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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:

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: Accessed 11 June 2019.

3. Food and Drug Administration. Insanitary Conditions at Compounding Facilities Guidance for Industry September 2018 (Draft); Available at:

4. Food and Drug Administration. Compounding and the FDA: Questions and Answers. Available at: 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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