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DSCSA: BIO files Comments on FDA Draft Guidance Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers

November 19, 2018

Re: Docket No. FDA-2018-D-3175: Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers

Dear Sir/Madam:

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on FDA’s Draft Guidance for Industry “Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers” (Draft Guidance).

BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products.

General Comments

BIO appreciates the release of this Draft Guidance as it helps to answer common questions Sponsors may have regarding the use of product identifiers as required under the Drug Supply Chain Security Act (DSCSA). BIO member companies are committed to ensuring the US drug supply chain is secure, patients are receiving authentic products, and legitimate medications continue to move through the supply chain without unnecessary delays. We believe that DSCSA will help improve the security of the US pharmaceutical supply chain only through the shared responsibilities and collaborative efforts across all supply chain Stakeholders. Securing the US supply chain and protecting our patients from counterfeit products remain important priorities for BIO and its member companies.

In order to ensure this Draft Guidance provides clear and effective guidance to all Stakeholders and allows for sufficient flexibility to reduce the likelihood of rework and potential product delays and shortages, BIO would like to provide the Agency with the following suggestions and feedback.

Order and Format of Product Identifier Requirements

The Draft Guidance discusses the order and format of the human-readable portion of the product identifier in lines 263-267; while BIO appreciates that this a recommendation, we note that not all manufacturers align the order of this information with FDA’s recommendation of NDC, serial number, lot, and expiration date. BIO believes that there should be sufficient flexibility for a manufacturer to have this information in a different order based on their internal decisions as long as all information required in the human-readable portion of the package label is easily located and understood.

Additionally, we appreciate FDA’s acknowledgement that variations may exist in abbreviations in the human-readable portion of the label (lines 272-275). BIO asks that FDA also state that this variation and flexibility in how manufacturers abbreviate the information in the label is acceptable.

Expiration Date Formatting

The Draft Guidance in lines 277-283 discusses FDA’s recommendation for how the human-readable expiration date on the drug package label should be formatted. The current FDA recommendation is YYYY-MM-DD for numerical only characters or YYYY-MMM-DD for alphabetical characters for the month; for packages with space limitations YYYY-MM if using only numerical characters or YYYY-MMM if using alphabetical characters for the month.

BIO notes that manufacturers currently use a wide variety of formats for the expiration date on drug package labels and as long as the expiration date is interpretable and intelligible, these variations should be allowed. For instance, some of the more frequently used formats are MM/YYYY or MMYYYY. BIO also notes that the format as suggested in this Draft Guidance is at odds with FDA’s suggestion in the 2013 Draft Guidance for Industry “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors” of “using three-letter text for the month, two-digit numerals for the day (if included), and four-digit numerals for the year” (MMMYYYY (e.g., JAN2013) or MMMDDYYYY (e.g., JAN012013)).[1] Further, the DSCSA suggests conformance with international standards development organizations on many portions of the law requirements, the GS1 standard for expiration date offers another suggestion of YYMMDD.[2]

Again, BIO suggests that as long as the expiration date on the human-readable portion of the drug package label is interpretable and intelligible, these variations in expiration date format should be allowable. Changes in the expiration date format will have a significant impact on processes and systems. Since the current format is acceptable for pharmacies, prescribers, and patients, BIO recommends that any unnecessary disruption be avoided.

Use of the GTIN and NDC

The Draft Guidance states that the product identifier on the product label must contain the NDC and that the GS1 Global Trade Identification Number (GTIN) cannot be used in the human-readable portion of the product identifier on the drug package label (lines 289-298). While we appreciate FDA’s concern that the use of the GTIN by itself could “lead to improper identification of the NDC and drug product,” we note that much of the industry has moved ahead using the GTIN which contains the NDC.

