The Drug Supply Chain Security Act (DSCSA): Current Implementation Update

Greenleaf Regulatory Landscape Series

In the seventh year of implementation of the Drug Supply Chain Security Act (DSCSA), trading partners involved in manufacturing, repackaging, distributing, and dispensing pharmaceuticals in the U.S. (industry) continue to grapple with its requirements. The goal of the DSCSA, which was enacted in November 2013 under Title II of the Drug Quality and Security Act,1 is to produce a system that enhances national pharmaceutical supply chain security by implementing a fully interoperable and electronic system for securing and tracing products by November 2023.2 Trading partner authorization, product tracing, verification, and product identification (including serialization) are four key components needed to achieve this goal.3

Since enactment of the DSCSA, two phases of implementation have been imposed. In the first phase, traceability requirements at the lot level were implemented beginning in 2015. In the second phase, interoperability requirements allowing for product tracing at the package level are scheduled to become effective in November 2023. Once in place, the interoperability requirements will involve: the exchange of transaction data by authorized trading partners; the ability of trading partners to verify products at the package level; and the maintenance of product tracing processes such that transaction data going back to the manufacturer can be provided upon request.4

The interoperability requirements, as opposed to the traceability requirements, are not clearly defined by the DSCSA, and yet, are particularly complex due to their electronic interconnectedness across the various industry sectors.5 As such, industry stakeholders have reported slow uptake of requirement testing and implementation thus far, which has been fueled by a lack of consistency, clarity, and awareness among trading partners, as well as added burdens related to the pandemic.6 Specifically, important testing of data systems by some manufacturers has not occurred at rates needed to ensure requirements are in place by 2023. Needed collaboration with trading partners, greater system governance, consistent DSCSA legal interpretation, and missing standards are all additional challenges weighing down implementation efforts.

Figure 1

FDA Efforts to Support Industry Readiness

To help enhance industry’s overall readiness ahead of 2023, the Food and Drug Administration (FDA or Agency) released four guidance documents in June 2021 aimed at providing clarity and understanding around various DSCSA requirements.7 These guidance documents are summarized in Figure 2 below. The Agency also hosted multiple webinars in 2021 outlining key DSCSA requirements and explaining its new guidance documents and how they fit into the overall 2023 implementation scheme.8

Figure 2 9

Additionally, in February 2022, the FDA issued a proposed rule setting forth licensing standards for wholesale distributors and third-party logistics providers (3PLs), as mandated by the DSCSA.10 A national licensing system for distributors and 3PLs falls under the law’s key requirement that trading partners involved in the exchange of prescription drugs must be authorized such that they are appropriately registered or licensed to receive or transfer products.11 Establishment of national licensing standards eliminates an existing patchwork of state standards and is meant to provide industry-wide uniformity to better ensure all trading partners along supply chains are appropriately qualified to distribute prescription drugs. Diverging from its initial position issued in a 2014 draft guidance, the FDA’s proposed rule preempts state licensing laws that establish stricter standards, meaning that states can only continue licensing distributors and 3PLs if they match federal requirements.12 Once the rule is finalized, wholesale distributors will have two years, and 3PLs will have one year, before requirements take effect. Stakeholders have until June 2022 to comment on the proposed rule.13

Remaining Implementation Challenges: A Need for Further Clarity and Alignment

Despite new guidance and key implementation updates provided by the Agency, industry has continued to call for stronger alignment and the provision of more information around interoperability requirements. At a November 2021 public meeting,14 industry stakeholders called for the finalization of draft guidance on standards for secure, interoperable exchanges of product data and the endorsement of the global GS-1 standard for creating and sharing transaction data, or Electronic Product Code Information Services (EPCIS).15 The FDA has given assurance that finalized guidance is forthcoming.16 The Federal Food, Drug, and Cosmetic Act, as amended by the DSCSA, mandates17 that the FDA recommend data exchange standards that comply with those of widely recognized international organizations in order to facilitate the adoption of secure, interoperable, electronic data exchange along pharmaceutical distribution supply chains.18 Draft guidance released in November 2014 recommended the use of EPCIS, but also mentioned other methods and standards that could be used as well.19 The lack of a finalized standard recommendation has made many in industry reticent to begin implementing and testing data exchange systems, which are essential for ensuring systems are ready to go live in November 2023

