Home - Blank Rome LLP

Register to receive insights and analyses on breaking news and trends across varying industries.
<a class="link-primary mt-4" href="/subscribe">Subscribe</a>

Philadelphia, PA

New York, NY

Wilmington, DE

Cincinnati, OH

Princeton, NJ

Los Angeles, CA

Houston, TX

Tampa, FL

Shanghai

South Florida

Pittsburgh, PA

Washington, D.C.

Chicago, IL

Orange County, CA

Dallas, TX

Boston, MA

Main

Rachael advises life sciences and healthcare clients on the full range of healthcare regulations impacting companies operating in this industry. Widely regarded as a thought leader in the compounding sector, Rachael represents coalitions of compounding pharmacies and outsourcing facilities to challenge the Food and Drug Administration (“FDA”), state regulators, or other regulatory bodies on critical issues defining the industry. As a recognized national authority, Rachael is ranked by Chambers USA in Band 1 for the Illinois Healthcare: Pharmaceutical/Medical Products Regulatory category. Clients describe her as “quick to understand and support the perspective of the business, allowing her to help formulate business solutions that fit into the regulatory framework of our industry” and say “[h]er intellect, measured responses, written expertise and work ethic are unsurpassed.”Rachael has notable strength in representing healthcare facilities in high-stakes FDA, Drug Enforcement Administration (“DEA”), and state agency investigations and related litigation, as well as acting as regulatory counsel for large-scale, high-profile transactions involving major healthcare players in the compounding space. She provides industry-tailored advice to innovative healthcare-focused companies, such as telehealth platforms, drug distributors, physician and veterinary practices, and online pharmacy and prescription management services, as well as pharmacies (commercial/retail, nuclear, compounding, and institutional), hospital systems, and outsourcing facilities.Rachael also maintains an active civil action and pro bono practice, focusing on assisting clients affected by sexual exploitation.

core/freeform

Illinois

United States Court of Appeals for the Third Circuit

United States Court of Appeals for the Eleventh Circuit

U.S. District Court - Eastern District of New York

U.S. District Court - Northern District of Florida

U.S. District Court - Northern District of Illinois

United States Court of Appeals for the Federal Circuit

United States Court of Appeals for the Second Circuit

United States Court of Appeals for the Seventh Circuit

U.S. District Court for the District of Massachusetts

Supreme Court of Illinois

U.S. District Court - Northern District of Illinois Trial Bar

U.S. Circuit Court - Cook County, Illinois

Healthcare

Healthcare IT

Healthcare – Public Policy, Government Contracts Counseling & Compliance

Healthcare – Financing Transactions

Healthcare – Litigation & Product Liability

Life Sciences

Life Sciences – Transactions

Life Sciences – Commercial and Product Liability Litigation

Life Sciences – Regulatory & Public Policy

2nd Annual Summit on GLP-1 Law & Policy

Blank Rome Secures Win for Telehealth Platform in Lanham Act False Advertising Case

Compounding Conundrums: SAFE Act, State Bills, and FDA Scrutiny

Under the Microscope: Legal Issues in Life Sciences & Healthcare

Stephanie K. Hor-Chen and Rachael G. Pontikes Named Notable Women in Law 2026 by Crain’s Chicago Business

Novo Nordisk Files Patent Infringement Suit Involving Compounded Semaglutide Products

Marketing & Legal: GLP-1 Messaging Do’s and Don’ts

A New Deal For GLP-1s

Prescription for Change: HHS and FDA Seek New Take on Direct-to-Consumer Drug Ads

FDA Launches “Green List” to Combat Illegal GLP-1 Imports

Blank Rome Attorneys Recognized in 2026 Best Lawyers in America®

Federal and State Agencies Ramp Up Scrutiny of the GLP-1 Drug Market

Protecting Exclusivity: Drug Classification, Compounding Risks, and Market Access Challenges

180 Days of the Trump Administration—Quick Hits on Executive Orders, Actions, and Policies

Chambers USA 2025 Recognizes Blank Rome Attorneys and Practices

Compounding, Drug Shortages, and Regulatory Challenges

Regulatory Rundown: What Compounders Need to Know Now

Rachael G. Pontikes: Noteworthy Media Coverage

Blank Rome Welcomes Trio of Leading Regulatory and Litigation Partners in Chicago and Philadelphia

