1

The Drug Supply Chain Security Act

and 2D Vaccine Barcodes

Prepared for

National Center for Immunization and Respiratory Diseases Immunization Services Division

Centers for Disease Control and Prevention

1600 Clifton Road Atlanta, GA 30333

Prepared by

Regina Cox

Millie Malai

Deloitte Consulting LLP

January 2020
2

1 Executive Summary

The Drug Supply Chain Security Act (DSCSA), signed into law on November 27, 2013, aims to enhance 

the FDA’s ability to protect consumers by identifying and removing counterfeit and dangerous 

medicines/products from the U.S. pharmaceutical supply chain. The DSCSA stipulates that by 2023, the 

U.S. will have an electronic, interoperable system that will be able to monitor the movement of 

prescription drugs from manufacturing to dispensation. To operationalize this objective, the DSCSA 

requires that manufacturers imprint, in human readable form, a product identifier to each package and 

case of a product that they intend to introduce into the supply chain. In addition, the product identifier 

must include the National Drug Code, Serial Number, Lot Number and Expiration date encoded within 

a 2D barcode. 

Product serialization is a key building block and enabler of traceability; in the public health context, 

traceability can support improved recall capabilities and the ability to validate the authenticity of 

pharmaceutical products. These gains, however, are highly dependent on the integration and 

interoperability of information systems and processes. 
3

Background and Overview

1.1 Background

Ongoing regulatory efforts to bolster drug distribution security have promoted an enhanced focus on 

ways to leverage two-dimensional (2D) barcodes to improve how pharmaceutical product information is 

stored, distributed, managed, and used. To transcend limitations around the amount of data contained in 

linear barcodes, leading industry stakeholders evaluated alternative technologies. This manifested in the 

passing of Title II of the Drug Quality and Security Act (DQSA)—also referred to as the Drug Supply 

Chain Security Act (DSCSA). 12 The DSCSA outlines steps to build an electronic, interoperable systems 

to identify and trace certain prescription drugs as they are distributed in the United States.3 The system is 

intended to enhance the FDA’s ability to: 1) protect consumers from drugs that may be counterfeit, 

stolen, contaminated or otherwise harmful; and 2) detect and remove potentially dangerous drugs from 

the drug supply chain.4 This act requires the consistent traceability of pharmaceutical products from the 

manufacturer to the dispenser, and is one in a series of regulations intended to improve the safety of 

products in the U.S. pharmaceutical supply chain.

5

The goal of DSCSA is to develop and use an electronic system to identify and trace pharmaceuticals 

throughout the U.S. supply chain by 2023.

6 This will facilitate information exchange at the individual 

package level, improve recall efficiency, and enable swifter action against products identified as 

illegitimate or counterfeit.

7 Serialization, or product identification, requires a product identifier in human 

readable form as well as encoded within a data carrier. The product identifier consists of the National 

Drug Code (NDC), Serial Number, Lot Number, and Expiration Date. Per the DSCSA, the data carrier 

is required to be a 2D data matrix barcode when affixed on the product package. The impact of 

serialization on vaccines is discussed later in this document. 

There are three phases to DSCSA. Over a ten-year period, from 2013 to 2023, the implementation will 

cover lot- and chain-of-ownership data with a 2015 deadline (phase 1); item-level serialization and 

marking with a 2017 deadline (phase 2); and exchange of item-level serialization and traceability back to 

origin by 2023 (phase 3).8

 1 Upton, Fred. “H.R.3204 - 113th Congress (2013-2014): Drug Quality and Security Act.” Webpage, November 27, 2013. 

https://www.congress.gov/bill/113th-congress/house-bill/3204. 2 Center for Drug Evaluation and Research. “Drug Supply Chain Security Act (DSCSA).” FDA, 20 May 2019, /drugs/drugsupply-chain-integrity/drug-supply-chain-security-act-dscsa. 3 Ibid

4 Ibid 

5 Coustasse, Alberto, Craig A. Kimble, Robert B. Stanton, and Mariah Naylor. “Could the Pharmaceutical Industry Benefit 

from Full-Scale Adoption of Radio-Frequency Identification (RFID) Technology with New Regulations?” Perspectives in Health 

Information Management 13, no. Fall (October 1, 2016). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5075230/. 6 “The Drug Supply Chain Security Act (DSCSA) Working Towards Enhanced Drug Distribution Security 

in the U.S.” presented at the GS1 Healthcare Conference, n.d. 

https://www.gs1.org/sites/default/files/docs/Bogota/Day2_20181104_Bogota_US%20Drug%20Suppl

y%20Chain%20Security.pdf.

