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Sources

1. Food and Drug Administration. FDA’s Human Drug Compounding Progress Report: Three Years After Enactment of the Drug Quality and Security Act (January 2017), Available at: https://www.fda.gov/drugs/human-drug-compounding/fdas-human-drug-compounding-progress-report-three-years-after-enactment-drug-quality-and-security

2. Food and Drug Administration. Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act (Guidance for Industry) December 2018; Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/current-good-manufacturing-practice-guidance-human-drug-compounding-outsourcing-facilities-under. Accessed 11 June 2019.

3. Food and Drug Administration. Insanitary Conditions at Compounding Facilities Guidance for Industry September 2018 (Draft); Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/insanitary-conditions-compounding-facilities-guidance-industry

4. Food and Drug Administration. Compounding and the FDA: Questions and Answers. Available at: https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers. Accessed 10 June 2019.

5. West and Ompi can provide guidance depending on which product is selected and the target filling equipment.

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Amy Kim

Amy Kim,

Sr, Specialist, Scientific Communications

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