FDA Law Blog: Biosimilars

AUGUST 4, 2023

Houck — Anabolic steroids that include testosterone, methyltestosterone, nandrolone decanoate and oxandrolone are schedule III controlled substances with currently accepted medical uses in the U.S. Labeling Requirements DASCA also added a labeling requirement in the CSA to identify products containing anabolic steroids.

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Controlled Substances Labelling 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. HHS forwards FDA’s analysis and recommendation to DEA.

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Controlled Substances Chemotherapy Compounding Dosage 69

FDA Law Blog: Biosimilars

APRIL 21, 2024

Karst — If you’ve been following this blog since the early days, then you know we fervently followed the more-than-decade-long soap opera that was The Medicines Company’s efforts to obtain a Patent Term Extension (“PTE”) from the U.S. It’s not terribly uncommon for FDA to issue corrected approval letters (and corrected labeling).

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Labelling Controlled Substances 59

FDA Law Blog: Biosimilars

AUGUST 16, 2023

And before CooperSurgical, another 2021 Warning Letter was issued to AcelRx for the infamous “Tongue and Done” tagline used to promote a Schedule II controlled substance subject to a REMS program that requires a healthcare professional’s precise placement of the drug using a single-dose applicator into the patient’s sublingual space.

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Labelling Controlled Substances Communication 52

The Happy PharmD

APRIL 26, 2023

Dexamethasone oral solution is not a narcotic or controlled substance. Sometimes, I check the directions on the label as well. After this incident, I’ll always check the directions on the label. This one baffled me. It is not a product that a pharmacy would be scared to have on its shelf (due to theft).

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Dosage Hospitals Pharmacy Technician Prescription Filling 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.

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Controlled Substances Chemotherapy Dosage Labelling 69

FDA Law Blog: Biosimilars

MARCH 24, 2025

Department of Health and Human Services (HHS), based on the federal Controlled Substances Acts (CSAs) Eight Factor Analysis, recommended that the Drug Enforcement Administration (DEA) reschedule marijuana from schedule I to schedule III. Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed. By Larry K.

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Controlled Substances Labelling 71