Proposed Federal Legislation Would Permit Office Use Compounding, Revise MOUs in Section 503A of FD&C Act

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Legislation proposed by Senator David Vitter (R-LA) would revise Section 503A of the FD&C Act to exempt drug products where the pharmacy’s product is “compounded and distributed to a practitioner where, as permitted under State law, the drug product is used in the treatment of or administered to a patient of the practitioner.” The Saving […]

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Rogue Internet Drug Sellers Scrutinized at Congressional Committee Hearing on Internet Accountability

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The United States House of Representatives Judiciary Subcommittee on Courts, Intellectual Property, and the Internet held a hearing today, May 13, 2015, to hear testimony from stakeholders regarding the Internet Corporation for Assigned Names and Numbers, how the Internet is governed, and steps for trust and accountability in the Internet’s operation. As part of the […]

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California Pharmacists May Now Dispense Naloxone Without Prescription

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Pharmacists in California may now provide naloxone, the medication that can help to reverse the effects of an opioid overdose, without a prescription after the California State Board of Pharmacy approved new emergency regulations (PDF). To be eligible to dispense the drug under the new regulations, pharmacists must complete one hour of continuing education (CE) […]

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Change State Laws to Support Pharmacists’ Participation in Integrated Health Care Teams, Say Nation’s Governors

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Pharmacists can greatly improve patient outcomes and help reduce costs when participating in interdisciplinary health care teams, states a new paper (PDF) from the National Governors Association (NGA). However, many state laws and regulations prevent pharmacists from being able to practice “to the full scope of their professional training,” the NGA reports. The association suggests […]

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South Carolina Council Calls for PMP Participation to Reduce Prescription Drug Abuse

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Physicians should be required to register with South Carolina’s prescription monitoring program (PMP) database, recommends Governor Nikki Haley’s Prescription Drug Abuse Prevention Council, a committee charged in March with creating a plan to fight the state’s prescription drug abuse problem. South Carolina’s PMP was established in 2008, but prescriber registration is voluntary, and only 21% have […]

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Pennsylvania Naloxone Law Goes into Effect This Week

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Beginning November 29, 2014, pharmacies in Pennsylvania may be requested to fill standing orders or prescriptions for the opioid reversal drug naloxone to first responders and friends and family of those at risk. Pennsylvania’s Act 139, signed by Governor Tom Corbett on September 30, 2014, also provides immunity from prosecution for those responding to and […]

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FDA Issues Final and Revised Draft Documents for Compounding Facilities Under DQSA

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Food and Drug Administration (FDA) has issued three additional guidance documents to help compounding entities register as outsourcing facilities. The policy documents also provide guidance for complying with other provisions of the Drug Quality and Security Act (DQSA). The new documents are: Final guidance (PDF) on registration of human drug compounding outsourcing facilities under Section […]

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California Requires Outsourcing Facilities to Be Registered as Pharmacies if Compounding or Dispensing Drug Within or Into the State

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The California Board of Pharmacy is reminding its licensees that licensure as an outsourcing facility under Section 503B of the Food Drug and Cosmetic Act does not exempt or except pharmacies from state licensure requirements. To compound or dispense drug products within or into California, pharmacies must be licensed in California as a resident or […]

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