The Pharmacy Times® 503B Compounding Pharmacy Resource Center is a comprehensive resource for clinical news and expert insights on issues related to compounding pharmacies and drug safety.
November 1st 2024
Martha Rumore, PharmD, Esq, discusses the legal and regulatory complexities surrounding tirzepatide compounding following FDA’s removal of the drug from the shortage list, which prompted a lawsuit and led to ongoing uncertainty for 503A and 503B facilities regarding enforcement discretion and future compounding restrictions.
FDA Proposes the Removal and Addition of Substances to Its 503A Bulks List
January 2nd 2017The FDA has created a new proposed rule that adds 6 bulk drug substances to an existing list of substances that can be used in compounding. It has also proposed the removal of 4 other bulk drug substances from the list.
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Parenteral Nutrition Compounding Practices at Work
December 8th 2016Health-system pharmacies can regulate cost-effective and efficient operations for parenteral nutrition compounding practices. Laura Mark, MS, PharmD, FASHP, led a tech talk at the Baxter Booth at the ASHP Midyear Clinical Meeting to discuss parenteral nutrition compounding practices.
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Lack of Sterility Assurance Spurs Compounding Pharmacy Recall
January 21st 2016Abbott's Compounding Pharmacy is voluntarily recalling all of its unexpired lots of sterile compounded products, including injectable medications, eye drops, sterile solutions, and eye ointments, out of concern for sterility assurance.
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