Guidance for Industry 
Standards for Securing the Drug 
Supply Chain - Standardized 
Numerical Identification for 
Prescription Drug Packages 
 
 
 
FINAL GUIDANCE 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of the Commissioner (OC) 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
Office of Regulatory Affairs (ORA) 
March 2010 
 
   
Guidance for Industry 
Standards for Securing the Drug Supply 
Chain - Standardized Numerical 
Identification for Prescription Drug 
Packages  
 
 
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and/or 
 
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U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of the Commissioner (OC) 
Center for Drug Evaluation and Research 
Center for Biologics Evaluation and Research 
Office of Regulatory Affairs 
 
March 2010 
 
  Contains Nonbinding Recommendations 
 
TABLE OF CONTENTS 
 
I.  INTRODUCTION..............................................................................................................................................1 
II.  BACKGROUND................................................................................................................................................2 
A.  Food and Drug Administration Amendments Act of 2007...............................................................................2 
B.  Scope of this Guidance....................................................................................................................................2 
III.  STANDARDIZED NUMERICAL IDENTIFIERS....................................................................................4 
A.  What should be designated as a package-level SNI for most prescription drugs?..........................................4 
B.  What should be designated as a package-level SNI for certain biological products?....................................4 
C.  Does the SNI include expiration date and/or lot or batch number?................................................................5 
D.  Why did FDA select the serialized NDC for package-level SNI for most prescription drugs?.......................6 
E.  Should the SNI be in human- and machine-readable forms?..........................................................................6 
F.  Is the SNI that FDA is recommending compatible with international standards?..........................................7 
 
  Contains Nonbinding Recommendations 
Guidance for Industry1 
Standards for Securing the Drug Supply Chain - Standardized 
Numerical Identification for Prescription Drug Packages  
 
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic.  It 
does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  
You can use an alternative approach if the approach satisfies the requirements of the applicable statutes 
and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for 
implementing this guidance.  If you cannot identify the appropriate FDA staff, call the appropriate 
number listed on the title page of this guidance.  
 
 
I.  INTRODUCTION 
This guidance is intended to address provisions set forth in Section 505D of the Federal Food, 
Drug, and Cosmetic Act (the Act) regarding development of standardized numerical identifiers 
(SNIs) for prescription drug packages. In this guidance, FDA is identifying package-level SNIs, 
as an initial step in FDAs development and implementation of additional measures to secure the 
drug supply chain. 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited. The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required. 
                                                 
1 This guidance has been prepared by the Office of the Commissioner (OC), the Center for Drug Evaluation and 
Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Office of Regulatory Affairs 
(ORA) at the Food and Drug Administration.  
  1 Contains Nonbinding Recommendations 
II.  BACKGROUND 
A.  Food and Drug Administration Amendments Act of 2007 
On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 (FDAAA) 
(Public Law 110-85) was signed into law. Section 913 of this legislation created section 505D of 
the Federal Food, Drug, and Cosmetic Act, which requires the Secretary of Health and Human 
Services (the Secretary) to develop standards and identify and validate effective technologies for 
the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, 
substandard, adulterated, misbranded, or expired drugs. Section 505D directs the Secretary to 
consult with specific entities to prioritize and develop standards for identification, validation, 
authentication, and tracking and tracing of prescription drugs.  The statute also directs that, no 
later than 30 months after the date of enactment of FDAAA, the Secretary shall develop an SNI 
to be applied to a prescription drug at the point of manufacturing and repackaging at the 
package- or pallet-level, sufficient to facilitate the identification, validation, authentication, and 
tracking and tracing of the prescription drug.  An SNI applied at the point of repackaging is to be 
linked to the SNI applied at the point of manufacturing and, to the extent practicable, the SNI 
should be harmonized with international consensus standards for such an identifier. (See Section 
505D(b)(2)).  The provisions in section 505D(b) of the act complement and build upon FDAs 
longstanding efforts to further secure the U.S. drug supply.  This guidance finalizes the draft 
guidance of the same title dated January 16, 2009 (74 FR 3054).   
B.  Scope of this Guidance 
This guidance is intended to be the first of several guidances and regulations that FDA may issue 
to implement section 505D of the Act, and its issuance is intended to assist with the development 
of standards and systems for identification, validation, authentication, and tracking and tracing of 
  2 Contains Nonbinding Recommendations 
prescription drugs.2  This guidance defines SNI for package-level identification only.  For the 
purpose of this guidance, FDA considers the prescription drug package to be the smallest unit 
placed into interstate commerce by the manufacturer or the repackager that is intended by that 
manufacturer or repackager, as applicable, for individual sale to the pharmacy or other dispenser 
of the drug product. Evidence that a unit is intended for individual sale, and thus constitutes a 
separate package for purposes of this guidance, would include the package being accompanied 
by labeling intended to be sufficient to permit its individual distribution.   For example, if a 
manufacturers smallest unit of sale package is a container holding six drug-filled syringes, a  
single SNI would be the package-level identifier for the container holding the six drug-filled 
syringes;  there would be no SNIs for the individual syringes, not intended by the manufacturer 
for individual sale.  If a repackager then breaks that container down and repackages each syringe 
for individual sale, then the repackager must ensure that appropriate labeling accompanies each 
individual syringe3 and a new and unique SNI would be the package-level identifier for each 
new package (e.g., each individual drug-filled syringe).  SNIs applied to each new package by 
the repackager are to be linked back to the manufacturers SNI for the container of six drug-filled 
syringes (505D(b)(2)).    
This guidance does not address how to link a repackager SNI to a manufacturer SNI, nor does it 
address standards for prescription drug SNI at levels other than the package-level including, for 
example, the case- and pallet-levels. Standards for track and trace, authentication, and validation 
are also not addressed in this guidance because this guidance only addresses the standardized 
numerical identifier itself and not implementation or application issues.  
                                                 
