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San Diego State University Manufacturing and Compounding Questions

San Diego State University Manufacturing and Compounding Questions

Question Description

In 2012, 753 patients in 20 states were diagnosed with fungal infections afterreceiving injections of preservative-free methylprednisolone acetate (MPA)manufactured by NECC. Of those 753 patients, the U.S. Centers for Disease Controland Prevention (CDC) reported that 64 patients in nine states died. The governmenthas since identified a total of 793 patients throughout the country harmed by NECC’scontaminated steroids.

General Directions:
 Find and Read the California State Board of Pharmacy Accusation:


Answer the following Questions:

  1. ListallcitedlawsandregulationsthatNECCallegedlyviolated.
  2. Whatisthedifferencebetween“manufacturing”and“compounding”?
  3. Whatisthe2013DrugQuality&SecurityAct(DQSA),andhowdoesitdirectlyrelate to this case?
  4. IsthereanywaythataCalifornia-licensedpharmacycouldlawfullyengageinboth drug manufacturing AND compounding?

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