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Navigating Legal and Regulatory Risks in Direct-to-Consumer Pharmacy Models

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The direct-to-consumer (DTC) pharmacy space continues to evolve but is tightly regulated at the state level, with licensing and operational compliance as critical gatekeepers.

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Manufacturer involvement raises heightened scrutiny under both state law and federal fraud and abuse laws.

Third-party fulfillment models are more common but still require careful structuring and contractual controls to ensure compliance.

Stakeholders should conduct state-by-state regulatory assessments before entering new markets or launching DTC pharmacy offerings.

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As pharmaceutical manufacturers, digital health companies and telehealth platforms continue to reshape the delivery of medications, DTC pharmacy models have emerged as a critical component of patient engagement and commercialization strategy. These models promise greater convenience, improved adherence and enhanced control over the supply chain, but they also raise complex legal and regulatory considerations, particularly given that the practice of pharmacy is regulated at the state level in the United States.

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This alert outlines key considerations for entities pursuing DTC pharmacy strategies, including licensing, ownership structures and operational compliance. We also compare the legal implications of two common models: manufacturer-owned pharmacies and third-party fulfillment arrangements.

The Legal Foundation: Pharmacy Is a State-Regulated Activity

At the core of any DTC pharmacy strategy is the recognition that dispensing prescription drugs is a regulated activity governed by state pharmacy boards. While federal laws such as the Food, Drug, and Cosmetic Act (FDCA) and the Drug Supply Chain Security Act (DSCSA) provide baseline standards for drug safety and traceability, state law dictates who may dispense medications, under what conditions and in which jurisdictions.

Some foundational legal requirements for operating a pharmacy include:

Pharmacy Licensure: A pharmacy must be licensed in each state where it dispenses prescription drugs to patients.

Pharmacist Oversight: States often require that dispensing be overseen by a licensed pharmacist-in-charge (PIC) who is individually licensed in that state.

Nonresident Pharmacy Rules: If a pharmacy is located in one state but ships into another, it typically must obtain a nonresident pharmacy license in the receiving state.

DTC Pharmacy Models: Legal Considerations

1. Manufacturer-Owned or Affiliated Pharmacies

Some pharmaceutical manufacturers have explored owning or affiliating with a pharmacy to exert more control over patient experience, collect data and streamline specialty drug distribution. This model presents both opportunities and legal hurdles.

Ownership Restrictions and Disclosure Requirements: Many states restrict who may own a pharmacy, meaning that certain individuals are barred from owning a pharmacy outright. Each state has differing ownership disclosure requirements. States such as California and Kansas have particularly stringent ownership disclosure requirements in that applicants must disclose each entity in the chain of ownership based on threshold beneficial interest percentages.

Conflicts of Interest/Kickback Risk: Manufacturer involvement in the pharmacy function can raise Anti-Kickback Statute (AKS) concerns, particularly if prescribers are incentivized or required to use the affiliated pharmacy.

Patient Choice: Payers, pharmacy benefit managers (PBMs) and regulators may require that patients be permitted to choose their dispensing pharmacy, raising issues for closed or exclusive models. Even when the DTC model does not accept government or commercial insurance, certain jurisdictions require patients to have the freedom to choose their dispensing pharmacy.

Compliance Best Practices:

Structure the pharmacy as a legally distinct subsidiary that complies with all state pharmacy laws.

Ensure independence of the pharmacy’s and pharmacist’s clinical decision-making.

Avoid steering or mandatory referral arrangements that could trigger AKS or state analogues.

2. Third-Party Fulfillment Pharmacy Partnerships

A more common and scalable model involves contracting with licensed third-party pharmacies to fulfill prescriptions while the manufacturer or DTC platform controls the front-end patient experience (e.g., via a digital interface).

Licensure and Dispensing Authority: The third-party pharmacy must be licensed in each state where it ships medications and must handle dispensing activities under its own pharmacist oversight.

Service Agreements and Delegation: Care must be taken to ensure that the manufacturer or platform is not performing functions that require pharmacy licensure (e.g., drug dispensing, medication counseling).

Data Sharing and HIPAA: Business associate agreements (BAAs) are essential when handling protected health information (PHI). Manufacturers must also be mindful of HIPAA constraints when collecting patient data through digital tools.

Telepharmacy/Telehealth Integration: If prescribing is done through a telehealth platform integrated with the DTC model, prescribing and dispensing must remain appropriately separated to avoid potential self-referral or kickback issues.

Maintain clear contractual delineation between the fulfillment pharmacy and the platform/manufacturer.

Implement robust oversight and compliance monitoring of the fulfillment pharmacy.

Ensure patient consent and transparency regarding data usage and pharmacy selection.

Our team advises pharmaceutical companies, digital health innovators and pharmacy operators on the full life cycle of DTC pharmacy ventures, from entity formation and licensure strategy to risk assessments and compliance audits. If you are considering launching or partnering in a DTC pharmacy model, we welcome the opportunity to support your legal strategy.

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