DEA

News & Analysis as of

Congress and Obama Administration Take Steps to Ease Buprenorphine Access

On Friday, July 22, President Obama signed the Comprehensive Addiction and Recovery Act of 2016 (CARA). Following on federal, state and local trends, CARA seeks to expand access for persons needing opioid treatment....more

DOJ Folds Criminal Case Against Federal Express

In another set back last week, after a contentious criminal prosecution, the government dismissed its criminal charges against Federal Express. DOJ indicted Federal Express for drug trafficking relating to shipping of illegal...more

Tackling a Panamanian Money Laundering Organization: OFAC Sanctions the Waked Money Laundering Organization, Colombia Arrests the...

OFAC Sanctions - On May 5, 2016, the U.S. Department of Treasury, Office of Foreign Assets Control (OFAC) announced sanctions against 77 entities and individuals associated with the Waked Money Laundering Organization...more

The Challenges of the Evolving Marijuana Industry: Reconciling State Legislation with Federal Prohibition

Cultivation, production, distribution, or possession of marijuana is a federal criminal offense under the Controlled Substances Act (the CSA). Yet, despite federal prohibition, state-sanctioned marijuana industries have...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

Pharmaceutical Diversion – Risks and Steps to Address a Major DEA Focus

The opioid crisis, an ever-increasing focus of the Obama administration and 2016 Presidential Primary field, has highlighted the efforts of the Drug Enforcement Administration (DEA) and the Department of Justice (DOJ) to...more

The Proponent Testimony Goes Unrefuted As Renowned Physician Dr. Sue Sisley Highlights The Testimony Of Ten Witnesses Before The...

Thursday, February 17, 2016, was the first evening session of the Ohio House of Representatives’ Medical Marijuana Task Force (“Task Force”), which heard a full complement of testimony, all in support of legalizing medical...more

FDA Regulatory and Compliance Monthly Recap — November 2015

Bill that refines marketing exclusivity for DEA scheduled drugs becomes law - The Improving Regulatory Transparency for New Medical Therapies Act (H.R. 639) was passed in the House of Representatives and was sent to...more

Marijuana Regulations Growing Like Weeds in California

Although California legalized medical marijuana in 1996, cities have differed widely in their response to medical marijuana dispensaries. Recently, Newport Beach joined Huntington Beach, Laguna Hills, Anaheim and Rancho Santa...more

Congress Clears Controlled Substances Act Scheduling Legislation

On November 16, 2015, the House of Representatives approved HR 639, the Improving Regulatory Transparency for New Medical Therapies Act, clearing it for the President. The legislation would amend the Controlled Substances...more

Expanding Scope of Federal Wiretapping Powers

USA Today’s front-page headline, above the fold, on November 12, 2015 read, “Massive Wire-tapping Operation in L.A.” The secondary headline read, “Drug Agents Intercept More Than 2 Million Conversations in USA.” ...more

FDA Regulatory and Compliance Monthly Recap — October 2015

FDA releases draft ICH guidance with aim to improve pharmaceutical benefit-risk assessments - The agency released ICH guidance to regulate how pharmaceutical makers should present benefit-risk information in regulatory...more

Federal court rules that DEA must stop interfering with compliant medical marijuana businesses

On October 19, 2015, the United States District Court for the Northern District of California rejected an argument by the US Government seeking a narrow interpretation of congressional legislation designed to limit federal...more

Health Care Physicians in the Crosshairs: Criminal Prosecution

Recent changes to our health care system have been at the forefront of the American news cycle for several years. But certain aspects have not received adequate attention. One example is the scrutiny federal and state...more

“My, what beautiful eyes you have . . .” – Biometric Data and Privacy

Biometric data – obviously not in just the movies anymore. It is alive, well, and increasingly being used in our everyday society. But, on September 23, 2015, when the Office of Personnel Management revealed that fingerprint...more

Don’t Flush the Drugs! The EPA is Coming!

The Environmental Protection Agency (EPA) recently issued a pre-publication Proposed Rule (40 C.F.R. part 266, subpart P) regulating the management and disposal of drugs deemed “hazardous waste pharmaceuticals” by healthcare...more

EPA Proposes Hazardous Waste Rule for Pharmaceuticals

A pre-publication draft of a proposed rule by EPA may clarify hazardous waste requirements for obsolete or defective pharmaceuticals. EPA proposes a new Subpart P entitled “Hazardous Waste Pharmaceuticals” to 40 CFR Part 266...more

EPA Proposes New Rules for Pharmaceutical Wastes That Qualify as RCRA Hazardous Wastes

On August 31, 2015, the Administrator of the U.S. Environmental Protection Agency (“EPA” or the “Agency”) signed a proposed rule that would establish special management standards for pharmaceutical wastes that are classified...more

The Telehealth Top 10 for 2015

Telehealth continues to be an innovative alternative to traditional brick-and-mortar medicine. The number of providers offering telehealth services is rapidly increasing and states are enacting laws requiring health plans to...more

Telemedicine Prescribers Should Read This Case: U.S. vs. Zadeh

Health care providers who use telemedicine for remote prescribing of controlled substances should pay close attention to an important case currently pending at the Fifth Circuit Court of Appeals. The case will decide whether...more

Think Twice about DEA Voluntary Surrender

It can be an intimidating experience to be sure… A DEA agent or Diversion Investigator, on an unscheduled visit to your office, confronts you with a KASPER, a KBML complaint or some other state regulatory action and alleges...more

Lines Crossed: From Enforcing to Breaking the Law

Silk Road was a notorious black market for narcotics that used seemingly untraceable digital currencies (i.e., Bitcoins) to facilitate illegal activities on the “dark web.” Last week, former Drug Enforcement Agency (“DEA”)...more

Drones: New Technology, New Opportunity?

The guidance states that drones recently “have emerged as a viable law enforcement tool.” In addition to affirming DOJ’s commitment to civil rights and privacy laws, the guidance imposes rules on who can order drone support...more

Locke Lord QuickStudy: Medical Marijuana Apps – Illegal Communication Facilities or the Next Big Thing?

A number of recent news articles have discussed the increased activity in the area of technology companies that facilitate the delivery of medical marijuana to patients. For example, according to a recent Forbes Magazine...more

Bringing Predictability and Speed to DEA’s Scheduling of New Drugs

A bipartisan bill working its way through Congress could have a major effect on how the Drug Enforcement Agency (DEA) classifies drugs under the Controlled Substances Act (CSA). The Improving Regulatory Transparency for New...more

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