AUCTA COMPLIANCE STATEMENT
Aucta Pharmaceuticals is an emerging drug product development company focusing on new products and technology platform-based niche generics. We focus on developing enhanced products for patients with a therapeutic focus on CNS disorders, as well as Ophthalmics, and Inhalation therapies.
California Compliance Declaration
Aucta Pharmaceuticals will conduct their activities in accordance with all applicable laws and regulations and is committed to establishing a corporate culture of compliance.Aucta has established Compliance Policies that are consistent with the requirements of California Health and Safety Code sections 119400 and 119402, (“California Compliance Law"). This program has been developed in accordance with the laws applicable to the biopharmaceutical industry, the Compliance Program Guidance for Pharmaceutical Manufacturers published by the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services in April 2003 & the General Compliance Program as updated in November 2023, and the PhRMA Code on Interactions with Health Care Professionals as updated in January 2022.
As required by California Health and Safety Code section 119402, with specific reference to the provision of gifts, promotional material, or items or activities that a pharmaceutical company may provide to an individual medical or healthcare professional, Aucta has established an aggregate, annual dollar limit of $2,500 on promotional items and/or meals directed to an individual medical or health care professional who resides or practices in California.The dollar limit is a maximum only.
The annual limits do not include the following:
·Drug samples provided to physicians and healthcare professionals
·Financial support for continuing medical education forums
·Financial support for health educational scholarships
·Payments for legitimate professional services, and any meals or expenses associated with the provision of such services
·ltems of nominal value with a retail value of less than $10 (e.g., visual aids, reprints of medical journal articles)
·Patient educational materials provided to patients by their physician with the purpose of educating the patient or enhancing the patient's understanding or management of the condition
Aucta declares that, to the best of our knowledge, and based on our good faith understanding of the statutory requirements of the California Health & Safety Code sections 119400 and119402, we are following our Compliance Policies.We also declare that the structure of our Compliance Policies will incorporate the principles articulated in the Compliance Program
Guidance for Pharmaceutical Manufacturers published by the Office of the Inspector General of the United States Department of Health and Human Services in April 2003 & the General Compliance Program as updated in November 2023, and the Code on Interactions with Healthcare Professionals as updated in January 2022 adopted by the Pharmaceutical Research and Manufacturers of America.
The company's Compliance Policies require Aucta employees to comply with all applicable laws and regulations, as well as company policies and procedures. Aucta is committed to achieving the highest standards of integrity and complying with applicable legal and regulatory requirements. The company's Compliance Policies serve as a guide for all Aucta employees to maintain those standards.
Any questions or comments regarding the company's business practices should be directed to Aucta Compliance at compliance@auctapharma.com or by telephone at 888-671-4730.
© 2024 Aucta Pharmaceuticals, Inc. Feb 2024, 033-7000