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.

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Labelling Packaging Controlled Substances 130

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). 01.014.13).

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FDA Law Blog: Biosimilars

AUGUST 16, 2023

By Dara Katcher Levy — Well, if you, like many within industry, felt emboldened to disseminate promotional materials that may push the envelope on efficacy (so long as your risk information was tight) think again! Let’s go over some background information relating to Breztri and the OPDP Warning Letter. Pretty egregious stuff, right?

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Labelling Controlled Substances Communication 52

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. Interim Order: Safeguarding the Drug Supply.

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Controlled Substances Labelling Communication Vaccines 52

National Association of Boards of Pharmacy

FEBRUARY 27, 2024

Finding information online about ketamine can be overwhelming, leaving a lot of patients and their families confused about its approved uses. 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.

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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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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. I’d love to hear from you!

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