Understanding when the new Drug Quality Safety Act (DQSA), formerly known as H.R. 3204, will start to impact Manufacturers of Drug Product?

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If you are a pharmaceutical manufacturer, repackager, wholesaler or dispenser of drug products then the DQSA Law (formerly known as H.R. 3204) passed on November 27th 2013 is applicable to you. It supersedes all current state laws including the California e-Pedigree law. In this article I will focus on the timelines applicable for a drug product manufacturer. In future articles I will deal with the timelines for the other supply chain players.

What are the timelines applicable for a manufacturer?

1. Manufacturer of drug product
   1. 1st January 2015
      1. Product Tracing at the Lot level.
         - Must provide / receive transaction history, information and statements prior to or at the time of change of ownership of a drug product
         - Transaction history - list of transaction information of all changes of ownership going back to the manufacturer
         - Transaction statement is a document attesting to the details that you are supplying to that partner
         - Must be provided as a single document - paper or electronic
      2. Verification of product and transactions in the case of suspect product.
         - Must have the ability to validate with partners the validity of the product and it's transaction history.
         - Must have systems in place to support the investigation of suspect products.
         - The systems must also have the ability to notify the FDA and all immediate trading partners of suspect product
      3. Request for information
         - On request - shall provide, within 1 business day (not to exceed 48hrs), the transaction info, history and statements for that product
   2. 27th November 2017
      1. Product Identifiers (Serialization).
         -  All drug products must be encoded with a unique product identifier at the smallest saleable unit.
         - Downstream partners may not buy such a product without this identifier.
      2. Verification at the package level
         - Ability to verify the product at the package level (including SNI)
      3. Request for verification
         - Respond to requests for verification of a product by a trading partner for product in the trading partner's possession
         - 24hrs to respond
         - Product identifier (including SNI)
   3. 27th November 2023
      1. Product Tracing at an Item level.
         - Must provide / receive transaction history, information and statements prior to or at the time of change of ownership of the smallest saleable unit level
         - Transaction history - list of transaction information of all changes of ownership going back to the manufacturer
         - Secure electronic manner
         - Includes product identifier (SNI) or serialization info at the unit level or package level

So to summarize:

• Jan 1st 2015 manufacturers need to be able to verify and provide information of their drug product at a lot level. This information can be provided in a written form
• 4yrs after enactment on 27th November 2017 manufacturers will be required to encode their products with a unique identifier (including an SNI) paving the way for serialized tracing. Verification at the package level
• 10yrs after enactment on 27th November 2023 manufacturers will be required to provide product details electronically for the purpose of serialized track and trace

To download the DQSA Bill text (Click Here)

If you have any comments or questions please feel free to leave a post and we'll get back to you.

FREE 1 day seminar on Serialized Track and Trace - See the details and register at http://qdatausa.wordpress.com/about/serialization/