20 CSR 2220-2.025 - Nonresident Pharmacie
PURPOSE: This amendment updates and clarifies requirements 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 2220-2.020(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 law
(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
*Original authority: 338.140, RSMo 1939, amended 1981, 1989, 1997; 338.220, RSMo 1951, amended 1969, 1981, 1989, 1997, 1999, 2001; and 338.280, RSMo 1951, amended 1971, 1981.
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
PURPOSE: This amendment updates and clarifies requirements 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 2220-2.020(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 law
(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
*Original authority: 338.140, RSMo 1939, amended 1981, 1989, 1997; 338.220, RSMo 1951, amended 1969, 1981, 1989, 1997, 1999, 2001; and 338.280, RSMo 1951, amended 1971, 1981.