Traceability law takes effect

Federal Drug Quality and Security Act of 2013 creates a national standard for tracing drug products from the unit level back to the factory

Providers and suppliers have embarked on a 10-year journey implementing the provisions of the Federal Drug Quality and Security Act of 2013. Signed by President Obama in November 2013, the law creates a uniform national system for tracing all human drug products from the unit level (i.e., the bottle, tube, etc.) back to the manufacturer’s factory.

Concerns about counterfeiting, compounding and gray-market selling have dogged the pharmaceutical industry for years. Traceability – often called “pedigree” – has been addressed on a state-by-state basis, resulting in what some call a patchwork quilt of regulations, which has created difficulty for manufacturers and wholesalers servicing multiple states. The U.S. Food and Drug Administration has tried to address the issue for years – some would say clumsily. But it took the 2012 fungal meningitis outbreak, blamed on the New England Compounding Center in Framingham, Mass., to spur Congress to action.

Ten years after enactment, the system will facilitate the exchange of information at the individual package level about where a drug has been in the supply chain, according to the FDA. The new system is intended to:

  • Enable verification of the legitimacy of the drug product identifier down to the package level.
  • Enhance detection and notification of illegitimate products in the drug supply chain.
  • Facilitate more efficient recalls of drug products.

The Three Ts
Manufacturers, distributors and providers will notice that the word “pedigree” is becoming obsolete, replaced by new terminology, which some are calling the “Three T’s”:

  • Transaction Information (TI): Includes the name of the product, strength and dosage form, NDC, container size, number of containers, lot number, transaction date, the shipment date and the name and address of the sellers and buyers.
  • Transaction History (TH): Paper or electronic statement that includes the transaction information for each prior transaction back to the manufacturer.
  • Transaction Statement (TS): Paper or electronic attestation by the entity transferring ownership of the product that it: 1) is authorized under the Act, 2) received the product from an authorized party, 3) received TI and TS from the previous seller, 4) did not knowingly ship suspect or illegitimate product, 5) had systems and processes in place to perform verification, and 6) did not knowingly provide false transaction information and did not alter the transaction history.

Manufacturers were to begin sending distributors TI, TH and TS information beginning on Jan. 1, 2015. Manufacturers will be required to pass this information in electronic format by November 2017.

Next steps
An adjunct of traceability is the adoption of a universally recognized, universally applied numbering system for products in the supply chain.

The DQSA calls for manufacturers to affix a product identifier to each individual package and case of product by 2017, noted Liz Gallenagh, Esq., vice president, government affairs and general counsel, Healthcare Distribution Management Association, speaking at an HDMA seminar on traceability this fall. Repackagers must affix product identifiers by 2018. A product identifier is a standardized graphic (a two-dimensional data matrix) that carries the product’s standardized numerical identifier (SNI), lot number, and expiration date in both human- and machine-readable format, she said. By 2023, supply chain members must electronically trace product at the individual package (unit) level.

Resources
The Drug Quality and Security Act contains provisions for a number of things in addition to traceability, including:

  • Licensure of wholesalers and third-party-logistics providers
  • Identification, reporting and disposition of suspect products
  • Returns
  • Repackaging
  • Third-party-logistics providers
  • Recordkeeping

The Healthcare Distribution Management Association has a variety of informational materials on pharmaceutical traceability and the Drug Quality and Security Act of 2013 at http://www.healthcaredistribution.org/ir_issues/pedigree.asp.

The U.S. Food and Drug Administration offers explanations of the law at http://www.fda.gov/drugs/drugsafety/drugintegrityandsupplychainsecurity/drugsupplychainsecurityact/default.htm

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Key provisions of the Drug Quality and Security Act of 2013

Drug manufacturers, wholesale drug distributors, repackagers, and many dispensers – primarily pharmacies – will be called on to work in cooperation with the U.S. Food and Drug Administration to develop a new traceability system over the next 10 years, says the FDA. Among key provisions to be implemented are requirements for:

  • Product identification. A unique product identifier on certain prescription drug packages, for example, using a bar code that can be easily read electronically.
  • Product tracing. Information about a drug and who handled it each time it is sold in the U.S. market.
  • Product verification. Systems and processes in place to verify the product identifier on certain prescription drug packages.
  • Detection and response. A system to quarantine and promptly investigate a drug that has been identified as suspect, meaning that it may be counterfeit, unapproved, or potentially dangerous.
  • Systems and processes to notify FDA and other stakeholders if an illegitimate drug is found.
  • Wholesaler licensing. Wholesale drug distributors to report their licensing status and contact information to FDA. This information will then be made available in a public database.
  • Third-party-logistics provider licensing. Third-party-logistics providers, those who provide storage and logistical operations related to drug distribution, to obtain a state or federal license.

Source: U.S. Food and Drug Administration, http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/default.htm