The product identifier definition in section 581(14) of the FD&C Act (21 U.S.C. 360eee(14)) calls for conformance to “standards developed by a widely recognized international standards development organization.” In response, industry partnered with GS1 to define standards that addressed DSCSA requirements, resulting in the GS1 “Healthcare Implementation Guide: Applying GS1 Standard for DSCSA and Traceability” (Release 1.2, Nov 07 2016). Here, GS1 defines an SNI which leverages a GTIN based on the NDC, in both human and machine-readable forms. As noted, industry at large adopted this convention and invested accordingly.

Additionally, the GTIN is allowed to be used in the 2D data matrix. The human-readable portion’s purpose is to allow reading of the digital information in case it becomes unreadable. As a result, the human-readable portion needs to reflect the 2D data matrix content. The NDC and GTIN cannot both be present in the 2D barcode matrix. Two product identifiers will cause more confusion.

The GTIN is vital to successfully implement serialization for a number of reasons. First, the GTIN is designed to be unique across all markets. The NDC is US-specific. This means that the combination of NDC and serial number may not be globally unique and an identical number string may be found in a product from a different country. This could cause unexpected data issues and potential errors in identifying physical products. Secondly, the GTIN format provides an indicator digit for multi-level packaging hierarchy (unit, bundle, case et cetera). The NDC does not. Without the packaging indicator, there could be potential impact on the aggregation and verification of serial numbers. Further, the GTIN is used for verification purposes during verification requests and within systems such as the VRS and wholesaler systems. If the 2D data matrix is damaged, a verification request would not be possible using the NDC alone. It should also be expected that trading partners may have outages of their technical capabilities, specifically the ability to read a 2D data matrix, as this depends on having the right scanners in place, in working order, and with relevant IT systems in operation. If the ability to read the 2D data matrix is not available the human-readable should represent the encoded value(s).

Stipulating use of an NDC instead of a GTIN would be highly impactful to the industry, requiring an extended amount of time and significant resources to revise all production systems and product packaging once again; this could lead to line downtime and potential delays in moving product through the supply chain and ultimately getting it to patients.

BIO recommends that FDA allow the use of a GTIN derived from an NDC as the product identifier – instead of explicitly the NDC – as part of the SNI. We also note that the NDC is typically prominently located on the label and that the use of a GTIN as the product identifier and an appropriate header for the SNI, along with an NDC printed elsewhere on the product packaging, will meet FDA’s intentions for good drug product identification practices.

Further, the 2010 FDA Guidance “Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages” discusses the use of the GTIN to identify items at the package level throughout the supply chain and that the “sNDC is compatible with, and may be presented within, a GTIN”. This Guidance also acknowledges that “the GTIN is used worldwide by twenty-three industry sectors, including healthcare, and has been adopted by sixty-five countries to uniquely identify pharmaceutical products”, pointing to the high acceptance and implementation of the use of the GTIN.[3]

Timely Release of Guidance Documents

We note that while FDA guidance is often helpful, it is extremely important for this guidance to also be timely. If guidance is released close to the statutory requirement deadlines, individual companies and their trading partners will have instituted procedures and policies to meet the requirements that could be badly affected if the published guidance is not consistent with what has been planned or implemented. The timeliness of FDA guidance will be increasingly critical as industry begins to transition from the current system requirements to the fully functioning 2023 system, particularly because this system is not articulated in detail in the DSCSA.

Implementation of the 2023 requirements without dialogue between industry partners and FDA, feedback, and collaboration would create significant impediments to successful implementation. As such, we ask FDA to discuss its expectations for the 2023 system with the broader supply chain stakeholders to ensure that the conversations on this topic are constructive and in line with FDA thinking on the topic as well as release related guidance far in advance of any statutory deadlines and requirements to allow for discussions.

Conclusion

BIO appreciates this opportunity to comment on the Draft Guidance for Industry “Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers.” We would be pleased to provide further input or clarification of our comments, as needed.

 

[1] Lines 500-507; FDA Draft Guidance for Industry “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors” April 2013 https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM349009.pdf  

[3] Section F; FDA Final Guidance for Industry “Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages” March 2010 https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM206075.pdf