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label repackaging
label requirements for repackaging single unit / unit dose packages
| Question | Answer |
|---|---|
| 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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