pharmaphorum

OCTOBER 14, 2020

It is the only FDA-approved drug to treat cataplexy associated with narcolepsy not scheduled as a controlled substance by the US Drug Enforcement Administration. The company added another alternative, Xywav (calcium, magnesium, potassium, and sodium oxybates) earlier this year although these drugs lack the cataplexy use on their label.

Labelling

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.

Controlled Substances

LifeProNow

MARCH 10, 2023

million in investments in food safety and nutrition modernization, including food labeling and animal food safety oversight. Funding will support broader development of opioid overdose reversal treatments and treatments for substance use disorders and enhance regulatory oversight, expand compliance, enforcement and laboratory support.

Labelling

Pharma in Brief

JANUARY 7, 2024

Eligible drugs must: (i) be approved by Health Canada; and (ii) meet FDA-approval conditions for a drug currently marketed in the US (aside from US labeling). Biologics, controlled substances, and certain other drugs are not eligible for importation. 01.014.13).

Controlled Substances

FDA Law Blog: Biosimilars

APRIL 21, 2024

Post-AIA, and a later change to the law to account for controlled substance FDA application approvals, the PTE statute at 35 U.S.C. § Accordingly, had Taiho marketed the product with labeling containing those errors, that labeling would have been false. sections 331(a) and 352. sections 331(a) and 352.(a)(l),

Labelling

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.

Labelling

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).

Dosage

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.

Controlled Substances

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.

Controlled Substances

Pharma in Brief

NOVEMBER 29, 2020

of the US Importation Rule, drugs eligible for importation must have received an NOC and DIN in Canada and meet FDA approval conditions, aside from US labeling. Controlled substances, biologics, and certain injectable drugs are not eligible for importation. Interim Order Context.

Controlled Substances

National Association of Boards of Pharmacy

FEBRUARY 27, 2024

Simply put, ketamine is an anesthetic with some hallucinogenic properties and is classified as a Schedule III non-narcotic substance under the federal Controlled Substances Act. Ketamine infusion centers have opened across the US, offering off-label treatment for many psychological disorders.

Controlled Substances

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

FDA Law Blog: Biosimilars

DECEMBER 14, 2023

As justification, the governors argued that state-regulated cannabis would require age verification, packaging and labeling standards, testing and warning symbols or statements, and allow for tracking products from seed to sale.

Controlled Substances

The Thyroid Pharmacist

NOVEMBER 15, 2024

Ozempic is a GLP-1 agonist and is actually marketed as a diabetes drug, but many physicians are prescribing it for weight loss (off label-use). Ozempic’s label warns, “In studies with rodents, Ozempic® and medicines that work like Ozempic® caused thyroid tumors, including thyroid cancer.

Diabetes