noteSee definitions of label and labeling in Labeling in the section Preservation, Packaging, Storage, and Labeling of the General Notices and Requirements.
The label states the name of the preparation; in the case of a liquid preparation, the percentage content of drug or amount of drug in a specified volume; in the case of a dry preparation, the amount of active ingredient; the route of administration; a statement of storage conditions and an expiration date; the name and place of business of the manufacturer, packer, or distributor; and an identifying lot number. The lot number is capable of yielding the complete manufacturing history of the specific package, including all manufacturing, filling, sterilizing, and labeling operations.
Where the individual monograph permits varying concentrations of active ingredients in the large-volume parenteral, the concentration of each ingredient named in the official title is stated as if part of the official title, e.g., Dextrose Injection 5%, or Dextrose (5%) and Sodium Chloride (0.2%) Injection.
The labeling includes the following information if the complete formula is not specified in the individual monograph: (1) In the case of a liquid preparation, the percentage content of each ingredient or the amount of each ingredient in a specified volume, except that ingredients added to adjust to a given pH or to make the solution isotonic may be declared by name and a statement of their effect; and (2) in the case of a dry preparation or other preparation to which a diluent is intended to be added before use, the amount of each ingredient, the composition of recommended diluent(s) [the name(s) alone, if the formula is specified in the individual monograph], the amount to be used to attain a specific concentration of active ingredient and the final volume of solution so obtained, a brief description of the physical appearance of the constituted solution, directions for proper storage of the constituted solution, and an expiration date limiting the period during which the constituted solution may be expected to have the required or labeled potency if it has been stored as directed.
Containers for Injections that are intended for use as dialysis, hemofiltration, or irrigation solutions and that contain a volume of more than 1 L are labeled to indicate that the contents are not intended for use by intravenous infusion.
Injections intended for veterinary use are labeled to that effect.
The container is so labeled that a sufficient area of the container remains uncovered for its full length or circumference to permit inspection of the contents.
strength and total volume for single- and multiple-dose injectable drug products
For single-dose and multiple-dose injectable drug products, the strength per total volume should be the primary and prominent expression on the principal display panel of the label, followed in close proximity by strength per mL enclosed by parentheses. For containers holding a volume of less than 1 mL, the strength per fraction of a mL should be the only expression of strength. Strength per single mL should be expressed as mg/mL, not mg/1 mL.
The following formats are acceptable for contents of greater than 1 mL:
Total strength/total volume: 500 mg/10 mL
Strength/mL: 50 mg/mL
Total strength/total volume: 25,000 Units/5 mL
Strength/mL: 5,000 Units/mL
The following format is acceptable for contents of less than 1 mL: 12.5 mg/0.625 mL
There are, however, some exceptions to expressing strength per total volume. In certain cases, the primary and prominent expression of the total drug content per container would not be effective in preventing medication errors (e.g., insulin). An example is the use of lidocaine or other similar drugs used as a local anesthetic where the product is ordered and administered by percentage (e.g., 1%, 2%) or a local anesthetic in combination with epinephrine that is expressed as a ratio (e.g., 1:100,000). In such cases, the total strength should be expressed: for example, 1% (100 mg/10 mL). Dry solids, which need to be reconstituted, should follow the same format, with the exception that only the total strength of the drug should be listed, not the strength/total volume or strength/mL.
Aluminum in Large-Volume Parenterals (LVPs), Small-Volume Parenterals (SVPs), and Pharmacy Bulk Packages (PBPs) Used in Total Parenteral Nutrition (TPN) Therapy
The package insert for all LVPs, SVPs, and PBPs used in the preparation of TPN products must contain a warning statement. This warning must be contained in the Warning section of the labeling and must state the following: WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions that contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 µg per kg per day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration of TPN products.