Karla L. Palmer
Karla L. Palmer focuses on DEA and FDA enforcement and litigation matters, with particular emphasis on Controlled Substances Act (CSA) issues. Ms. Palmer advises clients throughout the supply chain, from manufacturers and distributors to pharmacies and doctors on a range of issues including government inspections and investigations, warning letters, consent decrees, and administrative and federal proceedings.
Ms. Palmer also advises compounding pharmacies and outsourcing facilities on all aspects of the Drug Quality and Security Act, and has closely followed developments in the law prior to and since its enactment in late 2013.
Over the course of her career, Ms. Palmer has been involved in all aspects of commercial litigation. 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 is an immediate past member of the Board of Directors of the Law School Alumni Association at the University of Richmond, and is a former board member of Chattering Children, a nonprofit that provides speech and language education, therapy, and services to hearing impaired children throughout the Washington, D.C. area.
• Provides counsel on DEA registration matters, investigations, and enforcement actions to registrants throughout the drug supply chain.
• Advises on the regulation of listed chemicals, including pre-cursor ingredients used in the manufacture of controlled substances.
• Provides guidance on business procedures concerning DEA registration, record keeping and reporting, and security requirements.
• Participates in administrative and judicial proceedings involving DEA and FDA matters.
• Counsels clients on FDA inspections including responding to FDA Form 483s and warning letters with particular focus on compounding pharmacies and outsourcing facilities.
• Counsels outsourcing facilities and compounding pharmacies concerning compliance and enforcement matters.
• Participates in litigation relating to approval of certain prescription drugs and medical devices.
Law School Alumni Board of Directors, University of Richmond
Federal Bar Association
Permanent Member of the Judicial Conference for the Fourth Circuit
Articles / Publications
• The Need for Clarity: Where Should FDA Focus Its Resources When Implementing the Compounding Provisions of the Drug Quality and Security Act?,
February 4, 2014
• Court Ruling Casts Doubt On FDA's Use Of Guidance Documents,
December 16, 2011
• In the Name of Graduate Medical Education: What Mount Sinai Medical Center's FICA Tax Victory Means for Today's Teaching Hospitals,
• International Vein Congress, Presentation on Compounded Drug Products, April 20-22, 2017
• IMS Health 19th Annual Controlled Substance & State Regulatory Conference, DSCSA (Title II) Legal Update, April 27-29, 2016
• FDLI - Drug Quality and Security in 2016, Recent FDA Guidance and Enforcement Discretion, February 23, 2016
• Federal Bar Association Annual Litigation Conference, Hot Topics, October 27, 2015
see fewer blog entries
• Is FDA’s Interim Policy on Section 503B’s So-Called “Bulks List 1” Illegal? Did FDA Overstep its Statutory Authority? The Courts May Soon Decide,
October 29, 2017
• Commissioner Gottlieb’s Statement: “We Want You”..Seeking Able-Bodied Compounders to Register as Outsourcing Facilities Pursuant to FDCA Section 503B,
October 4, 2017
• United States v. Medistat RX LLC Consent Decree: FDA’s Latest Enforcement Effort Related to Compounders and Title I of the Compounding Quality Act,
July 24, 2017
• Animal Drug “Compounding”: Criminal Indictment Against Pharmacy and Veterinarian Withstands Federal District Court’s Scrutiny,
July 12, 2017
• Any Drug Manufacturer (Repackager, Dispenser, Distributor) Affected by the Serialization Deadline in the Drug Supply Chain Security Act Should Read ,
July 2, 2017
• Letter Signed by 65 Members of Congress Urges FDA to Reconsider “Office Stock” Restrictions for Section 503A Compounders,
May 31, 2017
• Jury Rules on Charges against Owner and Head Pharmacist of NECC,
April 4, 2017
• DEA Administrative Decisions Update: (Un)official Notice Revisited,
February 22, 2017
• Do President Trump’s Regulatory Freeze-Out and “1-in-2-Out” Orders Affect the Regulation of Compounding?,
February 20, 2017
• FDA Issues Final Guidance Addressing Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities,
January 18, 2017
• FDA’s Publishes (Yet Another) Interim Policy on Compounding with Bulk Substances for Both Section 503A and Section 503B Compounders,
January 17, 2017
• Drug Compounding: FDA Issues Final Guidance on Section 503A’s Individually Identified Prescription Requirement, With At Least Three Noteworthy Change,
January 11, 2017
• FDA Finalizes DSCSA Guidance on “Identification of Suspect Product and Notification” with A Twist,
December 19, 2016
• States in the Mix: GAO Releases Report to Congressional Committees on Drug Compounding,
November 24, 2016
• Keeping Up with ..... FDA’s Drug Compounding Lists: Todays PCAC Meeting,
November 2, 2016
• The Update Continues: FDA’s List of Drugs that May Not Be Compounded Under 503A and 503B,
October 27, 2016
• DEA Administrative Decisions Update: DEA’s Questionable Practice of (Un)official Notice,
October 25, 2016
• DEA Withdraws Notice of Intent to Place Opioids Mitragynine and 7-Hydroxymitragynine, in CSA’s Schedule I,
October 16, 2016
• FDA Updates List of Drugs that May Not Be Compounded Under 503A and 503B: Preamble Reminds Industry when Listed Drugs Can Still Be Compounded,
October 9, 2016j
• Insanitary Conditions 101: FDA Issues Draft Guidance for Compounding Facilities Based on Prior FDA Inspections: Comments due October 3, 2016,
August 7, 2016
• FDA Releases “Notice” Advising of Change in Inspections of Pharmacies Compounding Drug Products within FDCA Section503A: Let’s Watch What Happens Next,
July 20, 2016
• FDA Publishes Draft Guidance on What is “Essentially” a Copy of a Commercially Available Drug Under FDCA Sections 503A & 503B: Outsourcing Facilities,
July 15, 2016
• FDA Publishes Draft Guidance on What is “Essentially” a Copy of a Commercially Available Drug Under FDCA Sections 503A & 503B: Section503A Compounders,
July 14, 2016
• GAO Releases Report Recommending that the DEA Take Additional Actions to Address Prior GAO Recommendations,
June 29, 2016
• FDA Publishes Final “Interim Policy” for Both Sections 503A and 503B Compounding from Bulk Substances: Section 503B Bulks,
June 20, 2016
• Congress' Dubious Delegation of Legislative Authority to USP Standards Results in Instructions-But Not Dismissal-Related to NECC Criminal Indictment,
May 12, 2016
• FDA Issues Draft Guidance on Hospital and Health System Compounding: FDA Will Permit Compounding in Advance of Prescription for Hospital Pharmacies,
April 22, 2016
• FDA Addresses “Facility Definition” For Outsourcing Facilities: Manufacturers Can Live With Outsourcing Facilities But Section 503A Compounders Cannot,
April 21, 2016
• What the Doctor Ordered? What the Pharmacist Understood? FDA Issues Compounding Draft Guidance Addressing Compounding for Office Use under FDC Act § 5,
April 21, 2016
• Compounding the Dilemma over the Permissibility of Office Use Compounding: Congressman Requests Answers to Questions from HHS Secretary Burwell,
March 29, 2016
• HP&M’s Karla Palmer to Speak at FDLI’s Drug Quality and Security in 2016 Conference,
February 9, 2016