Welcome!

News Feed Item

Unique Pharmaceuticals Registers as Outsourcing Facility with FDA

New Category Subject to More Rigorous Inspections and Quality Standards

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. 

Contact:
Amanda Anderson
[email protected] 
615-297-7766  

SOURCE Unique Pharmaceuticals, Ltd.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Automation is enabling enterprises to design, deploy, and manage more complex, hybrid cloud environments. Yet the people who manage these environments must be trained in and understanding these environments better than ever before. A new era of analytics and cognitive computing is adding intelligence, but also more complexity, to these cloud environments. How smart is your cloud? How smart should it be? In this power panel at 20th Cloud Expo, moderated by Conference Chair Roger Strukhoff, pane...
Grape Up is a software company, specialized in cloud native application development and professional services related to Cloud Foundry PaaS. With five expert teams that operate in various sectors of the market across the USA and Europe, we work with a variety of customers from emerging startups to Fortune 1000 companies.
SYS-CON Events announced today that Grape Up will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct. 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Grape Up is a software company specializing in cloud native application development and professional services related to Cloud Foundry PaaS. With five expert teams that operate in various sectors of the market across the U.S. and Europe, Grape Up works with a variety of customers from emergi...
Financial Technology has become a topic of intense interest throughout the cloud developer and enterprise IT communities. Accordingly, attendees at the upcoming 20th Cloud Expo at the Javits Center in New York, June 6-8, 2017, will find fresh new content in a new track called FinTech.
@ThingsExpo has been named the Most Influential ‘Smart Cities - IIoT' Account and @BigDataExpo has been named fourteenth by Right Relevance (RR), which provides curated information and intelligence on approximately 50,000 topics. In addition, Right Relevance provides an Insights offering that combines the above Topics and Influencers information with real time conversations to provide actionable intelligence with visualizations to enable decision making. The Insights service is applicable to eve...
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 20th Cloud Expo, which will take place on June 6-8, 2017 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 add...
Building a cross-cloud operational model can be a daunting task. Per-cloud silos are not the answer, but neither is a fully generic abstraction plane that strips out capabilities unique to a particular provider. In his session at 20th Cloud Expo, Chris Wolf, VP & Chief Technology Officer, Global Field & Industry at VMware, will discuss how successful organizations approach cloud operations and management, with insights into where operations should be centralized and when it’s best to decentraliz...
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm.
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, 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.
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
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...
With major technology companies and startups seriously embracing Cloud strategies, now is the perfect time to attend @CloudExpo | @ThingsExpo, June 6-8, 2017, at the Javits Center in New York City, NY and October 31 - November 2, 2017, Santa Clara Convention Center, CA. Learn what is going on, contribute to the discussions, and ensure that your enterprise is on the right path to Digital Transformation.
@GonzalezCarmen has been ranked the Number One Influencer and @ThingsExpo has been named the Number One Brand in the “M2M 2016: Top 100 Influencers and Brands” by Analytic. Onalytica analyzed tweets over the last 6 months mentioning the keywords M2M OR “Machine to Machine.” They then identified the top 100 most influential brands and individuals leading the discussion on Twitter.
In his keynote at 19th Cloud Expo, Sheng Liang, co-founder and CEO of Rancher Labs, discussed the technological advances and new business opportunities created by the rapid adoption of containers. With the success of Amazon Web Services (AWS) and various open source technologies used to build private clouds, cloud computing has become an essential component of IT strategy. However, users continue to face challenges in implementing clouds, as older technologies evolve and newer ones like Docker c...
Developers want to create better apps faster. Static clouds are giving way to scalable systems, with dynamic resource allocation and application monitoring. You won't hear that chant from users on any picket line, but helping developers to create better apps faster is the mission of Lee Atchison, principal cloud architect and advocate at New Relic Inc., based in San Francisco. His singular job is to understand and drive the industry in the areas of cloud architecture, microservices, scalability ...