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

JUNE 27, 2024

District Court for the District of Texas on Zarzamora Healthcare LLC for repeatedly dispensing opioids and other controlled substances “by filling prescriptions while ignoring red flags.” As for high dosage opioid prescriptions, the expert found that: Patient A.R. Gulf Med Pharmacy; Decision and Order, 86 Fed.

Controlled Substances 52

Controlled Substances Dosage Documentation 52

FDA Law Blog: Biosimilars

JULY 1, 2024

For each factor, the NPRM noted that for DEA , additional information during the rulemaking w ould inform about the appropriate schedule for marijuana.

Dosage 52

Dosage Controlled Substances 52

Pharmaceutical Technology

APRIL 12, 2023

Containment and controlled substance capabilities are defining and necessary features for these manufacturing facilities, but not all contract manufacturers have the specialist equipment and capabilities required for high potency small molecule API production. For more information download the paper below.

Controlled Substances 52

Controlled Substances Dosage Communication Pharmaceutical Companies 52

FDA Law Blog: Biosimilars

MAY 21, 2024

Houck — Last August Health and Human Services (“HHS”) recommended rescheduling marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed. By Larry K. 44,597 (May 21, 2024). 29, 2023) (“Basis”); NPRM at 44,603.

Controlled Substances 69

Controlled Substances Chemotherapy Dosage Labelling 69