IJPC

Ethical and Regulatory Implications of Sourcing during a Drug Shortage

For FDA-reported drug shortages, particularly for complex sterile injectable formulations, the preference for utilization of 503B outsourcing facilities is ethically and clinically justified. These facilities are held to rigorous FDA oversight, adhere to current Good Manufacturing Practices (cGMP), and are equipped to produce standardized, sterile drug products in bulk.

503B facilities' speed, efficiency, and commitment to quality assurance make them indispensable partners in addressing ongoing challenges in the healthcare supply chain.

Read the full article in the March/April 2026 issue of IJPC. https://ijpc.com/CurrentIssue/?page=35

Hi Everyone, IJPC is preparing to release the Mar/Apr issue in the next week or so – which means now is the last chance for non-subscribers to freely review the Jan/Feb issue currently available on our homepage at https://ijpc.com before we switch it over to the next issue.

Jan/Feb’s veterinary focus section included a articles on the FDA's GFI #256 for animal drug compounding, treatment of Equine Protozoal Myeloencephalitis, and a pharmacist’s perspective on wildlife medicine. Review these for free while you can!

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