For single- 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/mL enclosed by parentheses. For containers that hold 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 greater than 1 mL:

The following format is acceptable for contents less than 1 mL:

There are 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). Another example is the use of lidocaine (or similar drugs for local anesthesia where the product is ordered and administered by percentage (e.g., 1% or 2%). In such cases, the total strength should be expressed: for example, 1% can be expressed as

Dry solids that must 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.

Single-entity drug products that can also be expressed as a ratio, such as epinephrine, shall be labeled only in terms of strength/mL. A ratio expression such as 1:1000 is an unacceptable format for single-entity drug products.

Examples:

When combined with a local anesthetic, the concentration of epinephrine will be expressed as a ratio.

Examples:

Where a container is offered as a Pharmacy Bulk Package, the label shall: (a) state prominently “Pharmacy Bulk Package—Not for direct infusion”; (b) contain or refer to information on proper techniques to help assure safe use of the product; and (c) bear a statement limiting the time frame in which the container may be used once it has been entered, provided it is held under labeled storage conditions (see Packaging and Storage Requirements 659).

Healthcare practitioners using injectable products must be able to easily see and act on labeling statements that convey important safety messages critical for the prevention of imminent life-threatening situations. These cautionary labeling statements must be simple, concise, and devoid of nonessential information. Products that do not require cautionary statements should be free of information, so that those with cautionary statements are immediately apparent. Accomplishing this requires a systematic approach to the labeling of injectable products, and one that ensures that the ferrule and cap overseal—an area of these products that is highly visible to practitioners as they use these medicines—is reserved for critical safety messages. Accordingly:

The use of a black closure system on a vial (e.g., a black cap overseal and a black ferrule to hold the elastomeric closure) or the use of a black band or series of bands above the constriction on an ampul is prohibited, except for Potassium Chloride for Injection Concentrate (see Packaging and Storage Requirements 659).

All injectable preparations of neuromuscular blocking agents and paralyzing agents must be packaged in vials with a cautionary statement printed on the ferrules and cap overseals. Both the container cap ferrule and the cap overseal must bear in black or white print (whichever provides the greatest color contrast with the ferrule or cap color) the words: “Warning: Paralyzing Agent” or “Paralyzing Agent” (depending on the size of the closure system). Alternatively, the overseal may be transparent and without words, allowing for visualization of the warning labeling on the closure ferrule.

The package insert for all LVIs, SVIs, and PBPs used in the preparation of TPN admixtures or formulations shall contain the following statement in the Warnings section of the labeling:

The strength of a drug product is expressed on the container label in terms of micrograms, milligrams, grams, or percentage of the therapeutically active moiety or drug substance, whichever form is used in the title, unless otherwise indicated in an individual monograph. Both the active moiety and drug substance names and their equivalent amounts are then provided on the container label and in the labeling (see Nomenclature 1121, Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations).

Official articles in capsule, tablet, or other dosage forms shall be labeled to express the quantity of each active moiety and/or drug substance or recognized nutrient contained in each unit. Unit-dose oral solutions or suspensions (whether supplied as liquid preparations or as liquid preparations that are constituted from solids upon addition of a designated volume of a specific diluent) shall be labeled to express the quantity of each active moiety and/or drug substance or recognized nutrient delivered under the conditions prescribed in Deliverable Volume 698. Official drug products not in unit-dose packaging shall be labeled to show the quantity of each active moiety and/or drug substance in each milliliter or in each gram, or to express the percentage of each such ingredient (see General Notices and Requirements 8.140, Percentage Concentrations). Exceptions are oral liquids or solids intended to be constituted to yield oral liquids that, alternatively, can be labeled in terms of each 5-mL portion of the liquid or resulting liquid. Unless otherwise indicated in a monograph or chapter, declarations of strength or quantity shall be stated only in metric units [see also General Notices and Requirements 5.50.10, Units of Potency (Biological)].

The label of an official drug product or nutritional or dietary supplement product shall bear an expiration date. All products shall display the expiration date so that it can be read by an ordinary individual under customary conditions of purchase and use. The expiration date shall be prominently displayed in high contrast to the background or it shall be sharply embossed, and easily understood (e.g., “EXP 6/13,” “Exp. June 13,” or “Expires 6/2013”). [Note—For additional information and guidance, refer to the Consumer Products Association's Voluntary Codes and Guidelines of the Consumer Healthcare Products Industry. ]

The monographs for some preparations state how the labeled expiration date shall be determined. In the absence of a specific requirement in the individual monograph for a drug product or nutritional supplement, the label shall bear an expiration date assigned for the particular formulation and package of the product, with the following exceptions: the label need not show an expiration date if the drug product or nutritional supplement is packaged in a container that is intended for sale without prescription, and the labeling states no dosage limitations, and if the product or supplement is stable for NLT 3 years when stored under the prescribed conditions.

If an official product is required to bear an expiration date, the product shall be dispensed solely in or from a container labeled with an expiration date, and the date on which the article is dispensed shall be within the labeled expiry period. The expiration date identifies the time during which the article can be expected to meet the requirements of the compendial monograph, provided it is kept under the prescribed storage conditions. The expiration date limits the time during which the article may be dispensed or used. If an expiration date is stated only in terms of the month and the year, then the intended expiration date is the last day of the stated month.

