Current through Register Vol. 49, No. 6, March 15, 2024
PURPOSE: This rule establishes guidelines for
license/registration procedures for out-of-state drug
distributors.
(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-
(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
(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) 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.
(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. 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;
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;
3.
Pay all appropriate fees;
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;
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
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.
(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.
(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.
(4) Registration in lieu of
licensure may be sought by an out-of-state drug distributor when the following
provisions exist:
(A) The out-of-state drug
distributor is a drug manufacturer;
(B) The manufacturing facility is used for
both the production (manufacture) and distribution of legend drugs;
(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;
(D) The state in which the manufacturing
facility is located issues a license and the license is current and in good
standing; and
(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. The board shall provide, on an
annual basis, a registration renewal form to all registered out-of-state
distributors.
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.
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.
4. Each renewal
application must be submitted along with a filing fee of ten dollars
($10).
*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.
