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

Cell Line Genetics, Inc

Cell Line Genetics, Inc,(CLG) is the leading independent provider of multi-species Quality Assurance services and products for the Regenerative Medicine market. Headquartered in Madison, Wisconsin and with offices in New York City, CLG’s clients include leading universities and research institutes, as well as biotechnology and pharmaceutical companies.

OTHER WHITEPAPERS
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Reimagining the pharma landscape with design thinking

whitePaper | July 29, 2021

As pharma companies strive for increased commercial success the customer-centric focus can get lost in the adoption of new commercial endeavours. As a result, many have been looking toward the world of design as a way of enhancing their customer engagement and accelerating their position in the market.

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Starting Materials For Homeopathic Drug Products

whitePaper | December 31, 2021

The scope of this white paper includes GMPs relevant for mass manufacturing/batch53 processing of products intended for widescale retail marketing. Starting materials and 54 packaging components for drug products

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Considerations for migrating a drug product presentation from vial to pre-filled syringe

whitePaper | December 9, 2022

There is an upward trend for pharmaceutical companies to ask their contract development and manufacturing organisations (CDMO) to support the conversion.

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Ultrasafe film Ultra-high barrier Product stability Patient safety

whitePaper | December 22, 2022

Every viable pharmaceutical packaging system must comprise materials proven to protect its contents against moisture and other atmospheric variables, and be safe for use with the specified dosage form and the route of administration1

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National Council for Prescription Drug Programs

whitePaper | May 12, 2022

This document is Copyright © 2022 by the National Council for Prescription Drug Programs (NCPDP). It may be freely redistributed in its entirety provided this copyright notice is not removed.

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MEETING CURRENT AND FUTURE SERIALISATIONCHALLENGES

whitePaper | December 5, 2022

Serialisation has emerged as a complex challenge for the pharmaceuticals sector which is facing a multiplicity of differing regulations that vary from one country to another.

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Spotlight

Cell Line Genetics, Inc

Cell Line Genetics, Inc,(CLG) is the leading independent provider of multi-species Quality Assurance services and products for the Regenerative Medicine market. Headquartered in Madison, Wisconsin and with offices in New York City, CLG’s clients include leading universities and research institutes, as well as biotechnology and pharmaceutical companies.

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