WORLD TRADE G/TBT/Notif.97.385
6August 1997
ORGANIZATION
(97-3334)
Committee onTechnical Barriers toTrade
NOTIFICATION
Thefollowing notification isbeing circulated inaccordance withArticle 10.6.
1. Member toAgreement notifying: UNITED STATES
Ifapplicable, name oflocalgovernment involved (Articles 3.2and7.2):
2. Agency responsible: Food andDrug Administration (14)
Agency orauthority designated tohandle comments regarding thenotification canbe
indicated ifdifferent from above:
3. Notified under Article 2.9.2 [X],2.10.1 [],5.6.2 [],5.7.1 [],other:
4. Products covered (HSorCCCN where applicable, otherwise national tariff heading.
ICSnumbers maybeprovided inaddition, where applicable): Human andVeterinary
Drug Products (HSChapter 30)
5. Title, number ofpages andlanguage(s) ofthenotified document: Current Good
Manufacturing Practice inManufacturing, Processing, Packing, orHolding ofDrugs;
Revision ofCertain Labelling Controls (4pages, English)
6. Description ofcontent: TheFood andDrug Administration (FDA) isproposing toamend
thepackaging andlabelling control provisions ofthecurrent good manufacturing
practice regulations forhuman andveterinary drugproducts bylimiting theapplication
ofspecial control procedures fortheuseofcutlabelling toimmediate container labels,
individual unitcartons, ormultiunit cartons containing immediate containers thatarenot
packaged inindividual unitcartons. FDA isalsoproposing topermit theuseofany
automated technique, including differentiation bylabelling sizeandshape, thatphysically
prevents incorrect labelling from being processed bylabelling andpackaging equipment
when cutlabelling isused.
7. Objective andrationale: Toprotect consumers from labelling errors andtopermit
manufacturers touseabroader range oferror prevention andlabelling control
techniques.
8. Relevant documents: 62FR40489, 29July1997; 21CFR Part211. Willappear inthe
Federal Register when adopted.
9. Proposed dateofadoption: TheFood andDrug Administration proposes thatanyfinal
rulethatmayissue based onthisproposal become effective sixmonths afteritsdateof
publication intheFederal Register.
Proposed dateofentry intoforce:
10. Final dateforcomments: 27October 1997
11. Texts available from: National enquiry point [x]oraddress andtelefax number ofother
body: