DEA Pharmaceutical Industry

News & Analysis as of

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

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

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

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

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

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

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

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

Federal Court Upholds California County’s Safe Drug Disposal Ordinance

On August 28, 2013, the U.S. District Court for the Northern District of California issued an order upholding Alameda County's Safe Drug Disposal Ordinance as constitutional. The ordinance, passed in July 2012 by the Alameda...more

Disposing Of Pharmaceutical Waste: Some Progress

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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