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US Drug supply chain and security act has provided definition for Transaction history, information and statement. I kept reading about these definitions and tried to create a tentative formats which can be used post 1st January 2015.

According to DSCSA, “Transaction means the transfer of product between persons in which change of ownership occurs”. I felt instead of persons it should have been organizations or business entities.

There are few exemptions to this term “Transaction”. This means that below transaction are not considered as change of ownership. Few are

1. Intracompany distribution of any product between members of an affiliate or within a manufacturer.

If a manufacturer hires a 3PL to distribute his products, 3PL do not have liability of owning the product and these interactions between 3PL and manufacturers are not part of a transaction. If this thought of mine is right then, i feel that there would be good potential for drug counterfeiting.

2. Distribution of intravenous products.etc..

Check this document for complete details..

Transaction History is a statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product.

Every Manufacturer,Wholesale distributor,Dispenser and Re-packager must maintain transaction information history and statement for not less than six years after the date of the transaction.

Transaction Information should provide below details

1. The proprietary or established name or names of the product

2. The strength and dosage form of the product

3. The National Drug Code number of the product

4. The container size

5. The number of containers

6. The lot number of the product

7. The date of the transaction

8. The date of the shipment, if more than 24 hours after the date of the transaction

9. The business name and address of the person from whom ownership is being transferred

10. The business name and address of the person to whom ownership is being transferred.

Every Manufacturer,Wholesale distributor,Dispenser and Re-packager, whenever there is a change of ownership, should provide the subsequent owner with transaction history containing transaction information and transaction statement.

Transaction Statement

The ‘transaction statement’ is a statement, in paper or electronic form, that the entity transferring ownership in a transaction—

          (A) is authorized as required under the Drug Supply Chain Security Act

          (B) received the product from a person that is authorized as required under the Drug Supply Chain Security Act

          (C) received transaction information and a transaction statement from the prior owner of the product, as required under section 582

          (D) did not knowingly ship a suspect or illegitimate product

          (E) had systems and processes in place to comply with verification requirements under section 582

          (F) did not knowingly provide false transaction information and

          (G) did not knowingly alter the transaction history

So after 1st January 2015, whenever there is change of ownership of product, the owner of the product should provide the above transaction information and transaction statement to subsequent owner of the product. And also all owners should provide transaction history of the product for not less than 6 years after the date of the transaction.

Hypothetical example,

Manufacturer to Wholesale Distributor




image 01.jpg

Manufacturer called A Pharmaceutical Ltd produces Botulinum toxin under brand name iBotox. Its national drug code is 023-3921-02.

A Pharmaceutical received a sale order from Datson Pharma – A Whole sale distributor, for 1 carton of iBOTOX. A Pharma suggested delivery date as 17/01/2015 which was acceptable for Datson pharma.

A pharma started packing of 1 carton of iBotox with mandatory product identifiers and data, imprinted on every saleable unit in 2D barcode form.

A pharma procured services of a 3PL service provider to distribute this 1 carton of iBotox to its customer. So according to its delivery schedule A pharma called 3PL to pick the consignment and executed order delivery. Along with the necessary documentation, like sales invoice, packing list (optional), excise documents, this time A pharma provided 3PL with two new more documents called Transaction Statement and Transaction information. These documents along with the product have to be delivered to customer on or before 17/01/2015.

When product received at Datson pharma, warehouse executive and quality assurance officer will perform necessary checks along with scrutinizing Transaction information history document and perform goods receipt acceptance.

Later that rest of the payment process will get initiated.


Transaction Statement


image 03.jpg




Transaction Information History


image 04.jpg


Wholesale Distributor to Dispenser


image 02.jpg

Datson Pharma receives an order from Jupiter pharmacy to supply a carton of iBotox. Delivery requested date is 23.02.2015. Both parties agree for deal and Datson pharma initiates delivery process on 19.02.2015.

Along with necessary documents Datson pharma will staple transaction statement and transaction information history document to be sent to Jupiter pharmacy.

When product received at Jupiter Pharmacy, Pharmacist will perform necessary checks along with scrutinizing Transaction information history document and perform goods receipt acceptance.


Transaction Statement

image 05.jpg

Transaction Information History


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All these entities, Manufacturer, wholesale distributor and dispenser will have to retain these documents at least for 6 years from the date of transaction.

Upon a request by the Secretary or other appropriate Federal or State official, in the event of a recall or for the purpose of investigating a suspect product or an illegitimate product, a manufacturer/Distributor/Dispenser shall, not later than 1 business day, and not to exceed 48 hours, after receiving the request, or in other such reasonable time as determined by the Secretary, based on the circumstances of the request, provide the applicable transaction information, transaction history, and transaction statement for the product.

I have cited above example for bringing more clarity on the mentioned subject. Names of products and companies are mere fictitious and should not be referred to any of those existing ones.

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2 Comments

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  1. Oliver Nuernberg

    Hi, thanks for the post. However the large US wholesalers will not accept paper documentation or documentation in PDF. With 3 big wholesalers making up 90%+ of the US market, they basically dictate how you have to deliver the content. They will probably ask for serialized-ASNs (and maybe accept EPCIS) but will not accept paper or PDF or will impose high fees on any supplier who will not comply (see this customer letter: http://bit.ly/1m3qslY ).

    Oliver

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    1. Kishore Sirigiri Post author

      You are right. We can get the similar information in electronic formats if we have proper data interoperable systems in place with secured access to all concerned stake holders

      regards

      kishore

      (0) 

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