24
Aug
New-ISPE-Guide-on-503B-Compounding-Lachman-Consultants-Blog

New ISPE Guide on 503B Compounding

For those struggling with understanding all the complexities of running a 503B compounding facility, a new resource is now available. The International Society of Pharmaceutical Engineers (ISPE) has a new guide coming out titled “503B Compounding – Regulatory Basis and Industry Good Practices for Outsourcing Facilities” (here). Do you know why compounding exists? Shouldn’t all […]

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05
Apr

503B Outsourcing Facilities Batting 1 for 11 in This Round of Bulk Substances Reviewed

The 503B outsourcing facilities are able to compound drug products in certain circumstances using bulk ingredients but “[O]ne of the conditions that must be met for a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the FD&C Act is that the outsourcing facility may not compound a […]

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03
Aug

History of the 503B Bulk Drug Substance List – We’ve Come A Long Ways in a Long Time….and the List Is Getting Longer and Longer?

As part of the Agency’s ongoing efforts to ensure patient’s access to drugs, FDA is continuing to develop and evaluate a list of bulk drug substances that 503B Outsourcing Facilities can use in compounding, when it has been determined that there is a clinical/medical need that can’t be met by an available FDA-approved drug.  On […]

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