|By PR Newswire||
|January 20, 2014 11:46 AM EST||
TEMPLE, Texas, Jan, 20, 2014 /PRNewswire/ -- Unique Pharmaceuticals, Ltd., (UPI), today announced it has voluntarily registered with the U.S. Food and Drug Administration (FDA) as a Human Drug Compounding Outsourcing Facility following guidance from the recently enacted Drug Quality and Security Act.
"At Unique Pharmaceuticals we have always been and will remain firmly committed to the quality and safety of our compounded preparations," said Unique Pharmaceuticals President Travis A. Leeah, RPh, MBA, who has championed UPI's involvement with regulators on both the state and federal levels. "We have long embraced a heightened level of oversight and transparency and we are committed to continuing to provide reliable, sterile medications to patients in hospitals throughout the U.S."
Passage of the Drug Quality and Security Act on Nov. 27 brought definition to the regulation of the compounding industry by establishing a new oversight section of the FDA for "outsourcing facilities" like UPI, allowing facilities to voluntarily register with the FDA under Section 503B of the Federal Food, Drug and Cosmetic Act. This new category of large sterile compounders will be held to rigorous requirements and subject to routine FDA inspections and quality standards much like drug manufacturers.
In a letter recently, the FDA urged hospital purchasers to require compounding pharmacies that supplied medications to their facility to register as outsourcing facilities and consider voluntary registration of those facilities in their future purchasing decisions, stating that if they did so, "hospitals and other healthcare providers that purchase compounded drugs necessary to meet the medical needs of their patients can provide patients with drugs that were compounded in outsourcing facilities, which are subject to cGMP (Current Good Manufacturing Practices ) requirements and increased federal oversight."
Prior to recent legislation, Unique Pharmaceuticals voluntarily registered with the FDA. The company continues to make significant investments in technology, training and human capital in order to exceed current industry standards for providing sterile compounded medications.
In May 2013, the company adopted Chemunex ScanRDI technology across their operations to confirm sterility of preparations developed in their laboratory. UPI is one of the very few compounding pharmacies in the U.S. with the capability to detect and identify any microorganism in a raw ingredient or preparation – down to one microbial cell – within 48 hours.
About Unique Pharmaceuticals, Ltd.
Unique Pharmaceuticals, Ltd., (UPI) is a compounding pharmacy outsourcing facility dedicated to improving quality of life and providing trusted preparations for clinics, hospitals and surgery centers throughout the United States. UPI has more than 15 years of industry experience and is ISO 9001:2008 certified, VAWD (Verified-Accredited Wholesale Distributors) accredited, USP Chapter 797 compliant, the only national outsourcing facility to be CV certified by LDT Health Solutions and follows applicable GMPs (Good Manufacturing Practices). The company is headquartered in Temple, Texas, and is committed to delivering quality, assurance and peace of mind with every solution. For more information, please visit www.upisolutions.com or call 888-339-0874.
SOURCE Unique Pharmaceuticals, Ltd.
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain. In this power panel at @...
Oct. 23, 2016 09:45 PM EDT Reads: 1,855
Traditional on-premises data centers have long been the domain of modern data platforms like Apache Hadoop, meaning companies who build their business on public cloud were challenged to run Big Data processing and analytics at scale. But recent advancements in Hadoop performance, security, and most importantly cloud-native integrations, are giving organizations the ability to truly gain value from all their data. In his session at 19th Cloud Expo, David Tishgart, Director of Product Marketing ...
Oct. 23, 2016 09:30 PM EDT Reads: 2,441
November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Penta Security is a leading vendor for data security solutions, including its encryption solution, D’Amo. By using FPE technology, D’Amo allows for the implementation of encryption technology to sensitive data fields without modification to schema in the database environment. With businesses having their data become increasingly more complicated in their mission-critical applications (such as ERP, CRM, HRM), continued ...
Oct. 23, 2016 09:15 PM EDT Reads: 969
In past @ThingsExpo presentations, Joseph di Paolantonio has explored how various Internet of Things (IoT) and data management and analytics (DMA) solution spaces will come together as sensor analytics ecosystems. This year, in his session at @ThingsExpo, Joseph di Paolantonio from DataArchon, will be adding the numerous Transportation areas, from autonomous vehicles to “Uber for containers.” While IoT data in any one area of Transportation will have a huge impact in that area, combining sensor...
