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Zdrowie i gospodarka · 8.02.2019

Pilot Project Program Under the Drug Supply Chain Security Act; Program Announcement

The Food and Drug Administration (FDA or Agency) is announcing the start of the Pilot Project Program Under the Drug Supply Chain Security Act (DSCSA Pilot Project Program). The DSCSA Pilot Project Program is intended to assist FDA and members of the pharmaceutical distribution supply chain in the development of the electronic, interoperable system that will identify and trace certain prescription drugs as they are distributed within the United States. Under this program, FDA will work with stakeholders to establish one or more pilot projects to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. Participation in the DSCSA Pilot Project Program is voluntary and will be open to pharmaceutical distribution supply chain members to apply to the program. FDA will ensure that participation reflects the diversity of the supply chain, including large and small entities from all industry sectors. This notice establishes the DSCSA Pilot Project Program and includes instructions for submitting a request to participate and expectations for program participants.

Source: Federal Register — Food and Drug AdministrationOpen original release →