Additionally, in Fall 2021, a number of industry stakeholders submitted comments expressing concern for perceived inconsistencies between the track and trace system put forth in new draft guidance and the plain language of the DSCSA, as well as a lack of other important information about requirements for 2023 compliance.20 The new draft guidance, “Enhanced Drug Distribution Security at the Package Level Under the DSCSA,” sets out the Agency’s decision as to whether data security system structures should be centralized or distributed, backing a distributed/semi-distributed model based on the idea that this approach allows trading partners to maintain control over their own data.21 Industry and other stakeholders disagree, however, as to whether this is the right approach for achieving interoperability. An August 2021 report from the International Coalition of Medicines Regulatory Authorities (ICMRA) promoted a centralized model as the “most efficient and simple” design for storing and reporting traceability data from multiple entities (although, the report also noted that “it is perfectly possible […] to design a system with distributed databases where each originator stores their own data”).22 In comments submitted to the new draft guidance docket, the Healthcare Distribution Alliance (HDA) stated that it did not believe a distributed or semi-distributed model is feasible, noting that what currently exists is “an ecosystem … of thousands of privately owned and maintained systems that are all different” (emphasis added).23

Other comments submitted to the docket reiterated HDA’s concerns with the new draft guidance, and also addressed concerns related to the sharing of proprietary information between trading partners and government authorities/other trading partners.24 In calling for the withdrawal of the draft guidance, and noting discussed challenges and concerns, HDA and other stakeholders expressed uncertainty as to industry’s ability to meet implementation requirements of the proposed electronic system in time for the 2023 deadline.25 Despite this looming deadline, the FDA has maintained that its planned electronic, interoperable track and trace system will go live in November 2023.26

Conclusion

The FDA has stressed that a system for enhancing drug distribution security will need to be robust, yet flexible.27 The Agency has also said it will leverage a range of coordinated mechanisms, such as: standardized data; standardized data exchanges; data analyses; investigations of suspect and illegitimate products; and other compliance guidance documents and enforcement tools.28 The complexity involved in achieving full implementation of the DSCSA is apparent and has been exacerbated in recent years by the COVID-19 pandemic. Thus, greater industry understanding about requirements through additional guidance and communication from the FDA will be an important part of breaking down remaining challenges to full DSCSA implementation in 2023.


