Comprehensive Healthcare Compliance Program
I. Introduction
ARS Pharmaceuticals, Inc. (ARS Pharma) is committed to conducting its business in compliance with all applicable Healthcare laws, rules, and regulations and the highest standards of ethical conduct. To this end, we have established and will maintain a Comprehensive Healthcare Compliance Program (“Compliance Program”) in accordance with the OIG Compliance Program Guidance for Pharmaceutical Manufacturers (the “OIG Guidance”) published by the Office of Inspector General, U.S. Department of Health and Human Services. Our Healthcare Compliance Program is a key component of our commitment to adhering to the highest standards of corporate responsibility and fostering a culture of compliance that places a premium on doing business with integrity.
The purpose of our Healthcare Compliance Program is to (1) prevent, detect, and remediate violations of laws, rules, regulations, as well as ARS Pharma policies and procedures and (2) promote a culture of the highest ethics within the organization. It is ARS Pharma’s expectation that employees will comply with our Code of Business Conduct and Ethics and the policies and procedures established in support of such Code. As the OIG Guidance recognizes, however, the implementation of a Healthcare Compliance Program cannot guarantee the elimination of improper employee conduct.
ARS Pharma has described below the fundamental elements of our Healthcare Compliance Program. As recognized in the OIG Guidance, we have tailored our Compliance Program to fit the unique environment of our company. Moreover, our Healthcare Compliance Program is dynamic and we regularly review and enhance our Compliance Program to meet our evolving compliance needs.
You may obtain a copy of this Healthcare Compliance Program description by calling 1-877-652-3148.
II. Overview of Compliance Program
Leadership and Structure
Healthcare Compliance Officer. ARS Pharma has appointed a Healthcare Compliance Officer who is charged with developing, implementing, and monitoring the Compliance Program. We will ensure that the Compliance Officer has the ability to exercise independent judgment and effectuate change within the organization as needed. The Healthcare Compliance Officer reports to the President and Chief Executive officer of ARS Pharma, is a member of ARS Pharma’s Executive Committee, and has direct access to the ARS Pharma Board of Directors.
Healthcare Compliance Committee. ARS Pharma has established a Healthcare Compliance Committee made up of ARS Pharma senior management. The role of the Healthcare Compliance Committee is to advise and assist the Healthcare Compliance Officer in the development, implementation, and ongoing oversight of the Healthcare Compliance Program. The Compliance Committee meets on a regular basis to identify and manage areas of risk and areas of critical focus for the Compliance Program.
Written Standards
ARS Pharma has established policies and procedures, including our Code of Business Conduct and Ethics, which articulates our fundamental principles and values and provides a framework for ethical conduct within our organization. The Code of Business Conduct and Ethics establishes our expectation that management, employees, and agents of ARS Pharma act in accordance with all applicable laws, rules, regulations, and ARS Pharma policies and procedures, as well as the highest standards of ethics.
ARS Pharma has established an annual spending limit for certain promotional activities directed toward healthcare professionals who prescribe or may influence prescribing in California. At the present time our annual spending limit is $2,500. Examples of items that fall within this spending limit are occasional modest meals in connection with informational presentations and educational items. This annual spending limit does not include payments to healthcare professionals for bona fide consulting or other services.
It is ARS Pharma’s policy to not provide any item of value to any healthcare professional with the intent of influencing that healthcare professional’s prescribing habits.
Education and Training
A crucial element of our Healthcare Compliance Program is the education and training of our employees on their legal and ethical obligations under applicable laws, rules, regulations, and company policies and procedures. ARS Pharma regularly communicates our policies and procedures to ensure a thorough understanding of the company’s expectations and regularly reviews and updates these training programs.
Internal Lines of Communication
ARS Pharma actively fosters dialogue between management and employees. Our goal is that all employees should know to whom to turn when seeking answers to questions or reporting possible violations of company policies or procedures, and understand that they can make such reports without fear of retaliation. To that end, we have adopted an open-door policy, as well as confidentiality and non-retaliation policies. We have a confidential, toll-free hotline to which individuals may anonymously report any concerns or suspected violations of applicable laws, rules, regulations, or ARS Pharma policies or procedures.
Auditing and Monitoring
ARS Pharma’s Healthcare Compliance Program includes monitoring and auditing to evaluate adherence to ARS Pharma’s policies and procedures. We note that, in accordance with the OIG Guidance, the nature, extent, and frequency of our compliance monitoring and auditing may vary according to new regulatory requirements, changes in business practices, and other considerations.
Responding to Potential Violations
When ARS Pharma becomes aware of potential violations of applicable laws, rules, or regulations or company policies or procedures, the company will promptly investigate such matters and make a determination as to whether the facts substantiate the existence of a violation. ARS Pharma will document the conduct of such investigations.