7 Ibid 

8 GS1 U.S., “GS1 Standards for DSCSA Suppliers Certificate Course Summary.” Webpage, August 23, 2019. 

https://resources.gs1us.org/GS1-US-Store/Product-Viewer/dscsa-00614141026029
4

The original deadline for drug manufacturers to comply with item-level serialization requirements was 

November 2017, though, in recognition of the burden of the changes on manufacturers, enforcement of 

the regulation was delayed to November 28, 2018.

9 The FDA has planned these phases to align with

product serialization enforcement in 2018, product package level verification in 2019, and implementing 

an electronic interoperable system by 2023.10

The Centers for Disease Control and Prevention’s (CDC) National Center for Immunization and 

Respiratory Disease (NCIRD) is monitoring the evolution of DSCSA and its effects on vaccines and 

immunization information systems (IIS), if any. In September 2013, the CDC published the report 

“Evaluation of the Impact of 2D Barcodes on Vaccine Secondary Packaging” on its website.

11 Since 

then, CDC has conducted three pilot projects designed to evaluate the effects of vaccine barcode 

scanning and increase the adoption of 2D barcodes on the unit of use (i.e. individual vial and syringe) in 

provider settings and with IIS. These pilots have demonstrated that using scanners to collect product 

identifier, lot number, and expiration date increases accuracy and completeness of data collection while 

also saving time in recording this information in the patient record. 

1.2 Current State of DSCSA Implementation

Implementation of 2D barcodes on external packaging (known as the unit of sale, or UoS) requires

manufactures, distributors, and providers to make capital investments of infrastructure and system 

upgrades to create, verify, and scan 2D barcodes to collect data carried in those barcodes. As a result of 

this change, manufacturers have had to change their label design and testing of the 2D barcode content 

before products are distributed. Distributors and providers also invested in equipment (scanners) to read 

the 2D barcode and technology infrastructure changes to manage the data that is collected. 

In May 2018, in order to evaluate industry progress towards Phase 1 and Phase 2 DSCSA 

implementation, AmerisourceBergen, McKesson Pharmaceutical, and Cardinal Health, in collaboration 

with GS1 Healthcare US12, conducted an assessment of barcode capabilities.13 The assessment intended 

to quantify the number of packages and cases in the market with a readable barcode containing the four 

DSCSA-required data elements (NDC, serial number, lot number, and expiration date).14 Both 

AmeriSourceBergen and McKesson scanned packages at distribution centers (specialty medications and 

prescription pharmaceuticals), while Cardinal Health assessed homogenous case-level barcodes on 

pharmaceutical products in its Ohio National Logistics Center. Key assessment findings include:15

• Results from the AmerisourceBergen and McKesson assessments show a year-over-year increase 

of approximately 14 percentage points from 2017 to 2018. 

 9 “FDA Issues Draft Guidance: Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance 

Policy.” FDA, February 9, 2019. /drugs/drug-supply-chain-security-act-dscsa/fda-issues-draft-guidance-product-identifierrequirements-under-drug-supply-chain-security-act. 10 “The Drug Supply Chain Security Act (DSCSA) Working Towards Enhanced Drug Distribution Security 

in the U.S.”

11 https://www.cdc.gov/vaccines/programs/iis/2d-vaccine-barcodes/downloads/secondary-packaging-evaluation.pdf

12 GS1 US is a not-for-profit information standards organization that administers the Universal Product Code (UPC) barcode 

as well as other information standards and data carriers.