  1. H.R. 3204, Sec. 201, “Drug Supply Chain Security,” (November 2013), available at https://www.govinfo.gov/content/pkg/PLAW-113publ54/pdf/PLAW-113publ54.pdf. See also, FDA Webpage, “Drug Supply Chain Security Act (DSCSA)”, available at https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa.
  2. CDER SBIA Virtual Compliance Conference, Connie Jung, RhP, PhD, “Enhancing Drug Distribution Security under DSCSA” (January 2021), available at https://www.fda.gov/drugs/news-events-human-drugs/cder-compliance-conference-01142021-01142021.
  3. Id.
  4. Partnership for DSCSA Governance, “DSCSA 2023 Requirements,” available at https://dscsagovernance.org/.
  5. Id.
  6. RAPS Focus, “Panelists: Sluggish pace of DSCSA testing is worrisome” (May 2021), available at https://www.raps.org/news-and-articles/news-articles/2021/5/supply-chain-members-concerned-over-sluggish-testi?utm_source=MagnetMail&utm_medium=Email%20&utm_campaign=RF%20Today%20%7C%204%20May%202021.
  7. FDA In Brief, “FDA provides new guidance to further enhance the security of prescription drugs in the U.S. supply chain” (June 2021), available at https://www.fda.gov/news-events/press-announcements/fda-brief-fda-provides-new-guidance-further-enhance-security-prescription-drugs-us-supply-chain?utm_medium=email&utm_source=govdelivery.
  8. See, CDER SBIA Virtual Compliance Conference, Connie Jung, RhP, PhD, “Enhancing Drug Distribution Security under DSCSA” (January 2021), available at https://www.fda.gov/drugs/news-events-human-drugs/cder-compliance-conference-01142021-01142021; and CDER SBIA Webinar, Connie Jung, RhP, PhD, “Enhanced Drug Distribution Security in 2023 Under the DSCSA,” (October 2021), available at https://www.fda.gov/drugs/news-events-human-drugs/enhanced-drug-distribution-security-2023-under-dscsa-10052021-10052021.
  9. See, FDA Draft Guidance, “Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act,” (June 2021), available at https://www.fda.gov/media/149704/download; FDA Final Guidance, “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification” (June 2021), available at https://www.fda.gov/media/88790/download; FDA Revised Draft Guidance, “Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the DSCSA” (June 2021), available at https://www.fda.gov/media/111468/download; and FDA Final Guidance, “Product Identifiers Under the DSCSA Questions and Answers” (June 2021), available at https://www.fda.gov/media/116304/download.
  10. FDA Announcement, “FDA announces proposed rule: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers” (February 2022), available at https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/fda-announces-proposed-rule-national-standards-licensure-wholesale-drug-distributors-and-third-party?utm_medium=email&utm_source=govdelivery.
  11. See, supra n.8.
  12. Docket, FDA-2020-N-1663, available at https://www.regulations.gov/docket/FDA-2020-N-1663/document.
  13. Id.
  14. FDA Event, “Public Meeting on Enhanced Drug Distribution Security at the Package Level Under the DSCSA,” (November 2021), available at https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security#event-materials.
  15. RAPS Focus, “FDA urged to endorse EPCIS to spur manufacturers’ uptake of DSCSA” (November 2021), available at https://www.raps.org/news-and-articles/news-articles/2021/11/fda-urged-to-endorse-epcis-to-spur-manufacturers-u.
  16. FDA Draft Guidance, “Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act,” (June 2021), available at https://www.fda.gov/media/149704/download at p.6.
  17. FD&C Act, Sect. 582(h)(4)(A).
  18. See, supra n.16.
  19. Id.
  20. Docket, FDA-2020-D-2024, available at https://www.regulations.gov/document/FDA-2020-D-2024-0005/comment. See also, RAPS Focus, “Industry calls for withdrawal of FDA electronic tracing guidance” (September 2021), available at https://www.raps.org/news-and-articles/news-articles/2021/9/industry-calls-for-withdrawal-of-fda-electronic-tr.
  21. FDA Draft Guidance, “Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act,” (June 2021), available at https://www.fda.gov/media/149704/download.
  22. ICMRA Report, “Recommendations on common technical denominators for traceability systems for medicines to allow for interoperability” (August 2021), available at https://www.icmra.info/drupal/sites/default/files/2021-08/recommendations_on_common_technical_denominators_for_T&T_systems_to_allow_for_interoperability_final.pdf.
  23. See, supra n.20.
  24. Id.
  25. Id.
  26. RAPS Focus, “FDA official: Agency will not extend 2023 DSCSA interoperability deadline” (August 2021), available at https://www.raps.org/news-and-articles/news-articles/2021/8/fda-stands-firm-on-november-2023-interoperability.
  27. See, supra n.2.
  28. Id.

Navigating DSCSA Implementation: Key Requirements and 4 New FDA Guidances

This article was originally published as a guest column in Outsourced Pharma.

In its seventh year of implementation, trading partners involved in manufacturing, distributing, and dispensing prescription drugs in the U.S. (Industry) continue to grapple with requirements of the Drug Supply Chain Security Act (DSCSA), working to set up a fully interoperable electronic system for securing and tracing products across Industry sectors by November 2023. The goal of the DSCSA is to produce a system that enhances national pharmaceutical supply chain security; achieving this goal has required two phases of implementation. In the first phase, traceability requirements at the lot level were implemented beginning in 2015. In the second phase, interoperability requirements allowing for product tracing at the package level are scheduled to become effective in November 2023.

Interoperability requirements involve the exchange of transaction data by authorized trading partners, the ability of trading partners to verify products at the package level, and the maintenance of product tracing processes such that transaction data going back to the manufacturer can be provided upon request.[1] These requirements, as opposed to the traceability requirements, are not clearly defined by the DSCSA and yet are particularly complex due to their electronic interconnectedness across the various Industry sectors.[2] This lack of clarity around the requirements has created concern regarding how Industry can even begin to prepare to meet the requirements in time to meet the 2023 deadline.[3]

On June 3, 2021, the Food and Drug Administration (FDA or Agency) released four key guidance documents aimed at helping Industry sectors understand certain requirements and assist trading partners in becoming DSCSA compliant; these included:[4]

  • A final guidance on product identifiers;
  • A final guidance on identification and notification of suspect products;
  • A revised draft guidance on verification obligations for suspect and illegitimate products; and
  • A new draft guidance on the distribution security system attributes necessary for enabling secure product tracing at the package level.

This article first provides an overview of the four key implementation components of the DSCSA and the corresponding FDA guidance to assist trading partners in becoming compliant. The article next takes a deeper look at the four new FDA guidances released on June 3, 2021, as well as the significance of new information provided in each. Lastly, the article discusses Industry challenges and what more is needed before full DSCSA implementation can be achieved.

