Current through Register Vol. 49, No. 6, March 15, 2024
(1) Nonresident
third-party logistics (3PL) providers or drug out-sourcer facilities may not
act as a third-party logistics provider or a drug outsourcer or ship, mail, or
deliver legend drugs, or for drug outsourcers, compounded drugs into Missouri
without first obtaining the applicable license from the board. Nonresident
third-party logistics providers or drug outsourcers may be licensed by
reciprocity if they-
(A) Possess a valid 3PL
or drug outsourcer license or an equivalent license that is in good standing in
the state or foreign jurisdiction in which they are located that was issued
pursuant to legal standards comparable to those which must be met by a Missouri
third-party logistics provider or drug outsourcer; and
(B) Are located in a state or foreign
jurisdiction which extends reciprocal treatment to a third-party logistics
provider of this state or, for drug outsourcer applicants, a drug outsourcer of
this state.
(2) Except as
otherwise provided in this rule, applicants for a nonresident third-party
logistics provider or drug outsourcer license must comply with 20 CSR
2220-8.020, including, but not limited to, all application, change of
ownership, change of location, and change of name requirements. In addition to
the requirements of 20 CSR 2220-8.020, non-resident applicants must also submit
the following with their application:
(A) A
copy of the applicant's 3PL or drug outsourcer license or its equivalent from
the state or foreign jurisdiction where the nonresident third-party logistics
provider or drug outsourcer facility is located;
(B) An official verification from the state
or foreign jurisdiction where the third-party logistics provider or drug
outsourcer facility is located verifying that the applicant holds a current and
active third-party logistics provider license or its equivalent, for drug
outsourcer applicants, a drug outsourcer license or its equivalent issued by
such state or foreign jurisdiction;
(C) A copy of the applicant's most recent
inspection report or findings from the applicant's resident board of pharmacy
or its equivalent state/foreign regulatory body. For 3PL applicants, the
inspection must have occurred within the last twenty-four (24) months. For drug
outsourcer applicants, the inspection must have occurred within the last
eighteen (18) months. If a state inspection is unavailable, an inspection by
the Missouri Board of Pharmacy, the United States Food and Drug Administration
(FDA) or the National Association of State Boards of Pharmacy must be submitted
or a similar inspection by an entity approved by the board;
(D) If controlled substances will be shipped
into Missouri, 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;
and
(E) If requested by the board,
any inspection reports, correction active responses, warning notices,
deficiency notices, or any other related state, federal, or foreign
jurisdiction report or notice related to the applicant's handling,
distribution, manufacturing, or sale of medication.
