By John A. Gilbert On December 4 and 5, FDLI will hold a conference on Regulation of Controlled Substances: Balancing Medical Need and Diversion Control. The conference will focus on issues related to drug scheduling and regulation of controlled substances and List I chemicals and provide …
In an effort to eliminate rogue pharmacies from dispensing controlled substances over the Internet, Congress passed legislation amending the Controlled Substances Act (“CSA”). The Ryan Haight Act (H.R. 6353), which honors a teenager who died of an overdose of controlled drugs obtained over the Internet, …
A recent decision by the U.S. Court of Appeals for the District of Columbia in Chein v. DEA demonstrates the Court’s deference to agency expertise and a registrant’s heavy burden in overturning final action by the Drug Enforcement Administration (“DEA”) absent a “flagrant departure from …
In Novelty Distributors, Inc. v. Leonhart, the U.S. District Court for the District of Columbia recently confronted the issue of whether district courts have jurisdiction over a challenge to an agency action that is admittedly not final. Novelty Distributors, Inc. (“Novelty”), a distributor of controlled …
On June 27, 2008, the U.S. Drug Enforcement Administration (“DEA”) published a much anticipated Notice of Proposed Rulemaking Regarding Electronic Prescriptions for Controlled Substances. The proposed regulations are in addition to existing prescribing requirements for controlled substances and are expected to work in tandem with …
On May 22, 2008, the Drug Enforcement Administration (“DEA”) issued a final rule to allow every qualified practitioner to offer maintenance or detoxification treatment to 30 patients without obtaining a separate registration regardless of the number of other qualified practitioners within their medical practice. DEA …
A U.S. District Court recently denied the Drug Enforcement Administration’s (“DEA’s”) attempt to use an injunction to suspend a physician’s DEA registration. The court noted that the Controlled Substances Act (“CSA”) provides adequate administrative procedures to suspend a DEA registration. The court also denied the …
Dextromethorphan is an important ingredient in many cough/cold medications. The World Health Organization (“WHO”) is considering whether to schedule dextromethorphan as a controlled substance under the international conventions of the United Nations system. If that occurs, then the U.S. government will be obligated to schedule …
On November 27, 2007, the Drug Enforcement Administration (“DEA”) issued a proposed rule to implement a new format for DEA Official Order Forms (so-called “DEA-222s”). DEA requires registrants to acquire Schedule I or II controlled substances using triplicate, carbon-paper DEA-222s. DEA observes that processing transactions …
The Drug Enforcement Administration’s (“DEA”) final rule allowing individual practitioners to issue multiple Schedule II prescriptions to individual patients to be filled sequentially went into effect on December 19, 2007. The rule will allow practitioners to prescribe up to a 90-day supply of a Schedule …
The Drug Enforcement Administration (“DEA”) recently issued an advisory announcing that as of January 1, 2008, manufacturers of methadone HCl 40 mg tablets have voluntarily agreed to limit distribution due to the reported increase of adverse events related to methadone. This raises new issues for …
On November 20, 2007, the Drug Enforcement Administration (“DEA”) issued a proposed rule to remove the thresholds for distributing, importing, and exporting pseudoephedrine and phenylpropanolamine (“PPA”). In September 2007, DEA indicated in testimony before the Senate Finance Committee that the Agency was in the process …
In early October, we reported on legislation introduced in the U.S. House intended to restrict the distribution and possession of raw dextromethorphan, an antitussive drug found in many over-the-counter cold/cough drug products. Dextromethorphan is not a federally-controlled substance, however, the Drug Enforcement Administration (“DEA”) recently …
The U.S. Court of Appeals for the Seventh Circuit, in its recent opinion in United States v. Global Distributors, Inc., remanded for reconsideration to the U.S. District Court for the Northern District of Illinois (Eastern Division) the imposition of the maximum allowable monetary penalties under …
On September 27, 2007, the U.S. House of Representatives Committee on Energy and Commerce passed H.R. 970, the Dextromethorphan Distribution Act of 2007, after a legislative “mark-up” session. Similar legislation was introduced in the U.S. Senate in May 2007 (S. 1378) and was referred to …
