FDA Law Blog: Biosimilars

JULY 31, 2023

CARA amended the Controlled Substances Act (“CSA”) to enable physicians or patients to request pharmacists to partially fill prescriptions for schedule II substances including opioids and to allow remaining quantities to be filled up to 30 days after issuance of the prescription (up to 72 hours for emergency oral prescriptions).

Controlled Substances 98

Controlled Substances Long-Term Care Facilities Dosage Communication 98

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. 11, 2023 ( DOJ Press Release ). 6, 2023 ( DOJ Press Release ). Zarzamora Press Release.

Controlled Substances 139

Controlled Substances Documentation Dosage Prescription Filling 139

FDA Law Blog: Biosimilars

APRIL 8, 2024

Specifically, DEA establishes an aggregate production quota (APQ) for each class of controlled substance listed in schedule I and II, and for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, which limits the amount of each substance that can be manufactured in a given year.

Inpatient 59

Inpatient Hospitals Dosage Controlled Substances 59

The Happy PharmD

APRIL 26, 2023

I decided to calculate the dosage quickly. A 5ml dosage contains 1.8g Or maybe there might be a different dosage of what you (the resident) want. It was available at a dosage of 0.5mg/5 ml. Dexamethasone oral solution is not a narcotic or controlled substance. Writing the dosage as a percentage.

Dosage 52

Dosage Hospitals Pharmacy Technician Prescription Filling 52

FDA Law Blog: Biosimilars

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. By Larry K.

Controlled Substances 69

Controlled Substances Chemotherapy Compounding Dosage 69

FDA Law Blog: Biosimilars

MAY 5, 2024

Houck — The Associated Press reported on Tuesday following confirmation by five anonymous individuals with knowledge that the Drug Enforcement Administration (“DEA”) is moving to reschedule marijuana from schedule I to the less stringently controlled schedule III. 29, 2023). Letter to U.S. Letter to President Joseph R. 21 U.S.C. §

Controlled Substances 95

Controlled Substances Chemotherapy Dosage Labelling 95