FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. On October 10th, based on ability to pay, the U.S. 6, 2023 ( DOJ Press Release ). Zarzamora Press Release.

Controlled Substances 139

Controlled Substances Documentation Dosage Prescription Filling 139

FDA Law Blog: Biosimilars

MAY 19, 2025

While the presence of a dispensing red flag does not prohibit a pharmacist from filling a controlled substance, it means that there is a potential concern with the prescription, which the pharmacist must address andmake a record of its resolution, assuming it is resolvable.

Controlled Substances 64

Controlled Substances Dosage 64

FDA Law Blog: Biosimilars

APRIL 8, 2024

The White Paper notes that of the 123 drugs in shortage in January 2024, a quarter were first reported in shortage prior to 2020, with the oldest dating back to 2012, and shortages were experienced across therapeutic areas; analgesics/anesthetics (17%), anti-infective (12%), and cardiovascular (13%) products comprised 42% of shortages.

Inpatient 59

Inpatient Hospitals Dosage Controlled Substances 59