Drug Safety Project


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  • Charges Made for Deadly Outbreak Linked to Compounded Medicine

    Fourteen people—including former pharmacists, pharmacy technicians, and the owners of the New England Compounding Center in Framingham, Massachusetts—were charged Dec. 17 for their alleged roles in a 2012 outbreak of spinal meningitis that sickened more than 750 people and killed 64. Contamination of compounded steroid injections led to a recall of all the company’s products in... Read More

  • Comments to FDA on 503B Quality Standards Draft Guidance

    On September 2, Pew submitted comments to the U.S. Food and Drug Administration in response to draft guidance on the implementation of Title I of the Drug Quality and Security Act. The comments highlight the need for more robust safeguards when compounding occurs on a larger scale and reference the Pew commissioned report “Ensuring the Safety of Compounded Drugs: Study highlights key... Read More

  • Ensuring the Safety of Compounded Drugs

    A new study compares safety measures followed by pharmaceutical companies that manufacture drugs with those used by compounding pharmacies, and it highlights the more robust safeguards needed when compounding occurs on a larger scale. Quality Standards for Large-Scale Sterile Compounding Facilities, authored by Clinical IQ LLC and commissioned by The Pew Charitable Trusts, chronicles the... Read More

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