Annual Description of Comprehensive Compliance Program (CCP)
Pursuant to California Health and Safety Codes §§ 119400-119402
A. Introduction
Our mission at Intra-Sana Laboratories LLC is to develop and successfully market innovative products to prevent and cure diseases, ease suffering and enhance the quality of life.
We are committed to maintaining the highest standards of ethical conduct and complying with all applicable laws, regulations, and codes.
On January 1, 2026, and in compliance with the annual declaration requirement under California Health and Safety Code §§119400 – 119402, Intra-Sana Laboratories LLC made its 2026 declaration for the twelve (12) month period covering January 1, 2025 through December 31, 2025.
Below is an overview of our CCP. As described by the OIG Guidance, this program was designed to fit our unique compliance needs. We continuously assess the effectiveness of our CCP to enable it to implement necessary adjustments or refinements.
B. Overview of CCP
1. Leadership and Structure
A. Compliance Officer– Intra-Sana Laboratories LLC has a Chief Compliance Officer who is charged with the responsibility for developing, operating, and monitoring the compliance program. The Chief Compliance Officer reports directly to the Chairman and Chief Executive Officer at Intra-Sana Laboratories LLC. Our Compliance Officer has the ability to effectuate change within the organization and to exercise independent judgment.
B. Compliance Committee– Intra-Sana Laboratories LLC has a Compliance Committee that advises the Chief Compliance Officer on compliance-related activities and issues for the purposes of assessing compliance risks, helping to prevent compliance violations from occurring and, ensuring appropriate responses to compliance violations that may occur.
The members of the Compliance Committee are high-level personnel from multiple business functions across the company.
2. Written Standards and Closing
Intra-Sana Laboratories LLC has developed and distributed written compliance policies, procedures, and practices that guide the company and the conduct of our employees in day-to-day commercial operations. These policies and procedures have been developed under the direction and supervision of our Compliance Officer, Compliance Committee, Legal Counsel, and management from various functional areas.
The Intra-Sana Laboratories LLC Code of Conduct is a written statement of ethical and compliance principles, policies, and procedures that all our management, employees, and contractors are expected to follow. The Code of Conduct was designed to provide guidance on how to fulfill requirements of the Company’s compliance program, resolve questions about the appropriateness of our conduct, and report possible violations of law or ethical principles. An employee’s obligations under the Code of Conduct include strict observance of all laws and regulations applicable to our Company (e.g., laws and regulations governing the Federal health care programs), ethical standards, and applicable Intra-Sana Laboratories LLC policies and procedures.
The OIG Guidance addresses several areas of potential risk for pharmaceutical manufacturers and suggests that companies develop compliance policies in these areas: data integrity pertaining to government reimbursement practices; kickbacks or other illegal remuneration; and distribution of drug samples. Intra-Sana Laboratories LLC has implemented written standards addressing each of these areas.
In addition, with respect to business activity in California, Intra-Sana Laboratories LLC has established “a specific annual dollar limit on educational items and promotional activities Intra-Sana Laboratories LLC may give or otherwise provide to an individual medical or healthcare professional.” This annual dollar limit is $2,500 and represents a maximum limit that takes into account a variety of factors, including our Company’s specific situation with our field force of representatives that present to medical or health professionals regarding a diverse portfolio or products as well as the capabilities of current information systems that capture promotional spend-related data.
Our relationships with healthcare professionals are intended to benefit patients and to enhance the practice of medicine. Informational presentations and discussions by Company representatives and others speaking on behalf of Intra-Sana Laboratories LLC provide valuable scientific and educational benefits. In connection with such presentations or discussions, Intra-Sana Laboratories LLC may offer occasional meals and items designed primarily for the education of patients and healthcare professionals in accordance with the PhRMA Code.
The current spend limit will be in effect for the period of January 1, 2026 through December 31, 2026. Intra-Sana Laboratories LLC will evaluate this limit on an annual basis and make any necessary adjustments consistent with any operational or practical issues related to complying with this new requirement as well as any new legislative requirements.
3. Education and Training
Intra-Sana Laboratories LLC educates and trains employees on the facets of our compliance program through programs developed and conducted by compliance and legal professionals. Our education and training covers a variety of laws and regulations that impact the way we conduct business. Our live and computer-based programs include, but are not limited to, meaningful discussion of the application and consequences of the False Claims Act, Anti-Kickback Statute, OIG Guidance, PhRMA Code, as well as other applicable federal, state, and industry rules and guidelines. Intra-Sana Laboratories LLC regularly reviews and updates its training programs and identified additional areas of training on an “as needed” basis.
4. Internal Lines of Communication
Intra-Sana Laboratories LLC is committed to fostering dialogue between management and employees. Our goal is that all employees, whether seeking answers to questions or reporting potential instances of fraud and abuse, will know who to turn to for a meaningful response and should be able to do so without fear of retribution. To that end, we have adopted open-door, confidentiality, and non-retaliation policies. As part of its commitment to ethical and legal behavior, Intra-Sana Laboratories LLC requires its employees to report any actual or suspected violations of law or ethical standards so that they can be appropriately investigated and addressed. Employees can raise their concerns in a number of ways including with an appropriate member of management or through our Human Resources Department.
5. Auditing and Monitoring
Our CCP includes activities to monitor, audit, and evaluate compliance with the Company’s policies and procedures. Our approach includes targeted monitoring and auditing based on identified and prioritized risk areas. In accordance with the OIG Guidance, the nature of our reviews as well as the extent and frequency of our compliance monitoring and auditing varies according to a variety of factors, including new regulatory requirements, changes in business practices, and other considerations.
6. Responding to Potential Violations
Adherence to the Code of Conduct is a condition of employment at Intra-Sana Laboratories LLC. Any violation of an employee’s obligations under the Code of Conduct can subject an employee to serious disciplinary measures, including possible termination of employment. Although each situation is considered on a case-by-case basis, Intra-Sana Laboratories LLC undertakes significant efforts to ensure consistent and appropriate disciplinary action is taken in response to violations.
7. Corrective Action Procedures
As part of our compliance program, Intra-Sana Laboratories LLC has established a comprehensive internal investigation and corrective action protocol to ensure that timely, complete, and objective investigations are conducted in response to allegations regarding the Intra-Sana Laboratories LLC Code of Conduct applicable policies. In accordance with the OIG Guidance, the exact nature and level or thoroughness of the internal investigation will vary according to the circumstances. Upon conclusion of an internal investigation, corrective action and preventative measures are determined and implemented as appropriate.
Intra-Sana Laboratories LLC is dedicated to the maintenance and ongoing assessment required of an effective compliance program. As changes are made to either the OIG Guidance or the PhRMA Code, the Intra-Sana Laboratories LLC CCP must be updated with corresponding modifications within six months.
This Description is effective as of January 1, 2026. Intra-Sana Laboratories LLC will assess its CCP at least annually, for the purpose of declaring compliance with California Health and Safety Codes §§ 119400-119402.
A copy of this Declaration may be obtained by calling Intra-Sana Laboratories LLC at phone number: (800) 217-7973 or email us at: info@intrasanalaboratories.com