13 “Assessing Current Implementation of DSCSA Serialization Requirements.” GS1. Accessed May 22, 2019. 

https://www.gs1us.org/industries/healthcare/standards-in-use/pharmaceutical/dscsa-barcodeassessment?mkt_tok=eyjpijoit0dnm1phvm1omkzqtmpndyisinqioijhswkwdzhozjvob0fuulzttkcyoflvuuq5d2zgexdzsvj5umpcuh

p6umhvmvj2ttvpnlvvzew4bkfpxc9uumjpaityeenzcvnmvlwvk0plxc9hmvh0c0ria2vuc.

14 Ibid 

15 Ibid
5

• Overall, approximately 15-21% of packages scanned at all three providers had a readable barcode 

with all four DSCSA-required elements—which is substantially lower than the expected 30-40%. 

• The placing of the barcodes remains an issue on product cases; insufficient white space between 

barcodes and wrapping barcodes around the case often render them unreadable. 

• Serialization remains a challenge and AmerisourceBergen found that only 77% of the 2D

barcodes included serial numbers. Low serialization figures are largely driven by the fact that 

serialization processes require additional technology (to create, capture, and send serial numbers) 

that suppliers may lack. 

• The FDA published the “Grandfathering Policy for Packages and Homogenous Cases of 

Product Without a Product Identifier” guidelines in 2018.16 These guidelines allowed unexpired 

pharmaceuticals (manufactured and repackaged) that were packaged and in inventory before the 

November 2018 deadline to remain in the supply chain. The bulk of pharmaceutical products 

have a multi-year life cycle and realization of full DCSA serialization will likely take until late 

2021.17

Since the initiation of the CDC’s efforts to encourage 2D barcodes on vaccine units of use (UoU) 

products in 2011, NCIRD has maintained quarterly communication with vaccine manufacturers. During 

this outreach, NCIRD requests information for vaccines that use the 2D barcode data carrier for either 

the UoS or UoU, or both. This outreach is an opportunity to keep the list of vaccine presentations with 

2D barcoded UoU current. As providers move to use 2D barcode scanning for inventory management 

and data collection at the point-of-administration of vaccines, mappings tables for vaccines that are 2D 

barcoded have become necessary. As of February 2019, four of seven U.S. vaccine manufacturer selfreported that all of their new vaccine products are affixed with 2D barcodes on UoS.

18

In interviews conducted with two leading electronic health record (EHR) vendors and one U.S. vaccine 

manufacturers in July 2019, very few challenges persist for Phase 1 and Phase 2 of DSCSA 

implementation. The EHR vendors interviewed did not report any issues stemming from the 

implementation. They reported that the cost of equipment is a barrier to 2D barcode scanning for their 

customers and not the functionality of the system to scan 2D barcodes. One EHR vendor reported that 

the benefit of having the 2D barcode on the UoU was the ability to more easily capture important 

information (like NDC, lot number, and expiration date) into inventory, further stating that he “wished 

the drug manufacturers included lot number and expiration date on all units of use, too; it would make 

things so much easier.”

In our interview with one U.S. vaccine manufacturer, they reported that there were no current challenges 

with complying with the DSCSA implementation and that most of their products were compliant for the 

original deadline of November 2017. There are still products in inventory at pharmacies and provider 

sites that may not have the 2D barcode on the UoS, but as these are used, or reach their expiration dates, 

will become fewer and fewer. 

 16 “Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier Guidance for 

Industry.” FDA, n.d. https://www.fda.gov/media/109591/download.

17 “Assessing Current Implementation of DSCSA Serialization Requirements”

18 GSK, Sanofi Pasteur, Dynavax, Wyeth, Merck, Seqiris, Medimmune representatives, email messages to author, February 

2019.
6

2 Traceability and Applications of

DSCSA to Vaccine Products

The International Organization for Standardization (ISO)19 9000:2000 guidelines define traceability as 

the “ability to trace the history, application or location of an object;” when considering products or 

services, traceability can relate to the origin of materials or parts, processing history, and the distribution 

and location of the product or service after delivery.20 Traceability systems can be adapted to sectoral 

and organizational objectives, and vary along metrics of the breadth,21 depth,22 and precision.

23 These 

systems alone cannot improve patient safety, but they provide the ability to more quickly determine the 

source of a problem. 

