Compliance

Pinnacle Biologics’ mission is to serve our patients and their families, to commit to the highest legal and ethical standards in everything we do and to always do the right thing. Accordingly, Pinnacle demands both of itself and its employees a commitment to full compliance with all applicable international, federal, state and local laws, as well as all applicable industry and ethical standards, including, but not limited to, the Pharmaceutical Research and Manufacturers of America (PhRMA) Voluntary Code on interactions with healthcare professionals. In furtherance of this commitment, Pinnacle has, among other things, adopted a Compliance Program designed to

  • Establish a company environment where full compliance with all applicable laws and industry and ethical standards is demanded, embraced and attained
  • Prevent, detect and correct violations of law and company policy and procedures
  • Assure the establishment of compliance-related company policies and procedures
  • Assure development of training and other programs designed to educate company employees regarding applicable policies, procedures and standards
  • Regularly assess, audit and monitor compliance with such policies, procedures and standards
  • Encourage and ensure internal reporting of misconduct or questionable or inappropriate activities to enable timely investigation and resolution
  • Assure appropriate corrective action is taken to prevent recurrence of misconduct or other inappropriate activities
  • Regularly assess, audit, monitor and improve the effectiveness of company compliance efforts

As part of Pinnacle Biologics’s continuing commitment to corporate compliance, Pinnacle declares that, to the best of its knowledge, and based on a good faith understanding of the statutory requirements of California Health and Safety Code 119400 and 119402, it has adopted a Comprehensive Compliance Program as mandated by this California law. To the best of our knowledge, as of August 31, 2020, Pinnacle believes that it is in compliance with its Comprehensive Compliance Program and its good faith understanding of the requirements of California Health and Safety Code 119400 and 119402.

Additionally, to comply with California law, Pinnacle has established a maximum annual aggregate dollar limit of $2,700 for gifts, promotional materials or activities provided to California health care professionals. This dollar limit represents a spending cap, not a goal or average, and typically the amount spent per physician is anticipated to be substantially less than this maximum amount.

For questions about our Comprehensive Compliance Program or to obtain a copy, please contact us at 773-312-3723.