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

The FDA Law Blog

Unusual Amounts and Dosages Dispensing high doses of opioids in quantities far exceeding the daily morphine milligram equivalent (“MME”) dose recommended by the Centers for Disease Control and Prevention (“CDC”). The CDC has advised clinicians to carefully assess increasing total opioid dosage to greater than 50 MMEs per day).

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New Trends & Requirements from Digitalization, Annex 1, Continuous Manufacturing & High Potent Manufacturing

ISPE

In this blog, we will briefly explore the challenges and opportunities of digitalized aseptic production, fully contained and automated production and collaborative work with CMOs. We will also address the ways in which these approaches can help to improve adherence to new Annex 1 and the overall quality and safety of pharmaceutical products.

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Pharmacists in Florida (and Elsewhere): Waive Prescribing Red Flags at Your Peril

The FDA Law Blog

DEA recently revoked the registration of Coconut Grove Pharmacy (“Coconut Grove”), like Gulf Med Pharmacy also in Florida, for its failure to resolve prescribing red flags and document such resolution. By Larry K. Coconut Grove Pharmacy; Decision and Order, 89 Fed. 50,372 , 50,377 (June 13, 2024). 50,372 at 50,372-73.

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Connecting with Patients at Home

Pharmacy Is Right For Me

In addition to learning more about unique pathways on-site, you can also understand more about the career paths of these pharmacists here on our blog. Another unique aspect of this model is that all interprofessional team members can access and document within a universal electronic medical record (EPIC).

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Draft Guidance on Biosimilars and Interchangeables Tries to Smooth Path for Post-Approval Changes

The FDA Law Blog

As for minor changes that have minimal effect of product quality, the draft guidance notes that applicants can document those in their annual report, as opposed to a discreet filing with the agency. In our experience such a change is rare, but perhaps FDA is of the mind here to clarify how this might happen.

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Unlocking the Potential: The Power of Drug Repurposing in Modern Medicine

Impact Pharmaceutical Services

If commercial, accessibility of cGMP API for proof of concept (POC) studies is much more possible in bulk in the open market, and may already be packaged in a suitable dosage form or strength for human trials. Repurposed commercial drugs also provide the advantage of having many patient years of reported safety data.

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ISPE Communities of Practice Leaders – Nik Krpan

ISPE

iSpeak Blog. Some recent projects include upgrading a biologics manufacturing process facility and expanding manufacturing capabilities at an oral solid dosage facility. ISPE Communities of Practice Leaders – Nik Krpan. Trudy Patterson. Wed, 11/30/2022 - 11:07. ISPE Communities of Practice Leaders – Nik Krpan. Marcy Sanford.