Current through Register Vol. 49, No. 6, March 15, 2024
PURPOSE: This rule establishes licensing requirements
and procedures for drug outsourcers and third-party logistics
providers.
(1) No person or
entity may act as a third-party logistics provider (3PL) or a drug outsourcer
unless the person/entity has obtained the applicable 3PL or drug outsourcer
license from the board. A separate license is required for each facility owned
or operated as a 3PL or drug outsourcer.
(A)
Applicants must submit a completed application to the board with the applicable
fee along with the following information:
1.
The name, full business address, e-mail address, and telephone number of the
applicant and the facility where third-party logistics provider services or
drug outsourcer activities will be provided, if different;
2. All trade or business names used by the
licensee;
3. For 3PL applicants,
the name, address, telephone number, and e-mail address of a manager-in-charge
that meets the requirements of 20 CSR 2220-8.030 along with his/her employment
history for the previous seven (7) years and a notarized manager-in-charge
affidavit;
4. For drug outsourcer
applicants, the name, address, telephone number, and e-mail address of a
pharmacist responsible for supervising the facility who holds a current and
active pharmacist license issued by a U.S. state or territory. If the
designated pharmacist does not have a current and active Missouri pharmacist
license, official verification must be submitted from the board of pharmacy or
equivalent pharmacist governmental licensing agency verifying that the
designated pharmacist holds a current and active pharmacist license issued by
such state/territory;
5. The type
of ownership or legal structure; and
6. The name(s) of the owner, operator, or
both, of the licensed entity, including:
A.
If a sole proprietorship, the full name of the sole proprietor and the name of
the business entity. The sole proprietor must sign the application;
B. If a partnership or limited liability
partnerships, the name of each partner and the name of the partnership. A
partner or general partner must sign the application; or
C. If a corporation, the name of the
corporate 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. An officer
of the corporation must sign the application.
(B) A license will not be issued to a
facility located in Missouri until the board or its duly authorized agent has
inspected the premises of the new location and approved it. For nonresident
applicants, an inspection report must be submitted as required by 20 CSR
2220-8.030.
(C) All third-party
logistics provider and drug outsourcer licenses will expire on the date
specified by the director of the Division of Professional Registration by
appropriate rule. Once issued, licenses must be conspicuously posted in the
licensed facility where 3PL or drug outsourcer operations are
conducted.
(D) A 3PL or drug
outsourcer license will not be issued to any location where drugs are stored or
maintained that is in a residence or that shares an address and/or physical
space with a business not related to distributing prescription drugs or
drug-related devices, or not licensed and regulated by the state of
Missouri.
(E) An application will
become null and void if the applicant fails to complete the process for
licensure within six (6) months after the application is received by the
board.
(F) All application fees are
non-refundable.
(2)
Change of Ownership. A third-party logistics provider or drug outsourcer
license shall become void on the effective date of any change of ownership. The
subsequent owners must obtain a new license from the board prior to operating
as a third-party logistics provider or drug outsourcer in this state, provided
a temporary license may be issued to the new ownership until a new license is
granted as outlined in section (5). Facilities located in Missouri must be
inspected by the board prior to issuing a new license.
(A) A change of ownership of a sole
proprietorship is deemed to have occurred when-
1. The business is sold and the sale becomes
final;
2. The proprietor enters
into a partnership with another individual or business entity; or
3. The proprietor dies, provided, the
proprietor's estate may continue to operate the third-party logistics provider
or drug out-sourcer facility for a period of no more than one (1) year if all
appropriate fees are paid.
(B) If a corporation owns a third-party
logistics provider or drug outsourcer, a new license is not required if the
owners of the stock change. If a limited liability partnership or a limited
liability company owns a third-party logistics provider or drug outsourcer, a
new license is not required if the partners or members of the company change,
as long as the partnership or company is not dissolved by the change. Written
notice must be filed with the board within thirty (30) days after a change of
twenty-five percent (25%) or more in the ownership of corporation stock, or the
partners of a limited liability partnership, or the members of a limited
liability company. The required notification must be in writing and
notarized.
(C) When a sole
proprietorship, corporation, limited liability partnership, or limited
liability company begins or ceases ownership of a third-party logistics
provider or drug outsourcer, a new license must be obtained regardless of the
relationship between the previous and subsequent owners.
