News & Analysis as of

DEA Pharmaceutical Industry

DOJ Settlement Looks to Set New Benchmarks for Suspicious Order Monitoring

by Ropes & Gray LLP on

This week, the U.S. Department of Justice and Drug Enforcement Administration announced a $35 million settlement with a major pharmaceutical manufacturer to resolve alleged failures to monitor and report suspicious orders for...more

DEA Tweaks, Walks Back Changes to Renewal Process

by Akerman LLP - Health Law Rx on

DEA recently revised an earlier announcement that would have eliminated the grace period for renewals of controlled substance registrations. After initially declaring that prescribers and other registrants would no longer be...more

Ninth Circuit Considers Limits to DEA Access to Oregon PDMP

by McDermott Will & Emery on

On November 7, 2016, the US Court of Appeals for the Ninth Circuit heard arguments in Oregon Prescription Drug Monitoring Program v. United States DEA, No. 14-35402 (9th Cir. 2016). Here, the Drug Enforcement Administration...more

DEA Posts Significant Change to Registration Renewal

by McDermott Will & Emery on

The DEA recently posted to its website notice of a significant change to its registration renewal process. This change eliminates the informal grace period which the DEA had previously allowed registrants to renew their...more

Pharmacy Drug Take-Back Programs Get Green Light in California

by Morrison & Foerster LLP on

On October 26, 2016, the California Board of Pharmacy adopted regulations largely tracking the federal Drug Enforcement Administration’s program encouraging pharmacies to voluntarily collect and dispose of unwanted, unused or...more

The Marijuana Industry’s Big Win: The DEA’s Refusal to Reschedule

by Wilson Elser on

Earlier this year, when the U.S. Drug Enforcement Agency (DEA) indicated it would have an announcement regarding a now five-year-old petition to reschedule cannabis, numerous industries on the “outside looking in” were...more

Congress and Obama Administration Take Steps to Ease Buprenorphine Access

by McDermott Will & Emery on

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

by Michael Volkov on

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

A&B Healthcare Week in Review

by Alston & Bird on

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

by K&L Gates LLP on

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

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

by BakerHostetler on

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

by Williams Mullen on

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

by Beveridge & Diamond PC on

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

DEA Rules On Disposal of Controlled Substances - What's Up? - EndNotes February 2015

by Poyner Spruill LLP on

Questions remain about the U.S. Drug enforcement agency’s rules on secure disposal of controlled substances and exactly how they will be implemented with regard to the disposal of controlled substances by hospice personnel...more

Washington Healthcare Update

by McGuireWoods LLP on

This Week: President’s FY2016 Budget Request... FDA Commissioner Hamburg to step down... Tennessee Medicaid expansion plan rejected by legislature. 1. Congress House House Ways and Means Committee Hosts Hearing...more

DEA Authorizes Take-Back Programs for Pharmacies

by BakerHostetler on

The U.S. Drug Enforcement Administration (DEA) recently issued a Final Rule expanding the facilities that can collect unused prescription drugs to now include retail pharmacies, hospitals and pharmaceutical manufacturers, as...more

Legal Landscape and Guidance for Companies Involved in Marijuana Activity

by Holland & Knight LLP on

Many states now permit the use of marijuana for medical or recreational purposes and the federal government has revised certain enforcement policies related to marijuana-related crimes. The possession, use,...more

DEA Schedules Tramadol As A Schedule IV Controlled Substance

by King & Spalding on

On July 2, 2014, the Drug Enforcement Administration (DEA) published its Final Rule placing tramadol into Schedule IV of the Controlled Substances Act (CSA). Tramadol is a synthetic opioid analgesic used in the...more

Disposing Of Pharmaceutical Waste: Some Progress

by Pepper Hamilton LLP on

In 2008, the U.S. Environmental Protection Agency (EPA) seemed to be on the road to providing some much-needed clarity to hospitals and other medical facilities concerning the disposal of pharmaceuticals by proposing that...more

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