|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.
One of the hottest areas in cloud right now is DRaaS and related offerings. In his session at 16th Cloud Expo, Dale Levesque, Disaster Recovery Product Manager with Windstream's Cloud and Data Center Marketing team, will discuss the benefits of the cloud model, which far outweigh the traditional approach, and how enterprises need to ensure that their needs are properly being met.
Feb. 25, 2017 10:00 AM EST Reads: 5,323
As cloud adoption continues to transform business, today's global enterprises are challenged with managing a growing amount of information living outside of the data center. The rapid adoption of IoT and increasingly mobile workforce are exacerbating the problem. Ensuring secure data sharing and efficient backup poses capacity and bandwidth considerations as well as policy and regulatory compliance issues.
Feb. 25, 2017 10:00 AM EST Reads: 2,001
In his session at 20th Cloud Expo, Chris Carter, CEO of Approyo, will discuss the basic set up and solution for an SAP solution in the cloud and what it means to the viability of your company. Chris Carter is CEO of Approyo. He works with business around the globe, to assist them in their journey to the usage of Big Data in the forms of Hadoop (Cloudera and Hortonwork's) and SAP HANA. At Approyo, we support firms who are looking for knowledge to grow through current business process, where even...
Feb. 25, 2017 10:00 AM EST Reads: 839
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 with...
Feb. 25, 2017 10:00 AM EST Reads: 7,707
Cloud Expo, Inc. has announced today that Andi Mann and Aruna Ravichandran have been named Co-Chairs of @DevOpsSummit at Cloud Expo 2017. The @DevOpsSummit at Cloud Expo New York will take place on June 6-8, 2017, at the Javits Center in New York City, New York, and @DevOpsSummit at Cloud Expo Silicon Valley will take place Oct. 31-Nov. 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Feb. 25, 2017 09:30 AM EST Reads: 2,139
SYS-CON Events announced today that Outlyer, a monitoring service for DevOps and operations teams, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Outlyer is a monitoring service for DevOps and Operations teams running Cloud, SaaS, Microservices and IoT deployments. Designed for today's dynamic environments that need beyond cloud-scale monitoring, we make monitoring effortless so you...
Feb. 25, 2017 09:15 AM EST Reads: 2,132
@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.
Feb. 25, 2017 09:00 AM EST Reads: 1,319
What are the new priorities for the connected business? First: businesses need to think differently about the types of connections they will need to make – these span well beyond the traditional app to app into more modern forms of integration including SaaS integrations, mobile integrations, APIs, device integration and Big Data integration. It’s important these are unified together vs. doing them all piecemeal. Second, these types of connections need to be simple to design, adapt and configure...
Feb. 25, 2017 09:00 AM EST Reads: 3,623
It is one thing to build single industrial IoT applications, but what will it take to build the Smart Cities and truly society changing applications of the future? The technology won’t be the problem, it will be the number of parties that need to work together and be aligned in their motivation to succeed. In his Day 2 Keynote at @ThingsExpo, Henrik Kenani Dahlgren, Portfolio Marketing Manager at Ericsson, discussed how to plan to cooperate, partner, and form lasting all-star teams to change the...
Feb. 25, 2017 09:00 AM EST Reads: 5,227
"I think that everyone recognizes that for IoT to really realize its full potential and value that it is about creating ecosystems and marketplaces and that no single vendor is able to support what is required," explained Esmeralda Swartz, VP, Marketing Enterprise and Cloud at Ericsson, in this SYS-CON.tv interview at @ThingsExpo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Feb. 25, 2017 08:30 AM EST Reads: 1,047
The buzz continues for cloud, data analytics and the Internet of Things (IoT) and their collective impact across all industries. But a new conversation is emerging - how do companies use industry disruption and technology enablers to lead in markets undergoing change, uncertainty and ambiguity? Organizations of all sizes need to evolve and transform, often under massive pressure, as industry lines blur and merge and traditional business models are assaulted and turned upside down. In this new da...
Feb. 25, 2017 08:15 AM EST Reads: 7,984
When it comes to cloud computing, the ability to turn massive amounts of compute cores on and off on demand sounds attractive to IT staff, who need to manage peaks and valleys in user activity. With cloud bursting, the majority of the data can stay on premises while tapping into compute from public cloud providers, reducing risk and minimizing need to move large files. In his session at 18th Cloud Expo, Scott Jeschonek, Director of Product Management at Avere Systems, discussed the IT and busine...
Feb. 25, 2017 08:00 AM EST Reads: 5,915
In his General Session at 16th Cloud Expo, David Shacochis, host of The Hybrid IT Files podcast and Vice President at CenturyLink, investigated three key trends of the “gigabit economy" though the story of a Fortune 500 communications company in transformation. Narrating how multi-modal hybrid IT, service automation, and agile delivery all intersect, he will cover the role of storytelling and empathy in achieving strategic alignment between the enterprise and its information technology.
Feb. 25, 2017 08:00 AM EST Reads: 5,764
All clouds are not equal. To succeed in a DevOps context, organizations should plan to develop/deploy apps across a choice of on-premise and public clouds simultaneously depending on the business needs. This is where the concept of the Lean Cloud comes in - resting on the idea that you often need to relocate your app modules over their life cycles for both innovation and operational efficiency in the cloud. In his session at @DevOpsSummit at19th Cloud Expo, Valentin (Val) Bercovici, CTO of Soli...
Feb. 25, 2017 07:30 AM EST Reads: 1,164
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at Cloud Expo, Ed Featherston, a director and senior enterprise architect at Collaborative Consulting, discussed the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
Feb. 25, 2017 07:30 AM EST Reads: 5,933