Oct. 23, 2016 09:00 PM EDT Reads: 734
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at @ThingsExpo, James Kirkland, Red Hat's Chief Arch...
Oct. 23, 2016 09:00 PM EDT Reads: 5,990
In his session at @DevOpsSummit at 19th Cloud Expo, Robert Doyle, lead architect at eCube Systems, will examine the issues and need for an agile infrastructure and show the advantages of capturing developer knowledge in an exportable file for migration into production. He will introduce the use of NXTmonitor, a next-generation DevOps tool that captures application environments, dependencies and start/stop procedures in a portable configuration file with an easy-to-use GUI. In addition to captu...
Oct. 23, 2016 09:00 PM EDT Reads: 1,511
Successful digital transformation requires new organizational competencies and capabilities. Research tells us that the biggest impediment to successful transformation is human; consequently, the biggest enabler is a properly skilled and empowered workforce. In the digital age, new individual and collective competencies are required. In his session at 19th Cloud Expo, Bob Newhouse, CEO and founder of Agilitiv, will draw together recent research and lessons learned from emerging and established ...
Oct. 23, 2016 09:00 PM EDT Reads: 1,248
SYS-CON Events announced today that Enzu will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Enzu’s mission is to be the leading provider of enterprise cloud solutions worldwide. Enzu enables online businesses to use its IT infrastructure to their competitive advantage. By offering a suite of proven hosting and management services, Enzu wants companies to focus on the core of their online busine...
Oct. 23, 2016 08:45 PM EDT Reads: 1,286
Why do your mobile transformations need to happen today? Mobile is the strategy that enterprise transformation centers on to drive customer engagement. In his general session at @ThingsExpo, Roger Woods, Director, Mobile Product & Strategy – Adobe Marketing Cloud, covered key IoT and mobile trends that are forcing mobile transformation, key components of a solid mobile strategy and explored how brands are effectively driving mobile change throughout the enterprise.
Oct. 23, 2016 08:30 PM EDT Reads: 1,708
SYS-CON Events announced today that Cloudbric, a leading website security provider, will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Cloudbric is an elite full service website protection solution specifically designed for IT novices, entrepreneurs, and small and medium businesses. First launched in 2015, Cloudbric is based on the enterprise level Web Application Firewall by Penta Security Sys...
Oct. 23, 2016 08:30 PM EDT Reads: 1,103
@DevOpsSummit has been named the ‘Top DevOps Influencer' by iTrend. iTrend processes millions of conversations, tweets, interactions, news articles, press releases, blog posts - and extract meaning form them and analyzes mobile and desktop software platforms used to communicate, various metadata (such as geo location), and automation tools. In overall placement, @DevOpsSummit ranked as the number one ‘DevOps Influencer' followed by @CloudExpo at third, and @MicroservicesE at 24th.
Oct. 23, 2016 08:00 PM EDT Reads: 3,967
SYS-CON Events announced today that Roundee / LinearHub will exhibit at the WebRTC Summit at @ThingsExpo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. LinearHub provides Roundee Service, a smart platform for enterprise video conferencing with enhanced features such as automatic recording and transcription service. Slack users can integrate Roundee to their team via Slack’s App Directory, and '/roundee' command lets your video conference ...
Oct. 23, 2016 07:30 PM EDT Reads: 2,068
The best way to leverage your Cloud Expo presence as a sponsor and exhibitor is to plan your news announcements around our events. The press covering Cloud Expo and @ThingsExpo will have access to these releases and will amplify your news announcements. More than two dozen Cloud companies either set deals at our shows or have announced their mergers and acquisitions at Cloud Expo. Product announcements during our show provide your company with the most reach through our targeted audiences.
Oct. 23, 2016 07:00 PM EDT Reads: 4,558
Established in 1998, Calsoft is a leading software product engineering Services Company specializing in Storage, Networking, Virtualization and Cloud business verticals. Calsoft provides End-to-End Product Development, Quality Assurance Sustenance, Solution Engineering and Professional Services expertise to assist customers in achieving their product development and business goals. The company's deep domain knowledge of Storage, Virtualization, Networking and Cloud verticals helps in delivering ...
Oct. 23, 2016 06:45 PM EDT Reads: 1,010
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smar...
Oct. 23, 2016 05:30 PM EDT Reads: 845