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The Clock Is Ticking! Is your Drug Packaging Ready for the DSCSA Serialization Requirement?

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By Amy Vecchione and Gary Saner, Reed Tech

As part of the FDA Drug Supply Chain Security Act’s (DSCSA) product tracing scheme, manufacturers and repackagers are required to place a unique product identifier (serialization) on each package of human prescription drug product intended to be introduced into commerce beginning on November 27, 2018. The purpose of the serialization requirement is to enable product tracing throughout the supply chain and facilitate the detection of illegitimate products.

Who must include Product Identifiers (serialization) on drug packaging?

All manufacturers and repackagers of drug “products” defined by the DSCSA are required to comply with the DSCSA product identifier deadline unless a waiver, exemption, or exception is granted. Drug “products” defined by the DSCSA include human prescription drug products in a finished dosage form for administration to a patient without further manufacturing (such as capsules, tablets, etc.). However, this “product” definition does not include the following:

  • Over-the-counter (OTC) drugs
  • APIs, bulk, or drugs for further processing
  • Blood or blood components intended for transfusion
  • Certain radioactive drugs or radioactive biological products
  • Imaging drugs
  • Certain intravenous products
  • Medical gases
  • Homeopathic drugs

For the complete definition of “product,” see DSCSA Section 581(13). Also see: FDA Decision Tree: Should this drug package or case have a product identifier under the DSCSA?

What must be included in the Product Identifier?
Per the DSCSA sections 581(14) and 581(20), a product identifier must include:

· Standardized Numerical Identifier (SNI) comprised of:

› NDC (National Drug Code) – include labeler, product, and package codes; 10 (or 11) digits

› Serial Number – unique identifier up to 20 alphanumeric characters

· Lot Number

· Expiration Date – FDA recommended formats are YYYY-MM-DD (numerical month) or YYYY‑MMM‑DD (alpha month) or if there are space limitations the format can be YYYY‑MM (numerical month) or YYYY‑MMM (alpha month); use a hyphen or space between segments.

How is the Product Identifier represented on the drug package?
The product identifier must be presented in both human- and machine-readable formats on each package and homogenous case of product. The machine-readable format shall be a 2-dimensional (2D) data matrix barcode when affixed to or imprinted on a package or a linear or 2D data matrix barcode when affixed to or imprinted onto a homogeneous case of the product (see DSCSA section 582(a)(9)). Note: the DSCSA product identifier barcode does not replace the prevailing, separate FDA requirement for a drug label to have a linear barcode per CFR Sec 201.25.

What happens after November 27, 2018 if my product does not include the Product Identifier?
According to the FDA’s Guidance for Industry, introducing a product into commerce without product identifiers after the compliance date is prohibited under section 301(t) of the FD&C Act (21 U.S.C. 331(t)) and is subject to enforcement action under the FD&C Act.
Note: packages and homogenous cases of product that are already packaged by a manufacturer or repackaged by a repackager prior to November 27, 2018 are eligible for grandfathering under section 582(a)(5)(A) and do not need a product identifier. See the Grandfathering Policy.

How is the Product Identifier reported to the FDA?
The FDA considers the product identifier as part of “labeling” and as such must be submitted as part of the approval and registration/listing of human prescription drug products. A labeling change solely to include the product identifier may reported in the next annual report. In certain instances, it may be appropriate to submit a labeling change in a Prior Approval Supplement (PAS) or in a Changes Being Effected (CBE) instead of in an annual report.

Per FDA regulations drug listings must be reviewed and updated each June and December or preferably immediately upon the actual change. For products that do not require any updates, a company may submit a single “blanket” no changes certification once a year during the October 1 to December 31 renewal period. In regard to the DSCSA product identifier, the FDA requires the product identifier be shown in both human- and machine-readable format in the Principal Display Panel (PDP) image as part of the SPL listing submission. The FDA will allow a product identifier placeholder be shown in the PDP image. Note the PDP image is frequently represented in a “flattened” view showing all sides of the packaging. Also note that the FDA disallows a Blanket No Change Certification to be submitted for a product that does not have the product identifier included in the current drug listing. These guidelines require companies to update their human prescription drug SPL listing to include the product identifier before Dec 31, 2018.

Where can I go for help?

  • FDA Drug Supply Chain Security Act (DSCSA) Website
  • FDA Drug Supply Chain Security Act (DSCSA) Guidance Documents
  • Reed Tech to update your FDA Drug Labeling and Listing in electronic SPL submission format

Disclaimer
The Drug Supply Chain Security Act is a legal requirement and as such Reed Tech cannot advise you on it as a third-party pharmaceutical services vendor. Since this requirement affects your packaging, we strongly advise having your legal counsel review the law to ensure that you comply. We can only advise on requirements that impact your Electronic Structured Product Labeling Submissions.