Drug Safety Project

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Research & Analysis

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  • FDA Issues Strong Guidance on Prescription Requirement for Drug Compounders

    On Dec. 28, 2016, the U.S. Food and Drug Administration (FDA) finalized a guidance document interpreting provisions of federal law that govern compounded medications—customized drugs made by pharmacists or physicians rather than pharmaceutical manufacturers. “Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act” clarifies the law’s... Read More

  • Roundtable Identifies Opportunities for Outsourcers of Compounded Drugs

    Outsourcing facilities produce stock supplies of compounded drugs under quality standards appropriate for large-scale production. They were authorized by federal law in 2013, but the viability of this new sector depends on outsourcing facilities understanding the market for supplies of compounded drugs used by doctor’s offices and hospitals. The American Society of Health-System Pharmacists... Read More

  • Drug Shortages

    National drug shortages, defined by the U.S. Food and Drug Administration (FDA) as a period of time when the demand or projected demand for a drug within the United States exceeds the supply of the drug, remain a complex and multilayered issue in the U.S. health care delivery system. Read More

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