§ 37:3462 — Definitions

Louisiana § 37:3462

• Jurisdiction: Louisiana
• Title 37: Professions and Occupations

Text

§3462. Definitions
As used in this Chapter:
(1) "Applicant" means a person who applies for licensure as a legend drug or legend
device distributor.
(2) "Board" means the Louisiana Board of Drug and Device Distributors.
(3) "Bureau" means the Louisiana Bureau of Criminal Identification and Information
of the office of state police within the Department of Public Safety and Corrections.
(4) "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.
(5) "Designated responsible party" means a natural person designated by the
applicant or licensee as responsible for facility operations of the applicant or licensee facility.
(6) "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.
(7) "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.
(8) "FBI" means the Federal Bureau of Investigation of the United States Department
of Justice.
(9) "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.
(10) "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".
(11) "Licensure" means any license, permit, or registration that the board is
authorized by law to issue.
(12) "Manufacturer" means any of the following:
(a) A person who manufactures legend drugs or legend devices and includes a labeler
or distributor.
(b) A person who prepares legend drugs in dosage form by mixing, compounding,
encapsulating, entableting, or by other processes.
(c) A person who manufactures, assembles, processes, or modifies legend devices.
(d) An affiliate of a person described in Subparagraph (a), (b), (c), or (f) of this
Paragraph that receives the legend drugs or legend devices directly from a person described
in this Subparagraph or Subparagraph (a), (b), (c), or (f) of this Paragraph.
(e) A co-licensed partner of the person described in Subparagraph (a), (b), (c), or (f)
of this Paragraph that obtains the legend drugs or legend devices directly from a person
described in this Subparagraph or Subparagraph (a), (b), (c), or (f) of this Paragraph.
(f) A person who holds an approved new drug application under the United States
Food and Drug Administration or holds a biologics license issued by the United States Food
and Drug Administration for such product; or, if such product is not the subject of an
approved application or license, the person who manufactured the product.
(13) "Owner" means a natural person who owns greater than a ten percent interest
in the distributor.
(14) "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.
(15) "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.
(16) "Product" means a prescription drug in a finished dosage form for
administration to a patient without substantial further manufacturing (such as capsules,
tablets, and lyophilized products before reconstitution); however, "product", as used in this
Chapter, does not include any of the following:
(a) Blood or blood components intended for transfusion.
(b) A radioactive drug or radioactive biological product regulated by the Nuclear
Regulatory Commission or by a state pursuant to an agreement with the Nuclear Regulatory
Commission.
(c) An imaging drug.
(d) An intravenous product that, by its formulation, is intended for replenishment of
fluids and electrolytes or calories, for use to maintain the equilibrium of water and minerals
in the body, or for irrigation or sterile water whether for such purpose or injection.
(e) Any medical gas.
(f) A homeopathic drug marketed in accordance with applicable guidance under the
federal Drug Supply Chain Security Act.
(g) A drug compounded in compliance with the federal Food, Drug, and Cosmetic
Act.
(17) "Repackager" means a person who owns or operates an establishment that
repacks and relabels a legend drug, legend device, or package thereof for one of the
following purposes:
(a) Further sale.
(b) Distribution without a further transaction.
(18) "Third-party logistics provider" means a person that provides or coordinates
warehousing, facilitation of delivery, or other logistic services for a legend drug or legend
device in interstate and intrastate commerce on behalf of a manufacturer, distributor, or
dispenser of a legend drug or legend device but does not take ownership of the legend drug
or legend device nor have responsibility to direct the sale or disposition of the legend drug
or legend device.
(19) "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.
(20) "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.
(21) "Transaction information" means:
(a) The proprietary or established name or names of the product.
(b) The strength and dosage form of the product.
(c) The National Drug Code number of the product.
(d) The container size.
(e) The number of containers.
(f) The lot number of the product.
(g) The date of the transaction.
(h) The date of the shipment, if more than twenty-four hours after the date of the
transaction.
(i) The business name and address of the person from whom ownership is being
transferred.
(j) The business name and address of the person to whom ownership is being
transferred.
(22) "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.
(b) Received the product from a person that is authorized as required under the
federal Drug Supply Chain Security Act.
(c) Received transaction information and a transaction statement from the prior
owner of the product.
(d) Did not knowingly ship a suspect or illegitimate product.
(e) Had systems and processes in place to comply with verification requirements
under the federal Drug Supply Chain Security Act.
(f) Did not knowingly provide false transaction information.
(g) Did not knowingly provide false transaction history.
(23) "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.
(24) "Wholesale distributor" means any person engaged in wholesale distribution.

Legislative History

Acts 1988, No. 852, §1; Acts 2008, No. 597, §1; Acts 2015, No. 443, §1, eff. July 1, 2015.