FDA warns repackers distributing pharmaceutical ingredients, including opioids, for putting consumers at risk

FDA warns repackers distributing pharmaceutical ingredients, including opioids, for putting consumers at risk

Silver Spring, MD (STL.News) – The U.S. Food and Drug Administration has issued warning letters to three repackers of active pharmaceutical ingredients (API), B&B Pharmaceuticals, Inc., Asclemed USA, Inc., doing business as Enovachem and Spectrum Laboratory Products, Inc., for significant violations of current good manufacturing practice (CGMP) requirements.

“Repackers play a role in the pharmaceutical supply chain, and some distribute bulk API to drug manufacturers and pharmacy compounders.  The U.S. drug supply chain remains one of the safest in the world, yet because of the various players and increased globalization, it has become increasingly complex. 

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