RESTRICTED
WORLD TRADE G/TBT/Notif.95.311
26October 1995
ORGANIZATION
(95-3290)
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 (23)
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):
Labelling ofdrugproducts
5. Title andnumber ofpages ofthenotified document: Labelling ofDrug Products for
Over-the-Counter Human Use(1page)
6. Description ofcontent: TheAdministration ismodifying aproposed rulethatproposed
toamend thegeneral labelling policy forover-the-counter (OTC) drugproducts toallow
forinterchangeable useoftheterms "drug interaction precaution", "avoid mixing
drugs", or"donotmixdrugs" inlabelling required byanOTC drugmonograph. This
modification provides foroneadditional alternative term, "donotusewith***".
7. Objective andrationale: Health andsafety.
8. Relevant documents: 60FR52058, 4October 1995; 21CFR Part330. Willappear in
theFederal Register when adopted.
9. Proposed dateofadoption andentry intoforce: TheAdministration isproposing that
anyfinalrulethatmayissue based onthisproposal become effective 30daysafterthe
dateofitspublication intheFederal Register.
10. Final dateforcomments: 2January 1996
11. Texts available from: National enquiry point [X]oraddress andtelefax number ofother
body: