Some of the most prevalent questions compounding pharmacies and 503B outsourcers ask have to do with the do’s and don’ts of compounding essential copies of drugs. To help compounders sift through the confusion and interpretation, we discuss the most frequently asked questions about compounding an essential copy of an approved drug and provide real life examples.

Amy SummersAugust 18, 2021Essentially a Copy Guidance, Compounding Bulk Drug Substances, Pharmacy Compounding

FDA Removes Two Bulk Drug Substances Nominated for Use in 503B Outsourcing Facilities

This month, the FDA published final guidance for the list of bulk drug substances 503B facilities may use in compounding. The FDA decided to remove two substances from the previous version. This is a huge win for Big Pharma and a major loss for the compounding industry.

Amy SummersMarch 15, 2019Bulk Drug Substances, Vasopressin, Compounding Bulk Drug Substances

503A + 503B Compounding News

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