Pharmaceutics International Inc. (Pii) has been added to the FDA’s list of organizations officially registered as human drug outsourcing facilities under the updated requirements of Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 
 
According to Dr. Kurt Nielsen, CEO of Pii, “the amendments to 503B of the FDCA are intended to provide a reliable supply of safe and effective medicines for hospitals and clinics to use for their patients.” The agility of the pharmaceutical outsourcing community has Nielsen feeling optimistic about “CDMOs and CMOs with appropriate capacities, capabilities to help alleviate drug shortages by bringing critical medicines, manufactured under stringent cGMP guidelines, to patients in need.”  Pii will be actively working with hospital systems directly in all 50 states to mitigate drug shortages.
 
Nielsen feels that “patients, especially rare and orphan disease populations, will ultimately be better served by the pharma industry.” Medicines will be delivered in a dose and dosage form best suited for a patient’s disease and the needs of health-care providers at the point-of-care will be more effectively met.
 
“More than 300 professional staff at Pii are proud to be part of the solution to bring improvements in care delivery to patients, physicians, and pharmacists, it is a responsibility taken seriously.  Most of our staff have walked in the shoes of their clients and have a great deal of experience at the hard work of advancing medicines from discovery through commercialization and on to patients,” stated the company.
 
See the registry and learn more about it, along with changes to Sections 503A and 503B of Federal Food, Drug, and Cosmetic Act (FD&C Act) here.