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STAT+: Telehealth companies that prescribed controlled substances during the pandemic brace for business to change

STAT

Health tech companies that have taken advantage of the possibility to prescribe controlled substances online during the pandemic may soon find their businesses — and their ability to care for patients — in jeopardy. 

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Telemedicine and the Prescribing of Controlled Substances After the End of The Covid-19 Pandemic Emergency: DEA Announces Two Significant Proposed Rules: Read the Summary Below, But Learn All the Details and More at HPM’s Webinar on March 23, 2023 (Details Forthcoming….)

The FDA Law Blog

Palmer — The 2008 Ryan Haight Online Pharmacy Consumer Protection Act placed strict limits on online prescribing or the use of telemedicine encounters to prescribe controlled substances. DEA’s proposed rule when finalized would authorize telemedicine pursuant to the Controlled Substances Act, 21 U.S.C. § By Karla L.

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How to help patients taking controlled medications

The Checkup by Singlecare

The law states that a pharmacist must only fill a prescription for a controlled substance when it is issued for a legit medical reason by a legitimate practitioner acting within the usual scope of their professional practice. The DEA defines a controlled substance as a drug or chemical known to be addictive or habit-forming.

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Harmony’s sleep disorder drug Wakix gets US label extension

pharmaphorum

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.

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DEA Regs Bulk Up with 2014 Anabolic Steroid Control Law Additions

The FDA Law Blog

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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What is the best medication for anxiety and insomnia?

The Checkup by Singlecare

Ambien and Ambien CR are controlled substances , so they have the potential for substance abuse and dependence. Prescribers will consider past drug use or alcohol use and the potential for abuse and dependence before prescribing a controlled substance. It is a controlled substance.

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“Heigh-ho” Taiho! The PTO Says LYTGOBI Patent is Ineligible for PTE Because of Untimely Application. And a Corrected NDA Approval Letter is No Saving Grace

The FDA Law Blog

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),