Effective April 1, 2020, we have become fully integrated into Sun Pharmaceutical Industries Inc., who purchased Pharmalucence in July of 2014.
2020 UPPI Annual Member Meeting in Charlotte NC. September 24, 2020. Details to follow. (NOTE: this meeting has been postponed until September 2021).
Come see us at the 2020 Society of Nuclear Medicine and Molecular Imaging Annual Meeting at the Ernest N Morial Convention Center, June 13 – 16, New Orleans LA, Booth #314. (NOTE: this meeting has been postponed until June 2021 and will be held in Washington DC).
Compounding is necessary in special cases, but your nuclear pharmacy could also be supplying your hospital with lower-standard copies of FDA-approved radiopharmaceuticals without your knowledge1,2.
“Because compounded drugs are not FDA-approved, FDA does not verify their safety, effectiveness, or quality before they are marketed. … In addition, and of particular concern, poor compounding practices can result in serious drug-quality problems, such as contamination or medications that do not possess the strength, quality, and purity they are supposed to have. This can lead to serious patient injury and death.1“
-FDA’s Human Drug Compounding Progress Report
YOU ARE AT RISK
Individuals in a hospital can be held legally responsible when patients are harmed by improperly compounded products.2
YOUR INSTITUTION IS AT RISK
The use of non-FDA-approved nuclear medicines can negatively impact your institution’s quality of patient care, potentially tarnish its reputation, and lead to legal and financial liabilities.2
YOUR PATIENTS ARE AT RISK
Subpar compounded nuclear medicines can lead to misdiagnosis due to low-quality imaging. Even worse, compounded sterile products have become contaminated, causing patient harm and even deaths.
ASK YOUR NUCLEAR PHARMACY TODAY FOR DOCUMENTATION THAT THEY ARE SUPPLYING ONLY FDA-APPROVED RADIOPHARMACEUTICALS.
References: 1. FDA’s human drug compounding progress report three years after the Drug Quality and Security Act. U.S. Food & Drug Administration. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/UCM536549.pdf. Accessed August 31, 2018. 2. Gudeman J, Jozwiakowski M, Chollet J, Randell M. Potential risks of pharmacy compounding. Drugs R D.2013;13(1):1-8. 3. Kainer MA, Reagan DR, Nguyen DB, et al. Fungal infections associated with contaminated methylprednisolone in Tennessee. N Engl J Med. 2012;367(23):2194-2203. 4. Smith RM, Schaefer MK, Kainer MA, et al. Fungal infections associated with contaminated methylprednisolone injections. N Engl J Med. 2013;369(17):1598-1609. 5. Gupta N, Hocevar SN, Moulton-Meissner HA, et al. Outbreak of Serratia marcescens bloodstream infections in patients receiving parenteral nutrition prepared by a compounding pharmacy. Clin Infect Dis. 2014;59(1):1-8.
With all Pharmalucence products either fully transferred or in process for transfer to our Billerica MA facility, we have closed our original facility in Bedford MA.
Thanks for the memories!
The new Lyophilizer is the same make and model as our existing Lyo, and will be tied to our existing Bosch automated and isolated aseptic filling line. The project is expected to be completed by May 2017.
The Pharmalucence manufacturing site located at 29 Dunham Rd., Billerica, MA has received FDA approval for drug product aseptic fill-finish manufacturing operations. Our Tc 99m Sulfur Colloid Kit will be the first product manufactured at this new facility. Pharmalucence is now in the process of transferring the manufacturing process for all of its other injectable products to this site.