2 Prescription drugs as defined in section 503(b)(1) of the act. 
3 See, e.g., Sections 502 (b) and (f). 
 
  3 Contains Nonbinding Recommendations 
III.  STANDARDIZED NUMERICAL IDENTIFIERS 
A.  What should be a package-level SNI for most prescription drugs? 
The SNI for most prescription drug packages should be a serialized National Drug Code (sNDC).  
The sNDC is composed of the National Drug Code (NDC) (as set forth in 21 CFR Part 207) that 
corresponds to the specific drug product (including the particular package configuration)4 
combined with a unique serial number, generated by the manufacturer or repackager for each 
individual package.  Serial numbers should be numeric (numbers) or alphanumeric (include 
letters and/or numbers) and should have no more than 20 characters (letters and/or numbers). An 
example is shown below with a 10-character NDC. 
Example of a serialized National Drug Code (sNDC) 
 
    NDC             SERIAL NUMBER 
+      
                55555 666 77                   11111111111111111111 
 
  
labeler code + product code + package code            unique, up to 20 characters 
 
 
B.  What should be the package-level SNI for certain biological products that do not 
use NDC numbers?  
Some prescription drugs approved under Section 351 of the Public Health Service Act, such as 
blood and blood components and certain minimally manipulated human cells, tissues, and 
cellular and tissue-based products (HCT/Ps), do not currently use NDC numbers.  Examples of 
HCT/Ps that do not use NDC numbers include allogeneic placental/umbilical cord blood, 
peripheral blood progenitor cells, and donor lymphocytes for infusion.  Instead, such products 
                                                 
4In the case of repackaged drugs, each package type should have an NDC that corresponds to the repacker or private 
label distributor for whom the drug is repacked and to the new package configuration. 
  
  4 Contains Nonbinding Recommendations 
currently use other recognized standards for identification and labeling, such as ISBT 128, which 
creates a unique identification number for each product package.  See 
http://iccbba.org/about_gettoknowisbt128.html, Guidance for Industry: Recognition and Use of 
a Standard for Uniform Blood and Blood Component Container Labels,  
(http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guid
ances/Blood/ucm073362.htm.)  The SNI for these products should be the unique identification 
number created for each package under these other recognized standards, such as ISBT 128.5   
C.  Does the SNI include expiration date and/or lot or batch number? 
Expiration date and/or lot or batch numbers are not part of the recommended SNI.  Expiration 
date and/or lot or batch numbers are already accessible because FDA regulations require the 
inclusion of this information on the label of each drug product. (See 21 CFR  201.17, 201.18, 
211.130, 211.137, 610.60, and 610.61.)  In addition, the SNI can be linked to databases 
containing this and other information.   Addition of this information within the SNI will 
unnecessarily increase the length of, and introduce complexity into, the SNI.  However, if a 
manufacturer or repackager chooses to include expiration date and/or lot or batch number with 
the SNI, it should ensure that the resulting number still permits users to distinguish and make use 
of the SNI.  For example, expiration date and lot or batch number may be incorporated in 
accordance with the GS1 standards for use of Global Trade Item Numbers (GTIN)6 (discussed 
below in Section F).   
                                                 
