. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/USA/135 
18 July 2005 
 (05-3205) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   UNITED STATES 
 
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Department of Health and Human Services, Food and Drug 
Administration  (FDA) (140) 
Name and address (including telephone and fax numbers, e-mail and web-site 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:         
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):   Human Drug Products  
(HS Chapter 30;  ICS 11.120). 
5. Title, number of pages and langua ge(s) of the notified document:   Cold, Cough, Allergy, 
Bronchodilator, and Antiasthmatic Drug Prod ucts for Over-the-Counter Human Use; 
Proposed Amendment of the Tentative Fina l Monograph for Combination Drug Products 
(6 pages, in English). 
6. Description of content:   The Food and Drug Administration (FDA) is proposing to amend 
the tentative final monograph (TFM) for ove r-the-counter (OTC) cough-cold combination 
drug products to remove the combination of an oral bronchodilator (products containing 
ephedrine or its salts) and an e xpectorant, and to reclassify this combination drug product as 
Category II (not generally recognized as safe and effective for OTC use).  FDA is also 
proposing to classify the combination of an  oral bronchodilator and an oral nasal 
decongestant as Category II.  FDA is issui ng this notice of proposed rulemaking after 
considering data and informa tion on the appropriateness of th ese combination drug products 
to treat mild asthma. Elsewher e in this issue of the Federal Register, FDA is proposing to 
amend the final monograph (FM) for OTC bronchodilator drug products to require 
additional labeling for all ingredients included in  the FM.  These proposed rules are part of 
FDA's ongoing review of OTC drug products. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health 
8. Relevant documents:   70 Federal Register (FR) 40232 13 July 2005; Title 21 Code of 
Federal Regulations (CFR) Part s 310 and 341.  Will appear in the Federal Register when 
adopted. G/TBT/N/USA/135 
Page 2  
 
 9. Proposed date of adoption:   
Proposed date of entry into force:   }To be determined 
10. Final date for comments:   10 November 2005 
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body: 
Full Text of this Notification is Now Available on the Internet at URLs: 
http://a257.g.akamaitech.net/7/257/24 22/01jan20051800/edocket.access.gpo.gov/2005/05-
13708.htm 
http://a257.g.akamaitech.net/7/257/24 22/01jan20051800/edocket.access.gpo.gov/2005/pdf/
05-13708.pdf