G/TBT/N/USA/1531  
27 September 2019  
(19-6255) 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 AME RICA  
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) [1558]  
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 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Drug 
substances; Pharmaceutics (ICS 11.120)  
5. Title, number of pages and language(s) of the notified document:  Amendments to 
the List of Bulk Drug Substances That Can Be Used to Compound Drug Products in 
Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act (16 page(s), in 
English)  
6. Description of content:  Proposed rule - The Food and Drug Administration (FDA or 
Agency) has issued a regulation creating a list of bulk drug substances (active 
pharmaceutical ingredients) that can be used to compound drug products in accordance 
with certain compounding provisions of the Federal F ood, Drug, and Cosmetic Act (FD&C 
Act), although they are neither the subject of an applicable United States Pharmacopeia 
(USP) or National Formulary (NF) monograph nor components of FDA -approved drugs. This 
proposed rule would amend that list by placing f ive additional bulk drug substances on the 
list. This proposed rule also identifies 26 bulk drug substances that FDA has considered 
and proposes not to include on the list. Additional substances nominated by the public for 
inclusion on this list are curren tly under consideration and will be the subject of a future 
rulemaking.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Prevention of deceptive practices and consumer protection; Protection of 
human health or safety  
8. Relevant documents:   
• 84 Federal Register (FR) 46688, 5 September 2019; Title  21 Code of Federal 
Regulations (CFR) Part 1 and 216:  
https://www.govinfo.gov/content/pkg/FR -2019-09-05/html/2019 -18951.htm  
https://www.govinfo.gov/content/pkg/FR -2019-09-05/pdf/2019 -18951.pdf  G/TBT/N/USA/1531  
 
- 2 - 
 
  • List of Bulk Drug Substances That Can Be Used To Compound Drug Products in 
Accordance With Section 503A of the Federal Food, Drug , and Cosmetic Act, Final 
Rule published 19 February 2019:  
https://www.g ovinfo.gov/content/pkg/FR -2019-02-19/html/2019 -02367.htm  
https://www.govin fo.gov/content/pkg/FR -2019-02-19/pdf/2019 -02367.pdf  
• List of Bulk Drug Substances That Can Be Used To Compound Drug Products in 
Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act, 
Proposed Rule published 16 December 2016:  
https://www.govinfo.gov/content/pkg/FR -2016-12-16/html/2016 -30109.htm  
https://www.govinfo.gov/content/pkg/FR -2016-12-16/pdf/2016 -30109.pdf  
• G/TBT/ N/USA/214/Add.3  and G/TBT/N/USA/214/Add.3/Corr.1  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  4 December 2019  
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/cr nattachments/2019/TBT/USA/19_5302_00_e.pdf