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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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OPDP Comes out Swinging With A Warning Letter on Unsubstantiated Efficacy

FDA Law Blog: Biosimilars

By Dara Katcher Levy — Well, if you, like many within industry, felt emboldened to disseminate promotional materials that may push the envelope on efficacy (so long as your risk information was tight) think again! Let’s go over some background information relating to Breztri and the OPDP Warning Letter. Pretty egregious stuff, right?

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Small molecule API: Shining a spotlight on new innovations in milling

Pharmaceutical Technology

Containment and controlled substance capabilities are defining and necessary features for these manufacturing facilities, but not all contract manufacturers have the specialist equipment and capabilities required for high potency small molecule API production. For more information download the paper below.

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A winning combination: The benefits of micronization and containment in a single installation

Pharmaceutical Technology

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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Meet Epicur’s Advisory Council: Nicole Clausen Shares Her Viewpoint on the Veterinary Industry as an Inventory Management Consultant

epicur

We asked her to share her expertise on the importance of a robust inventory management system and best practices for finding a pharmacy partner, ordering and restocking, and care team communication. Getting the scoop out to people and disseminating the information. I’ve been in vet med for over 16 years now.

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Internet Pharmacies are an Often-Overlooked Part of the Medicines Supply Chain

Quality Matters

To set the stage, it’s clear that benefits of the Internet’s role can include convenience, rapid access to medical information, privacy, cost efficacy and transparency, at-home access, and the wide range of medicines available. The panel was titled “Securing the Downstream Supply Chain: Internet Pharmacies.” The risks, however, are numerous.