340B Compliance–Who is the Authorizing Official?

When completing the 340B registration forms, a healthcare organization will need to determine who its authorizing official is.  An authorizing official is one who signs the Registration Form.  Sounds easy, right?  It can be, but with certain entities, the answer may not be so obvious.  If OPA (Office of Pharmacy Affairs) determines that the signor is NOT an acceptable authorizing official, then the forms will not be processed.  This can be important for two reasons:

1.  There are quarterly deadlines for applying for 340B eligibility.  If a deadline is missed, then an organization may have to wait several months for acceptance into the program.

2.  Money.  The longer it takes the paperwork to be processed, the longer it takes the organization to become eligible for discounted pharmaceuticals.

For access to the OPA’s website and 340B registration forms, go here.

Who is the Authorizing Official?

Well, it depends on the type of healthcare organization that is applying.  Here’s a (non-exhaustive) list that is based on OPA’s website:

  • For STD and TB applicants, the Authorizing Official is the director of the State or City health department administering the respective STD or TB grant in your geographic area.
  • For Family Planning (FP) applicants, the Authorizing Official is a responsible representative of the funded grantee.
  • For hospitals, the Authorizing Official must be a senior managing official who can sign on behalf of an organization such as the CEO or CFO.
  • For Contract Pharmacies, the form must be signed by a responsible representative of each organization and submitted to OPA.  For the covered entity, the responsible representative may be the President, Chief Executive Officer, Chief Operating Officer, Chief Financial Officer, or Program Director.  For the pharmacy, the responsible representative may be the Owner, the President, Chief Executive Officer, Chief Operative Officer, or Chief Financial Officer.

(Disclaimer: This post is not intended as legal advice nor does it create an attorney-client relationship.  If you have questions regarding 340B compliance, please consult an attorney.)

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