Rachael G. Pontikes: Noteworthy Speaking Engagements

Litigation

Regulatory Compliance

Business Litigation

Corporate

Industry Advocacy
<ul>
<li>Retained by several industry stakeholders to spearhead comments to the July 2023 FDA draft guidance on Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act and advise on its implications.</li>
<li>Lead counsel for a coalition of compounding pharmacies in a suit brought against the FDA challenging its memoranda of understanding (“MOU”) issued under Section 503A of the DQSA, where FDA was proposing a volume limitation on interstate dispensing of compounds. The MOU is one of the most critical issues facing compounding pharmacies. Secured summary judgment in favor of our clients; the matter was remanded back to the FDA for the agency to comply with the Regulatory Flexibility Act. FDA ultimately decided to suspend its MOU and engage in a formal rulemaking process to promulgate regulations implementing the statutory requirements in question, which was relief sought by the coalition’s lawsuit.</li>
<li>Successfully obtained a remand to the United States Pharmacopeia (“USP”) Expert Committee of the revised beyond use dating requirements set forth in revised USP Chapters &lt;795&gt; and &lt;797&gt; on behalf of compounding industry members. Navigating a novel and nearly uncharted USP appeals process, this was a significant result for the industry as it ensures hundreds of thousands of patients continued access to critical compounded medications.</li>
<li>Represent a coalition of compounding pharmacies, outsourcing facilities, and medical companies in front of the National Association of Science Engineering and Medicine regarding their study of bioidentical hormones.</li>
<li>Represent a coalition of veterinary pharmacies in commenting to both the 2015 draft guidance for industry (“GFI”) #230 (withdrawn by FDA), and the 2019 GFI # 256, where FDA is exerting authority over regulating animal compounding. FDA authority over animal compounding is one of the most critical issues facing animal compounders.</li>
<li>Successfully obtained a revision by the Illinois Department of Financial and Professional Regulation to a proposed Illinois regulation, threatening to limit the compounded medications veterinary compounders can provide for office administration to animal patients. Represented a coalition of veterinary compounding pharmacies and in conjunction with Illinois Veterinary Medical Association, the revision obtained in this matter allows all animal compounding pharmacies nationwide to provide medications for Illinois veterinarians to administer in the office, to allow proper treatment of animal patients, especially those who present with urgent medical needs.</li>
<li>Represented a coalition of outsourcing facilities in commenting to an FDA draft guidance setting out FDA’s proposed framework for evaluating the bulk substances outsourcing facilities can use to compound, one of the most significant issues facing outsourcing facilities.</li>
</ul>
Healthcare Litigation
<ul>
<li>Represented a compounding pharmacy before a state board of pharmacy seeking to bring a fine and reportable discipline action against our client, which would have adversely affected our client’s licensure in other states. We convinced the board to move to no fine and a non-disciplinary instrument that was not reportable.</li>
<li>Successfully argued that a state board of pharmacy was exceeding its jurisdiction by seeking to enforce drug-related provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) against a compounding pharmacy. Our team was victorious for our client at the administrative level and, after the board nevertheless took adverse action against our client, the state’s superior court ruled in our client’s favor. This is the first ruling in the nation that has found a state board of pharmacy cannot enforce the FDCA through its disciplinary authority. Leveraging this success, we have settled some of the pending California matters and prevented other state boards from restricting compounding by enforcing the FDCA.</li>
<li>Successfully represented a healthcare company against a state board of pharmacy seeking to levy a large fine against our client, which would have been reportable to the national practitioner database and likely resulted in similar actions in other states. We demonstrated to the board that it was unlawfully attempting to enforce drug-related provisions of the Food, Drug, and Cosmetic Act in violation of the prohibition against non-federal enforcement and moved the board to instead issue a non-disciplinary instrument and no fine.</li>
<li>Represented an FDA-registered outsourcing facility in two separate investigations by a state board of pharmacy that had the potential to lead to a significant fine or restriction on its licensure—which could have had the domino effect of damaging administrative penalties in other states. Our team convinced the board to dismiss both matters in their entirety.</li>
<li>Secured dismissal of the Pennsylvania Board of Pharmacy’s disciplinary action against our client stemming from our client’s licensure surrender in another state. We convinced the board to instead issue a confidential letter of warning and no fine, avoiding the sort of reportable discipline that would have created a domino effect of damaging administrative penalties across the country for our client.</li>
