PURPOSE: This rule defines terms and requirements for the lawful licensure of drug distributors.

1. (1) A “wholesale drug distributor” is defined in section 338.330(3), RSMo. No wholesale drug distributor with physical facilities located in the state of Missouri shall knowingly purchase or receive legend drugs and/or drug related devices from a wholesale drug distributor or pharmacy not licensed or registered by the board. Knowledge of the licensure status of a drug distributor or pharmacy includes, but is not limited to, actual or con- 20 CSR 2220-5

structive knowledge. Knowledge of the license status of a drug distributor or pharmacy shall also include, but not be limited to, notification from the board by mail or electronic transmission.

1. (A) A wholesale drug distributor is further defined as anyone engaged in wholesale distribution of prescription drugs, including, but not limited to, manufacturers; repackers; own-label distributors; private-label distributors; jobbers; brokers; warehouses, including manufacturers’ and distributors’ warehouses, chain drug warehouses and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies that conduct wholesale distributions.

2. (B) A wholesale drug distributor does not include:

   1. 1. The sale, purchase or trade of a drug

or an offer to sell, purchase or trade a drug for emergency medical reasons. For purposes of this section, emergency medical reasons includes transfers of prescription drugs by a licensed pharmacy to anyone other than a licensed pharmacy that constitutes five percent (5%) or less of total gross sales of the pharmacy; and

1. 2. The sale, purchase or trade of blood

and blood components intended for transfusion and any other exemptions as provided for in Chapter 338, RSMo.

1. (C) Wholesale drug distributors shall inform the board of their current FAX number, any change in FAX number, and/or the fact that the wholesale drug distributor does not have a working FAX. In the event a wholesale drug distributor notifies the board that the wholesale drug distributor does not have a working FAX, notification from the board will be made to the wholesale drug distributor by first class mail. For the purposes of this rule, such notification by mail shall be considered effective three (3) days after mailing and shall have the same effect as notification by FAX.
2. (D) Failure to receive notification from the board shall not be a defense to violations of section (1) of this rule when the wholesale drug distributor has failed to comply with the requirements of subsection (1)(C) of this rule.

1. (2) All licenses for the operation of a drug distributor shall expire on the date specified by the director of the Division of Professional Registration by appropriate rule.
2. (3) Drug distributor licenses shall be issued on the application of the owners. If the owner is a corporation, an officer of the corporation must sign the application as the applicant. If the owner is a partnership, a partner must sign the application as the applicant. If the FINANCIAL INSTITUTIONS AND PROFESSIONAL REGISTRATION

owner is a limited liability partnership, a general partner must sign the application as the applicant. If the owner is a limited liability company, a member must sign the application as the applicant.

1. (4) Drug distributor license applications and renewal applications shall be completed and submitted to the Board of Pharmacy along with the appropriate fees before any license is issued or renewed. Information required on the application shall include:

   1. (A) The name, full business address, electronic facsimile transmission number (FAX) and telephone number of the licensee;
   2. (B) All trade or business names used by the licensee;
   3. (C) The address, telephone number and the name of the manager in charge for each facility used by the licensee for the storage, handling and distribution of prescription drugs;
   4. (D) The type of ownership or operation;

   5. (E) The name(s) of the owner, operator, or both, of the licensed entity, including:

      1. 1. If a person, the name of the person;
      2. 2. If a partnership, the name of each

partner and the name of the partnership;

1. 3. If a corporation, the name of the cor-

porate president, vice president, secretary, treasurer, chief executive officer, board of directors, and senior vice presidents or their equivalents, the corporate name(s) and the name of the state of incorporation; and

1. 4. If a sole proprietorship, the full name

of the sole proprietor and the name of the business entity;

1. (F) The name of the manager in charge who meets the requirements as set forth in 4 CSR 220-5.030(2) and completes the manager-in-charge affidavit of the license application and has it notarized; and
2. (G) An application for a wholesale or pharmacy drug distributor license will become null and void if the applicant fails to complete the process for licensure within six

1. (6) months of receipt of the application by the board.

2. (5) When a drug distributor changes ownership, the original license becomes void on the effective date of the change of ownership. Before any new business entity resulting from that change opens a facility as a drug distributor, it must obtain a new license from the board. A temporary license shall be issued once a completed application and fee have been received by the board. The effective date of the temporary license shall be the date the change of ownership is listed as effective on the application. Such license shall remain in effect until a permanent license is issued or denied by the board.

   1. (A) A change of ownership of a drug distributor facility owned by a sole proprietor is deemed to have occurred when—

      1. 1. The business is sold and the sale

becomes final;

1. 2. The proprietor enters into a partner-

ship with another individual or business entity; or

1. 3. The proprietor dies; provided, how-

ever, that the proprietor’s estate may continue to operate the drug distributor facility for a period of no more than one (1) year and only so long as appropriate fees are paid.

