Hyman Phelps and McNamara
 
John A. Gilbert, Jr.
Director
Photo of John A. Gilbert, Jr.

(202) 737-4293
jgilbert@hpm.com

Practice Areas
Prescription Drugs and Biologics
Enforcement
Controlled Substances
Drug Supply Chain and Distribution

Education
J.D., Columbus School of Law, The Catholic University of America
B.A., Political Science, Westfield State College

Bar Admissions
District of Columbia
Virginia

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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.


Related Experience
• 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.

Professional Affiliations
American Bar Association

Articles / Publications   
Efforts to Combat Prescription Drug Abuse Should Not Limit Access to Compounded Pain Medicine,  September 2009

Winning Legal Strategies for Food & Drug Companies,  January 2007


Speaking Engagements    -    see fewer speaking engagements
ACI Legal, Regulatory & Compliance Forum on Controlled Substances,  January 16 - 17, 2014  Setting the Stage: Overview of DEA and FDA Regulation of Pharmaceutical Controlled Substances

FDLI Controlled Substance conference,  March 28, 2013  DEA and FDA Regulation of Controlled Substances: What to Expect in 2013

FDLI: Controlled Substances Regulation - Understanding FDA and DEA Missions, Rules & Policies,  February 13, 2012  Moderator: "The Scheduling Process: What You Need to Know"

8th Annual Controlled Substances Industry, Pharmacy and Listed Chemicals Conference,  November 10 - 12, 2010  State and Federal Legal Update on Controlled Substances

Buzzeo/PDMA's 7th Annual Controlled Substances Conference,  November 4 - 6, 2009

State and PDMA Regulatory Conference,  April 3, 2009  Legal update on the increasing impact of federal and state requirements on sampling and prescription drugs

Planning Committee for FDLI's Regulation of Controlled Substances Conference,  December 4 - 5, 2008


Blog Posts    -    see more blog entries
DEA Controls Tramadol as a Schedule IV Controlled Substance, Effective August 18, 2014,  July 2, 2014
Proposed Federal Legislation Aims to Speed Up DEA,  April 7, 2014
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2014/03/state-marijuana-initiatives-put-us-in-the-hot-seat-with-the-incb.html,  March 17, 2014
Maryland Bill Would Place Wholesale Distributors in Catch-22 with DEA Suspicious Order Requirements,  March 9, 2014
DEA Representative States it has Received the HHS Recommendation on Rescheduling of Hydrocodone,  February 9, 2014