US Traceability Legislation: Drug Supply Chain Security Act (DSCSA)

Counterfeit and Falsified Pharmaceuticals

Counterfeit and falsified products, specifically counterfeit pharmaceuticals, are becoming an epidemic in industry today throughout the world. According to the United States Food and Drug Administration, it is estimated that counterfeits make up more than 10% of the global medicines market.[1] The World Health Organisation (WHO) has also estimated that more than 50% of medication and pharmaceuticals purchased online are falsified.[2}

 

New Legislation for Product Traceability

In an effort to combat the entry of these counterfeit and falsified pharmaceuticals into the legitimate supply chain, and their later consumption and usage by the general public, a range of different legislation has been drafted in recent years. This legislation is designed to increase, simplify and enforce product identification, traceability and verification worldwide.

 

EU - Falsified Medicines Directive

For example, as per the previous blog in this series; "Traceability, Falsified Products and New Legislation[3]" the Falsified Medicines Directive came into force in the European Union on the 2nd January 2013, with further related delegate acts due to come inot force throughout 2014. This legislation requires the introduction of serialisation and that an individual identifier be displayed at dispensing unit level of certain pharmaceutical products.[3]

 

USA - Drug Quality and Security Act (DQSA)

In the United States of America similar legislation was drafted in late 2013. The Drug Quality and Security Act (DQSA) was signed into law by President Barack Obama on the 27th November 2013.[4] Title II of the Drug Quality and Security Act (DQSA) is the Drug Supply Chain and Security Act (DSCSA).[4]

 
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USA - Drug Supply Chain and Security Act (DSCSA)

The aim of the DSCSA legislation, whose measures will be implemented over a period of 10 years according to the FDA (US Food and Drug Administration), is: 'to build an electronic, inter-operable system to identify and trace certain prescription drugs as they are distributed in the United States.[4]'

The measures of this legislation include the requirement for[4]:

  • Product Identification
  • Product Tracing
  • Product Verification
  • Detection and Response
  • Notification
  • Wholesaler Licensing
  • Third Party Logistics Provider Licensing

 

Product Identification

A unique product identifier must be placed on the individual package of specific prescription drugs by the manufacturer / repackager. E.g. A barcode

Product Tracing

Full traceability of a products journey is required through all the stakeholders in the pharmaceutical supply chain including the end purchaser / consumer.

Product Verification

All the stakeholders in the pharmaceutical supply chain, including; manufacturers, wholesalers, repackagers and pharmacies must establish systems and processes to enable verification of the product identifier on particular prescription drug packages.

Detection and Response

All the stakeholders in the pharmaceutical supply chain including; manufacturers, wholesalers, repackagers, and pharmacies must both quarantine and quickly investigate any pharmaceutical product that has been identified as suspect - meaning that it may be counterfeit, unapproved, or potentially dangerous.

Notification

All the stakeholders in the pharmaceutical supply chain including manufacturers, wholesalers, repackagers, and pharmacies are required to establish systems and processes to enable notification of the FDA and other stakeholders when an illegitimate drug is found.

Wholesaler Licensing

Wholesalers must report to the the FDA with both their licensing status and their particular contact information which will then be added to and made available in a public database.

Third-Party Logistics Provider Licensing

All those involved in storage and distribution of pharmaceutical products i.e. third-party logistics providers, are required to get either a state or federal license.

This system will be implemented on a phased basis over a period of ten years. The above requirements 'will include providing product and transaction information at each sale with lot level information, in paper or electronic format, and placing unique product identifiers on individual drug packages.[4]

 

Implementation of the Drug Supply Chain and Security Act (DSCSA)

On the 10th June 2014 the FDA issued its first draft guidance regarding one of the measures of the Drug Supply Chain and Security Act [5]. This guidance relates specifically to identifying suspect products in the pharmaceutical supply chain. The FDA has requested public comment on its proposal regarding how the stakeholders can both identify suspect products and how they can notify the FDA regarding their findings should an illegitimate drug be found.

The guidance also provides suggestions as to certain indicators that a pharmaceutical product may be suspect and ultimately illegitimate. Some of these indicators include[5]:

  • Product Labelling: The finished product may look different to the standard product or may have a different spelling than that of the standard label.
  • Product Look and Odour: The finished product may have a strange odour or may be a different shape or colour than that of the standard product.
  • Missing Information on Packaging: The outer packaging may be lacking specific identifying information such as the lot / batch number or the expiry date.
  • Tampered Package Seals: The product may have obvious signs of tampering, including having been opened, damaged or repaired or having altered seats.

 

Further guidance is due to be released in time regarding the implementation of the various measures under the Drug Supply Chain and Security Act (DSCSA) which will provide additional information to all stakeholders regarding requirements, time frames etc. According to the FDA the above-mentioned draft guidance is 'one of the first steps to implement this new law.[5]'

 
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[1] European Commission: Conference Paper: “Sanofi-Aventis Takes Action Against Counterfeiting”, [Online] Available From: http://ec.europa.eu/internal_market/indprop/docs/conf2008/wilfried_roge_en.pdf, [Accessed: 28th April 2014]

[2] World Health Organization: Medicines: General Information on Counterfeit Medicines, [Online] Available From: http://www.who.int/medicines/services/counterfeit/overview/en/, [Accessed: 28th April 2014]

[3] Brentech Data Systems: Blog: “Traceability, Falsified Products & New Legislation” [Online] Available From: http://www.bds.ie/blog-brentech-data-systems-blog/traceability-falsified-products-new-legislation.674.html [Accessed: 4th July 2014]

[4] FDA: Drugs: Drug Safety and Availability: Drug Supply Chain Integrity: Drug Supply Chain Security Act [Online] Available From: http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/default.htm [Accessed: 4th July 2014]

[5] FDA: Drugs: Drug Safety and Availability: “FDA issues draft guidance on identifying suspect drug products in the supply chain.” [Online] Available From: http://www.fda.gov/Drugs/DrugSafety/ucm400520.htm [Accessed: 7th July 2014]