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340B Contract Pharmacy Arrangements: Structuring Arrangements, Meeting Legal and Regulatory Requirements

Recording of a 90-minute CLE video webinar with Q&A

This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

Conducted on Tuesday, March 14, 2023

Recorded event now available

or call 1-800-926-7926

This CLE course will provide guidance to healthcare counsel on contract pharmacy arrangements and the key legal and regulatory considerations for structuring and documenting the arrangements in an uncertain regulatory environment.


Certain drug companies have recently begun taking steps to curb the use of contract pharmacies under the federal 340B drug pricing program, and HRSA has taken enforcement action against manufacturers that is the subject of federal litigation. Nevertheless, the use of contract pharmacy arrangements continues to be a key part of the 340B program.

To properly structure and document these arrangements, counsel must have a detailed understanding of the legal, business, and payor issues in contract pharmacy arrangements.

In the evolving landscape, it is important for counsel to stay abreast of new developments.

Listen as our authoritative panel of healthcare attorneys examines contract pharmacy arrangements and the key legal and regulatory concerns when structuring and documenting the arrangements.



  1. Recent 340B developments: What is the going forward impact on 340B contract pharmacy arrangements?
  2. Structuring and implementing contract pharmacy arrangements
    1. HRSA essential compliance elements
    2. Fee structures
    3. Discounts for uninsured patients
    4. Reconciliation (including DIR Fees)
  3. 340B entity compliance issues
    1. Prohibition against diversion
    2. Prohibition against duplicate discounts
    3. Inventory management issues
  4. HRSA audit enforcement, and litigation


The panel will review these and other key issues:

  • What compliance challenges must be overcome when structuring a contract pharmacy arrangement?
  • What does the future compliance landscape for contract pharmacy arrangements look like?
  • What operational and contractual considerations should counsel keep in mind when structuring and implementing these arrangements?


Davis, Jeffrey
Jeffrey I. Davis

Bass Berry & Sims

Mr. Davis advises healthcare organizations on Medicare and Medicaid billing and reimbursement issues, with a special...  |  Read More

Dresser, Jesse
Jesse C. Dresser

Frier Levitt

Mr. Dresser heads the firm’s Pharmacy Practice Group. In this role, his practice is dedicated to representing a...  |  Read More

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