In the U.S. food sector, traceability systems are largely motivated by economic incentives rather than 

stringent government traceability regulation.24 In this industry, private firms build traceability systems in 

order to improve supply-side management, increase safety and quality control, and to market foods with 

credence attributes/enhance brand reputation. The benefits associated with pursuit of these objectives 

include lower-cost distribution systems, reduced recall expenses, and increased sales of high-value 

products. Traceability, however, must be paired with other management, inventory, and safety/quality 

control tools to meaningfully make progress toward these objectives. For example, simply knowing 

where a product is in the supply chain does not improve supply chain management unless the traceability 

system is paired with a real-time delivery system or another inventory control system. Similarly, tracking 

food at different stages of the production process does not improve consumer safety unless linked to 

recall and safety control mechanisms. 

Take the traceability systems developed by the food industry in Japan, in particular the beef supply chain. 

In 2003, foodborne diseases like bovine spongiform encephalitis (BSE) led the Japanese government to 

pass the Cattle Traceability Law. To ensure the safety of Japanese beef, the law established stringent 

measures concerning the management and relay of information for individual identification of cattle. 25

Each cow is uniquely identified and tracked from “farm to fork”.26 In Japan, beef supply chain 

traceability has four levels of depth. “First, an ear-tag uniquely identifies each living animal. Then, a 10-

digit code corresponding to the ear-tag and the animal’s DNA is kept in a national database.”27 As the 

animal progresses through the supply chain, all feed and health information is associated with that serial 

number in the database. Finally, all meat derived and processed must be retained and identified with the 

animal’s serial number. Notably, consumers have direct access to this information: using an online or in-

 19 The ISO is a worldwide federation of national standards bodies that promotes the development of standardization and 

international standards for a wide range of products. ISO 9000 guidelines are quality management system standards. 

20 “ISO 9000:2015 Quality Management Systems — Fundamentals and Vocabulary.” Accessed May 23, 2019. 

https://www.iso.org/obp/ui/#iso:std:iso:9000:ed-4:v1:en. 21 Breadth refers to the amount of information the traceability system records. 

22 Depth of a traceability system refers to how far back or forward the system tracks. 

23 Precision reflects the degree of assurance with which the traceability system can pinpoint a product’s movement or 

characteristics. Precision is determined by the unit of analysis used in the system and the acceptable error rate.

24 Golan, Elise H. & Krissoff, Barry & Kuchler, Fred & Calvin, Linda & Nelson, Kenneth E. & Price, Gregory K., 2004. 

"Traceability In The U.S. Food Supply: Economic Theory And Industry Studies," Agricultural Economics Reports 33939, 

United States Department of Agriculture, Economic Research Service.

25 Schroeder, Ted C., and Glynn T. Tonsor. “International Cattle ID and Traceability: Competitive Implications for the 

US.” Food Policy 37, no. 1 (February 2012): 31–40. https://doi.org/10.1016/j.foodpol.2011.10.005. 26 Ibid

27 Souza Monteiro, Diogo M., & Julie A. Caswell. The economics of implementing traceability in beef supply chains: Trends in major 

producing and trading countries. No. 1669-2016-136420. 2004.
7

store lookup of the animal’s 10-digit number (found on each package of beef), a consumer can quickly 

find all relevant details tracked from birth to slaughter date.28

The Japanese beef supply chain example exhibits all three attributes of a traceability system. Breadth 

indicates the amount of information collected for each unique product. In this case, the animal’s 

location, DNA, feed and health information are maintained in the national database. Depth indicates the 

backward and forward traceability of the system, not only “farm to fork” but also “fork to farm.” The 

Japanese system starts when the animal is alive and living on the farm and the serial number follows the 

processed products to consumers. Precision indicates how well the system allows the identification of 

any one product and is usually increased by the creation of unique identifiers. 

DSCSA aims to create traceability of drugs and vaccines in the pharmaceutical supply chain. Traceability 

allows for the validation of the product via confirmation of the product identifiers, the lot numbers, and 

expirations dates as pharmaceuticals move from the manufacturers to product re-labelers to healthcare 

providers and pharmacies. Traceability systems with breadth, depth, and precision can further enhance 

patient safety by identifying and removing counterfeit drugs from the supply chain.

