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DS CSA Implementation Panel Discussion Chaired by Mr. Scott Mooney, Vice President Distribution Operations Supply Chain Assurance, McKesson Pharmaceutical Mr. Christopher Reed, Global Operations Manager
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How to fill out dscsa implementation
01
Familiarize yourself with the DSCSA requirements and guidelines.
02
Ensure that you have the necessary infrastructure and technology in place to support DSCSA implementation.
03
Identify the unique identifier requirements for each product and ensure that you can generate and transmit these identifiers accurately.
04
Establish a comprehensive system for product tracing and documentation, including the ability to capture, store, and retrieve transaction information.
05
Develop procedures to handle suspect and illegitimate products, including the ability to investigate and report incidents.
06
Train your staff on DSCSA compliance measures and keep them updated on any changes in regulations.
07
Conduct regular audits to ensure ongoing compliance with DSCSA requirements.
08
Stay informed about any updates or changes to DSCSA regulations and adjust your implementation strategies accordingly.
Who needs dscsa implementation?
01
Pharmaceutical manufacturers
02
Wholesalers and distributors
03
Repackagers
04
Dispensers (pharmacies and hospitals)
05
Third-party logistics providers
06
Repackagers
07
Third-party logistics providers
08
Trading partners involved in the distribution of prescription drugs in the United States.
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What is dscsa implementation?
DSCSA implementation refers to the process of complying with the Drug Supply Chain Security Act.
Who is required to file dscsa implementation?
Pharmaceutical manufacturers, repackagers, wholesale distributors, and dispensers are required to file DSCSA implementation.
How to fill out dscsa implementation?
DSCSA implementation can be filled out electronically through the FDA's secure portal.
What is the purpose of dscsa implementation?
The purpose of DSCSA implementation is to enhance the security of the pharmaceutical supply chain and improve tracking of prescription drugs.
What information must be reported on dscsa implementation?
Information such as lot number, expiration date, and transaction history must be reported on DSCSA implementation.
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