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In order to safeguard life and health and to promote the public welfare, any person engaged in the wholesale distribution of drugs as defined in this Chapter shall be required to submit evidence that he is qualified to be engaged in the wholesale drug distribution business and shall be licensed as hereinafter provided.

(2) “Wholesale drug distribution” means distribution of legend drugs to other than the consumer or patient, including but not limited to distribution by manufacturers, repackers, own label distributors, jobbers, and wholesale drug distributors.

(3) “Wholesale drug distributor” means any person who sells legend drugs to other than the consumer or the patient, including but not limited to manufacturers, repackers, own label distributors, jobbers, brokers, agents and pharmacies.

(4) “Legend drug” means any drug intended for use by humans that carries on its label the statement: “Warning—Federal law prohibits dispensing without a prescription”.

(5) “Manufacturer” means a person who manufactures legend drugs and includes a labeler, primary distributor, or person who prepares legend drugs in dosage form, by mixing, compounding, encapsulating, entableting, or by other process.

A. The Louisiana Board of Wholesale Drug Distributors is hereby created within the Department of Health and Hospitals and is subject to the provisions of R.S. 36:803. The board shall administer the provisions of this Chapter. It shall be composed of seven members, five of whom shall be licensed wholesale drug distributors and two of whom shall be actively engaged in the pharmaceutical manufacturing industry.

B. The governor shall appoint, subject to Senate confirmation, members to the board from a list containing the names of five persons, submitted by the Louisiana Association of Wholesale Drug Distributors and from a list containing the names of two persons, submitted by the Pharmaceutical Research and Manufacturers of America. In the event of the death or resignation of any member of the board, the governor shall appoint his successor in the manner of the original appointment for the remainder of the unexpired term.

C. (1) Effective January 8, 1996, board members shall serve the following staggered terms:

D. Each member shall serve until his successor has been appointed and qualified.

E. The presidents of the Pharmaceutical Research and Manufacturers of America and the Louisiana Association of Wholesale Drug Distributors shall submit the nominations within sixty days after receipt of notice of death, resignation, or removal of a member of the board and at least thirty days prior to the expiration of the term of a member of the board.

F. (1) Any member of the board may be removed by the governor, or a majority vote of the board, after notice and a hearing by the board wherein grounds for removal have been established. Grounds for removal shall include but not be limited to incompetence, neglect of duty, unprofessional or dishonorable conduct, or a violation of this Chapter.

(2) A board member’s seat shall be considered vacant after two consecutive absences by that member from official board meetings without a reason acceptable by the board.

G. Each member of the board shall receive seventy-five dollars a day and reimbursement for actual expenses and mileage at the same rate set by the Division of Administration for state employees under the provisions of R.S. 39:231 for each day while engaged in the discharge of their duties.

H. The board shall elect a chairman, vice chairman, secretary-treasurer, and such other officers as it considers necessary to carry out the discharge of their duties or functions of the board.

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 the pharmaceutical manufacturing business or the wholesale drug distribution business for at least three years.

The board shall hold at least two regular meetings each year. Special meetings may be held at such time and place as specified by a call of the chairman or secretary. Reasonable notice of all meetings shall be given in writing to each member of the board. A quorum of the board shall be a majority of its members.

(1) Approve, deny, revoke, or suspend licenses of qualified applicants for licensure as wholesale drug distributors and renew licenses.

(3) Monitor compliance with all federal and state laws and regulations regarding the distribution of wholesale drugs by wholesale drug distributors and promulgate rules and regulations relative thereto.

(5) Conduct hearings on charges relative to the violation of any provision of this Chapter.

(6) Exercise all other powers necessary and proper to perform its duties within the scope of this Chapter.

(1) Issue subpoenas and administer oaths to persons giving testimony at hearings.

(2) Employ and fix compensation of persons necessary to carry on the work of the board.

(3) Appoint an attorney to represent the board in all matters pertaining to the administration of this Chapter, define his duties, and fix his compensation.

(4) Adopt all rules and regulations necessary to implement the provisions of this Chapter.

C. The board shall make rules and regulations, not inconsistent with law, and shall take such other action as may be necessary to comply with the requirements set forth in the Federal Food, Drug, and Cosmetic Act, as it pertains to wholesale drug distribution, and with the rules and regulations promulgated pursuant thereto, and other pertinent federal authority.

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.

A. Every applicant or responsible party for licensure as a wholesale drug distributor shall be at least twenty-one years of age and of good moral character and temperate habits. Conviction of a felony violation of federal or state law may be grounds for denial of a license.

B. The application for licensure shall be made on a form provided by the board. Each application shall be accompanied with the reasonable licensure fee prescribed by the board. Each application shall contain language that authorizes the board to conduct a background check on the applicant to determine if he has ever been convicted of a felony violation of federal or state law.