The most robust traceability mechanisms provide the individual identification of each product and its 

characteristics along all points of the supply chain. In the Japanese beef market, the unique 10-digit 

identifier (that links an animal’s individual ear tag with enciphered DNA) is a key building block and 

contributor to traceability. In the example above, cattle in Japan were each given a 10-digit serial number 

that linked their individual ear tag with an enciphered DNA code. Similarly, within the U.S. 

pharmaceutical supply chain, the identifying information in each 2D barcode (NDC, serial number, lot 

number, expiration date) is crucial to enhancing traceability throughout. With enhanced traceability, 

there are opportunities to improve data and inventory management of vaccines and emergency response 

efforts related to vaccines. 

2.1 Data and Inventory Management

Deduplication 

The deduplication of immunization records encompasses both the deduplication at the 

demographic/patient level (e.g. two records describe the same patient) and deduplication at the 

vaccination level (e.g. two records describe the same immunization).29

The use of 2D barcode scanning, in conjunction with an Electronic Health Record (EHR) system, have 

several notable benefits for patients, providers, and the wider health community.30 Employing 2D 

barcode scanning supports the increased accuracy of immunization records by limiting errors introduced 

via manual entry and improving the completeness of that data in the patient’s record. The time spent on 

data entry is also diminished when 2D barcode scanning is employed at the point-of-administration. 31

While no published studies could be found describing how serialization of the vaccine UoS improves 

deduplication of vaccination level records, one can extrapolate that deduplication could be enhanced 

with serialized data. In addition to using data element indicators such as the product identifier and lot 

number to identify potentially duplicative records, registries could also use the serial number of the 

 28 Ibid 

29 “IIS | Deduplication Toolkit | Vaccines | CDC,” May 6, 2019. https://www.cdc.gov/vaccines/programs/iis/technicalguidance/deduplication.html.

30 “Immunization Information Technology: A Guide for Pediatricians on Immunization Information

Systems and Two-Dimensional Barcoding.” The American Academy of Pediatrics, 2019. 31 Ibid 
8

vaccine package to identify vaccine level duplicates. However, for this to be possible, the EHR system 

would need to map the vaccine’s UoU to the UoS and include the UoS serial number in the vaccination 

level record. To enable the use of serial numbers to further aid in deduplication, functional capability 

guidance could be published describing the need for such mapping tables, and for the documentation of 

the serial number in the patient’s record. However plausible, it remains to be investigated whether the 

addition of the UoS serial number improves deduplication of vaccination level records.

Provider Inventory Management

It is recommended that providers store vaccine in original packaging in order to protect vaccine from 

light exposure, which can negatively impact vaccine potency.32 Despite this recommendation, however, 

following inventory receipt process, a portion of providers discard secondary packaging upon receipt of 

a product and instead store the vaccine in its primary container (i.e. vial or syringe) to maximize 

refrigerator storage space. Once a vaccine is administered to a patient, providers are legally required to 

record key vaccine product information including lot number, product ID, expiration date, 

manufacturer, and product name. Most providers enter this information into the patient medical record 

based on the UoU, and not the UoS. This occurs primarily due to the risk of incorrect data entry of 

information such as lot number or expiration date on the secondary packaging. This information can be 

entered manually, selected from preloaded drop-down lists, or scanned from the vial or syringe. 

Providers handle and administer both privately purchased and publicly subsidized vaccines. Certain 

public vaccine stocks require additional inventory reporting on data elements such as quantities, lot 

number, and expiration dates; most of which is entered manually into online inventory tracking 

databases. IIS reporting requirements vary by state; however, CDC publishes recommended core data 

elements that they endorse on their website. 

Aside from certain hospitals and large provider practices, ambulatory providers may not have 2D 

scanning capabilities for inventory management purposes; some may not yet have linear scanning for 

inventory purposes. Again, the reported main barrier to adopting scanning for inventory management 

purposes is the cost of equipment. Two EHR vendors with large market shares reported that many 

outpatient customers are considering using 2D barcode scanners, but the cost of scanners and related 

equipment is a limiting factor.33

Outpatient healthcare providers have thus far made limited technology upgrades to accommodate 2D 

barcode scanning. DSCSA requires providers to have lot-level traceability by November 2019, however, 

it does not require that providers use 2D barcode scanning to achieve this level of traceability. Based on 

the experience of providers using 2D barcode scanning, it is evident that scanning will be faster and 

more accurate than other methods of inventory tracking.

