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Practices & Industries

Cannabis Law, Psychedelics, and Emerging Therapies

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Baker Donelson attorneys and public policy advisors are well-positioned and well-equipped to advise companies, financial institutions and investors in this burgeoning industry, on a wide range of legal and public policy issues.

Overview


Key Contacts

The legal landscape surrounding cannabis, hemp, psychedelics, and innovative therapeutic treatments continues to evolve at an unprecedented pace. Businesses operating in these industries face complex regulatory frameworks, rapidly changing laws, heightened enforcement, and unique commercial challenges.

Our Cannabis Law, Psychedelics, and Emerging Therapies Practice represents and advises not only cannabis, hemp, and emerging therapy businesses, but also hospitals, health systems, long-term care facilities, behavioral health providers, and other health care organizations navigating the legal and operational implications of evolving cannabis and emerging therapy laws. We combine deep regulatory knowledge with practical business counsel to help clients navigate emerging markets while managing legal and operational risk.

Whether advising state-licensed cannabis businesses, hemp companies, ketamine clinics, clinical researchers, health care facilities, academic medical centers, health care innovators, or investors, we provide strategic guidance tailored to highly regulated industries where legal and business considerations are closely intertwined.

Cannabis

We represent licensed cannabis businesses across every stage of growth, providing comprehensive corporate, regulatory, and litigation counsel to operators, investors, and ancillary businesses.

Transactional Representation

Our attorneys advise cannabis companies on a broad range of business matters, including:

  • Counsel and advice on rescheduling of cannabis
  • Mergers and acquisitions
  • Corporate structuring and reorganizations
  • Asset and equity transactions
  • Financing and capital raises
  • Commercial contracts
  • Real estate transactions and leasing
  • Strategic partnerships and joint ventures

We work with cultivators, manufacturers, processors, distributors, wholesalers, retailers, testing laboratories, delivery operators, management companies, and ancillary service providers throughout the regulated cannabis supply chain.

Licensing and Regulatory Compliance

Operating in the cannabis industry requires ongoing compliance with complex and frequently changing state regulations. We counsel clients through every phase of the licensing and regulatory process, including:

  • New license applications
  • License transfers and ownership changes
  • Regulatory due diligence
  • Compliance programs and internal policies
  • Standard operating procedures
  • Regulatory audits and inspections
  • Product labeling, packaging, advertising, and marketing compliance
  • Inventory control and operational compliance
  • Administrative responses to regulatory inquiries

Our team works proactively with clients to identify regulatory risks before they become enforcement issues.

Health Care Facilities and Institutional Cannabis Policies

As the use of medical cannabis becomes increasingly prevalent due to the rescheduling of state licensed medicinal cannabis products to Schedule III, hospitals, long-term care facilities, rehabilitation centers, behavioral health providers, hospice organizations, and other health care institutions face complex legal and operational questions regarding patient use of cannabis within regulated health care settings.

We advise health care providers and facilities on developing legally sound policies and procedures that balance patient care, regulatory compliance, workplace safety, and risk management.

Our representation includes counsel regarding:

  • Development and implementation of institutional cannabis policies
  • Patient admission and intake procedure considerations involving medical cannabis use
  • Storage, handling, security, and controlled substance policies
  • Medication administration and self-administration policies
  • Patient safety and clinical risk management considerations
  • Compliance with applicable state health care regulations and licensing requirements including Drug Enforcement Administration (DEA) registrations
  • Review and revision of existing policies to address evolving cannabis laws and standards of care

We work closely with health care organizations to develop practical, compliant policies that address the intersection of patient rights, clinical judgment, regulatory requirements, and institutional operations while promoting patient safety and minimizing organizational risk.

Administrative Proceedings and Litigation

When disputes or enforcement actions arise, we advocate for clients before administrative agencies and in state and federal courts.

Our experience includes:

  • Administrative enforcement proceedings
  • License suspension and revocation matters
  • Regulatory investigations
  • Civil litigation
  • Commercial and partnership disputes
  • Contract litigation
  • Emergency injunctive relief
  • Compliance and enforcement strategy

We focus on developing practical legal strategies that protect our clients' licenses, businesses, and long-term objectives.

Hemp/CBD

The hemp industry continues to evolve through changing federal and state regulations governing cultivation, processing, manufacturing, cannabinoids, consumer products, and interstate commerce.

We counsel hemp businesses, manufacturers, processors, distributors, retailers, and investors on the legal and commercial issues affecting the industry.

