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Pharmacy Law and Licensing Highlights 2025

FDA Law Blog: Biosimilars

The rules were implemented to enhance patient safety protections via revised drug handling, packaging, and delivery requirements. The rules include changes to the notification process, medication packaging, the handling of reports, and safety issues.

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FDA guidance highlights E&L considerations for ophthalmic drug products

European Pharmaceutical Review

This document is revised from a version published in October 2023. Firstly, leachables can compromise a products quality and therapeutic effect, by potentially interacting with the formulated drug product, the document reported. Moreover, manufacturers should document information about their safety thresholds, the guidance stated.

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Leading pharmaceutical compounding companies in contract marketing

Pharmaceutical Technology

Pharmaceutical compounding is a method of preparing personalised medications for patients by mixing the individual ingredients in the exact strength and dosage form required by the patient. Discover the top pharmaceutical compounding companies in contract marketing. Packaging. • Benefits of pharmaceutical compounding.

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Episode 864: Why Did ISMP Remove the Do Not Crush List from Their Website?

Pharmacy Joe

Subscribe on iTunes , Android , or Stitcher If you navigate to the page on the website for the Institute for Safe Medication Practices that once hosted the document titled “Oral Dosage Forms That Should Not Be Crushed” you will instead find a notice that the list has been removed from the ISMP website.

Dosage 111
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Safe Handling of Hazardous Drugs

RX Note

Workplace activity involves how healthcare workers use and handle the drug in the workplace - such as opening shipments, compounding, administering or cleaning up after use or spills. The Hidden Truth Studies have shown that the antineoplastic residues can be found be on the external packaging of both oral and IV drugs.

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Validation master plan (VMP) – when and how to create one?

GMPSOP

A validation master plan (VMP) is a strategic document that identifies the elements to validate, the approach to each element, organizational responsibilities, and a strategy for maintaining validation documentation. – General guidance for validation document format. Additional documents included each month.

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Veterinary Medicine Outlook: 5 Changes and Trends Impacting Veterinary Practices

epicur

Implementation of GFI #256 Earlier this year, the FDA finalized regulatory guidance for compounded medications, known as GFI #256. If GFI is affecting your practice’s ability to get compounded medications for office use, partnering with a trusted 503B outsourcing facility can help you eliminate risks of limited ordering.