Key DSCSA Requirements and Corresponding FDA Guidance  

DSCSA has four key requirements: (1) trading partner authorization; (2) product tracing; (3) verification; and (4) product identification (including serialization).[5] Under Section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), these requirements apply to pharmaceutical manufacturers, repackagers, wholesale distributors, third-party logistic providers (3PLs), and dispensers (i.e., pharmacies). Each requirement is briefly reviewed below.[6] 

Trading Partner Authorization

Any trading partner involved in the transfer of prescription drugs “where a change of ownership occurs” must be authorized such that they are appropriately registered or licensed to receive or transfer products.[7] For manufacturers and repackagers, entities must be validly registered with the FDA; this can be confirmed through FDA’s drug establishment current registration site (DECRS) database.

For wholesale distributors and 3PLs, entities must have a valid state or federal licensure; at the state level, this can be confirmed by checking state databases or FDA’s wholesale distributor and 3PL database for self-reported information and respective state licensure.[8] Under the DSCSA, the FDA is required to issue new federal wholesale distributor and 3PL licensure standards in order to eliminate the current patchwork of state standards and enhance supply chain-wide uniformity. While the FDA has acknowledged the importance of these standards in supporting implementation and enhancing supply chain security, it has also acknowledged that it is still working on developing this policy.[9]

An August 2017 FDA guidance lays out the various entity requirements related to trading partner authorization and is intended to help Industry and state governments understand what activities require licensure and annual reporting and provide specific clarifications as to requirements for each trading partner.[10]

Product Tracing

Product tracing requirements involve receiving and providing product tracing data, including transaction history (TH), transaction information (TI), and the transaction statement (TS).[11] Product tracing data must be provided with each transaction (i.e., at the sale of prescription drugs) and only prescription drugs accompanied by the required product tracing data should be accepted or received by trading partners. In the event of a product recall or request to investigate a suspect or illegitimate product, trading partners must respond with product tracing data and, thus, are required to store this information for at least six years. Additionally, products can only be returned to the trading partners from which they were initially received.[12]

Currently, these requirements apply at the lot level, and TI, TS, and TH can be provided in either paper or electronic formats. However, by November 2023, product tracing requirements must apply at the package level and be provided only in electronic format.[13]

There are two FDA guidances related to product tracing standards. A November 2014 guidance establishes standards for interoperable information exchange and provides examples of data exchange methods.[14] A March 2018 guidance also provides information on standardizing TI, TS, and TH, as well as various documentation practices regarding when various product tracing information should be provided.[15]

Verification

Verification requirements under the DSCSA set forth practices for properly handling suspect and illegitimate products.[16] DSCSA requirements with respect to suspect products include investigation and quarantine to determine if they are illegitimate. Investigations of suspect products should include validating relevant transaction information and verifying the lot number and product identifier once a product has been serialized. Once determined to be illegitimate, trading partners must notify the FDA and relevant trading partners (the DSCSA requires notification occur within 24 hours) to ensure products do not reach patients. Additionally, information pertaining to investigations and dispositions of suspect and/or illegitimate products must be kept on record for at least six years.[17]

As will be discussed further below, the FDA recently updated two guidances focused on the identification of suspect products, steps for executing notification, and clarifying suspect and illegitimate product definitions for purposes of establishing trading partners’ verification obligations.[18]

Additionally, an October 2018 guidance provides further information for developing a robust verification system and addresses verification of saleable returns to the package level for product identifiers.[19] 

Product Identifier

Product identifier information includes a National Drug Code (NDC), unique serial number, lot number, and expiration date and must be made available in both human- and machine-readable formats.[20] Manufacturers have been required to encode the smallest saleable units of their products with this information since November 2018. Some drugs are excluded from these requirements or are grandfathered out of the requirements due to preexisting presence in the supply chain. Moreover, waivers, exceptions, or exemptions may also be granted by the Agency, depending on the individual product.[21]

Final FDA guidance on product identifier requirements was also among recently released DSCSA guidances and is discussed more fully below.[22]

Key Updates From Newly Released DSCSA Guidances

The four recently released DSCSA guidances provide further clarity and information in response to public comment and calls from Industry. A description of what’s new to each guidance, along with a brief overview of each, is provided below.