Vaccines for Children Inventory Management

The Vaccines for Children (VFC) program is a federally funded initiative that strives to protect children 

by providing public-purchased vaccines for children and adolescents who otherwise would be unable to 

afford them.

 32 “Vaccine Storage and Handling Toolkit,” CDC, last modified January 2019, accessed November 2019, 

https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf

33 EHR vendor, interviews with author, May 2019 & July 2019
9

There are currently approximately 38,000 provider sites nationwide registered as VFC providers. 

Children are eligible for vaccinations from the VFC program if they are under the age of 19, and are 

either uninsured, Medicaid-eligible, American Indian or Alaskan Natives, or underinsured with respect to 

vaccination when served in Federally Qualified Health Centers / Rural Health Clinics (FQHCs/RHCs). 

The VFC program currently offers vaccines against 16 vaccine preventable diseases to protect children, 

all recommended by the Advisory Committee on Immunization Practices (ACIP). 

The VFC program purchases vaccines at negotiating discounted prices with manufacturers and provides 

CDC’s immunization awardees with access to a centralized vaccine ordering system. Orders placed by 

providers through immunization program awardees are then shipped to providers using a centralized 

vaccine distribution mechanism. Enrollment of individual providers is managed by immunization 

program awardees, typically state health department immunization programs. These awardees are also 

responsible for receiving immunization information from providers and projecting annual demand for 

planning purposes.

The VFC program is aware of the industry movement toward 2D barcodes on secondary packaging and 

is cognizant of the fact that the industry may be impacted by this transition. 

2.2 Emergency Response

Pandemic Response

A pandemic34 occurs as infectious disease spreads throughout a wide region. Pandemic response requires 

the swift mobilization of international and national scientific, public health, public policy, and security 

communities to identify the virus, develop an effective vaccine, and mitigate the impact on citizenry.35

The quick progression of a pandemic overburdens healthcare resources at the local, regional, and 

national level while disseminating concern in the public. Lessons learned from a review of pandemic 

response literature suggest that the addition of 2D barcodes to the vaccine UoS will support improved 

security, effectiveness, and efficiency of pandemic response in the United States.

The inherent chaos of a pandemic event may prompt criminal elements to view them as opportunities 

for unlawful gain. The ability to leverage serialized 2D barcodes to verify the authenticity of a vaccine 

product will work to deter the introduction of illegitimate vaccine products into the vaccine supply chain 

during pandemic events. An additional benefit is the increased confidence of vaccinators that they have 

received and are administering the vaccine they ordered. 

Furthermore, the use of 2D barcodes promotes efficient and responsive inventory processes that 

support the effectiveness and efficiency of a response. These processes can be leveraged to understand 

the volume and location of vaccines in the healthcare system while providing important data on uptake 

rate across geographic locations. A review of the H1N1 pandemic response in the United States 

highlights the critical importance of a robust and visible vaccine supply chain to: 1) ensure vaccines are 

deployed effectively to reduce the burden of disease; 2) provide reliable data on vaccination rates; and 3) 

decrease costs associated with unused and disposed vaccines. 

 34 The World Health Organization (WHO) defines a pandemic as “the worldwide spread of a new disease.” 35 The Domestic and International Impacts of the 2009-H1N1 Influenza A Pandemic: Global Challenges, Global Solutions: Workshop 

Summary. Washington, D.C.: National Academies Press, 2010. https://doi.org/10.17226/12799
10

During a pandemic, the supply of influenza vaccine is often limited, and allocation thereof can 

significantly impact the burden of disease.36 In response to the 2009-2010 H1N1 Influenza pandemic, 

CDC coordinated an emergency vaccine distribution campaign utilizing the population-based or pro-rata 

allocation.37 According to this method, the CDC allocated vaccines to each state in proportion to the 

state’s population; after receiving vaccine inventory from CDC, states used CDC’s centralized vaccine 

distribution system to direct vaccine shipments to providers. CDC provided state and local planners 

with H1N1 Vaccination Campaign Planning guidelines that stressed the importance of collecting data 

and tracking vaccine usage to ensure supply was adequately directed where needed.38 In practice, 

however, few states collected and tracked this information, and overall there was limited reliable data on

uptake rates and vaccine inventory by geographic location. The lack of an efficient inventory process

contributed to the inability to deploy sufficient inventory to areas with high uptake rates, whilst 

approximately 40 million doses of the vaccine (worth an estimated US$260 million) were unused and 

eventually discarded.

