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label repackaging

label requirements for repackaging single unit / unit dose packages

QuestionAnswer
nonproprietary name the nonproprietary name and strength should be the most prominent part of package label; name of manufacturer should also appear on package
dosage form special characteristics of dosage form should be part of the label, i.e. extended release; route of administration should be labeled if other than oral such as topical or injection
*injection dosage form acceptable injectable route of administration should be stated on both outer and inner packages, i.e. both on the syringe unit and carton (if any)
strength should be stated in accordance with terminology in the American Hospital Formulary Service; use metric system only in smallest whole number (i.e. use mcg and mg through 999, then grams)
strength of dose and total contents delivered the total contents and total dose of the package should be indicated, i.e. a 500 mg dose of a drug in a liquid containing 100 mg/mL should be labeled "Delivers 500 mg (as 5 mL of 100 mg/mL)"
include special notes such as storage conditions, i.e. refrigerate or shake well
expiration must be on label; *if contents must be reconstituted prior to use, the shelf life of the final product should be indicated
control number lot number
*product identification codes the use of product identification codes, appearing directly on the dosage form, is encouraged
*evidence of entry the package should be designed so that it is evident that it has never been opened prior to use
Created by: DbaileyC
 

 



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