New Draft Guidance: Enhanced Drug Distribution Security at the Package Level Under the DSCSA

Most notably, this new draft guidance sets out the Agency’s decision as to whether data security system architectures should be centralized or distributed, weighing expressed Industry preferences and practices in its support of distributed and semi-distributed models so that trading partners can maintain control over data validation and management. [23]

Overall, the guidance provides information regarding enhanced drug distribution system attributes, product tracing, and verification needed for enabling secure product tracing at the package level. Missing from this guidance, however, are standards for secure, interoperable data exchanges, which the document notes will be addressed in forthcoming guidance.

Final Guidance: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification

New to this final guidance is the Agency’s interpretation of “immediate trading partner” under Section 582, which requires trading partners to notify FDA and certain immediate trading partners that a product in their possession was determined to be illegitimate.[24] While unspecified in its previous iteration, the final guidance explains that immediate trading partners, in this context, are those that the notifier has “reason to believe may have received the illegitimate product.” The guidance also replaces “suspicious” with “questionable” when describing scenarios that could increase the risk of a suspect product entering the supply chain, ensuring that trading partners understand the full context under which suspect products may be found. 

Additionally, the new version of the guidance clarifies that, when investigating a suspect product, trading partners should confer with manufacturers and consider whether the product has been subject to a public alert for quality issues. Lastly, the guidance points out that while notification of a suspect product is not generally required, it is required when a high-risk factor is present.[25] Each of these meant to increase the likelihood that suspect products are identified along distribution supply chains and are investigated for their legitimacy.

Overall, this final guidance provides several examples of heightened risk for suspect products entering the supply chain for the purpose of enhancing identification. The guidance also notes the process for notifying FDA about a product determined to be illegitimate using Form FDA 3911.

Revised Draft Guidance: Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the DSCSA

New to this revised draft guidance is the FDA’s understanding of what a “stolen” product is, which it says is “any product in its entirety (i.e., the prescription drug and its packaging) that has been taken or removed without permission of the owners of the product.”[26] The revised draft guidance also revises the definition of a product that is “unfit for distribution,” aligning it with language set out in the DSCSA such that it is now interpreted to mean a product that is “reasonably likely to result in serious adverse health consequences or death” based on “a reason to believe or credible evidence.”[27]

Additionally, the new version of the guidance notes scenarios that are unlikely to result in “diverted” products, carving out from the previously stated definition cases in which a product is obtained through a surveillance activity or by a patient outside the U.S. pharmaceutical distribution supply chain, through an FDA regulatory action to address a drug shortage, or where an emergency use authorization is in place. Lastly, the guidance expands the definition of the term “fraudulent transaction” such that it now includes situations where information has been “knowingly” falsified.[28]

Overall, this revised draft guidance defines key terms for determining suspect and illegitimate products for the purpose of assisting trading partners in complying with their verification obligations under the DSCSA.

Final Guidance: Product Identifiers Under the DSCSA Questions and Answers  

New to the final guidance on product identifiers are updates for Industry’s awareness in terms of technical data. [29] Key changes include an explanation of the importance of the NDC to patient safety and a clarification on how to adequately affix multiple bar codes on the label to avoid scanning errors. The new version of the guidance also recommends changes to the expiration data format, such as use of a hyphen or forward slash between day, month, and year, as opposed to a space.[30]

Overall, this guidance provides recommendations for standardizing human- and machine-readable formats of product identifiers and examples of when the product identifier and other information should be included on product packaging.

Industry Implementation Concerns

Industry stakeholders have reported slow uptake in rolling out new data systems that align with the 2023 requirements.[31] As mentioned above, product tracing data (i.e., TI, TS, and TH) exchanged between trading partners and tracked along pharmaceutical supply chains are aimed at achieving the DSCSA’s fully interoperable and electronic traceability function. Manufacturer testing of such data systems is an important step in overcoming technical challenges and ensuring compliant traceability systems will be fully interoperable by November 2023. Notably, a recent Healthcare Distribution Alliance (HDA) panel expressed concern that proactive testing of data systems by some manufacturers is not occurring at needed rates.[32] HDA panelists described this lack of testing as a potential major hurdle to achieving full implementation of applicable requirements on time, explaining that smaller manufacturers are at a higher risk of falling behind on necessary testing.

A November 2020 HDA survey on serialization readiness additionally found that collaboration with trading partners, system governance, variation in DSCSA legal interpretation, and standards are all additional challenges burdening implementation of an interoperable system.[33] The survey explained that understanding of DSCSA requirements across Industry is generally inconsistent and, thus, establishing stronger alignment and understanding across the various sectors will be important to enhancing overall readiness.

