Louisiana Revised Statutes 37:3467 – Duties and powers of the board
Terms Used In Louisiana Revised Statutes 37:3467
- Board: means the Louisiana Board of Drug and Device Distributors. 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
- Licensure: means any license, permit, or registration that the board is authorized by law to issue. See Louisiana Revised Statutes 37:3462
- Testimony: Evidence presented orally by witnesses during trials or before grand juries.
- 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 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
- 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
A. The board may perform all of the following functions:
(1) Approve, deny, revoke, suspend, limit, or restrict licenses of qualified applicants for licensure as distributors and renew licenses.
(2) Impose fines, assess costs, or otherwise discipline a licensee.
(3) Regulate the distribution of legend drugs or legend devices.
(4) Monitor compliance with all federal and state laws and regulations regarding the distribution of legend drugs or legend devices by distributors and promulgate rules and regulations relative thereto.
(5) Conduct inspections of wholesale distribution facilities.
(6) Conduct hearings on charges relative to the violation of any provision of this Chapter.
(7) Issue subpoenas and administer oaths to persons giving testimony at hearings.
(8) Employ and fix compensation of persons necessary to carry on the work of the board.
(9) Appoint an attorney to represent the board in all matters pertaining to the administration of this Chapter, define his duties, and fix his compensation.
(10) Adopt all rules and regulations necessary to implement the provisions of this Chapter.
(11) Require licensees to provide transaction history, transaction information, and a transaction statement.
(12) Designate and assign license types and sub-types for distributors, which include wholesale distributors, manufacturers, repackagers, and third-party logistic providers, which it will approve, deny, revoke, suspend, limit, or restrict, and renew pursuant to Paragraph (A)(1) of this Section.
(13) Exercise all other powers necessary and proper to perform its duties within the scope of this Chapter.
B. 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 and the federal Drug Supply Chain Security Act, as those acts pertain to distribution as defined by this Chapter; and with the rules and regulations promulgated pursuant to those Acts, and other pertinent federal authority.
C.(1) The board may require all distributors and wholesale distributors to furnish a bond or other equivalent means of security in accordance with regulations promulgated by the secretary of the United States Department of Health and Human Services.
(2) This Subsection shall not apply to manufacturers or affiliates or co-licensed partners of manufacturers.
Acts 1988, No. 852, §1; Acts 1991, No. 528, §1; Acts 1995, No. 1152, §1, eff. June 29, 1995; Acts 2008, No. 597, §1; Acts 2015, No. 443, §1, eff. July 1, 2015.