Compliance2019-06-05T09:27:33+00:00

Annual Declaration of Compliance

Romark, L.C. Comprehensive Compliance Program & California Law

 

NOTICE: This information is provided pursuant to the requirements of California Health & Safety Code, §§ 119400 119402 (“California Compliance Law”), which requires pharmaceutical companies doing business in California to set an annual aggregate dollar limit on gifts or incentives that Romark may provide to a medical or healthcare professional in California.

 

As part of its comprehensive compliance program (CCP), Romark has set an annual aggregate dollar limit on gifts, promotional materials, items and activities provided to healthcare professionals at $2,500.00 per covered healthcare professional. This limit, may be revised by Romark from time to time in its sole discretion, in which case the revised limit will be published in this section of Romark’s website. This limit represents an expenditure cap and not a goal or an average expenditure amount; in many cases, the amount spent per physician may be substantially less than the cap amount. Romark has established an internal monitoring system designed to help ensure compliance with the annual spending limits in California and is working to establish additional monitoring processes.

 

Not included in this limit are drug samples given to healthcare professionals intended for free distribution to patients, financial support for continuing medical education forums, financial support for health educational scholarships, or payments made at fair market value for legitimate professional services provided by healthcare professionals.

 

As of May 14, 2019, to the best of our knowledge, and based upon our good faith interpretation of the requirements of California Compliance Law, Romark is in substantial compliance with the requirements of these provisions and with our CCP.

 

As recognized by the Office of Inspector General (OIG) Compliance Guidance, even an effective compliance program cannot eliminate the possibility that one or more individual employees engage in conduct that would be considered improper. Accordingly, this declaration is not intended and should not be construed to imply that the Company has not identified any individual instances in which an employee has or may have violated one or more provisions of its Compliance Program. In such situations, the Company takes reasonable and appropriate remedial or corrective action in a manner consistent with its Compliance Program.

 

Copies of Romark’s CCP and our Annual Declaration of Compliance can be obtained by calling (877) 925-4642.

 

Comprehensive Compliance Program California (CCP)

Annual Declaration of Compliance