. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/USA/687 
4 April 2012  
 (12-1764) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Notifying Member:  UNITED STATES  
If applicable, name of local governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  Food and Drug Administration (F DA), Health and Human Services 
(HHS) (704) 
Name and address (including telephone and fax numbers, email and website 
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):  Drugs, labelling 
(ICS 11.120) 
5. Title, number of pages and language(s) of the notified document:  Current Good 
Manufacturing Practice in Ma nufacturing, Processing, Packing, or Holding of Drugs; 
Revision of Certain Labelling C ontrols (6 pages, English) 
6. Description of content:  The Food and Drug Administration (FDA) is amending the 
packaging and labelling control provisions of the current good ma nufacturing practice 
(CGMP) regulations for human and veterinary drug products by limiting the application of 
special control procedures for the use of cut labelling to immediate container labels, 
individual unit cartons, or multiunit cartons c ontaining immediate containers that are not 
packaged in individual unit cartons. FDA is also permitting the use of any automated 
technique, including differentiation by labelli ng size and shape that physically prevents 
incorrect labelling from being processed by la belling and packaging equipment when cut 
labelling is used. This action is intended to  protect consumers from labelling errors more 
likely to cause adverse health consequences , while eliminating the regulatory burden of 
applying the rule to labelling unlikely to reach or adversely affect consumers. This action is 
also intended to permit manufa cturers to use a broader range of error prevention and labelling 
control techniques than perm itted by current CGMPs. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of the consumers.  
8. Relevant documents:   77 Federal Register (FR) 16158,  20 March 2012; Title 21 Code of 
Federal Regulations (CFR) Part 211. Will appear in the Federa l Register when adopted. 29 
July 1997 Federal Register - Final rule; partial extension of compliance date - 
http://www.gpo.gov/fdsys/pkg/ FR-1997-07-29/html/97-19818.htm  G/TBT/N/USA/687 
Page 2  
 
  9. Proposed date of adoption:   
Proposed date of entry into force:    To be determined 
20 March 2013 
10. Final date for comments:  - 
11. Text available from:  National enquiry point [X], or address, telephone and fax 
numbers, e-mail and web-site addres ses, if available of the other body:    
Internet URL's: 
http://www.gpo.gov/fdsys/pkg/ FR-2012-03-20/html/2012-6502.htm  
http://www.gpo.gov/fdsys/pkg/FR-2012-03-20/pdf/2012-6502.pdf