Drug shortages are nothing new to the healthcare industry and it's only gotten worse during the pandemic. The global need for drugs used in treating and managing the symptoms of the COVID-19 virus has increased exponentially during the crisis, making it nearly impossible for hospitals to obtain life-saving drugs. Could compounding be the answer to the drug supply gap?
Read MoreWith the inability of outsourcers to adequately serve shortages, along with diminishing cost advantages and shrinking national supplies of outsourced compounds, many health systems are beginning to analyze their current supply chain strategy and are revisiting the pros and cons of insourcing batched compounds. Should your facility consider insourcing?
Read MoreA recent report by the Office of Inspector General found most hospitals obtain compounded drugs from outsourcing facilities. Several current hospital compounding needs are cited in the article, revealing key outsourcing facility business strategies.
Read MoreIn December of 2018, the FDA published a current good manufacturing practice guidance document for 503B outsourcing facilities. Then on May 21, 2019, the FDA opened its doors to hear public opinion on how this guidance document would impact office use compound access if made final. One medical specialty in particular will be affected by this guidance.
Read MoreLast week, the Food and Drug Administration announced the release of a revised draft guidance describing current good manufacturing practice (CGMP) requirements for 503B outsourcing facilities. The document provides direction and details as to how 503B’s can stay compliant with the Agency. Are you compliant?
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