Title 20-DEPARTMENT OF INSURANCE, FINANCIAL INSTITUTIONS AND PROFESSIONAL REGISTRATION

Division 2220-State Board of Pharmacy

Chapter 2-General Rules

ORDER OF RULEMAKING

By the authority vested in the Missouri Board of Pharmacy under sections 338.056, 338.059, 338.196, 338.250, 338.280, and 338.343, RSMo 2000 and sections 338.010, 338.055, 338.140, 338.150, 338.210, 338.220, and 338.240, RSMo Supp. 2011, the Missouri Board of Pharmacy adopts a rule as follows:

20 CSR 2220-2.675 is adopted.

A notice of proposed rulemaking containing the text of the proposed rule was published in the Missouri Register on October 3, 2011 (36 MoReg 2107-2115). 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: The Missouri Board of Pharmacy received three (3) comments on the proposed rule, as summarized below.

COMMENT #1: Section (9) of the proposed rule authorizes manually written prescription label information "or" prescription label numbers. However, section 338.059, RSMo, requires both written label information "and" written numbering.

RESPONSE AND EXPLANATION OF CHANGE: The board amended the proposed rule to be consistent with section 338.059, RSMo.

COMMENT #2: The board received a comment from the Missouri Agribusiness Association (MO-AG) requesting clarification on licensure requirements for entities operating several locations under the same ownership/association and for entities solely engaged in receiving shipments of medications for delivery/customer pickup.

RESPONSE: The commenter requested general clarification on the scope of the enabling legislation and Missouri's definition of a "pharmacy." The comment did not raise specific concerns regarding the proposed rule language. Accordingly, no changes to the rule have been made in response to the comment. However, the board met with representatives of MO-AG and MFA, Inc. to discuss the statutory language and related licensure requirements. The board will continue to work with MO-AG and other related entities to provide guidance.

COMMENT #3: The board received a comment that the proposed section (10) incorrectly references subsection (8)(B) instead of section (8).

RESPONSE AND EXPLANATION OF CHANGE: The proposed rule has been amended to correctly reference section (8).

20 CSR 2220-2.675 Standards of Operation/Licensure for Class L Veterinary Pharmacies

(9) Labeling. Prescriptions must be labeled as required by section 338.059, RSMo. Prescription labels may be manually written and numbered and shall include:

(10) Records. Class L pharmacy records shall be maintained as required by Chapter 338, RSMo, and the rules of the board, including, 20 CSR 2220-2.018 and 20 CSR 2220-2.080.

(C) The pharmacy's prescription records shall identify any prescription dispensed in a pharmacist's absence pursuant to section (8) of this rule.