<li>Obtained dismissal of an administrative matter initiated by a board of pharmacy against our outsourcing facility client, in which the board was attempting to discipline our client based on a non-disciplinary settlement our client had previously reached with a different state board of pharmacy. Our team convinced the board of the impropriety of trying to convert another state’s non-disciplinary matter into disciplinary action.</li>
<li>Represented a healthcare company based in Texas in investigations and proceedings brought by two different state boards of pharmacy. In both cases, no action was taken against our client’s licenses, resulting in a complete close out.</li>
<li>Represented an FDA-registered outsourcing facility in the aftermath of an FDA inspection that resulted in a high-stakes FDA conference. Our team led negotiations with the FDA and state regulators and ensured continuity of operations to safeguard the client’s licensure and business goals.</li>
<li>Represented an FDA-registered outsourcing facility in the aftermath of an FDA inspection that resulted in a series of voluntary recalls, administrative actions, and an FDA conference. Our team led negotiations with the FDA and state regulators and ensured continuity of operations to safeguard the client’s licensure and business goals.</li>
<li>Successfully defended prominent pharmacies (including nuclear), outsourcing facilities, hospital systems, drug distributors, and physician practices in bet-the-business FDA investigations, including defense during all aspects of FDA inspections and investigation (Form 483, Warning Letter, Untitled letters), and FDA compliance conferences.</li>
<li>As national counsel, successfully defended prominent pharmacies (including nuclear), outsourcing facilities, hospital systems, drug distributors, and physician practices in bet-the-business state investigations including emergency actions threatening shut down and recall, obtaining dismissals and non-disciplinary orders in several states, most notably, Alabama, California, Colorado, Florida, Hawaii, Illinois, Indiana, Maryland, Minnesota, Texas, Virginia, and Washington.</li>
<li>Obtained license reinstatement for an outsourcing facility by the Virginia Board of Pharmacy at administrative hearing, demonstrating by clear and convincing evidence (requiring 75 percent of the Board to agree) that the license should be reinstated.</li>
<li>Trial counsel for ten compounding pharmacies through the defeat of the motion to dismiss.</li>
<li>Trial and appellate counsel for a veterinary compounding pharmacy in the trial court and Third Circuit in actions against the FDA’.</li>
<li>Trial counsel for a veterinary compounding pharmacy in an administrative hearing against the DEA.</li>
</ul>
Transactions
<ul>
<li>Provided regulatory counsel to a compounding pharmacy in its acquisition of the assets of a retail pharmacy in Arizona; we handled regulatory diligence, drafting of regulatory provisions for the purchase agreement, and the transfer of all licenses.</li>
<li>Provided regulatory due diligence and counsel for a private debt and private equity firm in its acquisition of a full-service small animal veterinary hospital; our work included creating a strategy for and handling the change of ownership processes for many of ’the hospital’s most important state licenses to ensure it did not experience a single day of business interruption post-closing.</li>
<li>Provided a national network of compounding pharmacies with regulatory due diligence and counsel in its acquisition of four pharmacies. This included developing and implementing strategies for license transfer.</li>
<li>Provided regulatory counsel to an FDA-registered 503B outsourcing facility in its sale to private equity investors, which involved significant change of ownership work surrounding licensure transfers. While investor’s counsel is typically retained to strategize and implement licensure transfers (since licenses are the most fundamental aspects of these businesses), the investors and the client both agreed that the our regulatory team should strategize and implement the licensure transfer process given their experience and past successes.</li>
<li>Retained by a private equity-backed provider of veterinary health technology, pharmacy services, and care coordination solutions to provide regulatory due diligence and counsel—including developing and implementing a strategy for license transfer—in its acquisition of a number of veterinary compounding pharmacies and in its merger with the nation’s largest veterinary compounding pharmacy.</li>
<li>Represented a private equity firm’s portfolio company in a significant number of acquisitions of nationally recognized compounding pharmacies. Our team provided regulatory due diligence and counsel on these transactions, including implementing change of ownership strategies, which have involved up to 50 different licenses, registrations, and accreditations in many of these transactions.</li>
