Diphtheria and Tetanus Toxoids Adsorbed
»Diphtheria and Tetanus Toxoids Adsorbed conforms to the regulations of the FDAconcerning biologics (see Biologics á1041ñ).It is a sterile suspension prepared by mixing suitable quantities of plain or adsorbed diphtheria toxoid and plain or adsorbed tetanus toxoid,and an aluminum adsorbing agent if plain toxoids are used.The antigenicity or potency and the proportions of the toxoids are such as to provide an immunizing dose of each toxoid in the total dosage prescribed in the labeling,and each component meets the requirements for those products.It contains not more than 0.02percent of residual free formaldehyde.
Packaging and storage— Preserve at a temperature between 2and 8.
Expiration date— The expiration date is not later than 2years after date of issue from manufacturer's cold storage (5,1year).
Labeling— Label it to state that it is to be well shaken before use and that it is not to be frozen.
Auxiliary Information— Staff Liaison:Tina S.Morris,Ph.D.,Senior Scientist
Expert Committee:(VVI)Vaccines,Virology,and Immunology
USP28–NF23Page 672
Phone Number:1-301-816-8397