G/TBT/N/USA/1899  
26 July 2022  
(22-5622) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  UNITED STATES OF AMERICA  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  Food and Drug Administration (FDA), Health and Human Services 
(HHS) [1930]  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the not ification shall be indicated if different from above:   
Please submit comments to: USA WTO TBT Enquiry Point, Email: usatbtep@nist.gov  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN  where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  National 
drug code (NDC) label barcode requirements; Technical product documentation (ICS 
code(s): 01.110); Pharmaceutics (ICS code(s): 11.120 ) 
5. Title, number of pages and language(s) of the notified document:  Revising the 
National Drug Code Format and Drug Label Barcode Requirements; (11 page(s), in 
English)  
6. Description of content:  Proposed rule - The Food and Drug Administration (FDA, t he 
Agency, or we) is proposing to amend our regulations governing the format of the National 
Drug Code (NDC). The NDC is an FDA standard for uniquely identifying drug products 
marketed in the United States. This action, if finalized, will standardize the f ormat of all 
NDCs. Specifically, all NDCs will be required to be 12 digits in length with 3 distinct 
segments and 1 uniform format. The first segment is the labeler code and will be 6 digits, 
the second segment is the product code and will be 4 digits, and  the third segment is the 
package code and will be 2 digits. Additionally, we are proposing to revise the drug 
product barcode label requirements to permit the use of other data carriers that meet 
certain standards.  
7. Objective and rationale, including t he nature of urgent problems where 
applicable:  Consumer information, labelling; Prevention of deceptive practices and 
consumer protection; Protection of human health or safety; Cost saving and productivity 
enhancement  G/TBT/N/USA/1899  
 
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  8. Relevant documents:  87 Federal Register (FR) 44038, 25 July 2022; Title 21 Code of 
Federal Regulations (CFR) Parts 201 and 207:  
https://www.govinfo.gov/content/pkg/FR -2022-07-25/html/2022 -15414 .htm 
https://www.govinfo.gov/content/pkg/FR -2022-07-25/pdf/2022 -15414.pdf  
This proposed rule is identified by Docket Number FDA -2021-N-1351. The Docket Folder 
is available on Regulations.gov at https://www.regulations.gov/docket/FDA -2021-N-
1351/document  and provides access to primary documents as well as comments received. 
Documents are also accessible from Regulations.gov  by searching the Docket Number. 
WTO Members and their stakeholders are asked to submit comments to the USA TBT 
Enquiry Point  by or bef ore 4pm Eastern Time  on 11 November 2022. Comments received 
by the USA TBT Enquiry Point from WTO Members and their stakeholders will be shared 
with the regulator and will also be submitted to the Docket on Regulations.gov if received 
within the comment period.  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  22 November 2022  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
https://members.wto.org/crnattachments/2022/TBT/USA/22_4933_00_e.pdf