Molecular PharmaGroup Welcomes You
About Our Brand
Molecular PharmaGroup is a newly constructed FDA Registered 503B Outsourcing Facility in New Providence, New Jersey. The facility manufactures products from the FDA Shortage List and specialty compounds for hospitals, medical groups and independent practitioners.
The Drug Quality and Security Act, signed into effect as of 2013, created a new designation of sterile drug compounders, called Outsourcing Facilities, who must adhere to current good manufacturing practices (cGMP) in order to manufacture drug products that are on the FDA Drug Shortage list along with a variety of other formulations. These products are available without a prescription in order to serve patients in acute and institutional settings. Molecular PharmaGroup constantly monitors the currently regulatory landscape trailing the DQSA for updates to ensure they are following best practices.
Although not required for most pharmacies, Molecular PharmaGroup has elected to pursue FDA oversight to implement the highest standards of Quality Assurance for its facility and products.
Quality Assurance
Molecular PharmaGroup outsources sterility (USP 71), endotoxin (USP 85), and potency testing to an independent unbiased QA firm while adhering to cGMP, USP 797 and USP 800 standards. Each batch is accompanied with a Certificate of Analysis validating quality assurance and quality control at each processing stage.
Molecular PharmaGroup's staff of licensed pharmacists have access to GMP compliant equipment, state-of-the-art cleanrooms, and operate under procedures and practices that exceed the standards normally followed by state-licensed pharmacies. The facility is also equipped to comply with the latest regulations, including USP 800.
For more information on:
Guidance, Compliance, & Regulatory Information
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation
Registered Outsourcing Facilities
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm378645.htm
FDA Shortage List
https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm
