The Drug Supply Chain Security Act (Act), Title II of the Drug Quality and Security Act, was recently signed into law and contains provisions related to the integrity of the drug distribution supply chain. State boards of pharmacy have received correspondence from attorneys indicating that the Act preempts states from recognizing or requiring NABP’s Verified-Accredited […]
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New York Governor Andrew Cuomo plans to announce an executive action that would permit limited prescribing of medical marijuana in up to 20 hospitals within the state. According to The New York Times, Cuomo will utilize a 1980 public health provision, the Antonio G. Olivieri Controlled Substance Therapeutic Research Program, to implement his plan without approval […]
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On August 29, 2013, the District Court of Tulsa County in the state of Oklahoma granted a temporary injunction to enjoin the defendants, including Christopher Parks and OK Compounding, LLC (collectively, OK Compounding), from engaging in certain conduct in connection with plaintiff Rush University Medical Center (Rush). Among other things, the temporary injunction prohibits OK […]
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United States Pharmacopeial Convention (USP) labeling standards for ferrules and cap overseals that require warning messages with vital information aimed to prevent imminent life-threatening situations became official on December 1, 2013. “The standards explicitly state that warning messages – such as ‘Warning – Paralyzing Agent’ or ‘Dilute Before Using’ – are the only markings that […]
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Three draft guidance documents related to the Drug Quality and Security Act have been made available on the FDA Web site for comment. Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF) is intended for outsourcing facilities that compound human drugs and focuses […]
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FDA will hold a public meeting to obtain feedback on whether any changes to regulations concerning medical gas are needed. The meeting will take place on December 6, 2013, from 9 AM to 5 PM and will also be streamed online. FDA is using the public meeting as part of a review process initiated by […]
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Food and Drug Administration (FDA) plans to submit a formal recommendation to reclassify hydrocodone combination products as Schedule II controlled substances (CS) to the Department of Health and Human Services by early December 2013. FDA expects the National Institute on Drug Abuse (NIDA) to concur with the recommendation, indicates a statement on the FDA Web site. […]
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A Pennsylvania bill that would create a new prescription monitoring program (PMP) to include Schedule II through V CS has passed the state’s House of Representatives, reports The Bucks County Courier Times. The bill (H 1694), which was approved with overwhelming support in a 191-to-7 vote on October 21, 2013, would require prescription medication dispensers […]
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Governor Jerry Brown of California signed a new law (SB 294) that requires sterile compounding pharmacies to obtain additional licensure from the California State Board of Pharmacy before compounding or dispensing sterile drug products, or before shipping these products into the state. Under the law, compounding pharmacies will also be subject to random, annual inspections […]
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A new California law, signed by Governor Jerry Brown on October 1, 2013, will expand the scope of pharmacy practice within the state and improve patient access to care. The bill would establish board recognition for advanced practice pharmacists who, according to the National Community Pharmacists Association, will be able to do the following beginning […]
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