the Louisiana Board of Pharmacy. See Louisiana Revised Statutes 37:1164
  • delivery: means the actual, constructive, or attempted transfer of a drug or device from one person to another, whether or not for a consideration. See Louisiana Revised Statutes 37:1164
  • distribution: means the delivery of a drug or device other than by administering or dispensing. See Louisiana Revised Statutes 37:1164
  • Drug: means :

                (a) Any substance recognized as a drug in the official compendium, or supplement thereto, designated by the board for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases in humans or other animals. See Louisiana Revised Statutes 37:1164

  • Manufacturer: means a person who manufactures drugs and includes a labeler, primary distributor, or person who prepares drugs in dosage form by mixing. See Louisiana Revised Statutes 37:1164
  • Manufacturing: means the production, preparation, propagation, conversion, or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis, and includes any packaging or repackaging of the substance or labeling or relabeling of its container, and the promotion and marketing of such drugs or devices. See Louisiana Revised Statutes 37:1164

            A. Nothing in this Chapter shall be construed to prevent or restrict the practice of nursing by a licensed registered nurse or an advanced practice registered nurse in accordance with La. Rev. Stat. 37:911 et seq., 1031 through 1034, or any other laws, rules, or regulations governing the practice of nursing in the state of Louisiana.

            B. Nothing in this Chapter shall apply to a facility which engages solely in the distribution of dialysate, drugs, or devices necessary to perform home kidney dialysis to patients with end-stage renal disease if all of the following criteria are met:

            (1) The dialysate, drugs, or devices are approved or cleared by the United States Food and Drug Administration as required by federal law.

            (2) The dialysate, drugs, or devices are lawfully held by a manufacturer or manufacturer’s agent that is properly registered with the board as a distributor of legend drugs or legend devices.

            (3) The dialysate, drugs, or devices are held and delivered in their original, sealed packaging from the manufacturing facility.

            (4) The dialysate, drugs, or devices are delivered only by the manufacturer or the manufacturer’s agent and only upon receipt of a physician’s order.

            (5) The manufacturer or manufacturer’s agent delivers the dialysate, drugs, or devices directly to any of the following parties:

            (a) A patient with end-stage renal disease, or his designee, for self-administration of the dialysis therapy by the patient.

            (b) A healthcare provider or institution for administration or delivery of the dialysis therapy to a patient with end-stage renal disease.

            Acts 1999, No. 767, §1; Acts 2022, No. 154, §1.