John A. Gilbert, Jr.
John A. Gilbert, Jr. advises clients extensively on legal and regulatory issues concerning controlled substances, prescription drugs, and precursor chemicals. His expertise extends to all regulatory and enforcement areas on federal and state laws and regulations governing the scheduling, manufacturing, distribution, dispensing, import and export of drugs and chemicals. He has extensive knowledge of the relationship and interaction of the federal Controlled Substances Act (CSA) and state laws governing controlled substances and precursor chemicals.
Mr. Gilbert has advised hundreds of companies at all levels of the drug supply chain in regard to regulatory and enforcement matters including show cause actions and recordkeeping and reporting requirements. He has conducted numerous investigations and inspections related to compliance with federal and state laws related to controlled substances and listed chemicals. He routinely represents clients before the Drug Enforcement Administration (DEA) and has handled numerous litigation matters involving civil and administrative actions related to violations of the CSA and state laws. Mr. Gilbert represents clients in administrative proceedings before the DEA Office of Administrative Law Judges and civil actions initiated by U.S. Attorney Offices in federal court.
Mr. Gilbert also advises clients on compliance with federal and state requirements on licensing, pedigree, track and trace, and drug sampling requirements, including regulations associated with the Drug Quality and Security Act.
Mr. Gilbert also has extensive experience in scheduling and regulation of controlled substances under the international drug control treaties and issues related to the United Nations Drug Control Program. He has advised and represented clients on matters related to the World Health Organization's Expert Committee on Drug Dependence, the International Narcotics Control Board and the U.N. Commission on Narcotic Drugs.
Before joining the firm in 1995, Mr., Gilbert was an attorney in the DEA's Office of Chief Counsel, Diversion/Regulatory Section. He also served as law clerk to the DEA's Chief Administrative Law Judge as part of the U.S. Department of Justice's Honors Program.
• Advises clients on DEA regulations, policies and practices, and other federal and state criminal and civil statutes and regulations related to controlled substances and regulated chemicals.
• Provides counsel on DEA enforcement actions and registration issues.
• Negotiates and prepares MOA, MOU, registration restrictions, show cause hearings and proceedings, Letters of Admonition, and civil penalty demand letters.
• Evaluates prescription drug business practices to ensure procedures for record keeping comply with regulation.
• Advises on the regulation of chemicals, including pre-cursor ingredients used in the manufacture of controlled substances.
• Represents clients in various civil, criminal and administrative litigation proceedings.
• Provides guidance on business procedures around DEA registration, record keeping and reporting, and security.
American Bar Association
Articles / Publications
• A Matter of Substantial Discretion: A Recent Rift between DEA and Its ALJs Could Significantly Impact Registrants,
• Efforts to Combat Prescription Drug Abuse Should Not Limit Access to Compounded Pain Medicine,
• Winning Legal Strategies for Food & Drug Companies,
see fewer speaking engagements
• IMS Health 19th Annual Controlled Substance & State Regulatory Conference, DSCSA (Title II) Legal Update, April 27-29, 2016
• IMS Health 9th Annual Hospital Practices Seminar, JAG 4/27 Speech: “DEA and the Hospital Setting – Addressing the Changing Landscape”; MMM 4/27 Speech: “Medical Device Reporting (MDR) Regulation – Are you Prepared for an FDA Inspection?”, April 27, 2016
• 2016 HDMA Distribution and Management Conference, March 6-9., John Gilbert is speaking on regulatory issues in Combating Prescription Drug Abuse., 3/6/2016-3/9/2016
• ACI Legal, Regulatory & Compliance Forum on Controlled Substances, Setting the Stage: Overview of DEA and FDA Regulation of Pharmaceutical Controlled Substances, January 16 - 17, 2014
• FDLI Controlled Substance conference, DEA and FDA Regulation of Controlled Substances: What to Expect in 2013, March 28, 2013
• FDLI: Controlled Substances Regulation - Understanding FDA and DEA Missions, Rules & Policies, Moderator: "The Scheduling Process: What You Need to Know", February 13, 2012
• 8th Annual Controlled Substances Industry, Pharmacy and Listed Chemicals Conference, State and Federal Legal Update on Controlled Substances, November 10 - 12, 2010
• Buzzeo/PDMA's 7th Annual Controlled Substances Conference, November 4 - 6, 2009
• State and PDMA Regulatory Conference, Legal update on the increasing impact of federal and state requirements on sampling and prescription drugs, April 3, 2009
• Planning Committee for FDLI's Regulation of Controlled Substances Conference, December 4 - 5, 2008
see more blog entries
• Is it Scheduling or Rescheduling? DEA Issues Interim Rule on Oral Solutions of Dronabinol,
April 4, 2017
• Trying to Untie the Gordian Knot: New Attempts to Change Federal Law on Marijuana,
February 8, 2017
• DEA Finalizes Amendments on Imports and Exports, But Misses Opportunity to Improve Re-Export Requirements,
January 8, 2017
• DEA Administrative Hearings: “Open to the Public” Requires Notice to the Public,
October 26, 2016j
• How Many Federal Agencies Does it Take to Interpret the Industrial Hemp Law? USDA/DEA/FDA Weigh in on Industrial Hemp Research Requirements,
September 8, 2016