Automated Filling Systems

PURPOSE: This rule establishes standards for automated filling systems. (1) Definitions. The following definitions shall be applicable for purposes of this rule: (A) “Automated filling system”—An automated system used by a pharmacy to assist in filling a prescription drug order by selecting, labeling, filling, or sealing medication for dispensing. An “automated filling system” shall not include automated devices used solely to count medication, vacuum tube drug delivery systems governed by 20 CSR 2220-2.800, or automated dispensing and storage systems governed by 20 CSR 22202.900 used to dispense medication directly to a patient or to an authorized health care practitioner for immediate distribution or administration to the patient; (B) “Electronic verification system”—An electronic verification, bar code verification, weight verification, radio frequency identification (RFID), or similar electronic process or system that accurately verifies medication has been properly dispensed and labeled by, or loaded into, an automated filling system; (C) “Manufacturer unit of use package”—A drug dispensed in the manufacturer’s original and sealed packaging, or in the original and sealed packaging of a repackager, without additional manipulation or preparation by the pharmacy, except for application of the pharmacy label; (D) “Repackager”—A repackager registered with the United States Food and Drug Administration; and (E) “Repacked”—Any drug that has been removed from the original packaging of the manufacturer or a repackager’s packaging and is placed in a container for use in an automated filling system. (2) Medication Stocking. Automated filling systems (hereinafter “system”) may be stocked or loaded by a pharmacist or by an intern pharmacist or pharmacy technician under the direct supervision of a pharmacist. Pharmacy repacked medication, cartridges, or containers shall comply with 20 CSR 2220-2.130. (3) Verification. Except as provided herein, a licensed pharmacist shall inspect and verify the accuracy of the final contents of any medication filled or packaged by an automated filling system, and any label affixed thereto, prior to dispensing, as required by 20 CSR 2220-2.010(1)(B). (4) The pharmacist verification requirements of section (3) shall be deemed satisfied if— (A) The pharmacy establishes and follows a policy and procedure manual that complies with section (5) of this rule; (B) The filling process is fully automated from the time the filling process is initiated until a completed, labeled, and sealed prescription is produced by the automated filling system that is ready for dispensing to the patient. No manual intervention with the medication or prescription may occur after the medication is loaded into the automated filling system. For purposes of this section, manual intervention shall not include preparing a finished prescription for mailing, delivery, or storage; (C) A pharmacist verifies the accuracy of the prescription information used by or entered into the automatic filling system for a specific patient prior to initiation of the automatic fill process. The name, initials, or identification code(s) of the verifying pharmacist shall be recorded in the pharmacy’s records and maintained for five (5) years after dispensing; (D) A pharmacist verifies the correct medication, repacked container, or manufacturer unit of use package was properly stocked, filled, and loaded in the automated filling system prior to initiating the fill process. Alternatively, an electronic verification system may be used for verification of manufacturer unit of use packages or repacked medication previously AND INSURANCE verified by a pharmacist; (E) The medication to be dispensed is filled, labeled, and sealed in the prescription container by the automated filling system or dispensed by the system in a manufacturer’s unit of use package or a repacked pharmacy container; (F) An electronic verification system is used to verify the proper prescription label has been affixed to the correct medication, repackaged container, or manufacturer unit of use package for the correct patient; and (G) Daily random quality testing is conducted by a pharmacist on a sample size of prescriptions filled by the automated filling system. The required sample size shall not be less than two percent (2%) of the prescriptions filled by the automated system on the date tested or two percent (2%) of the prescriptions filled by the automated system on the last day of system operation, as designated in writing by the pharmacist-in-charge. Proof of compliance with this subsection and random quality testing date(s) and results shall be documented and maintained in the pharmacy’s records. (5) Policies and Procedures. Pharmacies verifying prescriptions pursuant to section (4) of this rule shall establish and follow written policies and procedures to ensure the proper, safe, and secure functioning of the system. Policies and procedures shall be reviewed annually by the pharmacist-in-charge and shall be maintained in the pharmacy’s records for a minimum of two (2) years. The required annual review shall be documented in the pharmacy’s records and made available upon request. At a minimum, the pharmacy shall establish and follow policies and procedures for— (A) Maintaining the automated filling system and any accompanying electronic verification system in good working order; (B) Ensuring accurate filling, loading, and stocking of the system; (C) Ensuring sanitary operations of the system and preventing cross-contamination of cells, cartridges, containers, cassettes, or packages; (D) Reporting, investigating, and addressing filling errors and system malfunctions; (E) Testing the accuracy of the automated filling system and any accompanying electronic verification system. At a minimum, the automated filling system and electronic verification system shall be tested before the first use of the system or restarting the system and upon any modification to the automated filling system or electronic verification system that changes or alters the filling or electronic verification process; (F) Training persons authorized to access, stock, restock, or load the automated filling system in equipment use and operations; (G) Tracking and documenting prescription errors related to the automated filling system that are not corrected prior to dispensing to the patient. Such documentation shall be maintained for two (2) years and produced to the board upon request; (H) Conducting routine and preventive maintenance and, if applicable, calibration; (I) Removing expired, adulterated, misbranded, or recalled drugs; (J) Preventing unauthorized access to the system, including, assigning, discontinuing, or changing security access; (K) Identifying and recording persons responsible for stocking, loading, and filling the system; (L) Ensuring compliance with state and federal law, including, all applicable labeling, storage, and security requirements; and (M) Maintaining an ongoing quality assurance program that monitors performance of the automatic fill system and any electronic verification system to ensure proper and accurate functioning. (6) Recordkeeping. Except as otherwise provided herein, records required by this rule shall be maintained in the pharmacy’s records electronically or in writing for a minimum of two (2) years. When the verification requirements of subsection (4)(D) of this rule are completed by a pharmacist, the name, initials, or identification code(s) of the verifying pharmacist shall be recorded in the pharmacy’s records and maintained for five (5) years after dispensing. Records shall be made available for inspection and produced to the board or the board’s authorized designee upon request. AUTHORITY: sections 338.250 and 338.280, RSMo 2000, and sections 338.140 and 338.210.4, RSMo Supp. 2013.* Original rule filed July 1, 2013, effective Jan. 30, 2014. *Original authority: 338.140, RSMo 1939, amended 1989, 1997, 2011; 338.210, RSMo 1951, amended 2001, 2011; 338.250, RSMo 1951, amended 1990, 1998; and 338.280, RSMo 1951, amended 1971, 1981.