FDA Releases Five Draft Documents Related to Compounding and Repackaging Requirements

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Food and Drug Administration (FDA) has issued five draft documents related to drug compounding and repackaging requirements under the Drug Quality and Security Act (DQSA). The draft documents are applicable to pharmacies, federal facilities, outsourcing facilities, and physicians and are as follows. Draft Guidance for Industry: For Entities Considering Whether to Register As Outsourcing Facilities […]

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FDA Approves Zohydro ER with Abuse-Deterrent Properties

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Food and Drug Administration (FDA) has approved a new formulation of Zohydro® ER with abuse-deterrent properties. The new formulation uses a technology that allows the drug to maintain its release properties when used as intended, according to a press release from Zogenix. The abuse-deterrent system, known as BeadTek, incorporates “pharmaceutical excipients” that create a viscous […]

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ACPE Releases Updated Definition of CPE and Guidance on CPD

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The Accreditation Council for Pharmacy Education (ACPE) has released two documents that provide guidance and support for continuing pharmacy education (CPE) and continuing professional development (CPD). The two documents, approved by the ACPE board of directors, are: The revised Definition of Continuing Education for the Profession of Pharmacy (PDF), which defines the quality of CPE […]

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Presidential Budget Proposal Includes Investment to Curb Antibiotic-Resistant Bacteria

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President Obama’s 2016 budget includes nearly doubling the amount of federal funding for efforts aimed at combating and preventing antibiotic resistance. The funding will “improve antibiotic stewardship; strengthen antibiotic resistance risk assessment, surveillance, and reporting capabilities; and drive research innovation in the human health and agricultural sectors,” according to a White House press release. In […]

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Pharmacy Compounding Advisory Committee to Meet in February, FDA Announces

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The Pharmacy Compounding Advisory Committee will meet on February 23-24, 2015 to provide advice on scientific, technical, and medical issues concerning drug compounding under the Drug Quality and Security Act (DQSA), Food and Drug Administration (FDA) announced in the Federal Register. The committee will discuss the list of bulk drug substances that may not be […]

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NABP Reviewing .Pharmacy Domain Name Applications for Sunrise Registration; Two More Special Launch Periods to Follow

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The National Association of Boards of Pharmacy® (NABP®) is currently reviewing .pharmacy domain name applications received from trademark holders who are registered in the Internet Corporation for Assigned Names and Numbers Trademark Clearinghouse (TMCH). The Sunrise Application period, which ended January 19, 2015, preceded the TMCH Sunrise Registration Period, which will end March 16, 2015. […]

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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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