39

Recall

With regard to biological products40 approved by the FDA, a recall is defined as a “firm’s removal or 

correction of a marketed product that the FDA considers to be in violation of the laws it administers 

and against which the agency could initiate legal action, e.g., seizure.”41 Recalls can be conducted on a 

firm’s own initiative, by FDA request, or by FDA under statutory authority.42 Vaccine recalls or 

withdrawals are primarily initiated by the vaccine manufacturer, and the FDA rarely issues a recall.43

When the manufacturer issues a recall, the manufacturer directly contacts vaccine distributors and 

healthcare facilities who might have purchased the vaccine to notify them of the suspected problem.44 In 

turn, the individual healthcare provider informs the patient/parents of the patient that the vaccine has 

been recalled.

In the healthcare supply chain, product recall has been historically challenging due to the dearth of 

product traceability and loose integration of information systems.

45 However, because of vaccine 

administration documentation requirements, driven by voluntary and mandated data exchange with 

jurisdictional immunization registries, vaccine product recall is much easier. Once a recall is initiated, 

providers can quickly identify patients who have received the recalled vaccine by tracing the product and 

the specific lot number to the patient. Serialization of the vaccine UoS does not appear to have any 

 36 Li, Zihao, Julie L. Swann, and Pinar Keskinocak. “Value of Inventory Information in Allocating a Limited Supply of 

Influenza Vaccine during a Pandemic.” Edited by Jeffrey Shaman. PLOS ONE13, no. 10 (October 25, 2018): e0206293. 

https://doi.org/10.1371/journal.pone.0206293.

37 Ibid

38 “CDC H1N1 Flu | State & Local Vaccination Guidance | CDC 2009 H1N1 Vaccination Campaign Planning Checklist.” 

Accessed May 17, 2019. https://www.cdc.gov/h1n1flu/vaccination/statelocal/planning_checklist.htm.

39 “Expired Swine Flu Vaccine Headed For Incineration.” NPR.org. Accessed May 17, 2019. 

https://www.npr.org/sections/health-shots/2010/07/01/128248906/happy-trails-swine-flu-vaccine.

40 The FDA defines a biological product, or biologic, as “a wide range of products such as vaccines, blood and blood 

components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.” 41 Research, Center for Drug Evaluation and. “Drug Supply Chain Security Act (DSCSA).” FDA, 22 May 2019, /drugs/drugsupply-chain-integrity/drug-supply-chain-security-act-dscsa. 42 Ibid

43 “Vaccine Recalls.” CDC, 24 Jan. 2019, https://www.cdc.gov/vaccinesafety/concerns/recalls.html. 44 Ibid 

45 Jayaraman, Raja, Fatima AlHammadi, and Mecit Can Emre Simsekler. “Managing Product Recalls in Healthcare Supply 

Chain.” In 2018 IEEE International Conference on Industrial Engineering and Engineering Management (IEEM), 293–97. Bangkok: 

IEEE, 2018. https://doi.org/10.1109/IEEM.2018.8607403.
11

benefits for provider-level vaccine recall. Vaccine manufacturers interviewed were not able to comment 

on the impact of serialization on recall. 

During an interview with one of the top four EHR vendors in the U.S., it was explained that their 

pharmaceutical inventory management functionality includes warning pop-ups to indicate if the vaccine 

being ordered or about to be administered is part of an active recall.46 To the extent that 2D barcode 

scanning supports product traceability and accurate documentation of immunization, it can positively 

contribute to recall efforts. However, potential gains are predicated upon integration of scanning into 

current systems and the interoperability of these information systems across the supply chain.47

 46 EHR vendor, interviews with author, July 2019 47N. Haque, Saira, Suzanne West, and Alan O’Connor. “Mapping of Standards to Facilitate Immunization Information 

Exchange through Two-Dimensional Bar Coding of Vaccine Products.” Perspectives in Health Information Management 14, no. 

