PURPOSE: This rule establishes guidelines for license/registration procedures for out-ofstate drug distributors.

1. (1) Out-of-state wholesale drug distributors or out-of-state pharmacy distributors may be licensed, as required by sections 338.210— 338.370, RSMo, by reciprocity if they—

   1. (A) Possess a valid license in good standing in the state or foreign jurisdiction in which they are located pursuant to legal standards comparable to those which must be met by a distributor of this state as prerequisites for obtaining a license under the laws of this state; and
   2. (B) Are located in a state or foreign jurisdiction which extends reciprocal treatment under its own laws to a wholesale distributor of this state.

2. (2) Out-of-state wholesale drug and pharmacy distributors shall not ship, mail or deliver prescription drugs into Missouri without first obtaining a license from the Missouri Board of Pharmacy.

   1. (A) In order for an out-of-state wholesale drug or pharmacy distributor to maintain a license, it must comply with each of the following:

      1. 1. Maintain in good standing a license

from the state or foreign jurisdiction in which the nonresident distributor is located provided that a license is issued by that state or foreign jurisdiction;

1. 2. Submit an application as provided by

the board for licensure in compliance with sections 338.333 and 338.337, RSMo and with 4 CSR 220-5.020;

1. 3. Pay all appropriate fees;
2. 4. Submit a copy of the state or foreign

jurisdiction license or its equivalent from the state or foreign jurisdiction in which the distributor is located provided that a license is issued by that state or foreign jurisdiction;

1. 5. Submit a copy of the state or foreign

jurisdiction and federal controlled substance registrations from the state or foreign jurisdiction in which they are located, if controlled substances are to be shipped into Missouri; and

1. 6. Submit copies, when requested by the

board, of any inspection reports, warning notices, notice of deficiency reports or any other related reports from the state or foreign jurisdiction in which it is located concerning the operation of an out-of-state drug or pharmacy distributor for review of compliance with state, federal or foreign jurisdiction drug laws.

1. (B) The Missouri Board of Pharmacy will extend reciprocal cooperation to any state or foreign jurisdiction that licenses and regulates out-of-state drug or pharmacy distributors for the purpose of investigating complaints against distributors located in Missouri or the sharing of information and investigative reports, as long as the other state or foreign jurisdiction will extend the same reciprocal cooperation to the Missouri Board of Pharmacy.

1. (3) An exemption to licensure is allowed when an out-of-state wholesale drug distributor supplies a drug to another drug distributor licensed in this state in an emergency situation. The amount of the distribution allowed must be confined to the emergency situation and the total amount of distribution for emergency situations must not exceed one percent (1%) of the total annual gross sales of the unlicensed distribution site.

2. (4) Registration in lieu of licensure may be sought by an out-of-state drug distributor when the following provisions exist:

   1. (A) The out-of-state drug distributor is a drug manufacturer;
   2. (B) The manufacturing facility is used for both the production (manufacture) and distribution of legend drugs;
   3. (C) The site has been inspected with a satisfactory rating by the Food and Drug Administration within the last two (2) years. Inspections of these facilities must comply with all standards and requirements as outlined in 4 CSR 220-5.040;
   4. (D) The state in which the manufacturing facility is located issues a license and the license is current and in good standing; and

   5. (E) The out-of-state distributor who qualifies for registration must complete an application as provided by the board and submit it along with a filing fee of ten dollars ($10).

      1. 1. The board shall provide, on an annu-

al basis, a registration renewal form to all registered out-of-state distributors.

1. 2. In order for a registration to remain in

good standing and in effect, the renewal must be returned to the Division of Professional Registration by an expiration date that is specified by the director of the division by appropriate rule.

1. 3. In order for a registration to be

renewed, it must comply with all the provisions for registering as a drug distributor facility as outlined in section 338.337, RSMo and this rule.

1. 4. Each renewal application must be

submitted along with a filing fee of ten dollars ($10).

AUTHORITY: sections 338.330, 338.335 and 338.350, RSMo Supp. 1999 and 338.333 and 338.337, RSMo 1994.* This rule originally filed as 4 CSR 220-5.050. Original rule filed Feb. 4, 1991, effective June 10, 1991. Amended: Filed March 15, 2000, effective Sept. 30, 2000. Moved to 20 CSR 2220-5.050, effective Aug. 28, 2006. *Original authority: 338.330, RSMo 1989, amended 1993, 1998; 338.333, RSMo 1989; 338.335, RSMo 1998; 338.337, RSMo 1989; 338.350, RSMo 1989, amended 1993, 1995.