<li>Provided regulatory due diligence and counsel to a private equity-backed healthcare company in its acquisition of a prominent compounding pharmacy. Our work included developing and implementing the strategy for a complex change of ownership process for the target, which involved more than 50 different licenses, registrations, and accreditations, including specialty licenses required for compounded sterile medicines.</li>
<li>Led a regulatory team advising a veterinary compounding pharmacy in relation to its acquisition of one of its chief competitors, in one of the most significant transactions for animal compounding pharmacies to date. ’Our regulatory team evaluated business synergies, performed due diligence, and performed the change of ownership process, involving 160 different state and federal licenses.</li>
<li>Led a regulatory team advising a nationally recognized compounding pharmacy and a federal outsourcing facility in Colorado in its acquisition by a private equity firm. Our regulatory team also performed the change of ownership process, involving over 60 state and federal licenses.</li>
<li>Led a pharmacy and FDA regulatory diligence team on behalf of a provider of home infusion services in connection with its agreement to merge with another provider of home infusion services to create one of the nation’s largest providers of home infusion services.</li>
</ul>
Regulatory
<ul>
<li>Represented an outsourcing facility with respect to an FDA inspection, including handling all written submissions to FDA and representing the facility in its most recent compliance conference with FDA. With our guidance, the client has maintained ongoing operations and worked efficiently and cooperatively with FDA to ensure compliance with applicable standards.</li>
<li>Represented an FDA-registered compounding pharmacy in an FDA inspection, including fielding inquiries from FDA investigators and preparing comprehensive responses to Form 483 and subsequent inquiries.</li>
<li>Counseled a nationally recognized FDA-registered compounding pharmacy on its arrangement with major telemedicine providers and platforms, including providing advice and counsel on all manner of telehealth compliance issues including the latest telehealth regulatory changes at the state level.</li>
<li>Advised a publicly traded dietary supplement company on its introduction to the dietary supplement and drug space with its innovative new drug product. The work of introducing the new product into drug space included advising on the process for executing drug studies; crafting outsourcing fulfilment agreements; reviewing and commenting on proposed marketing initiatives; advising on anti-kickback and fraud and abuse issues; and assessing planned foreign marketing initiatives.</li>
<li>Provided regulatory review of a publicly traded healthcare company’s marketing and advertising plans to ensure compliance with FDA regulations and guidelines, including performing a comprehensive review of the client’s website, direct-to-consumer advertising, physician marketing programs, pamphlets, labels, and other potentially patient-facing materials. Additionally, the team provided regulatory counsel in preparation for the company’s initial public offering.</li>
<li>Counsels pharmacies (including nuclear), outsourcing facilities, hospital systems, drug distributors, and physician and veterinary practices with compliance with various state and federal healthcare laws including the Drug Quality and Security Act’s Compounding Quality Act (“DQSA-CQA”), DEA, and relevant state board regulations.</li>
<li>Counsels telehealth platforms, online prescription management services, and other innovative technological business models with compliance with state and federal healthcare laws, including the DQSA-CQA, DEA, and relevant state board regulations.</li>
</ul>
Commercial Litigation
<ul>
<li>Lead trial and appellate counsel for an Italian vineyard on $18 million breach of the warranty of merchantability claim, obtaining a defense verdict following a month-long jury trial. ’Successfully defended the jury verdict’. Lead American liaison counsel assisting with American law issues in the companion Italian matter.</li>
<li>Lead trial counsel in defending a United States construction corporation against a challenge from an Italian quarry in a contract dispute. Lead American liaison counsel assisting with the American law issues in the companion Italian matter.</li>
<li>As appellate counsel, successfully defended a judgment of $3.3 million.</li>
</ul>
Child Pornography Civil Actions
<ul>
<li>Trial counsel for two sets of minor girls who alleged that an entertainment brand and its founder and creator created child pornography featuring them.</li>
<li>As lead appellate counsel, successfully overturned the district court to allow plaintiffs to proceed anonymously at trial.</li>
</ul>
Pro Bono Work
<ul>
<li>Vacated prostitution convictions for several trafficked women with the Chicago Alliance Against Sexual Exploitation (“CAASE”), under the Illinois Justice for Victims of Sex Crimes Trafficking Act.</li>
</ul>

Trump Administration Resource Hub

Rachael G. Pontikes

Rachael G. Pontikes

Offices

Stay Connected

Slide Menu

Slide Search

Offices

Stay Connected