DSCSA IMPLEMENTATION FOR PHARMACEUTICAL 3PL PROVIDERS

With the stroke of a pen in 2013, the pharmaceutical industry mobilized in order to comply with sweeping changes enacted by the Drug Quality and Safety Act. The law includes the Drug Supply Chain Security Act (“DSCSA”), written to increase patient safety by minimizing risk from unauthorized pharmaceutical drug products entering the marketplace. The Federal Drug Administration, charged with enforcing the Act, set deadlines for the industry to comply with this law. The law requires all companies within the pharmaceutical supply chain to develop an electronic system designed to increase patient safety by minimizing drug diversion and reducing counterfeit products. The FDA set a deadline of November 2017 for companies to be in compliance with the law. Pharmaceutical manufacturers that do not confirm their supply chain is DSCSA-compliant before the deadline risk affecting patient health and may face regulatory penalties.

Spotlight

Hovione

Hovione has over 57 years of experience as a CDMO and is currently a fully integrated supplier offering from drug substance to drug product intermediate to drug product. With four FDA inspected sites, USA, China, Ireland and Portugal and development laboratories in Lisbon, Portugal and New Jersey, USA, Hovione provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs including highly potent compounds. For generic pharmaceutical customers, the company offers niche off-patent API products. Hovione also provides proprietary product development and licensing opportunities for drug products.

OTHER WHITEPAPERS
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How Specialty Pharmacy Can Drive Better Outcomes in Cystic Fibrosis

whitePaper | June 28, 2022

CF is a rare, autosomal recessive disease caused by mutations in the cystic fibrosis transmembrane regulator (CFTR) gene that encodes the CFTR protein, an anion channel normally present in the epithelial membrane.1,2

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Strengthening Engagement and Influence with Key Decision Makers

whitePaper | January 5, 2023

This report follows up on the jointly hosted Pharmaforce and elandas webinar which took place on July, 12, 2016, featuring contributions from participating industry leaders who formed the expert panel, as well as the live contributions of the audience of healthcare sales and marketing professionals.

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Understanding Net Pharmaceutical Expenditure Dynamics in Europe

whitePaper | April 12, 2022

The level of pharmaceutical expenditure is closely watched and often commented upon, but the composition of that expenditure and its dynamics are not as well understood.

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A Comparison of Substance Use Disorders before and during theCOVID-19 Pandemic

whitePaper | September 22, 2022

During the COVID-19 pandemic, drug overdose deaths have increased. At the same time, access to and utilization of substance use disorder treatment services have decreased.

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DEVELOPING AND OPTIMIZING CLEANING PROCESSES

whitePaper | November 1, 2022

Equipment cleaning in manufacturing companies is often not given the same emphasis as other processes. It can be viewed as a task.

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Non-Clinical Testing Considerations: Drugs vs Devices

whitePaper | November 8, 2022

While drugs and devices differ in their development, clinical trial phases and regulatory guidelines, the most important difference is that medical devices do not achieve their principal action by pharmacological means.

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Spotlight

Hovione

Hovione has over 57 years of experience as a CDMO and is currently a fully integrated supplier offering from drug substance to drug product intermediate to drug product. With four FDA inspected sites, USA, China, Ireland and Portugal and development laboratories in Lisbon, Portugal and New Jersey, USA, Hovione provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs including highly potent compounds. For generic pharmaceutical customers, the company offers niche off-patent API products. Hovione also provides proprietary product development and licensing opportunities for drug products.

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