Pii is a Key Part of the FDA’s 503B Solution

The FDA has updated Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to advance its public health mission. Pii is proud to be a part of this industry-wide effort to deliver critical medicines reliably and safely to patients.

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Innovative Therapies Supporting 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act)

Innovative therapies including customized, patient-specific compounds, are transforming healthcare, and presenting new challenges for pharmaceutical development, manufacturing, and supply chain management. Our healthcare ecosystem is experiencing tectonic shifts and providing a reliable supply of safe and effective medicines for hospitals and clinics to use for their patients will require an innovative, problem-solving mindset. The experienced scientists, engineers, and staff at Pii pride themselves in solving challenging problems, it is part of our DNA.

As more innovative therapies transform modern healthcare best practices, FDA has updated Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to advance its public health mission. Pii is proud to be a part of this industry-wide effort to deliver critical medicines reliably and safely to patients.

Kurt Nielsen Pii
Kurt Nielsen, Ph.D.
President and CEO

“I am extremely optimistic about how CDMOs and CMOs with appropriate capacities and capabilities will help alleviate drug shortages by bringing critical medicines, manufactured under stringent cGMP guidelines, to patients in need. Pii is actively working with hospital systems directly in all 50 states to mitigate drug shortages. Pii’s ability to operate with great agility will contribute significantly to the patient-centric healthcare system of the future.”

The more than 300 professional staff at Pii are proud to be part of providing real solutions for patients, physicians, and pharmacists, now and into the future. Most of the 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—it’s our life’s work.

Pharmaceutics International, Inc. (Pii) is a registered member of the FDA’s human drug outsourcing facilities under the updated requirements of Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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To 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), go to https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities

Read our Press Release on FD&C 503B