Drug Safety Project


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  • Comments to FDA on 503B Quality Standards Draft Guidance

    On September 2, Pew submitted comments to the U.S. Food and Drug Administration in response to draft guidance on the implementation of Title I of the Drug Quality and Security Act.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 changes... Read More

  • Drug Distribution Security: Title II of the Drug Quality and Security Act

    Persistent weaknesses in the U.S. pharmaceutical distribution supply chain have jeopardized patient health. In 2012, for example, 48 people were charged in a scheme to purchase and repackage an estimated $500 million worth of prescription drugs that had already been dispensed to patients. The drugs were sold back to pharmacies through licensed wholesalers, exposing patients to potentially... Read More

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