The beyond-use date is the date after which a product shall not be used. The dispenser shall place on the label of the prescription container a suitable beyond-use date to limit the patient's use of the article based on any information supplied by the manufacturer or this subsection. The beyond-use date shall not be later than the expiration date on the manufacturer's container. Also see the section Compounded Preparations below.

For articles that require constitution before use, a suitable beyond-use date for the constituted product shall be identified in the labeling.

For all other dosage forms, in determining a beyond-use date the dispenser shall take into account, in addition to any other relevant factors:

After considering these factors, the dispenser shall label a container with a suitable beyond-use date to limit the patient's use of the article. Unless otherwise specified in the individual monograph or in the absence of stability data to the contrary, the beyond-use date shall be not later than: (a) the expiration date on the manufacturer's container; or (b) 1 year from the date the drug is dispensed, whichever is earlier. For nonsterile solid and liquid dosage forms that are packaged in single-unit and unit-dose containers, the beyond-use date shall be 1 year from the date the drug is packaged into the single-unit or unit-dose container or the expiration date on the manufacturer's container, whichever is earlier, unless stability data or the manufacturer's labeling indicates otherwise.

The label on the container or package of an official compounded preparation shall bear a beyond-use date after which the compounded preparation should not be used. Beyond-use dates are assigned on the basis of criteria different from those applied to assigning expiration dates to manufactured drug products.

The label on the container package of an official compounded preparation shall include the word “compounded” after the drug name (e.g., Baclofen Compounded Oral Solution). Additionally, USP official compounded preparations for animal patients will include the word “veterinary” following the full official name (e.g., Atenolol Compounded Suspension, Veterinary).

Flexible containers for injections that are intended for use as dialysis, hemofiltration, or irrigation solutions, and that contain a volume of more than 1 L, should be labeled to indicate that the contents are not intended for use by intravenous infusion.

To help minimize the possibility of errors in drug dispensing and administration, when the quantity of active moiety and/or drug substance is expressed in whole numbers it shall be shown without a decimal point followed by a terminal zero (e.g., express as 4 mg, not 4.0 mg). When the quantity of active moiety and/or drug substance is expressed as a decimal number smaller than 1, it shall be shown with a zero preceding the decimal point (e.g., express as 0.2 mg, not .2 mg).

The alcohol content in a liquid preparation shall be stated on the label as a percentage (v/v) of C2H5OH.

The label of an herb or other botanical intended for use as a dietary supplement shall bear the statement, “If you are pregnant or nursing a baby, seek the advice of a health professional before using this product.”

The concentration of electrolytes for replacement therapy (e.g., sodium, potassium, chloride) shall be stated on the label in milliequivalents (mEq)/volume. [Note—Phosphorus containing injections shall be expressed in milliMoles (e.g., mM/volume). The label of the product shall also indicate the quantity of ingredient(s) in terms of weight or percentage concentration. ]

A product intended for injection or topical use shall state the names of all added substances (see General Notices and Requirements 5.20, Added Substances).

It is an established principle that official articles shall have only one official title (see General Notices and Requirements 2.20 and compendial nomenclature requirements in Nomenclature 1121). For purposes of saving space on labels and because chemical symbols for the most common inorganic salts of drugs are well known to practitioners, the following alternatives are permitted in labeling official articles that are salts: HCl for hydrochloride; HBr for hydrobromide; Na for sodium; and K for potassium. The symbols Na and K are intended for use in abbreviating names of the salts of organic acids, but these symbols are not used when the word Sodium or Potassium appears at the beginning of an official title (e.g., Phenobarbital Na is acceptable, but Na Salicylate is not).

The label of any form of Capsule or Tablet intended for administration other than by swallowing intact shall bear a prominent indication of the manner in which it should be used (see Compendial Nomenclature, Nomenclature Guidelines on the USP website at www.usp.org).

The vitamin content of an official drug product shall be stated on the label in metric units per dosage unit. The amounts of vitamins A, D, and E may also be stated in USP Units. Quantities of vitamin A declared in metric units refer to the equivalent amounts of retinol (vitamin A alcohol). The label of a nutritional supplement shall bear an identifying lot number, control number, or batch number.

Articles may be labeled for storage at “controlled room temperature” or at “up to 25”, or other wording based on the same mean kinetic temperature (see Packaging and Storage Requirements 659).

When an opaque covering is used to provide protection from light for a light-sensitive product packaged in a clear or colorless or translucent container, the label of the container will bear a statement that the opaque covering is needed until the contents are to be used or administered (see Containers—Performance Testing 671, Light Transmission Test and Packaging and Storage Requirements 659).

Each single-unit container shall be labeled to indicate the identity, quantity and/or strength, name of the manufacturer, lot number, and expiration date of the article (see Packaging and Storage Requirements 659).

A single-dose container shall be labeled as such, and when space permits, should include on the label appropriate discard instructions (see Packaging and Storage Requirements 659).

A unit-of-use container shall be labeled as such, without further modification except for the addition of appropriate labeling (see Packaging and Storage Requirements 659).

The container label shall bear an appropriate instruction to protect the article from freezing if subject to loss of strength or potency, or to destructive alteration of its characteristics (see Packaging and Storage Requirements 659).

At a minimum, a prescription container shall be labeled in a patient-centered manner. The label shall contain essential information that is important for the patient's safe and effective use of the medicine. Labels should be designed and formatted to optimize readability and understanding (see Prescription Container Labeling 17).