The FDA Law Blog

FEBRUARY 27, 2023

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. That emergency declaration is set to expire on May 11, 2023. By Karla L. 21 U.S.C. §

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Controlled Substances FDA Documentation Labelling 59

The FDA Law Blog

AUGUST 16, 2023

Prior to the CytoDyn letter in 2022, OPDP issued a Warning Letter in 2021 to CooperSurgical for a DTC video entitled “Paragard: Family Planning During the Pandemic” which failed to communicate ANY risk information. This seems to suggest that FDA expects this type of outcome claim to be included in labeling. But a Warning Letter?

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FDA Labelling Controlled Substances Communication 52

The Checkup by Singlecare

DECEMBER 12, 2023

The Food and Drug Administration (FDA) even sent a special communication to call attention to this risk. The Drug Enforcement Administration (DEA) categorizes zolpidem as a controlled substance, meaning that it has significant potential for abuse. For that reason, it is typically best to avoid combining opiates with zolpidem.

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Adverse Reactions Controlled Substances Labelling Communication 52

The Checkup by Singlecare

DECEMBER 26, 2023

Some healthcare providers may prescribe it off-label for erectile dysfunction or to women for certain conditions. The FDA has classified testosterone drugs as Schedule III controlled substances because of their potential for abuse and dependency. It’s also used to treat teen males with delayed puberty.

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FDA Dosage Mayo Clinic Controlled Substances 52