This specification deals with identification of small volume containers of drugs intended to be diluted before parenteral administration such as container shape, labeling statements, vial closures and ampoule marking. Drugs in liquid form requiring dilution before parenteral administration shall not be packaged in containers that resemble a normal syringe. The design of such containers shall preclude direct intravenous line injection of the solution. The labels on each container shall bear the words “dilute before use“. Such black metal closures and black flip-off type caps and use of a black band or series of bands above the contracture on an ampoule shall only be used for Potassium Chloride for Injection Concentrate. With this, identification of such vials and ampoules shall be easy.
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1.1 This specification deals with identification of small volume containers of drugs intended to be diluted before parenteral administration, as follows:
1.1.1 Container shape,
1.1.2 Labeling statements.
1.1.3 Vial closures and Flip-Off, type caps, and
1.1.4 Ampoule marking.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D996 Terminology of Packaging and Distribution Environments
D4267 Specification for Labels for Small-Volume (100 mL or Less) Parenteral Drug Containers
D4775 Specification for Identification and Configuration of Prefilled Syringes and Delivery Systems for Drugs (Excluding Pharmacy Bulk Packages)
D7298 Test Method for Measurement of Comparative Legibility by Means of Polarizing Filter Instrumentation
ampoules; drugs; label; vials;
ICS Number Code 11.120.10 (Medicaments)
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