RT Journal Article
SR Electronic
T1 What FDA Is Doing about Multivitamins and Trace Elements for Parenteral Use
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 72
OP 73
VO 35
IS 2
A1 Troendle, Gloria
YR 1981
UL http://journal.pda.org/content/35/2/72.abstract
AB All parenteral multivitamins were determined to lack evidence of efficacy by the Food and Drug Administration (FDA) on the basis of a review from the National Academy of Sciences-National Research Council Drug Efficacy Study Panel and the agency’s review of additional data. To allow time for a suitable formulation to be decided upon, an exception was made by court order to the legal requirement that such drugs be withdrawn from the market. The American Medical Association Department of Foods and Nutrition recommended formulations for multivitamins for intravenous and intramuscular use in children and adults. These formulations were accepted by FDA, which published conditions under which present formulations could remain on the market while gaining approval of the new formulations (Federal Register, July 13,1979). FDA provided for a conditional approval prior to clinical studies to expedite entry of the recommended formulations into the market. The American Medical Association Department of Foods and Nutrition has also recommended that certain trace elements be available for intravenov:. use, and FDA expects to publish in the Federal Register a notice of the availability of guidelines for trace element solutions in the near future.