Current through Register Vol. 43, No. 39, September 26, 2024
(a) Each wholesale distributor, virtual
wholesale distributor, third-party logistics provider, or outsourcing facility
shall provide the board with the following minimum information as part of the
registration requirements described in
K.S.A.
65-1645, and amendments thereto, and as part
of any renewal of any registration:
(1) The
name, commercial business address, and telephone number of the
registrant;
(2) each trade or
business name used by the registrant;
(3) the address, telephone number, and name
of the contact person for each facility used by the registrant for the storage,
handling, and distribution of prescription-only drugs or devices;
(4) the type of ownership or operation,
including partnership, corporation, or sole proprietorship;
(5) the name of each owner, operator,
facility manager, and designated representative of the registrant, including
the following:
(A) If a person, the name,
address, and date of birth of the person;
(B) if a partnership, the name, address, and
date of birth of each partner and the name of the partnership;
(C) if a corporation, the name, title,
address, and date of birth of each corporate officer and director, the
corporate name, and the name of the state of incorporation; and
(D) if a sole proprietorship, the name,
address, and date of birth of the sole proprietor and the name of the business
entity;
(6) a list of
all states where the registrant is registered as a wholesale distributor,
virtual wholesale distributor, third-party logistics provider, or outsourcing
facility;
(7) a copy of any current
DEA registration;
(8) all
disciplinary actions or sanctions by any state or federal agency against the
registrant or any principal, owner, director, officer, facility manager, or
designated representative thereof;
(9) if the facility is located outside of
Kansas, a record of the following:
(A) A
current registration in the state where the registrant is located;
(B) a satisfactory inspection conducted
within the previous 36-month period by the registering entity of the state
where the registrant is located. If no such inspection record is readily
available, the record of a satisfactory inspection conducted at the expense of
the registrant within the previous 36-month period by a third party recognized
by the board to inspect may be accepted; and
(C) a designated resident agent in Kansas for
service of process, the record of whom shall also be on file with the secretary
of state; and
(10) if
the registrant is an outsourcing facility, a record of the following:
(A) A current outsourcing facility
registration from the food and drug administration (FDA); and
(B) a current inspection report from an FDA
inspection conducted within the previous 24-month period that indicates
compliance with the requirements of the federal food, drug and cosmetic act,
including guidance documents and current good manufacturing practices
established by the FDA. If no such inspection record is readily available, the
record of a satisfactory inspection conducted at the expense of the registrant
within the previous 36-month period by a third party recognized by the board to
inspect may be accepted.
(b) Each registrant shall provide the board
with a surety bond that meets the requirements of
21
U.S.C. 360ee e-2.
(c) Each registrant shall provide and
maintain, in readily retrievable form, a list of all manufacturers, wholesale
distributors, third-party logistics providers, outsourcing facilities, and
dispensers with which the registrant is transacting business.
(d) Each registrant shall submit revised
information requested by subsection (a) within 30 days after any change in that
information.