(3) Change of Location. A third-party
logistics provider or drug out-sourcer license is only valid for the address
listed on the license issued by the board. If the location of a third-party
logistics provider or drug outsourcer facility changes either within the
existing facility or to a new facility, a change of location application must
be submitted to the board with the applicable fee. A Missouri located facility
may not open for business at the new location until the board or its duly
authorized agent has inspected the premises of the new location and approved
it. Once approved, the board will issue a license for the new location with the
same license number as the previous license. A license will remain valid if the
facility address changes but not the location, in such case an amended license
will be issued on request without charge.
(4) Change of Name. Licensees may only
conduct 3PL or drug outsourcing activities in the state of Missouri under the
name(s) licensed by the board. If a name change occurs, a change of name
application must be submitted to the board with the applicable fee within three
(3) business days of the change. The facility's license will be reissued under
the new name with the same license number. A change of ownership application is
required if the licensee is changing corporate or legal structure or otherwise
changing ownership.
(5) Temporary
Licenses. The board may grant a temporary license to an applicant, subject to
any terms or conditions the board deems necessary or appropriate, to allow the
business to continue operating in Missouri until the board makes a
determination on the applicant's license application. Unless otherwise
authorized by the board, temporary licenses are valid for one (1) year or until
final action by the board, whichever is less.
(A) The board will consider the following in
determining whether to issue a temporary license:
1. Any conduct or activity that constitutes
grounds for denial or discipline under section
338.055,
RSMo;
2. The applicant's compliance
with state and federal drug and/or distribution laws;
3. Any failure to produce records or
information requested by the board or failure to provide full and truthful
information;
4. Failure to
cooperate with any board request or inquiry related to the
application;
5. Current or pending
disciplinary action by any federal, state, or local government against any
license or registration currently or previously held by the
applicant;
6. Compliance with
licensing requirements under previously granted licenses, if any; and
7. Any other factor relevant to the
applicant's ability to safely or properly operate in Missouri.
(B) A notification letter will be
sent to the applicant once a decision is made on the applicant's permanent
license. The temporary license will be considered void ten (10) days after
board notification is sent to the applicant.
(C) Applicants issued a temporary license may
conduct business in this state as a third-party logistics provider or, for drug
outsourcer applicants, as a drug outsourcer as long as all state and federal
laws governing provider/drug outsourcing activities are followed and no action
that results in professional misconduct as outlined in section
338.055,
RSMo, occurs.
(6) A
nonresident third-party logistics provider or drug outsourcer licensed by the
board must designate a registered agent in Missouri for service of process. Any
licensee that does not designate a registered agent shall be deemed to have
designated the Missouri secretary of state to be its true and lawful attorney
for service of process in any action or proceeding against the third-party
logistics provider or drug outsourcer growing out of or arising from such 3PL
or drug outsourcing services. Service of process shall be accomplished as
authorized by law.
(7) Licensure
Exemptions. A Missouri 3PL or drug outsourcer license is not required for the
following activities-
(A) The sale, purchase,
transfer, or trade of a drug or an offer to sell, purchase, transfer, or trade
a drug for emergency administration to an individual patient if a delay in
therapy would negatively affect a patient outcome. Prior to the distribution,
the unlicensed entity or proposed recipient must file a written request with
the board to approve the emergency transaction. The amount sold, purchased,
transferred, or traded shall not exceed one percent (1%) of the 3PL's or drug
outsourcer's total gross prescription sales or, if prescriptions are not sold,
one percent (1%) of the 3PL's/drug outsourcer's total drug purchases;
(B) The storage or distribution of drugs by a
local, state, or federal facility that are received from the Strategic National
Stockpile or the state stockpile for the purpose of providing those drugs in an
emergency situation as authorized by a state or federal agency; and
(C) The sale, purchase, transfer, or trade of
a prescription drug by a 3PL to alleviate a temporary shortage of a
prescription drug that is in limited supply or unavailable due to delays in or
interruption of supply. Drugs sold, purchased, transferred, or traded pursuant
to this section shall only be sold, purchased, transferred, or traded directly
from an importer or manufacturer authorized by or registered with the United
States Food and Drug Administration (FDA) to import or manufacture the drug
that is unavailable or in short supply. In addition, sales, purchases,
transfers, or trades shall be limited to the period of shortage and to the drug
that is unavailable or in limited supply. Documentation of FDA authorization or
registration shall be maintained in the 3PL's records.
