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<h2 class="wp-block-heading" id="h-why-bakerhostetler">Why BakerHostetler</h2>

Regulatory Insight and Healthcare Experience

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Regulatory Insight and Healthcare Experience

Our longstanding relationships with key regulatory bodies enable us to deliver strategic guidance, and we regularly engage with agencies including the FDA, the Centers for Medicare and Medicaid Services (CMS) and the Federal Trade Commission (FTC). With in-house, industry, healthcare and pharmaceutical experience, our attorneys provide counsel grounded in first-hand, real-world experience.

Our longstanding relationships with key regulatory bodies enable us to deliver strategic guidance, and we regularly engage with agencies including the FDA, the Centers for Medicare and Medicaid Services (CMS) and the Federal Trade Commission (FTC). With in-house, industry, healthcare and pharmaceutical experience, our attorneys provide counsel grounded in first-hand, real-world experience.

Leadership in Drug Shortage and API Access Issues

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In a village of La Mancha, the name of which I have no desire to call to mind, there lived not long since one of those gentlemen that keep a lance in the lance-rack, an old buckler, a lean hack, and a greyhound for coursing.

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Leadership in Drug Shortage and API Access Issues

We are widely recognized for our work advising compounding pharmacy clients on drug shortages and access to active pharmaceutical ingredients (APIs) - a critical issue across compounding pharmacy models.

We are widely recognized for our work advising compounding pharmacy clients on drug shortages and access to active pharmaceutical ingredients (APIs) - a critical issue across compounding pharmacy models.

We routinely support clients navigating:

We routinely support clients navigating:

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List

<ul class="wp-block-list">
<li>Policy and regulatory hurdles</li>



<li>Supply chain disruptions</li>



<li>Evolving FDA guidance</li>



<li>Access to critical drug components</li>



<li>Complex FDA, CMS and FTC regulations</li>
</ul>

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List Item

<li>Access to critical drug components</li>

<li>Complex FDA, CMS and FTC regulations</li>

<ul class="wp-block-list"><li>Policy and regulatory hurdles</li><li>Supply chain disruptions</li><li>Evolving FDA guidance</li><li>Access to critical drug components</li><li>Complex FDA, CMS and FTC regulations</li></ul>

We advise pharmacies and outsourcing facilities across every aspect of their operations, including:

We advise pharmacies and outsourcing facilities across every aspect of their operations, including:

<ul class="wp-block-list">
<li>Helping pharmacies and outsourcing facilities address policy and regulatory challenges</li>



<li>Assisting with FDA registration and compliance programs</li>



<li>Supporting inspections, enforcement actions and regulatory responses</li>



<li>Counseling on manufacturing, labeling and distribution issues</li>



<li>Advising entities on establishing compounding facilities and registering them with the FDA as outsourcing facilities</li>



<li>API manufacturers and suppliers</li>



<li>Telehealth platforms</li>
</ul>

Helping pharmacies and outsourcing facilities address policy and regulatory challenges

<li>Helping pharmacies and outsourcing facilities address policy and regulatory challenges</li>

Assisting with FDA registration and compliance programs

<li>Assisting with FDA registration and compliance programs</li>

Supporting inspections, enforcement actions and regulatory responses

<li>Supporting inspections, enforcement actions and regulatory responses</li>

Counseling on manufacturing, labeling and distribution issues

<li>Counseling on manufacturing, labeling and distribution issues</li>

Advising entities on establishing compounding facilities and registering them with the FDA as outsourcing facilities

<li>Advising entities on establishing compounding facilities and registering them with the FDA as outsourcing facilities</li>

<ul class="wp-block-list"><li>Helping pharmacies and outsourcing facilities address policy and regulatory challenges</li><li>Assisting with FDA registration and compliance programs</li><li>Supporting inspections, enforcement actions and regulatory responses</li><li>Counseling on manufacturing, labeling and distribution issues</li><li>Advising entities on establishing compounding facilities and registering them with the FDA as outsourcing facilities</li><li>API manufacturers and suppliers</li><li>Telehealth platforms</li></ul>

