Bill Text: MO HB1997 | 2010 | Regular Session | Introduced
Bill Title: Exempts certain wholesale drug distributors from licensure
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced - Dead) 2010-02-24 - Public Hearing Completed (H) [HB1997 Detail]
Download: Missouri-2010-HB1997-Introduced.html
SECOND REGULAR SESSION
95TH GENERAL ASSEMBLY
INTRODUCED BY REPRESENTATIVE WASSON.
4730L.01I D. ADAM CRUMBLISS, Chief Clerk
AN ACT
To repeal sections 338.333, 338.335, and 338.337, RSMo, and to enact in lieu thereof three new sections relating to wholesale drug distributors.
Be it enacted by the General Assembly of the state of Missouri, as follows:
Section A. Sections 338.333, 338.335, and 338.337, RSMo, are repealed and three new sections enacted in lieu thereof, to be known as sections 338.333, 338.335, and 338.337, to read as follows:
338.333. 1. No person or distribution outlet shall act as a wholesale drug distributor or pharmacy distributor without first obtaining license to do so from the Missouri board of pharmacy and paying the required fee. The board may grant temporary licenses when the wholesale drug distributor or pharmacy distributor first applies for a license to operate within the state. Temporary licenses shall remain valid until such time as the board shall find that the applicant meets or fails to meet the requirements for regular licensure. No license shall be issued or renewed for a wholesale drug distributor or pharmacy distributor to operate unless the same shall be operated in a manner prescribed by law and according to the rules and regulations promulgated by the board of pharmacy with respect thereto. Separate licenses shall be required for each distribution site owned or operated by a wholesale drug distributor or pharmacy distributor, unless such drug distributor meets the requirements of subsection 2 of section 338.335.
2. An agent or employee of any licensed or registered wholesale drug distributor or pharmacy distributor need not seek licensure under this section and may lawfully possess pharmaceutical drugs, if he is acting in the usual course of his business or employment.
3. The board may permit out-of-state wholesale drug distributors or out-of-state pharmacy distributors to be licensed as required by sections 338.210 to 338.370 on the basis of reciprocity to the extent that an out-of-state wholesale drug distributor or out-of-state pharmacy distributor both:
(1) Possesses a valid license granted by another state pursuant to legal standards comparable to those which must be met by a wholesale drug distributor or pharmacy distributor of this state as prerequisites for obtaining a license under the laws of this state; and
(2) Distributes into Missouri from a state which would extend reciprocal treatment under its own laws to a wholesale drug distributor or pharmacy distributor of this state.
338.335. 1. Separate licenses shall be required for each distribution site owned or operated by a wholesale drug distributor or pharmacy distributor unless drugs are delivered only on a consignment basis as defined by the board.
2. A wholesale drug distributor distributing medical devices in this state shall not be required to obtain a license from the board for out-of-state distribution sites owned by the wholesale drug distributor if:
(1) The wholesale drug distributor has one or more distribution sites located in this state, and all such in-state distribution sites receiving shipments of medical devices are licensed by the board as a distributor;
(2) The wholesale drug distributor's out-of-state distribution sites shipping to the in-state distribution site or sites are in compliance with the licensing laws of their respective states; and
(3) The wholesale drug distributor's out-of-state distribution sites that deliver medical devices regulated by the board into this state for patient use deliver such devices to the licensed wholesale drug distributor's in-state distribution site or sites.
3. A Missouri wholesale drug distributor receiving shipments of medical devices from an out-of-state facility that is not required to be licensed as a distributor under subsection 2 of this section is responsible for all shipments received.
338.337. It shall be unlawful for any out-of-state wholesale drug distributor or out-of-state pharmacy acting as a distributor to do business in this state without first obtaining a license to do so from the board of pharmacy and paying the required fee, except as otherwise provided by law. Application for an out-of-state wholesale drug distributor's license under this section shall be made on a form furnished by the board. The issuance of a license under sections 338.330 to 338.370 shall not change or affect tax liability imposed by the Missouri department of revenue on any out-of-state wholesale drug distributor or out-of-state pharmacy. Any out-of-state wholesale drug distributor that is a drug manufacturer and which produces and distributes from a facility which has been inspected and approved by the Food and Drug Administration, maintains current approval by the federal Food and Drug Administration, and has provided a copy of the most recent Food and Drug Administration Establishment Inspection Report to the board, and which is licensed by the state in which the distribution facility is located, or, if located within a foreign jurisdiction, is authorized and in good standing to operate as a drug manufacturer within such jurisdiction, need not be licensed as provided in this section but such out-of-state distributor shall register its business name and address with the board of pharmacy and pay a filing fee in an amount established by the board.
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