Blog Controlled Substances Labelling 
FDA Law Blog: Biosimilars
MAY 4, 2025
(IMC Pro), a shipping and logistics company based in North Carolina, agreed to pay $400,000, not a significant amount compared to some recent settlements, but not chump change either, to resolve allegations that it violated the Controlled Substances Act for transshipping precursor chemicals. of 1-BOC-Piperidone and 138.66
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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epicur
JULY 8, 2025
The following blog is written by Epicur Pharma’s Advisory Council member, Nicole Clausen, CSSGB, CCFP. Every prescription should have an appropriate fee that covers the cost of the veterinarian calculating the dose, determining instructions, and the technician’s time to fill and label it. Think about creating different fee tiers too.
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.
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).
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.
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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