FDA, Drug Enforcement Administration and state regulatory enforcement

FDA, Drug Enforcement Administration and state regulatory enforcement

<ul class="wp-block-list">
<li>Representation in investigations and audits by federal and state regulators</li>



<li>Defense of enforcement actions involving compounding, dispensing and distribution</li>
</ul>

Representation in investigations and audits by federal and state regulators

<li>Representation in investigations and audits by federal and state regulators</li>

Defense of enforcement actions involving compounding, dispensing and distribution

<li>Defense of enforcement actions involving compounding, dispensing and distribution</li>

<ul class="wp-block-list"><li>Representation in investigations and audits by federal and state regulators</li><li>Defense of enforcement actions involving compounding, dispensing and distribution</li></ul>

Strategic counseling on compliance with the Drug Quality and Security Act

Strategic counseling on compliance with the Drug Quality and Security Act

<ul class="wp-block-list">
<li>Ongoing regulatory monitoring and risk mitigation</li>
</ul>

Ongoing regulatory monitoring and risk mitigation

<li>Ongoing regulatory monitoring and risk mitigation</li>

<ul class="wp-block-list"><li>Ongoing regulatory monitoring and risk mitigation</li></ul>

Pharmacy reimbursement and pharmacy benefit manager issues

Pharmacy reimbursement and pharmacy benefit manager issues

<ul class="wp-block-list">
<li>Audits and disputes involving pharmacy benefit managers</li>



<li>Reimbursement validation and underpayment recovery strategies</li>



<li>Contract structuring and compliance review</li>



<li>340B program counseling and operational assessments</li>
</ul>

Audits and disputes involving pharmacy benefit managers

<li>Audits and disputes involving pharmacy benefit managers</li>

Reimbursement validation and underpayment recovery strategies

<li>Reimbursement validation and underpayment recovery strategies</li>

Contract structuring and compliance review

<li>Contract structuring and compliance review</li>

340B program counseling and operational assessments

<li>340B program counseling and operational assessments</li>

<ul class="wp-block-list"><li>Audits and disputes involving pharmacy benefit managers</li><li>Reimbursement validation and underpayment recovery strategies</li><li>Contract structuring and compliance review</li><li>340B program counseling and operational assessments</li></ul>

Transactions, growth and strategic initiatives

Transactions, growth and strategic initiatives

<ul class="wp-block-list">
<li>Mergers and acquisitions involving pharmacies, telehealth companies and outsourcing facilities</li>



<li>Private equity investments in healthcare and pharmacy platforms</li>



<li>Structuring new business models at the intersection of telehealth and pharmacy services</li>



<li>Licensing and market expansion strategies</li>
</ul>

Mergers and acquisitions involving pharmacies, telehealth companies and outsourcing facilities

<li>Mergers and acquisitions involving pharmacies, telehealth companies and outsourcing facilities</li>

Private equity investments in healthcare and pharmacy platforms

<li>Private equity investments in healthcare and pharmacy platforms</li>

Structuring new business models at the intersection of telehealth and pharmacy services

<li>Structuring new business models at the intersection of telehealth and pharmacy services</li>

Licensing and market expansion strategies

<li>Licensing and market expansion strategies</li>

<ul class="wp-block-list"><li>Mergers and acquisitions involving pharmacies, telehealth companies and outsourcing facilities</li><li>Private equity investments in healthcare and pharmacy platforms</li><li>Structuring new business models at the intersection of telehealth and pharmacy services</li><li>Licensing and market expansion strategies</li></ul>

