On August 14, 2024, FDA received a complaint from a patient who noticed a black particulate in a vial of semaglutide distributed by Fullerton Wellness. On September 23, 2024, FDA received information from California regulatory authorities as part of ongoing collaboration between FDA and the state noting deficiencies found at Fullerton Wellness during a state inspection. After the state inspection, Fullerton Wellness voluntarily ceased operations.
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The agency urges manufacturers, including repackagers, to clearly identify any ingredients intended for use in foods or dietary supplements on the label. Providing this information on ingredient labels could help prevent compounders from using ingredients that are not appropriate for sterile drugs and may help prevent patient harm.
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This week the agency warned about compounding safety and sterility issues and a newly posted document shows inspectors enforcing manufacturing standards.
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Chinese companies and individuals indicted by the Department of Justice and a study examines how patients were harmed by the sudden removal of a medication from a drug formulary.
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The FDA recently announced that “connected trading partners” that have made progress in transmitting electronic data that identifies and follow medicines made for the U.S. drug supply will not be penalized if they are still working out challenges in the process. Are you wondering what that means? We can explain.
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Family advocates petition the Office of U.S. Trade Representative to take trade action over Chinese fentanyl precursors. The New York Times tackles PBMs and pharmacy deserts.
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Consumers taking this product should immediately consult with their health care professional to safely discontinue use of this product. The risks of withdrawal from corticosteroids should be assessed by a healthcare professional. Only licensed health care professionals can evaluate patients for the risk, or confirm the existence, of adrenal suppression. Consumers that have product which is being recalled should return to place of purchase or discard.
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The FDA granted exemptions for certain trading partners and small dispensers to avoid supply chain disruptions. Stories from the week in counterfeit medicine news.
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Our Executive Director, Shabbir Safdar, along with PSM members, shared examples of pharmaceutical counterfeits and helped attendees understand why current systems for stopping counterfeit product sales do not work well.
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An indictment by the Department of Justice against 18 individuals who allegedly sold counterfeit pills via dozens of fake pharmacy websites to residents in all 50 states prompts warnings from two additional federal agencies.
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