FDA Releases First Wholesaler and 3PL Facility Licensure Data to the Public | The National Law Review

“Users either can query the database when searching for a particular company here or download the entire data set as an Excel file from this page.  Although technically the law only requires a public wholesale distributor database, FDA determined that making the 3PL information public as well served the law’s goals, and it stated in a December […]

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New Pharmacy Laws for 2015 – California Board of Pharmacy

Just posted, the CA Board of Pharmacy – California Law Changes for 2015 (PDF). It covers all code sections that were added or amended during the 2014 Legislative Session. Unless otherwise indicated, all of the provisions go into effect on January 1, 2015. Go to DREprof.com: The Designated Representative and Exemptee Training Website CA Designated […]

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FDA Recommends New Testing Standards for Home Use Devices | RAPS

“A final guidance document issued by the US Food and Drug Administration (FDA) aims to make medical devices used by patients in their homes safer and more reliable. Background In general, medical devices can be divided into two categories: Those intended to be used in professional settings by healthcare professionals, and those intended to be […]

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HDMA – Issues in Distribution: Pharmaceutical Traceability and the Drug Supply Chain Security Act

“The Drug Supply Chain Security Act (DSCSA, or Title II of the Drug Quality and Security Act) was enacted on November 27, 2013. The act replaces a 50-state patchwork of pedigree requirements with one federal traceability solution for prescription medicines, and raises licensure standards across the U.S. The law will transform how the domestic supply […]

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Design Considerations for Devices Intended for Home Use – FDA Guidance

Read the full guidance:  Design Considerations for Devices Intended for Home Use – Guidance for Industry and Food and Drug Administration Staff (PDF – 205KB) As stated in the guidance, “This guidance is intended to assist manufacturers in designing and developing home use devices that comply with applicable standards of safety and effectiveness and other […]

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FDA DSCSA Workshop – Meeting Materials

Follow the link below to the FDA webpage of all related meeting materials and notices: “[This FDA public workshop, May 8-9, 2014, was] intended to gather information, current practices, research and ideas on the standards for the exchange of transaction information, transaction history and transaction statements, in paper or electronic format, for each transfer of […]

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