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HRD-82-11 1 (1981-10-28)

handle is hein.gao/gaobabcps0001 and id is 1 raw text is:                                                               II   I ,-,




B Y  T HE U .S , G E N E R A L   A C C O U N T IN G   O F F IC E


Report To The Secretary Of

Health And Human Services





FDA Should Reduce Expensive Antibiotic


Testing And Charge

Closety Reflect Cost





he Food and Drug Administration (FDA)
c rtifies batches of antibiotics, insulin, and
c lor additives. Certification is the testing of
tcatch samples for compliance with established
s andards and the issuing of certificates for
atches that pass the tests. FDA charges fees
t manufacturers to cover its cost of certifi-
oation.


Fees Which More

Of Certification









                            116781


he current level of antibiotic testing is not
ecessary. The number of batches failing cer-
fication tests has historically been low. Batch
ertification is an expensive product assurance
trategy and other less costly control mecha-
risms are available. Further, GAO believes
DA should revise the method for determining
he fees charged manufacturers for the cost of
~ertification.

AO makes several recommendations to the
;ecretary of the Department of Health and
Human Services to resolve these matters.








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    wlcuC


      H RD-82-1 1
OCTOBER 28, 1981

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