Rx Cares For Missouri Program

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. AUTHORITY: sections 338.140 and 338.280, RSMo 2016, and sections 338.142 and 338.710, RSMo Supp. 2019.* Emergency rule filed July 18, 2019, effective July 28, 2019, expired Feb. 27, 2020. Original rule filed July 18, 2019, effective Feb. 29, 2020. *Original authority: 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011, 2019; 338.142, RSMo 2017; 338.280, RSMo 1951, amended 1971, 1981; and 338.710, RSMo 2017.