1. (B) If a corporation owns a drug distributor facility, it is not necessary to obtain a new license if the owners of the stock change. If a limited liability partnership or a limited liability company owns a drug distributor company, it is not necessary to obtain a new license if the partners or members of the company change, as long as the partnership or company is not dissolved by that change. It is necessary to file written notice with the Board of Pharmacy within thirty (30) days after a change occurs of twenty-five percent (25%) or more in the ownership of corporation stock, or in partners in a limited liability partnership, or in members of the limited liability company. This notification must be in writing and certified. However, when a corporation, limited liability partnership, or limited liability company begins ownership of a drug distributor company or ceases ownership of a drug distributor company, a new license must be obtained regardless of the relationship between the previous and subsequent owners.

1. (6) If an individual or business entity operating a drug distributor facility changes the location of the facility either within the existing facility (structure) or to a new facility (structure), the facility shall not open for business at the new location until the board, its duly authorized agent or the Food and Drug Administration has inspected the premises of the new location and approved it and the facility has been in compliance with all state and federal drug laws pertaining to drug distribution. Upon this approval and receipt of a change of location fee, the board shall issue a license authorizing operation of a facility at the new location and the license shall bear the same number as the previous license. However, the license remains valid if the facility address changes, but not the location, and an amended license will be issued without charge under these circumstances.
2. (7) Separate licenses shall be required for each drug distribution site owned or operated by a drug distributor as defined in section 338.330, RSMo.

3. (8) The Board of Pharmacy may grant a temporary license to a wholesale or pharmacy drug distributor to allow for the conduct of business within the state until a determination by the board is made on the issuance of a permanent license.

   1. (A) Temporary licenses shall remain valid until a time the board shall find that the applicant meets or fails to meet the requirements for regular licensure or one (1) year, whichever is less.

      1. 1. The board will consider, at a mini-

mum, the following factors in reviewing the qualifications of persons who apply or renew as a drug distributor:

1. A. Any convictions of the applicant

under any federal, state or local laws relating to drug samples, wholesale or retail drug distribution, or distribution of controlled substances;

1. B. The person has been finally adju-

dicated and found guilty, or entered a plea of guilty or nolo contendere, in a criminal prosecution under the laws of any state or of the United States, for any offense reasonably related to the qualifications, functions or duties of any profession licensed or regulated under this chapter, for any offense an essential element of which is fraud, dishonesty or an act of violence, or for any offense involving moral turpitude, whether or not sentence is imposed;

1. C. The applicant’s past experience in

the manufacture or distribution of prescription drugs, including controlled substances;

1. D. The applicant furnishing false or

fraudulent material in any application made in connection with drug manufacturing or distribution;

1. E. Suspension, revocation or proba-

tion by federal, state or local government of any license or registration currently or previously held by the applicant for the manufacture or distribution of any drugs, including controlled substances;

1. F. Compliance with licensing require-

ments under previously granted licenses, if any; and

1. G. Requirements to maintain or make

available, or both, to the board or the federal, state or local law enforcement officials those records required under this section are followed.

1. 2. If an applicant for a license in any

way fails to provide information as requested by the board or does not cooperate with requests and inquiries made by the board or provides false or misleading information to the board and the temporary license expires or is denied, all fees paid by the applicant shall be forfeited.

1. 3. During the period of time that a tem-

porary license is in effect, the applicant may conduct business in this state as a drug distributor as long as all state and federal laws governing drug distribution are followed and no action that results in professional misconduct as outlined in section 338.055, RSMo is documented.

1. 4. If it is determined by the board that a

permanent license is to be denied to an applicant, a denial notification letter shall be sent to the applicant. The temporary license will be considered invalid ten (10) days after notification is sent to the applicant by certified mail.

1. (B) A license must be posted in a conspicuous place in the facility to which it is issued.

AUTHORITY: sections 338.330, 338.333, 338.335, 338.337, 338.340 and 338.350, RSMo 2000.* This rule originally filed as 4 CSR 220-5.020. Original rule filed Feb. 4, 1991, effective June 10, 1991. Amended: Filed April 28, 1992, effective Feb. 26, 1993. Amended: Filed Jan. 27, 1995, effective Sept. 30, 1995. Amended: Filed March 15, 2000, effective Sept. 30, 2000. Amended: Filed Nov. 1, 2000, effective June 30, 2001. Amended: Filed April 6, 2001, effective Nov. 30, 2001. Amended: Filed June 16, 2003, effective Jan. 30, 2004. Amended: Filed June 15, 2005, effective Jan. 30, 2006. Moved to 20 CSR 2220-5.020, 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; 338.340, RSMo 1989; and 338.350, RSMo 1989, amended 1993, 1995.