Karla L. Palmer Director 202-737-7542
Karla L. Palmer


With over 30  years’ experience as a litigator, Karla Palmer’s focus at Hyman Phelps is on DEA and FDA enforcement and litigation matters.  Ms. Palmer advises clients throughout the supply chain – from manufacturers and distributors to outsourcing facilities, pharmacies and doctors – on a range of issues including DEA and FDA regulations and guidance, government inspections (including Form 483s) and investigations, warning letters, recalls, consent decrees, and administrative and federal proceedings.  She has also handled administrative proceedings at DEA involving, but not limited to, registrant revocation actions, including the appeal of those matters in federal courts throughout the country.  She also regularly represents clients in board licensing actions throughout the United States.  In addition, she has written about and addressed industry audiences across the country on all aspects of the passage and implementation of the 2013 Drug Quality and Security Act including both compounding and supply chain issues, its guidance documents, and implementing regulations.  She is well-versed in compounding laws, regulations and guidance, and regularly counsels clients on these topics.

Over the course of her career, Ms. Palmer has also been involved in all aspects of general commercial litigation matters. She has served as trial counsel in federal, state, and administrative courts in the District of Columbia, Florida, Illinois, Maryland, New York, Nevada, Pennsylvania, Kansas, Virginia, and before the Court of Federal Claims, the U.S. Tax Court, and Federal Energy Regulatory Commission (FERC). She also has significant arbitration and mediation experience.

Before joining Hyman, Phelps & McNamara in 2010, Ms. Palmer was a partner at a large international law firm where she was head of the Washington, D.C. trial department and co-partner-in-charge of its national recruiting program. Following law school, Ms. Palmer clerked for the Honorable Claude M. Hilton, former Chief Judge of the U.S. District Court for the Eastern District of Virginia, Alexandria Division. She has served as both lead and local counsel in the Eastern District of Virginia.

While in law school, Ms. Palmer was an associate editor of The University of Richmond Law Review, a member of the McNeill Law Honor Society, and a legal writing teaching assistant.

Ms. Palmer currently serves on the Board of Governors, Health Law Section,  of the Virginia State Bar.

Education & Admissions


J.D., cum laude, University of Richmond School of Law
B.A., Economics and Government, College of William & Mary


District of Columbia
U.S. District Courts for Eastern and Western Districts of Virginia
U.S. District Court for the District of Columbia
U.S. Bankruptcy Courts for the Eastern and Western Districts of Virginia
U.S. Court of Appeals for the District of Columbia Circuit
U.S. Court of Appeals for the Fourth Circuit
U.S. Court of Federal Claims
U.S. Tax Court


  • Provides counsel on DEA registration matters, security, scheduling, investigations, and enforcement actions to registrants throughout the drug supply chain.
  • Participates in administrative and judicial proceedings involving DEA and FDA matters. Counsels clients on FDA inspections and investigations,  including responding to FDA Form 483s, recalls, and warning letters with particular focus on compounding pharmacies and outsourcing facilities.
  • Counsels outsourcing facilities and compounding pharmacies concerning investigations,  compliance and enforcement matters.
  • Participates in litigation relating to approval of certain prescription drugs and medical devices.

