In 2013, 503B Outsourcing Facilities came into existence as a result of the Drug Quality and Security Act (DQSA). The DQSA created Section 503B of the Federal Food, Drug, and Cosmetic Act, prompting extensive regulatory changes in the safe and effective compounding of drugs and medicines.
In addition, 503B compounders must provide non-sterile and sterile drug preparations expediently and cost-effectively because the provision of safe and of high-quality drugs are vital.
And that’s where the Nephron 503B Outsourcing Facility comes into play. This division of Nephron Pharmaceuticals supplies pre-filled syringes and sterile medications to alleviate drug shortage needs. In fact, the Nephron 503B Outsourcing Facility manufactures various products that are in short supply under Current Good Manufacturing Practice (cGMP) conditions.
This post is related to:
Admixture Compounding Services (503B Outsourcing Facilities)