in-20260422-IR-856250798FRA: HORMONAL CONTRACEPTIVES

TITLE 856 INDIANA BOARD OF PHARMACY Final Rule LSA Document #25-798 DIGEST HORMONAL CONTRACEPTIVES Adds rules at 856 IAC 1-43 regarding pharmacists prescribing hormonal contraceptives. Effective 30 days after filing with the publisher. HISTORY 60 Day Requirement: 20251224-IR-856250798ARA Notice of First Public Comment Period: 20260107-IR-856250798FNA Regulatory Analysis submitted with Notice of First Public Comment Period: 20260107-IR-856250798RAA Date of First Hearing: February 9, 2026 CITATION AFFECTED: 856 IAC 1-43 SUMMARY/RESPONSE TO COMMENTS The Indiana Board of Pharmacy (board) requested public comment from January 7, 2026, through February 6, 2026, and during the public hearing on February 9, 2026. The board received no comments in response to the Notice of First Public Comment Period. There was one public comment at the public hearing, but it was not substantive. The commenter at the public hearing was Veronica Vernon, speaking on behalf of the Indiana Pharmacy Association. The purpose of her comment was to indicate that the Indiana Pharmacy Association supports the rule. She did not make any additional comments. After the conclusion of the public hearing, the board voted to adopt the proposed rule. FINAL RULE 856 IAC 1-43-1 Scope 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. 856 IAC 1-43-2 Applicability Sec. 2. The definitions in IC 25-26-13 and IC 25-26-25 apply throughout this rule. 856 IAC 1-43-3 “Hormonal contraception” defined 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. 856 IAC 1-43-4 "Practitioner" defined Sec. 4. For purposes of this rule, "practitioner" means a physician, an advanced practice nurse, or a physician assistant. 856 IAC 1-43-5 Provider qualifications 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). 856 IAC 1-43-6 Prescribing and dispensing hormonal contraceptives 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. 856 IAC 1-43-7 Procedures 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: 856 IAC 1-43-8 Patient records 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. 856 IAC 1-43-9 Counseling required 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. LSA Document #25-798 Notice of First Public Comment Period: January 7, 2026 Last Hearing Held: February 9, 2026 Approved by Attorney General: March 23, 2026 Approved by Governor: March 26, 2026 Filed with Publisher: March 26, 2026, 3:03 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