20 CSR 2220-8.030 - Nonresident Third-Party Logistics Providers/Drug Outsourcer Facilities

PURPOSE: This rule establishes additional guidelines for non-resident third-party logistics providers and drug outsourcer applicants.

(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.

Notes

20 CSR 2220-8.030

Adopted by Missouri Register April 15, 2019/Volume 44, Number 8, effective 5/31/2019