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    Current 503B Product Lists

    Request a current list of registered 503B Pharmacies and the products they are currently producing. 

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    503B Consulting

    Request a consultant for 503B production, development, quality and more

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The 503B Hub is your centralized destination for all things related to compounding and 503B outsourcing pharmacies. It serves as a comprehensive platform for submitting production requests, accessing expert consulting services, and staying current with FDA 503B compliance requirements. The hub also provides real-time updates on the 503B bulk drug substances list, regulatory changes, and best practices—making it an essential resource for facilities, providers, and partners working in sterile compounding.

Resources:

The 503B Bulks List

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Current 503B Registered Pharmacies

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Bulk Drug Substances Nominated for Use in Compounding

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FDA 503B Guidance

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