Fall (October 1, 2017). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5653951/.
12

3 Findings and Future Opportunities

DSCSA requires product serialization on UoS packaging for pharmaceuticals manufactured by

November 2018. The additional data will be carried on 2D barcodes to enable better traceability through 

the drug supply chain. By 2023, DSCSA aims to implement an electronic interoperable system to 

facilitate information exchange throughout the pharmaceutical manufacturing and distribution process. 

For vaccines, 2D barcode scanning, made possible by the DSCSA, allows medical record and inventory 

management systems to accurately record NDC, serial number, lot number, and expiration date of each 

vaccine UoS product, however, the improved accuracy and completeness is dependent on the use of 

scanning to capture data via the 2D barcode. As described above, one of the largest EHR system 

vendors in the U.S. reported that they have inventory functionality at no additional cost, but not all 

customers have enabled this functionality. Their customers cite that equipment costs for scanners are a 

barrier to adoption. There is an opportunity to show the return on investment from the upfront 

equipment costs to implementing 2D barcode scanning adoption within medical practices. 

This same vendor has included a safety feature to trigger a warning pop-up when there is an issue or 

inconsistency between the order and the vaccine such as when recalled or expired pharmaceutical are 

ordered or taken from inventory for administration, or when the order and vaccine do not match. The 

warning, however, is independent from 2D barcode scanning and will pop-up even when orders and 

vaccine information are manually entered into the record. The drawback of not scanning vaccines at the 

point-of-use (when product is taken from inventory) is the ineffectiveness of warnings. If the warning 

pops-up after administration, it was not effective in preventing the administration of an incorrect, 

expired, or recalled vaccine. This is more of a clinical workflow and adherence issue than it is a 2D 

barcode scanning issue. There is continued opportunity to provide resources to promote 2D scanning 

workflow good practices and behavioral adherence strategies to support adoption efforts.

EHR system vendors are creating inventory modules that utilize 2D barcode scanning to dynamically 

track the number of vaccines in inventory and the movement of these vaccines from storage, to 

medication cabinets, and to patients. For a traceability system, this depth of information can be helpful 

to ensuring safety of patients. However, the breadth of this adoption across ambulatory healthcare 

settings is unclear, again, due to the limited adoption of 2D scanning as reported by some EHR system 

vendors.

There is yet to be industry-level consensus on best practices or lessons learned related to DSCSA 

implementation; however, this report will be updated as best practices and lessons learned are published. 

Today, under Section 201. 25 of the Code of Federal Regulations, Title 21, pharmaceutical products are 

required by the FDA to have at a minimum a barcode that contains “the appropriate NDC number in a 

linear barcode that meets European Article Number/Uniform Code Council (EAN/UCC) or Health 

Industry Business Communications Council (HIBCC) standards or another standard or format that has 

been approved by the relevant FDA Center Director.”48 Typically, if a UoU includes a linear barcode, 

then it will only include the product’s NDC. Because of physical size, expiration date, lot number, and 

serial number cannot be contained in a 1-dimensional, linear barcode. Since recalls are typically managed 

at the lot-level, scanning a linear barcode is of limited usefulness. Mapping the UoS serial number to the 

 48 US Food and Drug Administration. "CFR-code of federal regulations title 21." General labeling provisions Part 201 (2018).
13

UoU lot numbers may prove more helpful to home in on recalled products and limiting waste of viable 

vaccines. This assumption requires further investigation.

The research base on the benefits of serialization for vaccine recall in the United States is limited. Several 

assumptions about serialization’s benefits for improved data accuracy, reduced vaccine deduplication, 

and increasingly robust and accurate immunization documentation within state registries can be made 

from the improved ability to uniquely identify a vaccine package. The dearth of existing evidence creates 

future opportunities for research to test whether and to what extent these assumptions hold true, and 

whether serialization efforts support patient safety regarding recalls. 
14

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