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DEA Pharmaceutical Industry Final Rules

Quarles & Brady LLP

Brace Yourself: DEA’s Final Rule on Quotas Squeezes Inventory Levels and Signals Further Supply Restrictions

Quarles & Brady LLP on

On August 31, 2023, DEA published a final rule (“Final Rule”) regarding its management of controlled substance and List 1 Chemical (“L1 Chemical”) quotas for DEA-registered manufacturers. The Final Rule largely tracks DEA’s...more

Bass, Berry & Sims PLC

Final Rule to Allow for "One-Time Only" Transfer of Electronic Controlled Substance Prescriptions Between Pharmacies

Bass, Berry & Sims PLC on

On August 28, 2023, amendments to Drug Enforcement Agency (DEA) regulation 21 CFR 1306.08 will go into effect, which amend the regulations allowing the transfer of initial electronic prescriptions for schedule II-V controlled...more

Quarles & Brady LLP

New DEA Form 106 Theft & Loss Reporting Deadlines and Submission Requirements

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On June 22, 2023, DEA published a final rule regarding the timing with which registrants are required to report the theft or loss of controlled substances (the “Final Rule”). 88 FR 40707. DEA’s regulations have always...more

Foley & Lardner LLP

Medication or Hazardous Waste? EPA Creates Significant New Requirements for Managing Unused Pharmaceuticals

Foley & Lardner LLP on

On December 11, 2018, U.S. EPA Acting Administrator Andrew Wheeler signed a new hazardous waste pharmaceutical rule. The final rule retains a proposed requirement, opposed by industry, that prescription pharmaceuticals sent...more

King & Spalding

DEA Schedules Tramadol As A Schedule IV Controlled Substance

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

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