RS 37:3461 – General provisions and short title A. This Chapter shall be known and may be cited as the “Louisiana Drug and Device Distributors Act”. B. In order to safeguard life and health and to promote the public welfare, any person engaged in the distribution of legend drugs or legend devices as defined in […]
RS 37:3468 – Records, prima facie evidence The books, registers, and records of the board shall be prima facie evidence of the matter therein recorded in any court of law. The board shall keep a full record of all acts and proceedings of the board. Acts 1988, No. 852, §1.
RS 37:3469 – Qualifications and requirements for licensure 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 requirements of federal law and regulation. B. The application for licensure shall be made on a form provided by the board. […]
RS 37:3470 – Inspections 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. The board may conduct inspections during normal business hours of facilities that appear to be used by a distributor. The board may also conduct […]
RS 37:3471 – License; registering; evidence 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 act as a distributor in this state. The license or a renewal thereof shall be the only evidence of the […]
RS 37:3472 – Reinspection 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 discrepancy found by the board. Failure to comply with state and federal laws or the board’s regulations shall be prima facie evidence of a violation […]
RS 37:3473 – Applicants from other states; waiver of inspection 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 licenses distributors of the same type in another state, and if the standards adopted and enforced by […]
RS 37:3474 – Repealed by Acts 2015, No. 443, §2, eff. July 1, 2015.
RS 37:3474.1 – Discipline for licensees 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 the following causes: (1) Conviction of a felony of the licensee, responsible party, or owner. The record […]
RS 37:3474.2 – Enforcement action against other persons; penalties 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: (1) Participating or engaging in distribution as defined by this Chapter. (2) Using the term “distributor” or […]
RS 37:3474.3 – Injunction proceedings; penalties 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 obtains the necessary license under the provisions of this Chapter. Posting of a bond shall not be a cause […]
RS 37:3474.4 – Order to quarantine a legend drug or legend device 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 an order to quarantine the legend drug or legend device. B. Any order issued pursuant to […]
RS 37:3475 – Annual renewal of license All licensed distributors shall pay to the board a renewal fee as shall be determined by the board. Acts 1988, No. 852, §1; Acts 1995, No. 1152, §1, eff. June 29, 1995; Acts 2015, No. 443, §1, eff. July 1, 2015.
RS 37:3476 – Failure to renew license; penalties The failure to pay the renewal fee required by R.S. 37:3475 shall result in an automatic revocation of the license. In such cases, the person shall be reinstated if he files an application for reinstatement with the board within one year after the revocation and pays a […]
RS 37:3477 – Authorization to obtain criminal history record information 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 history record information as a condition for consideration of the licensure application. B. The board may charge […]
RS 37:3478 – Unlawful participation; penalty 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 provided for in this Chapter. B. No person shall use in connection with his name the term “distributor” or “wholesale distributor”, […]
RS 37:3479 – Fees A. To defray the cost of administering the provisions of this Chapter, the board shall fix fees not to exceed the following: (1) Initial license fee $600 (2) License renewal fee $600 (3) Initial inspection fee $300 (4) Duplicate license fee $100 (5) Reinstatement fee for licenses suspended, revoked, or expired […]
RS 37:3480 – Unauthorized sales 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 devices. Acts 1988, No. 852, §1; Acts 2008, No. 597, §1; Acts 2015, No. 443, §1, eff. July 1, 2015.
RS 37:3481 – Mandatory reporting Distributors shall provide copies of their United States Enforcement Accounting Records Controlled Order Substance Reports (ARCOS) to the Louisiana Board of Pharmacy, and copies of their controlled substance sales register for a specific controlled substance registrant in Louisiana and excessive controlled substance purchase reports for all controlled substance registrants in […]
RS 37:3482 – Applicability; conflicts 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 of the Louisiana Revised Statutes of 1950. If any provision of this Chapter conflicts with the provisions of Chapter […]