That being said, the newly released draft guidance Enhanced Drug Distribution Security at the Package Level Under the DSCSA covers some of the Agency’s expectations for enhanced (interoperable) drug distribution security systems needed for enabling secure product tracing at the package level. However, as discussed above, the FDA still leaves standards for secure, interoperable data exchanges for forthcoming guidance, so Industry will have to wait even longer for the clarification it needs in order to timely implement all of DSCSA’s requirements.[34]

Conclusion

The FDA has stressed that a system for enhancing drug distribution security will need to be robust, yet flexible, and that FDA will leverage a range of coordinated mechanisms, such as standardized data and data exchange, analyses, interoperability, investigations of suspect and illegitimate products, and other compliance guidance documents and enforcement tools.[35] The complexity involved in achieving full implementation of the DSCSA is certain and has been exacerbated in the past year by the COVID-19 pandemic. However, greater understanding around requirements across Industry sectors through additional guidance and communication from FDA will be an important part of breaking down remaining implementation hurdles moving forward. 


[1] Partnership for DSCSA Governance, “DSCSA 2023 Requirements,” available at https://dscsagovernance.org/.

[2] Id.

[3] RAPS Focus, “Panelists: Sluggish pace of DSCSA testing is worrisome” (May 2021), available at https://www.raps.org/news-and-articles/news-articles/2021/5/supply-chain-members-concerned-over-sluggish-testi?utm_source=MagnetMail&utm_medium=Email%20&utm_campaign=RF%20Today%20%7C%204%20May%202021.

[4] FDA In Brief, “FDA provides new guidance to further enhance the security of prescription drugs in the U.S. supply chain” (June 2021), available at https://www.fda.gov/news-events/press-announcements/fda-brief-fda-provides-new-guidance-further-enhance-security-prescription-drugs-us-supply-chain?utm_medium=email&utm_source=govdelivery.

[5] CDER SBIA Virtual Compliance Conference, Connie Jung, RhP, PhD, “Enhancing Drug Distribution Security under DSCSA” (January 2021), available at https://www.fda.gov/drugs/news-events-human-drugs/cder-compliance-conference-01142021-01142021.

[6] Additional information can be found in Dr. Jung’s January 2021 webinar presentation at the CDER SBIA Compliance Conference. See, supra note 5.

[7] See, supra note 5.

[8] Id.

[9] Id.

[10] FDA Procedural Guidance, “Identifying Trading Partners Under the DSCSA” (August 2017), available at https://www.fda.gov/media/106961/download.

[11] See, supra note 5.

[12] Id.

[13] Id.

[14] FDA Draft Guidance, “DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information” (November 2014), available at https://www.fda.gov/media/90548/download.

[15] FDA Draft Guidance, “Standardization of Data and Documentation Practices for Product Tracing” (March 2018), available at https://www.fda.gov/media/111451/download.

[16] See, supra note 5.

[17] Id.

[18] See, supra note 4.

[19] FDA Draft Guidance, “Verification Systems Under the DSCSA for Certain Prescription Drugs” (October 2018), available at https://www.fda.gov/media/117950/download.

[20] See, supra note 5.

[21] Id.

[22] See, supra note 4.

[23] FDA Draft Guidance, “Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act,” (June 2021), available at https://www.fda.gov/media/149704/download.

[24] FDA Final Guidance, “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification” (June 2021), available at https://www.fda.gov/media/88790/download.

[25] Id.

[26] FDA Revised Draft Guidance, “Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the DSCSA” (June 2021), available at https://www.fda.gov/media/111468/download.

[27] Id. at p.5.

[28] Id.

[29] FDA Final Guidance, “Product Identifiers Under the DSCSA Questions and Answers” (June 2021), available at https://www.fda.gov/media/116304/download.

[30] Id.

[31] HDA 2021 Traceability Webinar Series, “Foundational Elements of 2023: Master Data and Data Exchange” (April 2021).

[32] Id.

[33] HDA Executive Summary, “Serialization Readiness Survey” (November 2020), available at https://pink.pharmaintelligence.informa.com/-/media/supporting-documents/pink-sheet/2020/10/2020-serialization-survey-(1).pdf.

[34] FDA Draft Guidance, “Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act,” (June 2021), available at https://www.fda.gov/media/149704/download.

[35] See, supra note 5.

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