Pharmaceutic Labs Responds to the FDA's Drug Quality and Security Act: Quality Pharmaceuticals from a CGMP 503B Outsourcing Facility

May 28, 2015, 09:17 ET from Pharmaceutic Labs

ALBANY, N.Y., May 28, 2015 /PRNewswire/ -- Pharmaceutic Labs announces its official status as a "503B Outsourcing Facility" under section 503B of the FDA's Drug Quality and Security Act. To qualify for this title, the company is subject to Current Good Manufacturing Practice (CGMP) and increased federal oversight, producing bulk medications according to the highest standards of CGMP 21 CFR Part 210 and 21 CFR Part 211. To continuously comply with FDA regulations and ensure patient safety, Pharmaceutic Labs has implemented quality control and quality assurance procedures for its staff and state-of-the-art facility. The company has addressed all levels of compliance in its People, Process and Facility.

Pharmaceutic Labs' 503B Outsourcing Facility serves hospitals, surgery centers and veterinary clinics nation-wide with anticipatory bulk sterile and non-sterile medications. Their growing product line will respond to market demands for quality drugs produced for bulk compounding, admixing, drug shortages, clinical studies, clinical trials and contract manufacturing. Pharmaceutic Labs' initial focus will be on producing quality medications for the Acute Care market, Ophthalmology, Pain Management, and Veterinary Medicine. The company's goal is to be the leader in quality for all of its sterile and non-sterile products and a model of 503B standards.

"Our 503B Outsourcing Facility complies to the full extent of the law," explains Ernesto Samuel, President and CEO of Pharmaceutic Labs. "Therefore, our products reflect the highest levels of safety and quality for consumers, as defined by the FDA." All products are released into the market approved by the Quality Control and Quality Assurance Teams and labeled with the Pharmaceutic Labs quality seal--evidence of the company's commitment to excellence in quality and safety.

SOURCE Pharmaceutic Labs



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