The FDA Law Blog

JULY 31, 2023

CARA amended the Controlled Substances Act (“CSA”) to enable physicians or patients to request pharmacists to partially fill prescriptions for schedule II substances including opioids and to allow remaining quantities to be filled up to 30 days after issuance of the prescription (up to 72 hours for emergency oral prescriptions).

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Controlled Substances Long-Term Care Facilities Dosage Communication 98

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. Let’s go over some background information relating to Breztri and the OPDP Warning Letter.

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FDA Labelling Controlled Substances Communication 52

The Checkup by Singlecare

DECEMBER 26, 2023

The FDA has classified testosterone drugs as Schedule III controlled substances because of their potential for abuse and dependency. Healthcare professionals will monitor for these changes and discontinue testosterone treatment if they occur. Does testosterone cause drug abuse or dependency?

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Pharmaceutical Technology

JUNE 14, 2023

According to GlobalData’s Drugs database, 97% of marketed drugs are small molecule products and analysis shows an increased CMO appetite for specialized capabilities, with controlled substance and containment facilities highly sought after [i]. Please check your email to download the Whitepaper.

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