About Us

We spent our careers inside the FDA — writing policy, directing enforcement, and protecting patients. Now we apply that experience to help organizations navigate the most complex regulatory landscape in healthcare with confidence and precision.
We are former FDA senior officials united by one mission – strategic clarity for the compounding sector.
Our Services
Our Mission

To Advance the Integrity of the Drug Compounding Sector.

To advance the integrity of the drug compounding sector by providing the strategic clarity and regulatory foresight necessary to protect patients and strengthen healthcare. 

"We don’t speculate on regulatory expectations. We helped shape them."
— Compounding Strategy Advisors

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Years Combined Public Service

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Pharmacist Principals

Compliance Should Be Proactive, Not Reactive

We believe the most effective compliance programs are built before enforcement demands them — designed with regulatory intent in mind, not assembled in response to a 483 observation.

The "Why" Is as Important as the "What"

Understanding the policy intent behind a regulatory requirement is the difference between a program that checks a box and one that provides lasting protection. We bridge that gap.

Patient Safety is Foundational

Every recommendation we make is filtered through a single question: does this protect the patient? Organizations that align regulatory excellence with patient outcomes are the ones that endure.

Meet the Principals

Decades of FDA Experience.
One Shared Mission.

Our guidance is rooted in the belief that responsible, high quality compounding, which prioritizes patient safety and regulatory alignment, ultimately drives business success. There are no shortcuts in this space. We help clients achieve excellence not by cutting corners, but by mastering the complexity of the regulatory landscape.

Kathleen Anderson

Principal & Co-Founder
Compounding Strategy Advisors, LLC

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Kathleen Anderson, PharmD, is a senior regulatory leader with more than 35 years of experience at the U.S. Food and Drug Administration, specializing in compliance, enforcement, and complex prescription drug oversight.


Throughout her tenure, she held some of the most consequential positions in pharmaceutical compounding regulation in the federal government.

She served as Deputy Director and Acting Director of the Office of Unapproved Drugs and Labeling Compliance, where she guided the office through the 2012 fungal meningitis outbreak — an inflection point that claimed dozens of lives and drove passage of the landmark Compounding Quality Act (CQA) and the establishment of the FDA’s Office of Compounding Quality and Compliance (OCQC).

As Deputy Director of the newly established OCQC, Dr. Anderson played a central role in implementing and operationalizing the CQA across the industry. Her leadership created and advanced foundational programs including outsourcing facility registration, adverse‑event reporting systems, compounding incident management, and the risk‑based surveillance and inspection frameworks that govern the sector today.

Dr. Anderson’s expertise extends across prescription drug labeling, marketed unapproved drugs, repackaging, API importation, and broader regulatory compliance strategy. She is widely recognized for her ability to translate complex regulatory requirements into practical, scalable programs that strengthen public‑health protections while maintaining workable paths for industry.

Through Compounding Strategy Advisors, she continues to shape the evolving regulatory landscape — applying deep institutional knowledge and strategic insight to help organizations build compliance programs that are built to last, not just to pass.

Education & Credentials

  • BS Pharmacy, Duquesne University
  • PharmD, University of Arkansas for Medical Sciences
  • Licensed Pharmacist
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Ilisa Bernstein

Principal & Co-Founder
Compounding Strategy Advisors, LLC
President, Bernstein Rx Solutions, LLC

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Ilisa Bernstein, PharmD, JD, is a nationally recognized leader in drug and pharmacy regulatory strategy, policy, and compliance. Driven by a steadfast focus on drug quality and patient safety, she brings over 35 years of experience across government, non-profit, and private sectors — including some of the most senior regulatory and professional roles in the pharmacy profession.


For more than 30 years, Dr. Bernstein served in senior roles at the FDA, including as Deputy Director of the Office of Compliance in CDER — where she oversaw a 450-person multidisciplinary organization responsible for regulatory oversight across all human drugs, including compounding — and as senior policy advisor in the Office of the Commissioner. She was instrumental in developing the Compounding Quality Act and led implementation of the Drug Supply Chain Security Act, shaping the legal and operational framework for modern pharmaceutical compliance.

Following her FDA career, Dr. Bernstein served nearly five years at the American Pharmacists Association, including as its 14th CEO and Executive Vice President — the first woman to lead the 172-year-old organization in its history. In that role, she guided APhA as the voice of pharmacists across all practice settings, deepening her understanding of the full spectrum of compounding challenges at the clinical, regulatory, and advocacy levels.

Through Compounding Strategy Advisors, Dr. Bernstein applies decades of experience developing and implementing federal compounding policy to help stakeholders translate regulatory requirements into practical, actionable operational approaches. Through Bernstein Rx Solutions, she advises on drug and pharmacy regulatory policy and strategy, including drug supply chain security, distribution, pharmacy practice, and government affairs.

Education & Credentials

  • PharmD, University of Michigan College of Pharmacy
  • JD, American University Washington College of Law
  • Licensed Pharmacist & Attorney

Board Member

  • United States Pharmacopeia
  • FDA Alumni Association
  • Alliance for Safe Online Pharmacies
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Frances Gail Bormel

Principal & Co-Founder
Compounding Strategy Advisors, LLC

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Frances Gail Bormel, RPh, JD, is a nationally recognized leader in FDA compounding compliance and drug quality, with more than 30 years of experience across federal and state government, private legal practice, and regulated industry.


A licensed pharmacist and attorney, she has built a distinguished career at the intersection of law, science, and public health — advising on complex regulatory matters at the highest levels of the federal government.

Ms. Bormel served as the founding Director of the FDA’s Office of Compounding Quality and Compliance — the first and only person to hold that role — where she led a multidisciplinary team of more than 100 professionals overseeing the nation’s 503A and 503B compounding sectors through inspections, policy development, enforcement, and training. She established the Compounding Quality Center of Excellence to strengthen the outsourcing facility sector, and led key initiatives to modernize oversight, improve patient access, and support compliance during both routine operations and public health emergencies.

Earlier in her career, Ms. Bormel held senior leadership roles in FDA’s Office of Compliance, as well as legal and regulatory positions at the United States Pharmacopeia, the law firm of Hyman, Phelps & McNamara, P.C., and the Massachusetts Department of Public Health — giving her one of the most comprehensive vantage points in the field.

Widely respected for her leadership, integrity, and depth of regulatory expertise, Ms. Bormel helps clients navigate the most complex compounding challenges with clarity, confidence, and practical, implementable solutions.

Education & Credentials

  • JD with Honors, The George Washington University Law School
  • BS Pharmacy with High Honors, University of Maryland
  • Licensed Pharmacist & Attorney
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