20 CSR 2220-2.025 - Nonresident Pharmacies

PURPOSE: This rule establishes licensure guidelines for nonresident pharmacies.

(1) Nonresident pharmacies shall not ship, mail, or deliver prescription drugs into Missouri without first obtaining a pharmacy license from the Missouri Board of Pharmacy. An exemption to licensure is allowed when a nonresident pharmacy provides a prescription drug in an emergency situation or supplies lawful refills to a patient from a prescription that was originally filled and delivered to a patient within the state in which the nonresident pharmacy is located.

(2) To obtain a Missouri pharmacy license, a nonresident pharmacy must-

(A) Maintain a pharmacy license in good standing from the state in which the nonresident pharmacy is located;

(B) Submit an application as provided by the Missouri Board of Pharmacy for licensure in compliance with 20 CSR 22202.020(2), (3), (9), and (10);

(C) Pay all appropriate licensing fees;

(D) Submit a copy of the state pharmacy license from the state in which the nonresident pharmacy is located;

(E) If controlled substances will be shipped into Missouri, submit a copy of the applicant's federal controlled substance registration and, if applicable, a copy of the applicant's state controlled substance registration from the state where the applicant is located;

(F) If the designated pharmacist-in-charge does not have a current and active Missouri pharmacist license issued by the board, submit an official verification from the state board of pharmacy or equivalent state pharmacist licensing agency verifying that the designated pharmacist-in-charge holds a current and active pharmacist license in the state in which the nonresident pharmacy is located; and

(G) Submit a copy of the applicant's most recent pharmacy inspection by the applicant's resident state board of pharmacy or its equivalent state regulatory body. The inspection must have occurred within the last eighteen (18) months for sterile compounding pharmacy applicants or within the last twenty-four (24) months for all other pharmacy applicants. If a state inspection is unavailable, an inspection by the Missouri Board of Pharmacy or from the Verified Pharmacy Program (VPP) of the National Association of State Boards of Pharmacy or a similar inspection by an entity approved by the board may be accepted.

(3) Each nonresident pharmacy shall supply any inspection reports, warning notices, notice of deficiency reports, or any other related reports requested by the board or the board's authorized designee to review compliance with state and federal drug laws.

(4) The Missouri Board of Pharmacy will extend reciprocal cooperation to any state that licenses and regulates nonresident pharmacies for the purpose of investigating complaints against pharmacies located in Missouri or the sharing of information and investigative reports, as long as the other state will extend the same reciprocal cooperation to the Missouri Board of Pharmacy.

Notes

20 CSR 2220-2.025

AUTHORITY: sections 338.140, 338.210.4, 338.220, 338.240, and 338.280, RSMo 2016.* This rule originally filed as 4 CSR 220-2.025. Original rule filed Jan. 16, 1990, effective May 11, 1990. Amended: Filed June 28, 2002, effective Jan. 30, 2003. Moved to 20 CSR 2220-2.025, effective Aug. 28, 2006. Amended: Filed Oct. 10, 2017, effective April 30, 2018.

AUTHORITY: sections 338.140 and 338.280, RSMo 2000 and 338.220, RSMo Supp. 2001.* This rule originally filed as 4 CSR 220-2.025. Original rule filed Jan. 16, 1990, effective May 11, 1990. Amended: Filed June 28, 2002, effective Jan. 30, 2003. Moved to 20 CSR 2220-2.025, effective Aug. 28, 2006. Amended by Missouri Register March 1, 2018/Volume 43, Number 5, effective 4/30/2018