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<section class="wp-block-contentpilot-expand-more"><div class="wp-block-contentpilot-expand-more__excerpt is-visible" data-selector="expand-more"></div><div class="wp-block-contentpilot-expand-more__full-content" data-selector="expand-more">Leadership in Drug Shortage and API Access IssuesWe are widely recognized for our work advising compounding pharmacy clients on drug shortages and access to active pharmaceutical ingredients (APIs) - a critical issue across compounding pharmacy models.We routinely support clients navigating:<ul class="wp-block-list"><li>Policy and regulatory hurdles</li><li>Supply chain disruptions</li><li>Evolving FDA guidance</li><li>Access to critical drug components</li><li>Complex FDA, CMS and FTC regulations</li></ul>We advise pharmacies and outsourcing facilities across every aspect of their operations, including:<ul class="wp-block-list"><li>Helping pharmacies and outsourcing facilities address policy and regulatory challenges</li><li>Assisting with FDA registration and compliance programs</li><li>Supporting inspections, enforcement actions and regulatory responses</li><li>Counseling on manufacturing, labeling and distribution issues</li><li>Advising entities on establishing compounding facilities and registering them with the FDA as outsourcing facilities</li><li>API manufacturers and suppliers</li><li>Telehealth platforms</li></ul>FDA, Drug Enforcement Administration and state regulatory enforcement<ul class="wp-block-list"><li>Representation in investigations and audits by federal and state regulators</li><li>Defense of enforcement actions involving compounding, dispensing and distribution</li></ul>Strategic counseling on compliance with the Drug Quality and Security Act<ul class="wp-block-list"><li>Ongoing regulatory monitoring and risk mitigation</li></ul>Pharmacy reimbursement and pharmacy benefit manager issues<ul class="wp-block-list"><li>Audits and disputes involving pharmacy benefit managers</li><li>Reimbursement validation and underpayment recovery strategies</li><li>Contract structuring and compliance review</li><li>340B program counseling and operational assessments</li></ul>Transactions, growth and strategic initiatives<ul class="wp-block-list"><li>Mergers and acquisitions involving pharmacies, telehealth companies and outsourcing facilities</li><li>Private equity investments in healthcare and pharmacy platforms</li><li>Structuring new business models at the intersection of telehealth and pharmacy services</li><li>Licensing and market expansion strategies</li></ul></div><button class="wp-block-contentpilot-expand-more__more-button is-visible" data-selector="expand-more">View More</button><button class="wp-block-contentpilot-expand-more__less-button" data-selector="expand-more">View Less</button></section>

Andrew M. Grossman

Thomas E. Hogan

Laura E. Peterson

Nikki L. Morris

Timothy Longman

Matt Schock

Victoria L. Weatherford

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Adam J. Higgins

Christian B. Jones

Francis B. Palumbo

Lee H. Rosebush

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Our experience spans litigation, regulatory strategy, government affairs, corporate transactions and compliance for compounding pharmacies and pharma sectors:
<ul>
<li>Advocated before the FDA’s Pharmacy Compounding Advisory Committee (PCAC) on behalf of the American Academy of Peptide Medicine (AAPM) in connection with the Committee’s July 2026 review of seven peptides.  Presented arguments supporting the inclusion of the peptides on the 503A Bulks List to restore regulated access through licensed compounding pharmacies.  The Committee recommended that six of the seven peptides be added to the list.</li>
<li>Advising the Outsourcing Facilities Association in litigation against the Department of Health and Human Services and the FDA, urging agency action on nominations for active pharmaceutical ingredients used by outsourcing facilities.</li>
<li>Representing FarmaKeio in high-profile litigation matters involving the FDA’s clinical need list and peptide regulation, addressing patient access to essential medications.</li>
<li>Advocating for compounding pharmacies and outsourcing facilities at federal (FDA, DEA, HHS) agencies and state legislative and regulatory hearings.</li>
<li>Providing strategic counsel in connection with an FDA consent decree, securing a favorable outcome without an upfront shutdown, mandatory on-site FDA oversight or product recall.</li>
<li>Advising a global healthcare company on developing an enterprise-wide artificial intelligence (AI) and generative AI compliance framework, including FDA considerations.</li>
<li>Representing multiple private equity sponsors in multimillion- and billion-dollar acquisitions of multi-state clinical networks and pharmacies, including regulatory diligence and execution.</li>
<li>Counseling life sciences clients on the regulatory implications of cybersecurity incidents, including FDA and global compliance risks.</li>
</ul>

Compounding Pharmacies and Outsourcing Facilities

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