The DSCSA Pharmaceutical Serialization Deadline Looms

From the United Kingdom to the United States, Canada and China, countries around the globe have put into place governmental regulations to safeguard the health and well-being of consumers with respect to medical devices, pharmaceuticals and life science goods.  In America, the Food and Drug Administration (FDA) will start enforcing key provisions of the Drug Supply Chain Security Act (DSCSA) in November 2018, a little over 3 months from now.  Pharmaceutical companies, from manufacturers to repackagers and distributors are scrambling to be able to meet compliance guidelines. Extended from 2017, the DSCSA mandated pharmaceutical serialization deadline is November 27, 2018 for manufacturers, repackagers and wholesale distributors.

All prescription drugs sold in the United States are required by FDA regulation DSCSA to be serialized at both the individual (saleable unit) level as well as at the case level.

Key objectives of the Drug Supply Chain Security Act were designed to provide track and trace of drug products  across the pharmaceutical supply chain so that counterfeit and gray market prescription drug products can be identified before presenting a danger to consumers.  Understanding terminology and key concepts can be helpful in preparing for the serialization of pharmaceuticals.

DSCSA Product Identification (Pharmaceutical Serialization)

Many companies across the pharmaceutical supply chain have questions regarding the FDA DSCSA regulations involving a “unique product identifier” on certain prescription drug packages.

The two most recognized ways to implement package level Standardized Numerical Identifiers (SNI) for prescription drug products involve use of NDC + a serial number or use of a GTIN which incorporates NDC + a serial number.  Lot number and expiration date are also required.

National Drug Code (NDC):

The National Drug Code, identified on packages with the letters NDC, is the unique 10 digit 3-segment number that acts as a universal product identifier for human-grade pharmaceutical products in the United States.  An NDC is present on a prescription and non-prescription (over-the-counter) medication packages and inserts in the United States.  NDC codes are used to bill healthcare claims and may need to be converted from a 10 digit code to an 11 digit format for billing purposes.  Manufacturers and re-labelers use the NDC to submit registration and drug listing information to the FDA electronically.

GTIN vs. NDC

Although there is currently no product identifier used by 100% of the pharmaceutical industry, the top 3 wholesale pharmaceutical distributors have chosen to align to the GS1 standard.  If you already have an NDC, you should obtain a GTIN to use your NDC in GS1 barcodes including the U.P.C. barcode, GS1 DataMatrix and data sharing standards including EPCIS.  It is not necessary to register individual GTINs with GS1.  The FDA does not require registration of GTINs or have a requirement in DSCSA for any additional registration of the NDC beyond the original requirement.  GTINs are used in reporting transaction information and transaction history when ownership of individual instances of pharmaceuticals are transferred in the supply chain.

GTIN is the GS1 Global Trade Item Number, an established, recognized identification system used across the world in many industries. To obtain a GTIN, you must register with GS1.  First, become a GS1 member by registering your labeler code with GS1.  GS1 then turns your labeler code into a company prefix which is the base for the GTIN.

Many pharmaceutical industry companies are embracing GS1 standards including using EPCIS for the data exchange that DSCSA requires.  GS1’s EPCIS standards will then require assignment of GTINs to each of a manufacturer’s products at each level of packaging.

Using the GS1 standard, the GTIN repository would provide a single method for manufacturers to share consistent, accurate master data with downstream pharmaceutical supply chain partners.  This would relieve the manufacturer of the burden of sharing the same data multiple times with multiple trading partners.  GTINs would be submitted by manufacturers to the central repository.  The GTIN repository would then become the source for GTIN and related product information.

SGTIN

SGTIN is a combination of GTIN as well as a unique serial number of up to 20 alphanumeric characters.  Every instance of a respective trade item would receive a different serial number.

For example:

A particular GTIN may be assigned to a 30 capsule bottle of drug ABC.  All of the 30 capsule bottles of drug ABC would have the same GTIN however, every individual 30 capsule bottles of drug ABC would have a different serial number and so a different STIN

Conclusion:

With the impending DSCSA deadline approaching in November 2018, companies across the pharmaceutical industry supply chain are straining to learn more about serialization and to work towards compliance.  Pharmaceutical companies affected by this change include manufacturers, repackagers and wholesale distributors.

Understanding that serialization is a process that involves an entire operation is critical. As the FDA pushes ahead, pharmaceutical manufacturers, repackagers and wholesale distributors are working to gain a handle on the cost of pharma serialization.  Implementing serialization will mean rethinking life science packaging lines, packaging processes, data storage, labeling systems, operating software and global pharmaceutical supply chain regulations and needs.  Proper planning and collaboration on execution by cross-functional teams working on serialization is essential for the success of the project.