By the authority vested in the Missouri Board of Pharmacy under sections 338.140 and 338.215, RSMo Supp. 2020, the board adopts a rule as follows:
20 CSR 2220-2.680 is adopted.
A notice of proposed rulemaking containing the text of the proposed rule was published in the Missouri Register on October 15, 2020 (45 MoReg 1611-1615). Those sections with changes are reprinted here. This proposed rule becomes effective thirty (30) days after publication in the Code of State Regulations.
SUMMARY OF COMMENTS: Representatives from TelePharm and Cardinal Health jointly submitted three (3) comments on the proposed rule.
COMMENT #1: TelePharm and Cardinal Health indicated subsection (4)(A) of the proposed rule mistakenly states the pharmacist-in-charge of the Class R pharmacy must visit the remote dispensing site weekly during the first month of operation to verify compliance and monthly thereafter. The commenters suggested the intent of sections 338.215.3 and 338.215.8, RSMo, is to allow any pharmacist employed by the Class R supervising pharmacy to perform these activities and asked the board to amend subsection (4)(A) to reflect this intent.
RESPONSE: Section 338.215.3 provides that a remote dispensing site pharmacy shall be under the supervision and control of a supervising pharmacist employed by the supervising pharmacy. The term supervising pharmacist is not defined in section 338.215, RSMo, and does appear to be used in a different manner in distinct parts of section 338.215, RSMo. Since the pharmacist-in-charge is responsible and statutorily held accountable for the compliance with dispensing requirements at the Class R pharmacy along with the supervising pharmacy, the board believes it is appropriate for the pharmacist-in-charge of the Class R site to conduct the visits required under the statue and rule. No changes have been made in response to this comment.
COMMENT #2: TelePharm and Cardinal Health contend that the intent of section 338.215, RSMo, was to allow any pharmacy who shares common ownership with a remote dispensing site pharmacy to oversee/supervise dispensing activity at a Class R site. In line with this construction, the commenters suggested amending subsection (4)(D) of the rule to provide that a Class R site may be remotely supervised by a pharmacist at "a" supervising pharmacy rather than "the" supervising pharmacy. TelePharm and Cardinal Health suggest use of "the" supervising pharmacy throughout the rule implies that a Class R site cannot have multiple supervising pharmacies as the legislature intended.
RESPONSE: The board disagrees with the proposed statutory construction and interprets section 318.215, RSMo, to allow only one (1) supervising pharmacy per Class R remote dispensing site. No changes have been made in response to the comment.
COMMENT #3: TelePharm and Cardinal Health suggested the board amend subsection (2)(B) by eliminating the factors the board listed for consideration in granting a waiver of the ten (10) mile distance requirement between a Class R remote dispensing site pharmacy and an existing pharmacy. The commenters stated the factors are more restrictive than section 338.215.7, RSMo, which only requires an applicant to demonstrate how the proposed remote site dispensing pharmacy will promote public health.
RESPONSE AND EXPLANATION OF CHANGE: The factors listed in subsection (2)(B) all relate to how the dispensing site pharmacy will promote public health, and will provide guidance to applicants. However, the board will amend the section to emphasize that the primary inquiry is whether the proposed site will promote public health.