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Controlled Substance Reporting Isn’t Just for DEA Anymore

The FDA Law Blog

The Federal Controlled Substances Act (“CSA”) and its regulations require Drug Enforcement Administration (“DEA”) registrants to submit certain reports related to narcotic drug transactions, thefts and significant losses, and suspicious orders. They do not know that controlled substance reporting isn’t just for DEA anymore.

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Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

The FDA Law Blog

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. On October 10th, based on ability to pay, the U.S. 6, 2023 ( DOJ Press Release ). Zarzamora Press Release.

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Prescribing Red Flags: Pharmacists Be Wary of What the Doctor Orders

The FDA Law Blog

While the presence of a dispensing red flag does not prohibit a pharmacist from filling a controlled substance, it means that there is a potential concern with the prescription, which the pharmacist must address andmake a record of its resolution, assuming it is resolvable.

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DEA Reaffirms Synthetic THC Compounds Are Schedule I Controlled Substances

The FDA Law Blog

Houck — The Drug Enforcement Administration’s (“DEA’s”) February 13th determination that THC acetate ester (“THCO”) is a schedule I controlled substance under the federal Controlled Substances Act (“CSA”) has received a good amount of attention in the cannabis press. By Larry K. 51639, 51641 (Aug.

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Schedule III Marijuana Would Still Be Regulated Marijuana

The FDA Law Blog

Department of Health and Human Services (HHS), based on the federal Controlled Substances Acts (CSAs) Eight Factor Analysis, recommended that the Drug Enforcement Administration (DEA) reschedule marijuana from schedule I to schedule III. Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed. By Larry K.

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Electronic Controlled Substance RXs: Signed, Sealed, Delivered But Can’t be Filled

The FDA Law Blog

Houck — If a patient presents a paper prescription for a controlled substance to a pharmacy and the pharmacy cannot fill it, the patient can take that prescription to another pharmacy. Transfer of Electronic Prescriptions for Schedule II-V Controlled Substances Between Pharmacies for Initial Filling, 88 Fed. By Larry K.

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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.