The Drug Supply Chain Security Act (DSCSA) creates specific compliance requirements for manufacturers, re-packagers, wholesale distributors, dispensers of pharma products; and third-party logistics providers too that provide logistics services for the medicines in transit. A “dispenser” can also be any person authorized by law to dispense or administer prescription drugs and such a body must conform to DSCSA norms.
When a dispenser transfers ownership to another pharmacy, it will need to provide the 3T (transaction information, transaction history, and transaction statement) information to that downstream trading partner too so that compliance is maintained in the supply chain. Product returns will also need to be addressed in the DSCSA compliance format. Pharmacies cannot view the DSCSA as only requiring the passive receipt and maintenance of information from upstream trading partners and must look at automation to resolve issues due to operating multiple systems, lack of automation, duplication of effort and time taking report generation.
The traceability requirements generally apply to the transaction where the transfer of product between persons that cause a change of ownership and in prescription drugs intended for human use. With respect to that transaction between parties, the law outlines requirements for the transaction information, transaction history, and transaction statement (3T).
Transaction information include the established name of the product, the strength & dosage of the product, the National Drug Code number, container size and numbers, transaction & shipment dates, and the business name and address of both parties involved. The transaction history includes the transaction information from the current transaction to the manufacture of the product. The transaction statement is a statement in which the body transferring ownership in a transaction is authorized under DQSA to be involved in such a transaction, regularly receives the transaction information or transaction statement from the upstream owner of the product, and with safeguards for not shipping a spurious product.
As per the current requirements of DSCSA, all those in the pharma supply chain must use a product identifier that is a GS-1-compliant standardized that should carry the standardized numerical identifier, lot number, and expiration date of the product.
The FDA has defined “interoperability” encompasses the ability to exchange product tracing information precisely, efficiently, and regularly among trading partners and that for any system, process, to be interoperable, the subsequent purchaser must be able to successfully capture and maintain the product tracing information, regardless of whether the information is provided in a paper or electronic format. The FDA said that it may revisit this definition of “interoperability” as processes and capabilities that promote improved standardization and as electronic systems reinvent themselves.
By Nov 2017, manufacturers will be required to provide 3T (transaction information, transaction history, and a transaction statement) information electronically, serialize product, and meet enhanced verification requirements. In each succeeding year to 2017, re-packagers, wholesale distributors, and dispensers must follow suit.
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