151.47 WHOLESALE DRUG DISTRIBUTOR LICENSING REQUIREMENTS.
Subdivision 1. Requirements.
All wholesale drug distributors are subject to the requirements
in paragraphs (a) to (f).
(a) No person or distribution outlet shall act as a wholesale drug distributor without first
obtaining a license from the board and paying the required fee.
(b) No license shall be issued or renewed for a wholesale drug distributor to operate unless
the applicant agrees to operate in a manner prescribed by federal and state law and according
to the rules adopted by the board.
(c) The board may require a separate license for each facility directly or indirectly owned
or operated by the same business entity within the state, or for a parent entity with divisions,
subsidiaries, or affiliate companies within the state, when operations are conducted at more than
one location and joint ownership and control exists among all the entities.
(d) As a condition for receiving and retaining a wholesale drug distributor license issued
, an applicant shall satisfy the board that it has and will
(1) adequate storage conditions and facilities;
(2) minimum liability and other insurance as may be required under any applicable federal or
(3) a viable security system that includes an after hours central alarm, or comparable entry
detection capability; restricted access to the premises; comprehensive employment applicant
screening; and safeguards against all forms of employee theft;
(4) a system of records describing all wholesale drug distributor activities set forth in section
for at least the most recent two-year period, which shall be reasonably accessible as
defined by board regulations in any inspection authorized by the board;
(5) principals and persons, including officers, directors, primary shareholders, and key
management executives, who must at all times demonstrate and maintain their capability of
conducting business in conformity with sound financial practices as well as state and federal law;
(6) complete, updated information, to be provided to the board as a condition for obtaining
and retaining a license, about each wholesale drug distributor to be licensed, including all
pertinent corporate licensee information, if applicable, or other ownership, principal, key
personnel, and facilities information found to be necessary by the board;
(7) written policies and procedures that assure reasonable wholesale drug distributor
preparation for, protection against, and handling of any facility security or operation problems,
including, but not limited to, those caused by natural disaster or government emergency, inventory
inaccuracies or product shipping and receiving, outdated product or other unauthorized product
control, appropriate disposition of returned goods, and product recalls;
(8) sufficient inspection procedures for all incoming and outgoing product shipments; and
(9) operations in compliance with all federal requirements applicable to wholesale drug
(e) An agent or employee of any licensed wholesale drug distributor need not seek licensure
under this section.
(f) A wholesale drug distributor shall file with the board an annual report, in a form and on
the date prescribed by the board, identifying all payments, honoraria, reimbursement or other
compensation authorized under section
, clauses (3) to (5), paid to practitioners in
Minnesota during the preceding calendar year. The report shall identify the nature and value of
any payments totaling $100 or more, to a particular practitioner during the year, and shall identify
the practitioner. Reports filed under this provision are public data.
Subd. 2. Requirements must conform with federal law.
All requirements set forth in this
section shall conform to wholesale drug distributor licensing guidelines formally adopted by the
United States Food and Drug Administration; and in case of conflict between a wholesale drug
distributor licensing requirement imposed by the board and a Food and Drug Administration
wholesale drug distributor guideline, the latter shall control.
History: 1990 c 526 s 10; 1990 c 568 art 2 s 25; 1993 c 345 art 5 s 12