Missouri Code of State Regulations
Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE
Division 2220 - State Board of Pharmacy
Chapter 5 - Drug Distributor
Section 20 CSR 2220-5.020 - Drug Distributor Licensing Requirements
Current through Register Vol. 49, No. 6, March 15, 2024
PURPOSE: This amendment would waive Missouri drug distributor licensure requirements for entities shipping drugs or vaccines to treat or immunize patients during a state or federally declared disaster or emergency, or pursuant to an emergency use authorization issued by the United States Food and Drug Administration for a public health emergency.
(1) A "wholesale drug distributor" is defined in section 338.330(3), RSMo. No wholesale drug distributor with physical facilities located in the state of Missouri shall knowingly purchase or receive legend drugs and/or drug related devices from a wholesale drug distributor or pharmacy not licensed or registered by the board. Knowledge of the licensure status of a drug distributor or pharmacy includes, but is not limited to, actual or constructive knowledge. Knowledge of the license status of a drug distributor or pharmacy shall also include, but not be limited to, notification from the board by mail or electronic transmission.
(2) All licenses for the operation of a drug distributor shall expire on the date specified by the director of the Division of Professional Registration by appropriate rule.
(3) Drug distributor licenses shall be issued on the application of the owners. If the owner is a corporation, an officer of the corporation must sign the application as the applicant. If the owner is a partnership, a partner must sign the application as the applicant. If the owner is a limited liability partnership, a general partner must sign the application as the applicant. If the owner is a limited liability company, a member must sign the application as the applicant.
(4) Drug distributor license applications and renewal applications shall be completed and submitted to the Board of Pharmacy along with the appropriate fees before any license is issued or renewed. Information required on the application shall include:
(5) When a drug distributor changes ownership, the original license becomes void on the effective date of the change of ownership. Before any new business entity resulting from that change opens a facility as a drug distributor, it must obtain a new license from the board. A temporary license shall be issued once a completed application and fee have been received by the board. The effective date of the temporary license shall be the date the change of ownership is listed as effective on the application. Such license shall remain in effect until a permanent license is issued or denied by the board.
(6) If an individual or business entity operating a drug distributor facility changes the location of the facility either within the existing facility (structure) or to a new facility (structure), the facility shall not open for business at the new location until the board, its duly authorized agent or the Food and Drug Administration has inspected the premises of the new location and approved it and the facility has been in compliance with all state and federal drug laws pertaining to drug distribution. Upon this approval and receipt of a change of location fee, the board shall issue a license authorizing operation of a facility at the new location and the license shall bear the same number as the previous license. However, the license remains valid if the facility address changes, but not the location, and an amended license will be issued without charge under these circumstances.
(7) Separate licenses shall be required for each drug distribution site owned or operated by a drug distributor as defined in section 338.330, RSMo.
(8) The Board of Pharmacy may grant a temporary license to a wholesale or pharmacy drug distributor to allow for the conduct of business within the state until a determination by the board is made on the issuance of a permanent license.
(9) Each licensed corporate wholesale distributor located outside of this state that distributes drugs in this state shall designate a registered agent in this state for service of process. Any licensed corporate wholesale distributor that does not designate a registered agent shall be deemed to have designated the secretary of state of this state to be its true and lawful attorney, upon who may be served all legal process in any action or proceeding against any licensed corporate wholesale distributor growing out of or arising from such distribution. Service of process shall be accomplished as authorized by law.
*Original authority: 338.330, RSMo 1989, amended 1993, 1998; 338.333, RSMo 1989; 338.335, RSMo 1998; 338.337, RSMo 1989; 338.340, RSMo 1989; and 338.350, RSMo 1989, amended 1993, 1995.