The board, or a representative of the board, may conduct inspections of in-state facilities during normal business hours upon receipt of an application for licensure. The board may also conduct unannounced inspections of current licensees at sufficient intervals to determine compliance with state and federal requirements or when it considers it necessary. Upon inspection, a written report will be submitted to the board by the inspector. Applicants for licensure and licensees shall be notified in writing by certified mail if discrepancies are found and a deadline shall be set in which such discrepancies must be corrected.

A. Each applicant who meets the provisions of R.S. 37:3469 and successfully passes the inspection provided for in R.S. 37:3470 shall receive a license from the board authorizing him to act as a wholesale drug distributor in this state. The license or a renewal thereof shall be the only evidence of the right of a person to act as a wholesale drug distributor.

B. The license shall be registered in a record book to be kept by the board for that purpose. A copy of the license certified by the secretary of the board shall be received as evidence in all courts of this state.

Reinspections of in-state facilities may be conducted as follow-ups to the regular inspections or to guarantee 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 of this Chapter and shall subject the applicant or licensee either to disciplinary action by the board or forfeiture of the license.

The board may waive the inspection provided in RS 37:3470, if the applicant presents to the board a satisfactory certificate of registration or license from a board of wholesale drug distributors in another state, and if the standards adopted and enforced by such board are equal to those provided in this Chapter.

A. Any person licensed as a wholesale drug distributor under this Chapter may have his license revoked or suspended for a fixed period to be determined by the board for any of the following causes:

(1) Conviction of a felony violation of federal or state laws or regulations. The record of such conviction, or certified copy thereof from the clerk of court where such conviction occurred or by the judge of such court, shall be sufficient evidence to warrant revocation or suspension.

(2) Suspension or revocation by another state of a license to distribute wholesale drugs. A certified copy of the record of suspension or revocation by the state where such suspension or revocation occurred shall be conclusive evidence thereof.

B. Proceedings for disciplinary action or for the denial, revocation, or suspension of a license shall be conducted in accordance with rules and regulations adopted by the board pursuant to the Administrative Procedures Act. The board may require a person against whom disciplinary action has been taken to pay not more than one thousand dollars per violation with the maximum aggregate penalty not to exceed fifty times the maximum penalty per individual violation. No license shall be issued, reinstated, or renewed until such penalty has been paid in full.

All licensed wholesale drug distributors shall pay to the board a renewal fee as shall be determined by the board.

The failure to pay the renewal fee required by RS 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 reinstatement fee and all delinquent charges as provided by the board.

A. No person shall participate or engage in the wholesale drug distribution business 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 “wholesale drug distributor”, or otherwise assume or use such terms or advertise in any manner intending to convey the impression that he is a wholesale drug distributor, unless such person has been duly licensed under the provision of this Chapter.

C. Whoever violated the provisions of this Section shall be fined not less than one hundred dollars nor more than three hundred dollars or imprisoned for not less than ten days nor more than thirty days, or both.

A. To defray the cost of administering the provisions of this Chapter, the board shall fix reasonable fees to be assessed under this Chapter.

B. Any fees fixed by the board shall be subject to the legislative oversight review pursuant to the provisions of the Administrative Procedure Act, RS 49:950 et seq.

C. All monies collected under this Chapter shall be paid into the treasury of the board and may be expended by the board without appropriation for costs of administration, including salary of employees, travel allowances, and other necessary expenses. Any funds remaining unexpended and unencumbered at the end of each fiscal year shall be retained by the board for expenditure in succeeding years and no part thereof shall revert to the General Fund of the State of Louisiana.

D. This board shall be financially self-sufficient. It shall receive no state funds through appropriation or otherwise and shall not expend any such state funds. No state funds shall be expended or committed to expenditure for the group benefits program or any other health insurance or employee benefit program, for any retirement system, for any salary, per diem payment, travel or expenses, office supplies and materials, rent, purchase of any product or service, or for any other purpose.

Wholesale drug distributors shall sell or distribute drugs or devices only to an individual, corporation, or entity who is authorized, by law or regulation, to procure or possess such drugs or devices.

Wholesale drug distributors shall provide copies of the United States Enforcement Accounting Records Controlled Order Substance Reports (ARCOS) of the preceding month to the Louisiana Board of Pharmacy by the fifteenth day of each month, 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 Louisiana required by 21 CFR 1301.74(b) as requested by the Louisiana Board of Pharmacy. Notwithstanding any other law to the contrary, these reports shall be confidential and shall be destroyed when they have served their purpose.

Nothing in this Chapter shall be construed to authorize the Louisiana Board of Wholesale Drug 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 14 of Title 37 of the Louisiana Revised Statutes of 1950, the provisions of Chapter 14 of Title 37 of the Louisiana Revised Statutes of 1950 shall prevail.