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Controlled Substance Reporting Isn’t Just for DEA Anymore

FDA Law Blog: Biosimilars

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

FDA Law Blog: Biosimilars

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

FDA Law Blog: Biosimilars

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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Uh Oh, A Controlled Substance Bottle Spilled or Broke. Now What?

epicur

The following blog is written by Epicur Pharma’s Advisory Council member Jan Woods, a veterinary hospital consultant, and national speaker with expertise in DEA compliance, state and federal regulations, and clinic and hospital practice management. Have you ever broken or spilled a bottle of a controlled substance?

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Schedule III Marijuana Would Still Be Regulated Marijuana

FDA Law Blog: Biosimilars

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

FDA Law Blog: Biosimilars

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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A Long Time Coming: DEA Regs Finally Authorize Schedule II Prescription Partial Fills

FDA Law Blog: Biosimilars

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).