On February 9, 2016, the countdown to implementing the safety measures mandated by the Falsified Medicines Directive (FMD) Delegated Act started. This Act, which will come into force in early 2019, imposes item-level serialization and tamper evidence on pharmaceutical products in all European Union Member States.
Across the pond, the Drug Quality and Security Act (DQSA) was signed into law by President Barack Obama on November 27, 2013. Among other provisions, Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), requires that brand owners take steps to serialize their products at the item level. The end goal is for government officials and other stakeholders to be able to exchange “…transaction information, transaction history, and transaction statements”I in a secure, interoperable and electronic manner, about the location of a pharmaceutical product in the supply chain by 2023.
Manufacturers, repackagers, and wholesale distributors were required to phase in these product-tracing requirements beginning on January 1, 2015, whereas dispensers, primarily smaller, independent pharmacies and health systems, were given until March 1, 2016 to comply with the new policyII. These measures include:
Product identifier: Manufacturers and repackagers must “affix or imprint a product identifier to each package and homogenous product intended to be introduced in a transaction into commerce.III”
Product tracing: Manufacturers, repackagers, wholesale distributors, and dispensers are required to capture and “…provide the subsequent owner with transaction history, transaction information, and a transaction statement in a paper or electronic format.IV”
Product verification and notification: Manufacturers, repackagers, wholesale distributors, and dispensers need to have human sensory perception-based or machine-based processes in place to verify whether or not a product is authentic, suspect, or illegitimate. If, after investigation, the product is confirmed to be illegitimate, the current owner will quarantine the drug and notify the Food and Drug Administration (FDA) and his or her trading partners within 24 hoursV.
The Act stipulates that the Secretary of Health and Human Services, via the FDA, will develop standards VI, issue guidance documents VII, hold public meetings VIII, and establish pilot projects IXto implement these new requirements over a ten-year period. A summary of the planned implementation timeframe is available here: fda.gov .
Accordingly, the FDA held the first in a series of public workshops on April 5-6, 2016 on its campus in New Hampshire. This sold-out event convened key members of the supply chain to discuss and evaluate the technical capabilities necessary to adding a product identifier to pharmaceutical products in the packaging line, among other issues. Notes from the meeting were not yet published at the time of this article.
Now more than ever, manufacturers of pharmaceutical products and other stakeholders in the supply chain across the globe must take product identification and authentication seriously, as more than 80 per cent of all drugs sold in the worldX will be required by law to be uniquely identified, authenticated, and located from production, though distribution, and finally to the patient.
I Drug Supply Chain Security Act, Title II of the Drug Quality and Security Act, Section 582, Subsection (a)(2)(A), Retrieved 4 April 2016 at fda.gov
IIDSCSA Implementation: Product Tracing Requirements for Dispensers – Compliance Policy (Revised), October 2015, Retrieved 12 April 2016 at fda.gov
IIISee Reference 1, Section 582, Subsection (a)(3)(C)
IVSee Reference 1, Section 582, Subsection (b)(1)(A)(i)
VSee Reference 1, Section 582, Subsection (b)(4)
VISee Reference 1, Section 582, Subsection (a)(2)(A)
VIISee Reference 1, Section 203, Subsection (h)
VIIISee Reference 1, Section 203, Subsection (i)
IXSee Reference 1, Section 203, Subsection (j)
XChristoph Krähenbühl, 2016: The year to take serialisation seriously, 18 January 2016, Retrieved 13 April 2016 from securingindustry.com