What is T3 DSCSA?
Under the Drug Supply Chain Security Act (DSCSA), the T3 data for most medicines must be exchanged at change of ownership. The T3 data requirements includes the sending the Transaction history (TH), the Transaction information (TI), and the Transaction statement (TS).
What is a T3 pedigree?
The T3 report covers the product’s entire transaction history (pedigree) starting with the manufacturer, strength and dosage, lot numbers, and more.
What is DSCSA in pharmacy?
The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.
What is DSCSA compliance?
The Drug Supply Chain Security Act (DSCSA) outlines requirements for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). The requirements, development of standards, and the system for product tracing will continue to be phased in until 2023.
What is the purpose of the DSCSA?
The DSCSA was created to strengthen the security of the drug distribution supply chain by adding controls such as a national pharmaceutical track and trace system and establishing national standards for licensing of prescription drug wholesale distributors and third-party logistics providers (3PLs).
Does DSCSA apply to medical devices?
If your product is a device—even if the FDA requires your device to be dispensed only with a physician-issued prescription (“Rx Only”)—then it is not a prescription drug and therefore it is not covered by the DSCSA. Some devices are classified by the FDA as drug-device or biologic-device Combination Products (CPs).
What is T3 documentation?
T3 refers to the three pieces of product tracing documentation: transaction information (TI), transaction history (TH), and transaction statement (TS). Here is some detail about what needs to be included from those you purchase drugs from and what you must provide when transferring ownership to another trading partner.
What information does the product identifier contain Dscsa?
PRODUCT IDENTIFIERS UNDER THE DSCSA Therefore, each package and homogenous case of product intended to be introduced in a transaction into commerce must include the NDC, unique serial number, lot number, and expiration date in both human- and machine-readable formats.
What does the DSCSA do?
The DSCSA was enacted in 2013 to further secure our nation’s drug supply. It creates a tighter, closed prescription drug distribution system to prevent harmful drugs from entering the supply chain, detect harmful drugs if they do enter the supply chain, and enable rapid response when such drugs are found.
Why is DSCSA important?
Through the pursuit of these objectives, the DSCSA is transforming the pharma industry, making it safer, more transparent, and more efficient. Improve efficiency of recalls. Enable prompt response to suspect and illegitimate products when found. Create transparency and accountability in the drug supply chain.
What is the purpose of DSCSA?
What does the DSCSA address?
In November 2013, Congress enacted the Drug Supply Chain Security Act (DSCSA) as part of the Drug Quality and Security Act (DQSA) to address vulnerabilities in the drug supply chain and to facilitate the tracing of certain prescription drugs in finished dosage form throughout the pharmaceutical distribution supply …
What are the basic elements of the dscsa?
DSCSA basic elements The law requires ALLdrugs be traced as they move through the supply chain, and pharmacies must: •Only accept prescription drugs accompanied by three pieces of documentation – transaction information, transaction history, and transaction statement (T3). •Store product tracing documentation received for a minimum of six years.
How to contact the FDA about the dscsa?
If you have other DSCSA-related questions, such as those related to product tracing information, waivers, exceptions and exemptions, and trading partner requirements, email us at [email protected].
How is T3 data exchanged in the supply chain?
Under the Drug Supply Chain Security Act (DSCSA), the T3 data for most medicines must be exchanged at change of ownership. The T3 data requirements includes the sending the Transaction history (TH), the Transaction information (TI), and the Transaction statement (TS). What are the 3 Ts?