in-20260107-IR-856250798FNA: The Indiana Board of Pharmacy (board) is soliciting public comment on adding rules at 856 IAC 1-43 concerning hormonal contraceptives. The board seeks comment on the affected citations listed and any other provisions of Title 856 that may be affected by this rulemaking.

TITLE 856 INDIANA BOARD OF PHARMACY Notice of First Public Comment Period LSA Document #25-798 HORMONAL CONTRACEPTIVES PURPOSE OF NOTICE The Indiana Board of Pharmacy (board) is soliciting public comment on adding rules at 856 IAC 1-43 concerning hormonal contraceptives. The board seeks comment on the affected citations listed and any other provisions of Title 856 that may be affected by this rulemaking. ADDITIONAL DOCUMENTS Regulatory Analysis: 20260107-IR-856250798RAA Notice of Public Hearing: 20260107-IR-856250798PHA CITATIONS AFFECTED: 856 IAC 1-43 AUTHORITY: IC 25-26-13-4; IC 25-26-25-6 OVERVIEW Basic Purpose and Background This rulemaking establishes provider qualifications and provides procedures regarding pharmacists prescribing and dispensing self-administered hormonal contraceptives to individuals at least eighteen (18) years of age under IC 25-26-25-6. For purposes of IC 4-22-2-28.1, small businesses affected by this rulemaking may contact the Small Business Regulatory Coordinator: For purposes of IC 4-22-2-28.1, the Small Business Ombudsman designated by IC 5-28-17-6 is: Resources available to regulated entities through the small business ombudsman include the ombudsman's duties stated in IC 5-28-17-6, specifically IC 5-28-17-6(9), investigating and attempting to resolve any matter regarding compliance by a small business with a law, rule, or policy administered by a state agency, either as a party to a proceeding or as a mediator. REQUEST FOR PUBLIC COMMENT The board is soliciting public comment on the proposed rule. Comments may be submitted in one of the following ways: COMMENT PERIOD DEADLINE All comments must be postmarked or time stamped not later than February 6, 2026. The rule, Regulatory Analysis, appendices referenced in the Regulatory Analysis, and materials incorporated by reference (if applicable) are on file at the Indiana Professional Licensing Agency, 402 West Washington Street, Room W072, Indianapolis, Indiana and are available for public inspection. Copies of the rule, Regulatory Analysis, and appendices referenced in the Regulatory Analysis are available at the Indiana Professional Licensing Agency office. If the board does not receive substantive comments during the public comment period or public hearing, the rule may be adopted with text that is the same as or does not substantially differ from the text of the proposed rule published in this notice. PROPOSED RULE Sec. 1. The purpose of this rule is to adopt the state health commissioner's standing order under IC 25-26-25-5 for qualified pharmacists prescribing and dispensing hormonal contraceptives. Sec. 2. The definitions in IC 25-26-13 and IC 25-26-25 apply throughout this rule. Sec. 3. (a) For purposes of this rule, "hormonal contraception" includes a hormonal contraceptive patch as defined in IC 25-26-25-2, and a self-administered hormonal contraceptive as defined in IC 25-26-25-3. (b) This term excludes a drug, substance, or device that contains a progesterone receptor antagonist. Sec. 4. For purposes of this rule, "practitioner" means a physician, an advanced practice nurse, or a physician assistant. Sec. 5. (a) To prescribe or dispense hormonal contraceptives, a pharmacist shall: (b) A pharmacist who graduated from an Indiana school of pharmacy after May 1, 2023, and completed a training for prescribing contraceptives as part of the pharmacist's formal educational program is exempt from subsection (a)(2). Sec. 6. (a) A qualified pharmacist may prescribe and dispense hormonal contraception to a patient described in IC 25-26-25-4. (b) The pharmacist may prescribe and dispense a self-administered hormonal contraceptive for a period not to exceed the statutory maximum set in IC 25-26-25-5(c)(7). A second six (6) month supply may be prescribed if the patient is reassessed. (c) The pharmacist may not continue to dispense a self-administered hormonal contraceptive to a patient for more than the statutory maximum set in IC 25-26-25-5(c)(7) unless the statutory exception applies. Sec. 7. When a patient requests a medication for contraception or a pharmacist, in their professional judgment, decides to ask about pregnancy prevention and offers to initiate contraception counseling and treatment, the pharmacist shall complete the following steps: Sec. 8. (a) A pharmacist shall provide a written record of the contraceptive prescribed and advise the patient to consult with a primary care or women's health care practitioner. This record may be an electronic or a paper copy. (b) Documentation of the assessment and plan of a patient shall be maintained in the records for seven (7) years under IC 16-39-7-1. (c) A copy shall be made available to the patient or patient's practitioner, or both, on request. Sec. 9. (a) Once the appropriate self-administered hormonal contraceptive has been determined, the pharmacist shall offer to provide the patient counseling about the therapy. Counseling may include, but is not limited to, the following: (b) A patient experiencing side effects should be referred to a primary care or women's health practitioner for further evaluation and treatment.