| Title: | OGA FLAGS CHANGED ON CERTAIN TARIFFS |
|---|---|
| Date: | 1996-07-18 |
| To: | abi |
| Links: | previous, next |
THE FOLLOWING INFORMATION IS PROVIDED TO ABI FILERS
FILING ENTRIES USING THE FDA INTERFACE. ALL QUESTIONS
SHOULD BE DIRECTED TO DENNIS LINSLEY OF THE FDA,
AT 301 443 6553.
THE OGA FLAG ON GLYCERINE (HTS 1520000000 AND
2905450000) HAS BEEN CHANGED TO FD2 AT FDA'S REQUEST.
THIS WILL REQUIRE THE FILING OF FDA INFORMATION ON ALL LINES WITH
THESE TARIFF CLASSIFICATIONS. THE APPROPRIATE FDA PRODUCT
CODE TO USE WILL BE EITHER '55Q?-16' OR '55Q?-58' WHERE THE
'?' IS REPLACED WITH A 'P' IF THE GLYCERINE IS FOR PHARMACEUTIC
USE OR A 'Y' IF IT DOES NOT HAVE A PHARMACEUTIC USE. FDA IS ALSO
REQUIRING NO SUBSTITUTIONS BE MADE FOR THE ACTUAL MANUFACTURER
IDENTIFIED IN THE FDA DATA SET.
FDA REPORTS THEY ARE INVESTIGATING DEATHS IN HAITI WHICH
MAY HAVE BEEN CAUSED BY THE USE OF CONTAMINATED GLYCERINE
IN DRUGS. FDA HAS REQUESTED NOTIFICATION OF ALL
IMPORTATIONS OF GLYCERINE TO ASSURE U.S. MANUFACTURERS ARE
NOT RECEIVING CONTAMINATED GLYCERINE.