5 FDA currently also recognizes Codabar as a standard for blood and blood component container labels.    We note 
that ISBT 128 is becoming the more widely-used industry standard. 
6  See www.GS1.org  -- Healthcare GTIN Allocation Rules 
(http://www.gs1.org/docs/gsmp/healthcare/GS1_Healthcare_GTIN_Allocation_Rules.pdf ). 
  5 Contains Nonbinding Recommendations 
D.  Why did FDA select the serialized NDC for package-level SNI for most 
prescription drugs? 
FDA chose the sNDC as the package-level SNI for most prescription drugs because we believe 
that it serves the needs of the drug supply chain as a means of identifying individual prescription 
drug packages,7 which in turn should facilitate authentication and tracking and tracing of those 
drugs.  Most prescription drug product packages already have an NDC on them.   By combining 
a serial number of up to 20 characters with the NDC, the sNDC should be sufficiently robust to 
support billions of units of marketed products without duplication of an SNI.  This approach will 
allow manufacturers and repackagers to assign serial numbers to combine with the NDC for 
unique identification of individual product packages.  The SNI can also be linked to databases 
containing such product attributes as lot or batch number, expiration date, 
distribution/transaction history information, and other identifiers related to a product.  As already 
noted, defining the SNI is expected to be a first step to facilitate the development of other 
standards and systems for securing the drug supply chain.  Many aspects of the implementation 
of package-level identification will take shape in the future, as the standards that make use of 
SNI are developed.  
E.  Should the SNI be in human- and machine-readable forms? 
FDA believes that an SNI generally should be applied to each package in both human-readable 
and machine-readable forms.  However, at this time, FDA is not specifying the means of 
incorporating the SNI onto the package.  The SNIs described in this guidance are compatible 
with, and flexible for, encoding into a variety of machine-readable forms of data carriers, such as 
                                                 
7 As described above, ISBT-128 and Codabar serve the same function for certain biologics that lack NDCs. 
  6 Contains Nonbinding Recommendations 
2-dimensional bar codes and radio-frequency identification (RFID),8 leaving options open as 
technologies for securing the supply chain continue to be identified, and standards making use of 
SNI are developed.  A redundant human-readable SNI on the package would provide the ability 
to identify the package when electronic means are unavailable (e.g., in the event of 
hardware/software failure).  Due to the wide-variety of packaging required to accommodate 
different products and product integrity needs, FDA also is not specifying a location on the 
package where an SNI should be placed.  If the NDC is already printed on the package in 
human-readable form, then the serial number could be printed in human-readable form in a non-
contiguous manner elsewhere on the product package. Any SNI placed on the package must not 
obstruct FDA-required labeling information9 and should be placed in a manner that allows it to 
be readily scanned/viewed without damaging the integrity of the packaging or product..  
F.  Is the SNI that FDA is recommending compatible with international standards? 
In addition to facilitating other actions to secure the drug supply chain, adoption of the sNDC as 
the SNI for most prescription drugs, and of other recognized standards, such as ISBT 128, for 
certain biological products, satisfies the requirement in 505D(b)(2) that the SNI developed by 
FDA be harmonized, to the extent practicable, with internationally recognized standards for such 
an identifier.  Specifically, use of an sNDC is compatible with, and may be presented within, a 
GTIN, which can be serialized using an Application Identifier (AI) (21) to create a serialized 
GTIN (sGTIN) for use with RFID or for certain barcodes.10 GTIN is a global standard for item 
and object identification, established by GS1, a consensus-based, not-for-profit, international 
                                                 
8  FDA's enforcement policy with respect to the application of current good manufacturing practices to RFID 
technology is provided in Compliance Policy Guide  (CPG) Section 400.210.  See 
http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074357.htm.   This CPG 
would apply if an SNI were embedded into an RFID tag. 
9 See section 502(c) of the Act. 
10 See www.GS1.org  -- Healthcare GTIN Allocation Rules 
(http://www.gs1.org/docs/gsmp/healthcare/GS1_Healthcare_GTIN_Allocation_Rules.pdf ). 
  7 Contains Nonbinding Recommendations 
standards organization that works with manufacturers, distributors, retailers, and others in the 
drug supply chain.  A GTIN may be used to uniquely identify items at the package level 
throughout the supply chain.  FDA has been an active observer and participant in GS1 standards 
development related to healthcare and drug products.  According to documentation from GS1, 
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. 
                                                                                                                                                             
 
  8