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Pharmacies › Pharmaceutical Industry › Bulk Purchasing

Mintz - Health Care Viewpoints

FDA Invites Compounding Outsourcing Facilities' Comments to Understand Industry Challenges and Opportunities

Mintz - Health Care Viewpoints on

On July 29, 2019, the Food and Drug Administration (FDA) published a notice to the Federal Register (84 Fed. Reg. 36609). The notice invites comments on information collected in connection with FDA research by obtaining...more

Akin Gump Strauss Hauer & Feld LLP

FDA Finalizes Criteria, and First Two Exclusions, for Outsourcing Facility Compounding with Bulk Drug Substances

Akin Gump Strauss Hauer & Feld LLP on

• Five years after passage of the DQSA, FDA issued final decisions prohibiting the use of two bulk substances by outsourcing facilities, and finalized criteria for ongoing evaluations of other bulk substances that are...more

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