By Cyndi Root
Unique Pharmaceuticals, Ltd. (UPI) registered voluntarily with the U.S. Food and Drug Administration (FDA) as a Human Drug Compounding Outsourcing Facility. The company announced the move in a press release last week. UPI is a pharmacy outsourcing facility for hospitals, medical clinics, and surgery centers in the U.S. UPI has been in the business for over 15 years and has certifications, accreditations, and quality assurance practices.
Travis A. Leeah, RPh, MBA, the President of UPI said, "At Unique Pharmaceuticals we have always been and will remain firmly committed to the quality and safety of our compounded preparations.” He said that the company works closely with regulators at federal and state levels. Leeah added that the company is committed to transparency and oversight as part of its mission to provide sterile and reliable medication to patients.
UPI sought the registration under the Drug Quality and Security Act, passed in late 2013. The company stated that passage of the Act helped bring definition to the compounding industry, as it includes FDA oversight. The Act (H.R. 3204) amends the Federal Food, Drug, and Cosmetic Act under Section 503B. It allows specific provisions for the human drug compounding and drug supply chain. Compounding facilities can voluntarily register, but can expect FDA inspections and strict requirements.
In a recent media briefing, the FDA explained some of its efforts and intended actions to enforce the new Act. The agency sent letters to hospitals urging them to do business with compounding facilities that are registered with the FDA. FDA Commissioner Margaret Hamburg, M.D. said, “Congress has worked to develop a framework that would enhance the security of the drug supply chain, so that we can better help protect consumers from the dangers of counterfeit, stolen, contaminated, or otherwise harmful drugs.”
The Commissioner pointed out that last year, a compounding facility caused fungal meningitis in a contaminated product, sickening 750 people and killing 64 people. The New England Compounding Center in Framingham, Mass., shut down operations due to the tragedy.
Unique Pharmaceuticals, seeking to avoid the same fate, registered with the FDA and embraces oversight and accountability. Additionally, the company has invested in technological improvements like Chemunex ScanRDI, which can discover sterility issues and contamination as it identifies microorganisms down to the microbial cell.
Source:
http://www.upisolutions.com/upinews.php?id=18
Unique Pharmaceuticals, Ltd. (UPI) registered voluntarily with the U.S. Food and Drug Administration (FDA) as a Human Drug Compounding Outsourcing Facility. The company announced the move in a press release last week. UPI is a pharmacy outsourcing facility for hospitals, medical clinics, and surgery centers in the U.S. UPI has been in the business for over 15 years and has certifications, accreditations, and quality assurance practices.
Travis A. Leeah, RPh, MBA, the President of UPI said, "At Unique Pharmaceuticals we have always been and will remain firmly committed to the quality and safety of our compounded preparations.” He said that the company works closely with regulators at federal and state levels. Leeah added that the company is committed to transparency and oversight as part of its mission to provide sterile and reliable medication to patients.
UPI sought the registration under the Drug Quality and Security Act, passed in late 2013. The company stated that passage of the Act helped bring definition to the compounding industry, as it includes FDA oversight. The Act (H.R. 3204) amends the Federal Food, Drug, and Cosmetic Act under Section 503B. It allows specific provisions for the human drug compounding and drug supply chain. Compounding facilities can voluntarily register, but can expect FDA inspections and strict requirements.
In a recent media briefing, the FDA explained some of its efforts and intended actions to enforce the new Act. The agency sent letters to hospitals urging them to do business with compounding facilities that are registered with the FDA. FDA Commissioner Margaret Hamburg, M.D. said, “Congress has worked to develop a framework that would enhance the security of the drug supply chain, so that we can better help protect consumers from the dangers of counterfeit, stolen, contaminated, or otherwise harmful drugs.”
The Commissioner pointed out that last year, a compounding facility caused fungal meningitis in a contaminated product, sickening 750 people and killing 64 people. The New England Compounding Center in Framingham, Mass., shut down operations due to the tragedy.
Unique Pharmaceuticals, seeking to avoid the same fate, registered with the FDA and embraces oversight and accountability. Additionally, the company has invested in technological improvements like Chemunex ScanRDI, which can discover sterility issues and contamination as it identifies microorganisms down to the microbial cell.
Source:
http://www.upisolutions.com/upinews.php?id=18