Christopher R. Smith

“Pharmacy law sits at the intersection of federal policy, state regulation, and commercial reality. I help clients navigate all three.” —Christopher Smith

Pharmacies, pharmaceutical companies, drug distributors, plan sponsors, and plan administrators turn to Christopher Smith for strategic counsel on their regulatory, transactional, and compliance challenges. His advice reflects both an insider’s perspective and a lawyer’s command of this complex sector.

Whether a client is navigating change-of-ownership (CHOW) requirements, responding to a board of pharmacy investigation, negotiating a critical PBM contract, or structuring a private equity transaction involving pharmacy assets, Christopher provides guidance informed by years spent inside the pharmacy industry’s leading trade associations. There, he advised regulators and industry stakeholders on the laws that now govern his clients. His practice spans the full spectrum of pharmacy law, with substantial experience in drug distribution, licensing, supply chain compliance, and reimbursement.

Christopher leads CHOW licensing efforts for transactions of all sizes, from small independent pharmacies to large multistate portfolio acquisitions. He serves as primary regulatory counsel for private equity investors acquiring retail, mail-order, specialty, compounding, behavioral health, long-term care, PACE, home infusion, and non-dispensing pharmacies, coordinating multistate pharmacy and drug distributor licensing across all 50 states and conducting health regulatory due diligence in pharmacy M&A transactions. He also advises clients on structuring pharmacy operations, including telehealth, direct-to-consumer distribution, shared services, and central-fill arrangements, and counsels on compliance involving physician dispensing, compounding, and repackaging.

Pharmacies, plan sponsors, plan administrators, 340B covered entities, 340B TPAs, and 340B contract pharmacies rely on Christopher to negotiate the agreements that shape their operations. Across the pharmacy sector, he has successfully negotiated PBM, GPO, PSAO, payor, drug-purchasing, and ancillary-vendor agreements. Christopher also provides comprehensive 340B program counsel, helping clients protect and optimize their participation as manufacturer restrictions on contract pharmacies and agency guidance continue to shift.

Before entering private practice, Christopher served in senior policy roles at two leading national pharmacy trade associations: first as Director of Federal Public Policy, advocating for policies supporting patients and pharmacies, and later as Director of Policy and Regulatory Affairs, representing independent community pharmacists. Drawing on his work advising regulators and industry on Drug Supply Chain Security Act (DSCSA) implementation during his time at the trade associations, he counsels clients on DSCSA compliance, DEA and controlled-substance regulations, electronic prescribing and telehealth-related controlled-substance issues, reverse-distribution laws, and state PBM licensing developments.

Christopher defends pharmacies, PBMs, manufacturers, and other health care providers before state boards of pharmacy in investigations, disciplinary actions, and other adverse regulatory proceedings; in state Medicaid investigations and adverse actions; and in federal and state fraud, waste, and abuse matters, as well as anti-kickback matters. He also represents plan sponsors, plan administrators, pharmacies, and pharmacy vendors in PBM and 340B program disputes.

In addition to his pharmacy regulatory work, Christopher handles commercial litigation involving business disputes, trade secrets, and related claims. In the District of Columbia and Maryland, he also represents behavioral and mental health providers and long-term care facilities in matters involving licensing, regulatory certification, investigations, disciplinary actions, and Medicaid adverse actions.

Outside his legal practice, Christopher serves on the alumni board of the University of Richmond's Jepson School of Leadership Studies and on the board of directors of DNAngels, a nonprofit dedicated to helping individuals search for their biological parents.

What Christopher Delivers for Clients

• Anticipating Issues Before They Become Problems: Christopher's years inside pharmacy trade associations gave him a practical understanding of how federal and state agencies approach rulemaking, enforcement, and policy interpretation. He brings that perspective to transaction structures, contract terms, and compliance decisions, helping clients identify and address obstacles before they become disputes.
• Counsel That Keeps Transactions Moving: Pharmacy deals move quickly, and complexity on the licensing and compliance side is one of the most common sources of delay. Christopher's experience managing multistate licensing filings across all 50 states, coordinating due diligence workstreams, and negotiating health care provisions in purchase agreements helps keep the regulatory side of a transaction aligned with the commercial timeline.
• Contract Terms That Protect the Bottom Line: PBM and payor agreements directly affect how pharmacies get paid, and the details matter. Christopher negotiates these agreements for a broad range of pharmacy types and employer plan sponsors, with a strong understanding of both market terms and statutory constraints.
• 340B Counsel for a Program Under Pressure: The 340B program continues to face pressure from manufacturer restrictions on contract pharmacy arrangements, increased audit activity, and evolving agency guidance. Christopher counsels covered entities, contract pharmacies, and TPAs on protecting program participation and adapting arrangements to a more contested environment.
• Defense That Protects Both Legal Position and Regulatory Standing: Pharmacy defense matters rarely exist in isolation. A board investigation or Medicaid audit often unfolds alongside an ongoing licensure relationship or continued program participation. Christopher's background in policy and administrative proceedings helps clients defend their interests without losing sight of the regulator relationships their businesses depend on.

