Following cGMP audit of QuVa Pharma's Sugar Land and Temple, Texas facilities, the California Board of Pharmacy has issued Outsource Facility licenses to both QuVa locations. The California Board of Pharmacy introduced this category of license in 2017 recognizing that FDA's 503B regulations require Outsource Facilities to meet cGMP standards as opposed to traditional pharmacy US <797> guidelines. QuVa believes it is one of the first 503B registered business to achieve this license status in California.
QuVa is supplying California hospitals with Sodium Bicarbonate PF 8.4% (1mEq/ml) 50ml in a syringe (50mEq per syringe), as well as other products from its comprehensive product catalogue, including other drug shortage products Calcium Chloride, Potassium Phosphate, and Rocuronium.
"We are delighted to be one of the first recipients of this new category of California licensure which reinforces our industry leading position in cGMP compliant operations," commented Stuart Hinchen, CEO and Co-Founder of QuVa Pharma. "California State Board of Pharmacy continues to be one of the most strident proponents of product quality standards in the country." Hinchen commented further that "QuVa's ability to provide high quality products, including chronic drug shortage product such as Sodium Bicarbonate, is providing California based hospitals with immediate access to medicine to continue patient care."
QuVa's range of products are all compounded from starting material that is FDA approved, and each shipment is accompanied by a Certificate of Analysis verifying Sterility, Potency, and Endotoxin levels of the product.