Disciplinary and Corrective Action
While each substantiated violation will be considered on a case-by-case basis, where appropriate we will utilize disciplinary action consistent with company policy to address violative conduct and to deter future violations. We will also work to determine the root cause of the violation and assess whether the violation is due to gaps in company policies or procedures and take appropriate corrective action designed to prevent future violations.
III. State Compliance Program Declarations
ARS Pharmaceutical Operations, Inc. (“Company”) has adopted and maintains compliance programs designed to promote ethical conduct and compliance with applicable federal and state laws, regulations, and industry standards governing interactions with health care professionals and other stakeholders.
The following state-specific declarations are provided to satisfy applicable state law requirements. Each declaration reflects the Company’s good-faith assessment of compliance as of the applicable effective date and is reviewed and updated on an annual basis.
California Compliance Program Declaration
Effective Date: July 1, 2026
The Company has adopted and maintains a Comprehensive Compliance Program (“CCP”) in accordance with California Health & Safety Code §§ 119400–119402, the U.S. Department of Health and Human Services Office of Inspector General’s Compliance Program Guidance for Pharmaceutical Manufacturers, and the PhRMA Code on Interactions with Health Care Professionals.
The CCP is designed to prevent, detect, and address potential violations of applicable laws and to ensure that the Company conducts business in an ethical, transparent, and compliant manner.
Oversight of the CCP is the responsibility of the Company’s Chief Compliance Officer, who has access to senior management and, where appropriate, the Board of Directors. The Chief Compliance Officer is supported by a cross-functional Healthcare Compliance Committee to ensure that compliance responsibilities are integrated throughout the organization and that the CCP is periodically reviewed and updated.
The CCP includes written policies and procedures governing interactions with health care professionals, government officials, patients, and third parties; compliance training for employees; and mechanisms for confidential reporting of compliance concerns without fear of retaliation.
As required by California law, the Company has established an annual aggregate dollar limit on expenditures for California health care professionals, excluding categories of activity permitted by law, including the provision of drug samples, financial support for continuing medical education, scholarships, and payments for bona fide professional services provided at fair market value.
The CCP incorporates monitoring, auditing, and risk assessment processes proportionate to the size and scope of the Company’s operations.
To the best of the Company’s knowledge and based on a good-faith understanding of the statutory requirements, the Company declares that it is in compliance with its Comprehensive Compliance Program and California Health & Safety Code § 119402 as of the Effective Date above.
Nevada Compliance Program Declaration
Effective Date: July 1, 2026
The Company has adopted and maintains a corporate compliance program in accordance with Nevada Revised Statutes § 639.570, the U.S. Department of Health and Human Services Office of Inspector General’s Compliance Program Guidance for Pharmaceutical Manufacturers, and the PhRMA Code on Interactions with Health Care Professionals.
The compliance program is designed to promote ethical conduct, support appropriate interactions with health care professionals, and ensure compliance with applicable federal and state laws.
The compliance program is overseen by the Company’s Chief Compliance Officer with access to senior management and includes written standards, training for employees, internal reporting mechanisms, and monitoring activities appropriate to the nature and scope of the Company’s business.
To the best of the Company’s knowledge and based on a good-faith assessment, the Company declares that it maintains an effective compliance program and is in compliance with Nevada Revised Statutes § 639.570 as of the Effective Date above.
Massachusetts Compliance Program Declaration
Effective Date: July 1, 2026
The Company has adopted and implemented a compliance program in accordance with Massachusetts regulations at 105 CMR 970.000, the U.S. Department of Health and Human Services Office of Inspector General’s Compliance Program Guidance for Pharmaceutical Manufacturers, and the PhRMA Code on Interactions with Health Care Professionals.
The compliance program is reasonably designed to prevent and detect violations of applicable laws and regulations governing interactions with health care practitioners and includes written policies and procedures, compliance training for employees, monitoring and auditing activities, and mechanisms for reporting potential compliance concerns.
The compliance program is overseen by the Company’s Chief Compliance Officer, who is responsible for implementation and ongoing evaluation of the program’s effectiveness.
To the best of the Company’s knowledge and belief, the Company certifies that it has adopted and implemented a compliance program consistent with the requirements of 105 CMR 970.000 and is in compliance with such requirements as of the Effective Date above.
Annual Review and Availability
These declarations are publicly available and are reviewed and updated at least annually, or more frequently as required by applicable law.
Additional information regarding the Company’s compliance program, or to request a copy of the Company’s Comprehensive Compliance Program or annual declaration, may be obtained by calling 877-652-3148.