Pharmacy Transactions and Licensing

• Represented buyers and sellers in numerous private equity and family office pharmacy acquisitions and divestitures, ranging from single-location deals to billion-dollar portfolio transactions, covering all pharmacy types nationwide, including retail, mail-order, specialty, compounding, behavioral health, long-term care, PACE, home infusion, and non-dispensing pharmacies. The scope of work included health regulatory due diligence, multistate licensing coordination, responding to due diligence inquiries, and negotiating the health regulatory provisions of purchase agreements.
• Represented private equity buyers in multiple billion-dollar drug and device manufacturer acquisitions, providing regulatory due diligence support and coordinating federal and state licensing filings.
• Led and managed multistate licensing filings for several pharmacies and hospital pharmacies undergoing corporate restructuring.

Contract Negotiation

• Negotiated and drafted PBM and payor agreements on behalf of a wide range of pharmacy types and multiple large national employer plan sponsors.
• Negotiated and drafted drug purchase, drug manufacturer services, GPO, PSAO, pharmacy services, and management services agreements on behalf of pharmacies and device manufacturers.
• Negotiated and drafted contracts establishing numerous 340B contract pharmacy arrangements among hospitals, retail pharmacy chains, and 340B technology services vendors, and provided compliance counsel on the use of grant funding and 340B savings within the program.

Regulatory Compliance and Counseling

• Advised pharmaceutical manufacturers and pharmacies on compliance with the track-and-trace requirements of the DSCSA.
• Provided PBM and TPA state licensing and reporting compliance counsel to multiple PBMs navigating changing state PBM licensing laws, including in connection with PBM change-of-ownership transactions.
• Provided health regulatory counsel to a national retail pharmacy chain on SEC reporting compliance, state fraud, waste, and abuse reporting requirements, and COVID-19 vaccine regulatory compliance.

Dispute Resolution and Regulatory Defense

• Currently serves as lead outside counsel to a Medicaid managed care plan in administrative law disputes involving coverage denial matters.
• Represented a 340B pharmacy in multiple PBM audit disputes, obtaining favorable outcomes for the client.
• Represented a health plan administrator in arbitration against a PBM for wrongful withholding of drug rebates.
• Represented an employer plan sponsor in arbitration against a PBM for wrongful exclusion of rebates owed to the plan.
• Represented a 340B TPA in a fraud action.
• Obtained a favorable settlement for a managed care pharmacy in a Medicaid recoupment administrative law proceeding.
• Obtained a favorable settlement for two long-term care facilities in a Medicaid recoupment administrative law proceeding.
• Represented a Medicaid managed care organization in beneficiary coverage disputes before administrative law courts.
• Represented multiple behavioral and mental health providers in successfully preventing decertification by the District of Columbia and Maryland regulators.
• Represented a behavioral and mental health provider in a bid protest against the District of Columbia.

Business Litigation and Commercial Disputes

• Obtained a favorable settlement enforcing non-compete, non-solicitation, and trade secret protections against former employees of a residential lender operating across the East Coast.
• Obtained a favorable settlement for a nonprofit entity in a defamation and state law employment discrimination matter.
• Represented a large physician network in breach of employment contract, business tort, and employment discrimination claims brought by former network physicians.

Education

• American University, Washington College of Law (LL.M., 2011)
  • Law and Government, Health Law and Policy Concentration
  • Thomas O. Sargentich Award (for highest scholastic average)
• Vanderbilt University Law School (J.D., 2001)
  • Phillip C. Jessup International Moot Court Team
  • Executive Problem Editor, Moot Court Board
• University of Richmond (B.A., summa cum laude, 1998)
  • Phi Beta Kappa

Professional & Community Involvement

• American Society of Pharmacy Law