|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.
SYS-CON Events announced today that Isomorphic Software will exhibit at DevOps Summit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Isomorphic Software provides the SmartClient HTML5/AJAX platform, the most advanced technology for building rich, cutting-edge enterprise web applications for desktop and mobile. SmartClient combines the productivity and performance of traditional desktop software with the simp...
Aug. 28, 2016 03:30 AM EDT Reads: 2,339
With so much going on in this space you could be forgiven for thinking you were always working with yesterday’s technologies. So much change, so quickly. What do you do if you have to build a solution from the ground up that is expected to live in the field for at least 5-10 years? This is the challenge we faced when we looked to refresh our existing 10-year-old custom hardware stack to measure the fullness of trash cans and compactors.
Aug. 28, 2016 02:00 AM EDT Reads: 1,763
Extreme Computing is the ability to leverage highly performant infrastructure and software to accelerate Big Data, machine learning, HPC, and Enterprise applications. High IOPS Storage, low-latency networks, in-memory databases, GPUs and other parallel accelerators are being used to achieve faster results and help businesses make better decisions. In his session at 18th Cloud Expo, Michael O'Neill, Strategic Business Development at NVIDIA, focused on some of the unique ways extreme computing is...
Aug. 28, 2016 01:45 AM EDT Reads: 2,148
The emerging Internet of Everything creates tremendous new opportunities for customer engagement and business model innovation. However, enterprises must overcome a number of critical challenges to bring these new solutions to market. In his session at @ThingsExpo, Michael Martin, CTO/CIO at nfrastructure, outlined these key challenges and recommended approaches for overcoming them to achieve speed and agility in the design, development and implementation of Internet of Everything solutions wi...
Aug. 28, 2016 01:30 AM EDT Reads: 2,075
Cloud computing is being adopted in one form or another by 94% of enterprises today. Tens of billions of new devices are being connected to The Internet of Things. And Big Data is driving this bus. An exponential increase is expected in the amount of information being processed, managed, analyzed, and acted upon by enterprise IT. This amazing is not part of some distant future - it is happening today. One report shows a 650% increase in enterprise data by 2020. Other estimates are even higher....
Aug. 28, 2016 01:00 AM EDT Reads: 2,962
Today we can collect lots and lots of performance data. We build beautiful dashboards and even have fancy query languages to access and transform the data. Still performance data is a secret language only a couple of people understand. The more business becomes digital the more stakeholders are interested in this data including how it relates to business. Some of these people have never used a monitoring tool before. They have a question on their mind like “How is my application doing” but no id...
Aug. 28, 2016 12:15 AM EDT Reads: 1,821
The 19th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Digital Transformation, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportuni...
Aug. 27, 2016 11:00 PM EDT Reads: 3,995
Identity is in everything and customers are looking to their providers to ensure the security of their identities, transactions and data. With the increased reliance on cloud-based services, service providers must build security and trust into their offerings, adding value to customers and improving the user experience. Making identity, security and privacy easy for customers provides a unique advantage over the competition.
Aug. 27, 2016 08:45 PM EDT Reads: 2,349
Qosmos has announced new milestones in the detection of encrypted traffic and in protocol signature coverage. Qosmos latest software can accurately classify traffic encrypted with SSL/TLS (e.g., Google, Facebook, WhatsApp), P2P traffic (e.g., BitTorrent, MuTorrent, Vuze), and Skype, while preserving the privacy of communication content. These new classification techniques mean that traffic optimization, policy enforcement, and user experience are largely unaffected by encryption. In respect wit...
Aug. 27, 2016 08:45 PM EDT Reads: 1,776
Fact: storage performance problems have only gotten more complicated, as applications not only have become largely virtualized, but also have moved to cloud-based infrastructures. Storage performance in virtualized environments isn’t just about IOPS anymore. Instead, you need to guarantee performance for individual VMs, helping applications maintain performance as the number of VMs continues to go up in real time. In his session at Cloud Expo, Dhiraj Sehgal, Product and Marketing at Tintri, wil...
Aug. 27, 2016 06:15 PM EDT Reads: 739
19th Cloud Expo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterpri...
Aug. 27, 2016 06:00 PM EDT Reads: 3,097
Enterprises have forever faced challenges surrounding the sharing of their intellectual property. Emerging cloud adoption has made it more compelling for enterprises to digitize their content, making them available over a wide variety of devices across the Internet. In his session at 19th Cloud Expo, Santosh Ahuja, Director of Architecture at Impiger Technologies, will introduce various mechanisms provided by cloud service providers today to manage and share digital content in a secure manner....
Aug. 27, 2016 06:00 PM EDT Reads: 734
Smart Cities are here to stay, but for their promise to be delivered, the data they produce must not be put in new siloes. In his session at @ThingsExpo, Mathias Herberts, Co-founder and CTO of Cityzen Data, will deep dive into best practices that will ensure a successful smart city journey.
Aug. 27, 2016 05:15 PM EDT Reads: 1,582
SYS-CON Events announced today that 910Telecom 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. Housed in the classic Denver Gas & Electric Building, 910 15th St., 910Telecom is a carrier-neutral telecom hotel located in the heart of Denver. Adjacent to CenturyLink, AT&T, and Denver Main, 910Telecom offers connectivity to all major carriers, Internet service providers, Internet backbones and ...
Aug. 27, 2016 05:00 PM EDT Reads: 1,884
To leverage Continuous Delivery, enterprises must consider impacts that span functional silos, as well as applications that touch older, slower moving components. Managing the many dependencies can cause slowdowns. See how to achieve continuous delivery in the enterprise.
Aug. 27, 2016 04:45 PM EDT Reads: 1,636