FDA Law Blog: Biosimilars

MAY 16, 2024

Houck — Employee diversion of controlled substances from hospitals has been an issue since at least 1986 when I became a diversion investigator with the Drug Enforcement Administration (“DEA”). DEA alleged that UMHS failed to maintain complete and accurate records and failed to timely notify DEA of controlled substance thefts.

Controlled Substances 59

Controlled Substances Hospitals Intravenous Solutions 59

STAT

DECEMBER 21, 2022

California authorities are seeking to revoke a license held by a CVS Health mail-order pharmacy unit for violating several state laws that govern shipments of various controlled substances — including prescription painkillers and ADHD medicines — directly to patients.

Mail-Order Pharmacies 246

Mail-Order Pharmacies Controlled Substances 246

Board Vitals - Pharmacist

JANUARY 9, 2021

Alabama – 2 Credits The Alabama State Board of Medical Examiners requires 2 credit hours every 2 years on controlled substances for physicians. Connecticut – 1 credit The Connecticut Medical Examining Board requires 1 credit hour of training in prescribing controlled substances and pain management.

Controlled Substances 52

Controlled Substances 52

The Nontraditional Pharmacist

AUGUST 19, 2019

So I recently graduated in May of 2018 from VCU School of Pharmacy in Virginia and I work for a company called Kit Check, which is a Health I.T. What is really your current role, kind of a description of your day-to-day responsibilities and what you do. David [00:00:54] Yeah I’ll give you guys a little bit of backstory.

Controlled Substances 52

Controlled Substances Hospitals Pharmacy Technician 52

Pharmaceutical Technology

NOVEMBER 17, 2022

According to GlobalData analysis, specialist small molecule API capabilities such as containment or controlled substances are driving large contract manufacturing organisations (CMOs) to acquire facilities.

Controlled Substances 52

Controlled Substances Compounding 52

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

2018) , Arnold Partnership v. The PTO’s not-even-specious-argument, citing what certainly appears to us to be absolutely irrelevant case law, such as Novartis AG v. Ezra Ventures LLC, 909 F.3d 3d 1367 (Fed. Rogan , 246 F. 2d 460 (E.D. 2003) , and Biogen lnt’l v. Banner Life Sciences LLC, 956 F.3d 3d 1351 (Fed.

Controlled Substances 59

Controlled Substances Hospitals 59

FDA Law Blog: Biosimilars

SEPTEMBER 5, 2023

Houck — Scheduling Criteria Under the Controlled Substances Act (“CSA”) Schedule I: • High potential for abuse; • No currently accepted medical use in treatment in the U.S.; Schedule III: • Potential for abuse less than drugs or substances in schedules I and II; • Currently accepted medical use in treatment in the U.S.;

Controlled Substances 111

Controlled Substances 111