Pharmacies and Drug Control


Pharmacies, pharmacists, and wholesale drug distributors face a complex web of state and federal licensing laws and regulations.

Our team’s deep understanding of the legal nuances can help you navigate commercial and federal healthcare program payor guidelines, laws and regulations pertaining to handling of controlled substances, and regulations for participation in the NPIA “own use” and 340B pricing programs. 

We can help you understand the requirements and comply with the following:

  • State board of pharmacy licensure and compliance
  • DEA registration requirements
  • DEA requirements for the purchase, sale, and custody of controlled substances
  • Robinson-Patman Act anti-price discrimination parameters
  • Nonprofit Institutions Act, or “own use” requirements
  • 340B Drug Pricing Program participation and compliance
  • Prescription Drug Marketing Act or PDMA requirements

Our service offerings typically include:

  • Advising institutional and retail pharmacies regarding state licensure, DEA registration, and ongoing compliance with state and federal pharmacy and drug control statutes and regulations.
  • Assisting pharmacies with the licensure, Medicare and Medicaid change of ownership issues that arise in mergers and sales of hospitals and other care entities.
  • Advising schools and universities in designing and obtaining advisory opinions from the FTC for their NPIA, “own use” discount drug employee benefit program.
  • Assisting health system clients regarding the appropriate use and transfer of prescription drugs to health system patients and among health system programs, regarding compliance with the Robinson-Patman Act, the NPIA, and the Prescription Drug Marketing Act.
  • Providing guidance to 340B covered entities on the appropriate use of 340B drugs in the context of sales to patients, drafted contract pharmacy agreements, and advised regarding general compliance with 340B program requirements.
  • Working with trade associations in drafting legislation to allow off-site pharmacy operations for licensed hospital pharmacies.
  • Advising physician practices on in-office dispensing programs for compliance with state and federal laws.

Latest News and Insights

Legal Alerts5.17.23

Rx-tension: Temporary Rule Extends Telemedicine Flexibilities for Controlled Substance Prescribing

Providers now have until November 11, 2023, to continue prescribing controlled substances through…

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Press Releases8.18.22

180 Dykema Lawyers Listed in The Best Lawyers in America© 2023 and Best Lawyers “Ones to Watch”

Dykema, a leading national law firm, announced today that 180 of its attorneys, in multiple practice…

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Press Releases3.22.22

Five Dykema Attorneys Named as 2022 Texas Rising Stars by Super Lawyers

Dykema, a leading national law firm, announced today that five of its Texas-based attorneys have…

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