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California grants 503B license to Nephron Outsourcing Facility

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The California Board of Pharmacy has granted one of its first licenses to the Nephron 503B Outsourcing Facility in West Columbia.

The new California licensing regulation was introduced by the state’s Board of Pharmacy in early 2017 and the license to Nephron Pharmaceuticals was granted on July 5, the company announced in a press release.

Inspection reports of the Nephron facility indicate it complies with all cGMP standards and 503B outsourcing regulations required by the U.S. Food and Drug Administration, the release said.

Nephron is now licensed in 48 states, and is distributing products to hospitals and surgical centers across the United States.

According to the FDA website, an “outsourcing facility” is a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of section 503B, which regulates a category of compounders.

Nephron manufactures 8.4% Sodium Bicarbonate 50mL Injection in a prefilled syringe. In addition, Atropine Sulfate, Calcium Chloride, and Labetalol Hydrochloride, are available on the National Drug Shortage list. Additional products from the 503B Outsourcing Facility include Neostigmine Methylsulfate, Succinylcholine Chloride and others.

"We have escalated our production and recruiting efforts in recent weeks," said Lou Kennedy, CEO of Nephron. "We have increased batch sizes to accommodate more hospitals, and have recruited 100 new sterile pharmacy technicians and PharmD employees.

"New products, including sterile filled bags, sterile diluents, and controlled pain management medications are in the pipeline," Kennedy added.

Nephron produces over 1 billion sterile doses annually from its facility.

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