Effective - 28 Aug 2020
338.215. Remote dispensing site pharmacy — definitions — requirements — supervision — location — staffing — license required, when — rulemaking authority. — 1. For purposes of this section, the following terms mean:
(1) "Remote dispensing site pharmacy", any location in this state where the practice of pharmacy occurs and that is licensed as a pharmacy to dispense prescription drugs and is staffed by one or more qualified pharmacy technicians, as defined by the board, or intern pharmacists, whose activities are supervised by a pharmacist at a supervising pharmacy through a continuous real-time audio and video link. "Remote dispensing site pharmacy" does not include the office of a dispensing prescriber or an automated device;
(2) "Supervising pharmacy", a pharmacy licensed in this state under the provisions of this chapter that oversees the dispensation activities of a remote dispensing site pharmacy.
2. A supervising pharmacy that operates a remote dispensing site pharmacy, and the remote dispensing site pharmacy, shall be licensed as a pharmacy by the board of pharmacy. The board shall issue a license to a remote dispensing site pharmacy that meets the requirements of this subsection. The remote dispensing site pharmacy shall:
(1) Submit an application and pay the licensing fee established by the board;
(2) Be jointly owned by a supervising pharmacy; and
(3) Maintain a policy and procedures manual that includes the following:
(a) A description of how the supervising pharmacy and remote dispensing site pharmacy will comply with federal and state laws, rules, and regulations;
(b) The procedure for the supervising pharmacy to supervise the remote dispensing site pharmacy and counsel patients in accordance with the laws of this state prior to the dispensing of a prescription drug under this section;
(c) The procedure for reviewing the prescription drug inventory and drug records maintained by the remote dispensing site pharmacy;
(d) The policy and procedure for providing appropriate security to protect the confidentiality and integrity of patient information;
(e) The written plan for recovery from an event that interrupts or prevents a pharmacist from supervising the operation of the remote dispensing site pharmacy;
(f) The specific duties, tasks, and functions that a registered pharmacy technician or intern pharmacist is authorized to perform at the remote dispensing site pharmacy under the remote supervision of a licensed pharmacist at the supervising pharmacy; and
(g) The procedure for maintaining an up-to-date inventory of all controlled substances.
3. A remote dispensing site pharmacy shall be under the supervision and control of a supervising pharmacist employed by the supervising pharmacy. The supervising pharmacist shall not be required to be immediately physically present to supervise activities at the remote dispensing site pharmacy, but shall make monthly visits to the remote dispensing site pharmacy in order to ensure compliance with this section.
4. A supervising pharmacist and a remote dispensing site pharmacy shall share common ownership. A pharmacist shall neither be designated nor act as a supervising pharmacist for more than two remote dispensing site pharmacies at one time.
5. A pharmacist at the supervising pharmacy shall verify each prescription before it leaves the remote dispensing site pharmacy. Verification shall occur through the use of technology that includes bar coding and visual review via remote video. As applicable, a pharmacist, intern pharmacist, and pharmacy technician's initials or unique identifier shall appear in the prescription record to identify the name and specific activities of each pharmacist, intern pharmacist, or pharmacy technician involved in the dispensing process.
6. Unless a pharmacist is onsite at the remote dispensing site pharmacy, counseling shall be done by a supervising pharmacist at the supervising pharmacy via a HIPAA-compliant continuous real-time video and audio link before a drug or medical device is released to the patient. The system being used to perform the consultation shall retain the initials or unique identifier of the pharmacist who performs the consultation. The pharmacist providing counseling under this subsection shall be employed by and located at the supervising pharmacy and have access to all relevant patient information maintained by the remote dispensing site pharmacy.
7. A remote dispensing site pharmacy shall be located at least ten miles from an existing retail pharmacy unless:
(1) The remote dispensing site pharmacy is part of a community mental health center, federally qualified health center, rural health clinic, or outpatient clinic setting; or
(2) An applicant of a proposed remote dispensing site pharmacy demonstrates to the board how the proposed remote dispensing site pharmacy will promote public health.
8. The remote dispensing pharmacy shall be staffed by a pharmacist at least eight hours a month and shall reconcile the up-to-date controlled substance inventory twice a month. The supervising pharmacist may provide services as allowed in section 338.010 and as provided by policies and procedures.
9. If the average number of prescriptions dispensed per day by the remote dispensing site pharmacy exceeds one hundred fifty prescriptions, the remote dispensing site pharmacy shall, within ten days, apply to the board for licensure as a class A, B, or C pharmacy, as applicable. The average number of prescriptions dispensed per day shall be determined by averaging the number of prescriptions dispensed per day over the previous ninety-day period.
10. Unless otherwise approved by the board, the supervising pharmacy shall be located in this state and within fifty road miles of a remote dispensing site pharmacy to ensure that the remote dispensing site pharmacy is sufficiently supported by the supervising pharmacy and that necessary personnel or supplies may be delivered to the remote dispensing site pharmacy within a reasonable period of time of an identified need.
11. The board of pharmacy may promulgate all necessary rules and regulations for the implementation of this section, provided that no such rules and regulations shall restrict the practice of pharmacy at a remote dispensing site pharmacy. Any rule or portion of a rule, as that term is defined in section 536.010, that is created under the authority delegated in this section shall become effective only if it complies with and is subject to all of the provisions of chapter 536 and, if applicable, section 536.028. This section and chapter 536 are nonseverable and if any of the powers vested with the general assembly pursuant to chapter 536 to review, to delay the effective date, or to disapprove and annul a rule are subsequently held unconstitutional, then the grant of rulemaking authority and any rule proposed or adopted after August 28, 2020, shall be invalid and void.
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(L. 2020 H.B. 1682)