Current through Register Vol. 49, No. 6, March 15, 2024
PURPOSE: This rule establishes the Missouri Board of
Pharmacy's medication disposal program as part of the Rx Cares for Missouri
Program created by section
338.710,
RSMo and establishes standards/criteria for Program operation and
participation.
(1) Section
338.710,
RSMo, established the "Rx Cares for Missouri Program" within the Board of
Pharmacy to promote medication safety and to prevent prescription drug abuse,
misuse, and diversion in Missouri. As part of the Rx Cares for Missouri
Program, the board is hereby establishing a medication destruction and disposal
program (the "Program") for the purposes of collecting unused or unwanted
medication from the public for disposal in accordance with state and federal
law. Operation of the Program may be delegated to a board approved vendor or
third-party.
(2) Eligible
Participants. To be eligible for participation, applicants must be physically
located in Missouri and currently registered to collect unwanted controlled
substances with the United States Drug Enforcement Administration ("DEA") and
the Missouri Bureau of Narcotics and Dangerous Drugs ("BNDD") unless exempt
from registration by state or federal law. Additionally, the applicant must be-
(A) A licensed Missouri pharmacy or drug
distributor;
(B) A licensed
healthcare provider authorized to prescribe controlled substances;
(C) A hospital, office, clinic, or other
medical institution that provides health care services;
(D) A federal, state, local, or municipal
public health, law enforcement, or other governmental agency, or
(E) A higher education institution located in
Missouri that is accredited by a national or regional accrediting body
recognized by the United States Secretary of Education.
(3) Participant Requirements. Approved
participants must establish and operate a public medication collection program
in compliance with Program requirements, including, but not limited to, all
applicable board or vendor requirements for collecting, submitting, or
forwarding medication for destruction and disposal. Participants must promptly
enroll in the program after notification of approval is received from the
board.
(A) Subject to appropriation, approved
Program participants will be provided a collection receptacle and inner liners
to be used for collecting medication pursuant to the Program. Participants may
alternatively use an existing collection receptacle if approved by the board or
the Program vendor. Program participants are responsible for installation of
the collection receptacle in accordance with vendor requirements.
(B) Collection receptacles must be physically
located in the state of Missouri at an address approved by the board. A board
approved sign must be located on or near the receptacle indicating that the
collection program has been funded by the Missouri Board of Pharmacy as part of
the Rx Cares for Missouri Program. Collection receptacles may not be used to
dispose of medication from the pharmacy's inventory.
(C) Medication must be collected and handled
in compliance with all state and federal controlled substance laws. Program
participants may submit collected medication to the vendor or the vendor's
authorized designee for disposal at no cost to the participant up to twelve
(12) times per participation year. Program participants may arrange for
additional medication disposal at the participant's cost.
(D) Program participants shall notify the
board in writing within ten (10) days after ceasing or terminating Program
participation. Unless otherwise agreed by the board for good cause, Program
participants shall reimburse the board for the cost of the collection
receptacle if the participant fails to actively maintain and operate a
collection program during the participation year. Collection receptacle costs
must be remitted to the board within sixty (60) days after notification from
the board.
(4)
Application Procedures. Applications to participate in the Program must be
submitted to the board on a board approved form and include-
(A) The applicant's name, address, contact
telephone number, and e-mail address;
(B) The Missouri address where the collection
receptacle will be located;
(C) A
copy of the applicant's DEA and BNDD controlled substance collector
registrations;
(D) A description of
how the medication collection program will be operated, including operational
times and how the program will be advertised to the public;
(E) A designation of whether the applicant
will be using a board approved collection receptacle or supplying their own
collection receptacle subject to vendor approval; and
(F) A description of the need for a
medication collection program in the proposed collection site area along with
any supporting data or evidence.
(5) Approval Criteria. At the discretion of
the board, applicants will be approved for Program participation subject to
funding availability. Participation approval shall be valid for one (1)
calendar year. The following criteria will be considered by the board when
reviewing applications:
(A) The need for a
medication collection program in the proposed collection site area, including,
but not limited to, any alternative collection programs/opportunities
available;
(B) Relevant evidence or
data regarding drug use, abuse, fatalities, or trends;
(C) The number of applications submitted or
previously approved by the board for the applicant regardless of collection
site;
(D) The nature and structure
of the proposed collection program, including, but not limited to, operational
times and any public restrictions;
(E) Available staff, resources, or
expertise;
(F) Any state, federal,
or local disciplinary action, including any pending board complaints or
investigations;
(G) The applicant's
compliance with state and federal drug and controlled substance laws;
(H) The applicant's financial need and
available resources; and
(I) Any
other factor that may be relevant to the applicant's ability to participate in
or comply with the Program.
(6) Information Sharing. As a condition of
participation, applicants must agree that program information collected or
maintained by the vendor or the vendor's designee may be disclosed to-
(A) The board or the board's authorized
designee on request; and
(B) The
Missouri Governor and the Missouri General Assembly pursuant to section
338.710,
RSMo.
