§ 37:3461 A. This Chapter shall be known and may be cited as the “Louisiana Drug and Device Distributors Act”.
§ 37:3462 As used in this Chapter:
§ 37:3463 A. The Louisiana Board of Drug and Device Distributors is hereby created within the Louisiana Department of Health and is subject to the provisions of R.S. 36:803. The board shall ad
§ 37:3464 Each member of the board shall be at least twenty-one years of age, of good moral character and temperate habits, and a resident of this state and shall have engaged in distribution
§ 37:3465 Organization meetings
§ 37:3466 Domicile of the board
§ 37:3467 A. The board may perform all of the following functions:
§ 37:3468 Records, prima facie evidence
§ 37:3469 A. Every applicant for licensure as a distributor shall meet all qualifications and requirements designated by the board in accordance with this Chapter and all applicable requiremen
§ 37:3470 The board, or a representative of the board, may conduct inspections of distribution and sales facilities during normal business hours upon receipt of an application for licensure. T
§ 37:3471 A. Each applicant who meets the provisions of R.S. 37:3469 and successfully passes the inspection provided in R.S. 37:3470 shall receive a license from the board authorizing him to a
§ 37:3472 Reinspections of distribution and sales facilities may be conducted as follow-ups to the regular inspections or to guarantee that the applicant or licensee has corrected any discrepa
§ 37:3473 The board may waive the inspection provided in R.S. 37:3470, if the applicant presents to the board a satisfactory certificate of registration or license from an entity which license
§ 37:3474.1 A. Any person licensed as a distributor under this Chapter may have his license revoked, suspended, limited, or restricted for a fixed period to be determined by the board for any of
§ 37:3474.2 A. The board shall have the authority to take enforcement action against any non-licensee found by the board to be guilty of any of the following acts or offenses:
§ 37:3474.3 A. The board may seek in any court of competent jurisdiction a writ of injunction enjoining any person from participating in distribution as defined by this Chapter until such person
§ 37:3474.4 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 a
§ 37:3475 All licensed distributors shall pay to the board a renewal fee as shall be determined by the board.
§ 37:3476 Failure to renew license; penalties
§ 37:3477 A. The board may require that the applicant, designated responsible party, and any owners provide written consent to the board to request and obtain state and national criminal histo
§ 37:3478 A. No person shall participate or engage in the business of distribution as defined by this Chapter without a license issued therefor and compliance with other requirements as provid
§ 37:3479 Fees
§ 37:3480 Distributors shall sell or distribute legend drugs or legend devices only to a person who is authorized, by law or regulation, to procure or possess legend drugs or legend devi
§ 37:3481 Distributors shall provide copies of their United States Enforcement Accounting Records Controlled Order Substance Reports (ARCOS) to the Louisiana Board of Pharmacy, and copie
§ 37:3482 Nothing in this Chapter shall be construed to authorize the Louisiana Board of Drug and Device Distributors to regulate the practice of pharmacy as provided in Chapter 14 of Title 37

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

  • Applicant: means a person who applies for licensure as a legend drug or legend device distributor. See Louisiana Revised Statutes 37:3462
  • Bankruptcy: Refers to statutes and judicial proceedings involving persons or businesses that cannot pay their debts and seek the assistance of the court in getting a fresh start. Under the protection of the bankruptcy court, debtors may discharge their debts, perhaps by paying a portion of each debt. Bankruptcy judges preside over these proceedings.
  • 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
  • Deed: The legal instrument used to transfer title in real property from one person to another.
  • 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
  • Executor: A male person named in a will to carry out the decedent
  • FBI: means the Federal Bureau of Investigation of the United States Department of Justice. See Louisiana Revised Statutes 37:3462
  • Fiduciary: A trustee, executor, or administrator.
  • 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.
  • Lease: A contract transferring the use of property or occupancy of land, space, structures, or equipment in consideration of a payment (e.g., rent). Source: OCC
  • 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
  • Liabilities: The aggregate of all debts and other legal obligations of a particular person or legal entity.
  • 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

  • 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
  • Personal property: All property that is not real property.
  • 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
  • Presiding officer: A majority-party Senator who presides over the Senate and is charged with maintaining order and decorum, recognizing Members to speak, and interpreting the Senate's rules, practices and precedents.
  • 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.
  • Trustee: A person or institution holding and administering property in trust.
  • 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.