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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).

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May 11, 2023: The End of the COVID-19 Pandemic Emergency’s DEA Telemedicine Exemption? “Not So Fast,” Say DEA and SAMHSA

FDA Law Blog: Biosimilars

Palmer — We blogged earlier this week here that DEA is reconsidering its proposed rules for telemedicine prescribing of controlled substances and buprenorphine. part 1306 (which include DEA’s general requirements for prescribing controlled substances); 88 Fed. By Karla L. at 30,039 (emphasis added).

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Hyman, Phelps & McNamara, P.C. (HP&M) is Pleased to Announce the Addition of Sara M. Keup as the new State Licensing Regulatory Expert for the Firm’s Licensing Practice

FDA Law Blog: Biosimilars

Some of the services HP&M offers include: comprehensive regulatory assessments pre-launch licensing support license gap analysis support for new product/company acquisitions, regulatory diligences DEA registrations and state-controlled substance licenses With the complexities of licensure, Sara M. Palmer , Larry K.

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New Bill for Online Platform Accountability Looks Beyond Section 230

National Association of Boards of Pharmacy

In the latest round of Drug Enforcement Agency’s (DEA) enforcement action against counterfeit controlled substances (CS), popular apps such as Snapchat, Facebook Messenger, Instagram, and TikTok were involved in one-third of the 390 investigations. These investigations, which took place from May to September, seized a staggering 10.2

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Lifelong Learning in the Role of a Pharmacy Inspector 

National Association of Boards of Pharmacy

A pharmacy inspector must possess an inquisitive nature and strong communication skills to help them assess each situation appropriately and fairly.   During multiple pharmacy investigations, I discovered that pharmacists were diverting controlled substances for their personal use.

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Health Canada issues new Interim Order to prevent bulk exportation of prescription drugs from Canada

Pharma in Brief

Controlled substances, biologics, and certain injectable drugs are not eligible for importation. DEL holders who violate the terms of the Interim Order may be subject to enforcement actions, which could include corrective measures, issuance of public communications, or the suspension or cancellation of the DEL.