in-20251105-IR-856250236FRA: PHARMACY TECHNICIAN VACCINATIONS

TITLE 856 INDIANA BOARD OF PHARMACY Final Rule LSA Document #25-236 DIGEST PHARMACY TECHNICIAN VACCINATIONS Adds 856 IAC 4-2-1 to define terms used in the rule. Adds 856 IAC 4-2-2 concerning who may supervise a pharmacy technician administering immunizations. Adds 856 IAC 4-2-3 to establish that pharmacy technicians administering immunizations is a voluntary service. Adds 856 IAC 4-2-4 concerning guidance for the education and training required for a pharmacy technician to administer immunizations. Adds 856 IAC 4-2-5 concerning the duty and process for reporting adverse events. Effective 30 days after filing with the publisher. HISTORY Notice of First Public Comment Period: 20250521-IR-856250236FNA Regulatory Analysis submitted with Notice of First Public Comment Period: 20250521-IR-856250236RAA 60 Day Requirement: 20250528-IR-856250236ARA Date of First Hearing: July 14, 2025 Notice of Second Public Comment Period: 20250806-IR-856250236SNA Date of Second Hearing: September 8, 2025 CITATIONS AFFECTED: 856 IAC 4-2 SUMMARY/RESPONSE TO COMMENTS The Indiana Board of Pharmacy (board) requested public comment from May 21, 2025, through June 20, 2025, from August 6, 2025, through September 5, 2025, and during the public hearings on July 14, 2025, and September 8, 2025. One written comment was received during the first public comment period, and no comments were made during the public hearings. The comment received and the board’s response to the comment is summarized as follows: Comment: The proposed rule states that “direct supervision” has the meaning set forth in IC 25-26-16-4.5.  Reference to this particular code section is problematic because it does not include supervision by a pharmacist (supervision instead by a physician, APRN or physician assistant), but more importantly, this citation is meant for supervision of non-hospital pharmacists implementing a drug protocol.  Instead of citing to this section, that the definition of “direct supervision” be changed to: “’Direct supervision’ means that a physician, pharmacist, physician assistant, or advanced practice registered nurse is readily available to consult with the pharmacy technician while an immunization is being administered.” This proposed change preserves the intent of the proposed rule, while being more directly to immunization administration, and eliminates the need for future rulemaking in the event the legislature changes the definition of “direct supervision” as it relates to non-hospital pharmacists implementing drug protocols. Response: The board voted to amend the language in the proposed rule in accordance with the above comment. FINAL RULE Sec. 1. The following definitions apply throughout this rule: Sec. 2. A pharmacy technician who administers an immunization to an individual or individuals shall be under the direct supervision of: during administration of the immunization. Sec. 3. (a) A pharmacy technician may not be required to: if the pharmacy technician chooses not to administer any immunization. (b) If a pharmacy technician chooses not to administer any immunization, the pharmacy technician is not required to complete the accredited training program to maintain a license to practice as a pharmacy technician. Sec. 4. (a) Before administering an immunization, a pharmacy technician shall successfully complete a training program in administering immunizations. Training programs must be approved by the Accreditation Council for Pharmacy Education or board approved training programs by pharmacy organizations or colleges of pharmacy. The training must at least include instruction on: (b) Pharmacy technicians administering immunizations must maintain certification in cardiopulmonary resuscitation. (c) A pharmacy technician holding an immunization certification is responsible for keeping all training, including basic life support and Occupational Safety and Health Administration training, up to date and complete. (d) The pharmacy is responsible and shall maintain documentation of the immunization training completed by pharmacy technicians. (e) The supervisory pharmacist is responsible for assessing the appropriateness of an immunization before administration and conducting necessary counseling. (f) A program seeking to become a board approved training program shall submit the following to the board: Sec. 5. A pharmacy technician shall report adverse events of an immunization to the supervising pharmacist immediately after the technician knows an adverse event has occurred. LSA Document #25-236 Notice of First Public Comment Period: May 21, 2025 Approved by Attorney General: October 1, 2025 Approved by Governor: October 2, 2025 Filed with Publisher: October 7, 2025, 1:31 p.m. Documents Incorporated by Reference: None Received by Publisher Small Business Regulatory Coordinator: Elizabeth Walker, Small Business Regulatory Coordinator, Indiana Professional Licensing Agency, 402 West Washington Street, Room W072, Indianapolis, IN 46204, (317) 234-2912, elwalker@pla.in.gov