SPECIALTY RX FACTS

18Nov/130

HR 3024 Drug Quality and Security Act Passes in the Senate on to Obama for Signature

The United States Senate voted today to pass H.R. 3204, the Drug Quality and Security Act.

The Drug Quality and Security Act creates harmonized, Federal track and trace compliance requirements for pharmaceutical product tracing, serialization and verification of products / transactions across the supply chain starting January 1, 2015.

While serialization and track and trace will be pushed out a number of years, there will be significant demands on manufacturers, Third Party Logistics Providers, Repackagers, Distributors and Providers that will kick in starting 2015.

Plan on your 2014 to be very busy for many of these requirements if you are one of these entities.

For a full text on the bill see

www.govtrack.us/congress/bills/113/hr3204/text

Next steps after the President's signature:

  • The FDA will kick off a series of key activities which will shape the final information and implementation requirements across the supply chain
  • Industry involvement in guidance/rule development and supporting standards development will be crucial!
  • Preparing for Initial Deadlines (Lot Tracing, Verification, etc.)
  • Initial Draft Guidance  (published not later than 1 year after enactment – Nov 2014)
  • Establish standards for interoperable exchange of transaction information, history and statements (paper or electronic)
  • Consider feasibility of establishing standardized documentation to be used to convey Transaction Information, Transaction History (going back to the manufacturer) and Transaction Statement to a purchaser in a single document and to facilitate the exchange of lot-level data
  • Suspect and Illegitimate Product Guidance (published not later than 180 days after enactment – April 2014)
  • Identify specific suspect product risk scenarios
  • Provide recommendations on identification of suspect/illegitimate products
  • Preparing for Serialization and Product Tracing (Unit)

 

  • FDA to hold at least 5 public meetings
  • Steps to build capabilities and capacity for unit-level product tracing and the system attributes for such a system
  1. Public Meetings
  • Standards necessary to support secure interoperable electronic data exchange
  • Systems and processes needed to utilize serialized product identifiers for product tracing
  • Unit-level Tracing:  Not later than 18 months after a public meeting on secure tracing of product at the package level
  • System attributes for unit-level tracing, use of inference and aggregation, methods for secure tracing
  • Interoperable Data Exchange:  Not later than 18 months after a public meeting on interoperable standards
  • Standards necessary for secure, interoperable electronic data exchange
  1. Uniform processes or methodologies for product tracing
  2. Protection of confidential commercial information and trade secrets
  • Utilize serialized product identifiers for product tracing (including verification, aggregation and inference)

Get ready for the immediate next steps including:

  • Aggregation and Inference
  1. Will be a hard requirement in preparing for unit-level tracing deadlines
  2. Will likely be required much earlier to support trading partners for operational efficiency in meeting product identifier/serialization requirements
  3. A typical requirement for building a harmonized global serialization approach
  • Interoperable Data Exchange
  1. FDA will be developing standards and guidance for exchange of data starting soon and extending for years
  2. Transaction information, history and statements exchange between parties
  3. Lot-level and unit-level information exchange between parties, response to verification requests
  • How will you exchange required information with direct trading partners and manage your supply network?
  • How will you verify appropriateness of and efficiently respond to potential queries from unknown supply chain parties?
  • How will you efficiently generate or receive the Transaction Information, History and Statement data for all product transactions?
  1. Is a single paper document approach viable or can an existing electronic data method be adapted?
  • Lot Tracing
  1. Record Retention and Response to Queries
  2. How will you set up an IT infrastructure or paperwork filing system to manage 6 years of records
  3. How will you set up your data archival to comply with short time windows for retrieval of Transaction Information, History and Statement to comply with Requests for Information, etc.?

D2 is here to help you sort all of this out.  Shoot us a note.

 

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