Speaking Engagements

  • Presenter, A4PC, Compounding Pharmacy Owner Summit, Pain Points: How FDA Thinks, April 4-6, 2024
  • Presenter, Third Annual Puerto Rico Pharmaceutical Summit, Coming and Going: Exporting FDA Regulated Products from Puerto Rico, February 6, 2024
  • Co-Presenter and Organizer: The “End” of the COVID-19 Emergency: The Ryan Haight Act,  Telemedicine,
    and Next Steps?,”  DEA’s proposed rules on telemedicine prescribing for controlled substances, Webinar, Hyman, Phelps & McNamara, P.C., March 23, 2023
  • Co-Presenter, “FDA Drug Approvals and More,” Puerto Rico Pharmaceutical Summit, San Juan, Puerto Rico, February 15, 2023
  • Co-Presenter, “Opioid Treatment: Federal ‘Legal Speak’ 2023,”  Opioid Settlement Abatement Summit – Model Guidance for States, Counties, Municipalities and Tribes, Georgetown University, Washington, D.C., January 26, 2023
  • Co-Presenter, “Pharmacists Ask: ‘What is My ‘Corresponding Responsibility’ in 2022, and What Do I Do About It?’” American Society of Pharmacy Law, Naples, Florida, November 3-6, 2022
  • Co-Presenter, “Establishing a Legally Compliant Referral Network,” National Association of Specialty Pharmacies Law Day, Orlando, Florida, September 19-22, 2022
  • Presenter, FDLI Webinar, Updates and Developments in Drug Compounding, August 30, 2022
  • Presenter: APhA2022,  Pharmacists in Peril? Beyond the Rx: DEA Enforcement Trends for a Pharmacist’s Corresponding Responsibility Violations, March 2022
  • Co-presenter: HDA Distribution Management Conference and Expo, Controlled Substances Legal Panel: Enforcement Update, March 2022
  • Co-Presenter, HPM and Analysis Group Webinar: Controlled Substances Act Issues: Legal Perspective and Analytical Trends, The Pharmacist’s Corresponding Responsibility: Legal and Regulatory Requirements and Recent Enforcement Activity, April 27, 2021
  • Presenter, LawLine, Maintaining Compliance in Pharmacy Compounding: Regulatory and Enforcement Updates, December 2020
  • Co-Presenter, Compounding Pharmacy Compliance Virtual Event, Bulk Drugs & Essential Copies – What’s New & What’s Coming Next, November 2020
  • Co-Presenter, Eagle Analytical Virtual Seminar, “The Inspection – The Movie,” November 2020
  • Presenter, FDA News, Pharmacy Compounding Regulation: FDA’s Latest Guidance, Compliance and Enforcement Activities, October 2020
  • Presenter and Moderator, FDLI Webinar, Bulks and Compound Products in Light of COVID, September 2020
  • Co-Presenter, American Society for Pharmacy Law Conference, Blunt Talk About Cannabis: A Primer on the Legislation of CBD, November 2019
  • Co-Presenter, National Community Pharmacy Association Annual Convention, Hemp: Positioning Yourself as the Truth Expert, October 2019
  • Moderator, Healthcare Distribution Alliance, 2019 Traceability Seminar; DSCSA Supply Chain Traceability: Legal Expert Panel Discussion, October 2019
  • Presenter, NASCSA, Understanding the SUPPORT Act: State and Industry Implications,  October 2019
  • Presenter, CBI Compounding Pharmacy Compliance West, Inspection Preparation and Response: What to Expect During an Inspection of a 503A Pharmacy, September 2019
  • Presenter, FDANews Webinar, Pharmacy Compounding Regulation: A Fresh Look at Guidance, Compliance, Enforcement, July 2019
  • Panelist and Member of Planning Committee, Bulk Substances and Essential Copies: Draft Guidance and Recent Litigation, Food and Drug Law Institute Drug and Quality and Security Act Conference, December 4, 2018
  • Panelist,  Controlled Substances 2018: DEA and Industry Challenges, American Society for Pharmacy Law 2018 Fall Meeting, November 1, 2018
  • Presenter, FDANews Webinar, Pharmacy Compounding Regulation: Deconstructing Latest Guidance, Compliance & Enforcement Activities, October 2018
  • Presenter, FDA: Update, Inspections, and Best Practices, PCCA International Seminar, October 26, 2018
  • Presenter, An Examination on How to Navigate Compliance with Both the FDA and the Pharmacy State Board, CBI Compounding West, September 27, 2018
  • Co-Presenter, Law Line Course, Current Trends in DEA Diversion-Related Enforcement, available April 2018
  • Planning Committee Chair, Food and Drug Law Institute: Drug Quality and Security Act Conference,  November 15, 2017
  • Moderator, DQSA, Title II, Licensure of Wholesale Distributors and 3PLs: Where Does FDA Stand, Where do States Stand, What about VAWD, and What Can you Do about It?, Food and Drug Law Institute: Drug Quality and Security Act Conference, November 15, 2017
  • Speaker, American Society for Pharmacy Law; Developments in Pharmacy Law Seminar XXVII, What’s Now in the Mix? Compounding Four Years After NECC and the DQSA, November 2-5, 2017
  • Presenter, Public Affairs Workshop – FDA Inspections: What to Expect and Best Practices to Stay Compliant, PCCA International Seminar, October 5, 2017
  • Speaker, Webinar,  Compounding Still In the Mix: Title I of the DQSA, the Compounding Quality Act, Three Years Later, Food and Drug Law Institute, May 18, 2017
  • Co-Presenter, 20th Annual Controlled Substance and State Regulatory Conference, Legal Updates and Insights: DEA in 2016-2017, April 26-28, 2017
  • Co-Presenter, International Vein Congress Symposium, Presentation on Compounded Drug Products, April 20-22, 2017 
  • Co-Presenter, Law Line Course, A Guide to DEA Administrative Actions and Hearings, April 2017
  • Co-Presenter, 19th Annual Controlled Substances & State Regulatory Conference (IMS Health), Drug Quality and Security Act Title II: Drug Supply Chain Security Act, Legal Update, April 27-29, 2016
  • Co-Presenter, Food and Drug Law Institute – Drug Quality and Security in 2016, Recent FDA Guidance and Enforcement Discretion, February 23, 2016
  • Co-Presenter, Food and Drug Law Institute, Drug Compounding Panel, “Drug Quality and Security in 2016″, January 26, 2016
  • Co-Presenter, Federal Bar Association Annual Litigation Conference, Hot Topics in Litigation, October 27, 2015
  • Co-Presenter, Pennsylvania Bar Institute’s (PBI) Health Law Institute, ABCs of DEA Enforcement, March 13, 2015
  • FDLI and the University of Maryland Schools of Law and Pharmacy Present Emerging Issues in FDA Law: Implementation of DQSA: FDA’s Interim Guidance For Human Drug Compounding Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act, December 3, 2014
  • Co-Presenter, Association of Corporate Counsel, Health Law Committee, Recent DEA Enforcement Trends, August 6, 2013

J.D., cum laude, University of Richmond School of Law
B.A., Economics and Government, College of William & Mary


District of Columbia
U.S. District Courts for Eastern and Western Districts of Virginia
U.S. District Court for the District of Columbia
U.S. Bankruptcy Courts for the Eastern and Western Districts of Virginia
U.S. Court of Appeals for the District of Columbia Circuit
U.S. Court of Appeals for the Fourth Circuit
U.S. Court of Federal Claims
U.S. Tax Court

Practice Areas
FDA Regulatory Categories