Our representation includes:

  • Business formation and corporate governance
  • Commercial transactions
  • Manufacturing and supply agreements
  • Product development
  • Regulatory compliance
  • State and federal licensing
  • Food and Drug Administration (FDA) and consumer product issues
  • Labeling and marketing review
  • Regulatory investigations
  • Administrative proceedings
  • Commercial litigation
  • Product-related claims

Our attorneys help clients adapt to a rapidly changing regulatory environment while positioning their businesses for sustainable growth.

Psychedelics and Emerging Therapies

As innovative therapies continue to transform health care, companies, providers, researchers, and investors require legal counsel that understands both health care regulation and emerging treatment models.

Our practice advises clients operating at the intersection of health care, biotechnology, life sciences, behavioral health, and regulated therapeutics.

We counsel businesses involved in psychedelic-assisted therapies, novel treatment delivery models, clinical research, and related health care ventures.

Ketamine Clinics

We represent physician-owned practices, multidisciplinary clinics, management companies, and investors involved in ketamine treatment programs.

Our services include:

  • Corporate structuring
  • Health care regulatory compliance
  • Corporate practice of medicine considerations
  • Management service organization (MSO) structures
  • Health Insurance Portability and Accountability Act (HIPAA) and privacy compliance
  • Transactions and acquisitions
  • Operational compliance
  • State licensing and regulatory matters

We provide practical legal guidance designed to support compliant, efficient, and scalable clinic operations.

Clinical Research and Emerging Therapeutics

We advise sponsors, investigators, research organizations, health care institutions, startups, and investors engaged in the development of innovative therapeutics.

Our work includes:

  • Clinical trial agreements
  • Research collaborations
  • Joint ventures with academic medical centers
  • Licensing agreements
  • Intellectual property transactions
  • Regulatory compliance and strategy
  • FDA counseling
  • Investigational New Drug (IND) applications
  • Institutional Review Board (IRB) considerations
  • Clinical operations
  • Corporate transactions involving life sciences companies

We assist clients in navigating the legal, regulatory, and commercial issues associated with bringing innovative therapies from research through clinical development and into the marketplace.

Integrated Counsel for Emerging Industries

Clients operating in highly regulated industries require counsel who understand not only the law but also the practical realities of building and growing innovative businesses.

Our multidisciplinary team combines experience in corporate transactions, health care law, regulatory compliance, government enforcement, commercial litigation, and emerging industries to provide comprehensive legal solutions that support our clients' long-term success.

Results may vary depending on your particular facts and legal circumstances.

  • Represented a health care organization in the acquisition and integration of psychiatry and ketamine clinics across multiple jurisdictions, providing comprehensive counsel on health care regulatory compliance, corporate transactions, and post-acquisition operational issues.

  • Represented various psychiatry, therapy, and ketamine clinics on billing and reimbursement, in particular appropriate billing for Spravato.

  • Advised clinicians on the legal and regulatory requirements involved in establishing and operating ketamine clinics, including corporate structure, licensing, scope of practice, and applicable federal and state health care laws.

  • Provide ongoing counsel on regulatory compliance, risk management, policies and procedures, and operational issues to help ensure ketamine clinic services are delivered in accordance with evolving legal and professional standards.

  • Representation of various adult use cannabis state licensed operators in both state license applications and various purchase and sales of state legal cannabis licenses.

  • Representation of state licensed medicinal cannabis operator in all facets of its business governance and litigation strategies.

  • Representation of manufacturers of hemp-derived products and hemp beverages in connection with regulatory compliance, commercial agreements, and day-to-day legal matters supporting nationwide distribution, including advice and counsel on legal and business issues arising from the manufacture, marketing, and distribution of hemp products across multiple jurisdictions.

  • Advised hospitals on rescheduling of medicinal cannabis considerations as it relates to legal, operational and policy considerations as well as insurance, billing, and reimbursement issues.

  • Advised various businesses on pre-employment and random drug testing policy considerations.

  • Advised cannabis retailers on point-of-sale issues and concerns, marketing and advertising, online versus brick-and-mortar sales, as well as shipping and delivery, both within the client (e.g., internal distribution networks) and externally with respect to end users/purchasers.

  • Advised retailers, including national "big box" stores, on entering the legal cannabis market, whether to sell delta-9-tetrahydrocannabinol (THC)-containing products, zero-THC products such as ingestible and topical cannabidiol (CBD), or a combination of both.

  • Advised farmers and agricultural clients on qualifying as a licensed/regulated cannabis grower, processor, or both.

  • Advised multiple financial institutions on compliance issues related to the handling of funds derived from cannabis-related transactions.

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