Interim Revision Announcement
Official: September 1, 2023
7 LABELING
INTRODUCTION
This general chapter provides definitions and standards for labeling of official articles. Labeling standards
for an article recognized in USP–NF are expressed in the article’s monograph and applicable general
chapters. It is intended that all articles in USP or NF will be subject to the labeling requirements specified in
this chapter by means of a provision in
General Notices, 10 Preservation, Packaging, Storage, and Labeling,
unless different requirements are provided in a specific monograph. As with compendial standards for
naming, identity, strength, quality, and purity, compendial requirements for labeling have a role in the
adulteration and misbranding provisions of federal law [see the Federal Food, Drug, and Cosmetic Act
(FDCA) sections 501(b), 502(e)(3)(b), 502(g), and 502(h)]. Exceptions or additional requirements specific
to animal drug products and compounded preparations are provided in separate sections. Vaccine labeling is
not included in this general chapter.
DEFINITIONS
The term “labeling” includes all labels and other written, printed, or graphic matter on an article’s
immediate container or on, or in, any package or wrapper in which it is enclosed, except any outer shipping
container. The term “label” is that part of the labeling on the immediate container.
A shipping container that contains a single article, unless the container also is essentially the immediate
container or the outside of the consumer package, must be labeled with a minimum of product identification
(except for controlled substances), lot number, expiration date, and conditions for storage and distribution.
Beyond-use dates (BUDs) and expiration dates are not the same. An expiration date identifies the time
during which a conventionally manufactured product, active ingredient, or excipient can be expected to meet
the requirements of a compendial monograph, if one exists, provided it is kept under the prescribed storage
conditions. The expiration date limits the time during which the conventionally manufactured product, active
pharmaceutical ingredient (API), or excipient may be dispensed or used. Expiration dates are assigned by
manufacturers of conventionally manufactured products based on analytical and performance testing of the
sterility, chemical and physical stability, and packaging integrity of the product. Expiration dates are specific
for a particular formulation in its container and at stated exposure conditions of illumination and
temperature.
The beyond-use date (BUD) is the date or time beyond which a compounded preparation must be
discarded. The date or time is determined from the date the preparation was compounded.
LABELS AND LABELING FOR DRUG PRODUCTS AND COMPOUNDED PREPARATIONS EXPRESSED AS ACTIVE MOIETY IN
NAME AND STRENGTH
The names and strengths of drug products and compounded preparations formulated with a salt of an acid
or base are to be expressed in terms of the active moiety on the label (see
Nomenclature 〈1121〉,
Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations).
Labeling
The labeling clearly states the specific salt form of the active moiety that is present in the product or
preparation because this information may be useful to practitioners and patients. The names and strengths
of both the active moiety and specific salt form (when applicable) are provided in the labeling.
Exceptions
In rare cases in which the use of the specific salt form of the active moiety in the title provides vital
information from a clinical perspective, an exception to this policy may be considered. In such cases, when
C226732-M4908-NL2015, rev. 00 20200731
the monograph title contains the specific salt form of the active moiety, the strength of the product or
preparation is also expressed in terms of the specific salt form.
LABELS AND LABELING FOR INJECTABLE PRODUCTS
The labels
1
and the labeling state the following information:
Name of the product
In the case of a liquid, the quantity or proportion of each active moiety or drug substance in a
specified volume
In the case of any product to which a diluent must be added before use, the quantity or
proportion of each active moiety or drug substance, name and volume of diluent to be added,
the concentration after the diluent is added, directions for proper storage of the constituted
solution, and a BUD (see Expiration Date and Beyond-Use Date)
Route(s) of administration
Name and quantity or proportion of all inactive ingredients except ingredients added to adjust the pH
or to make the drug isotonic may be declared by name with a statement of their effect; if the vehicle
is
Water for Injection it need not be named
Statement of storage conditions
Name and place of business of the manufacturer, packer, or distributor
Identifying lot number and expiration date
“Rx only” for human drugs
The recommended or usual dosage.
The container must be labeled so that a sufficient area of the container remains uncovered for its full
length or circumference to permit inspection of the contents.
The lot number must be traceable to the complete manufacturing history of the specific package, including
all manufacturing, filling, sterilizing, and labeling operations.
If the individual monograph permits varying concentrations of active moiety or drug substance in a large-
volume injection (LVI), the concentration of each active moiety or drug substance named in the official title
is stated as if it were part of the official title (e.g., 5% Dextrose Injection, or Dextrose Injection 5%, or 5%
Dextrose and 0.2% Sodium Chloride Injection or Dextrose (5%) and Sodium Chloride (0.2%) Injection).
Quantity and Total Volume for Injectable Drug Products Packaged in Single- and Multiple-Dose Containers
For injectable drug products greater than 1 mL, whether packaged in single- or multiple-dose containers,
the quantity per total volume should be the primary and prominent expression on the principal display panel
of the label, followed in close proximity by quantity per milliliter enclosed by parentheses (quantity/mL).
For containers that hold a volume of less than 1 mL, the quantity per fraction of a milliliter should be the
only expression of strength. For containers that hold a volume equal to 1 mL, the strength should be
expressed as quantity per milliliter (quantity/mL), not quantity/1 mL.
The following example formats are acceptable:
1. For containers less than 1 mL: 12.5 mg/0.625 mL
2. For containers equal to 1 mL: 5 mg/mL (not 5 mg/1 mL)
3. For containers greater than 1 mL:
Example 1: 500 mg/10 mL
(50 mg/mL)
Example 2: 25,000 Units/5 mL
(5,000 Units/mL)
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In certain cases, the primary and prominent expression of the total drug content per container is not
effective in preventing medication errors and therefore in those cases, the total drug content per container
should not be the primary and prominent expression of strength. Insulin products are an example of a
product class that is an exception from the total drug content per container requirement. Another exception
to expressing strength as quantity per total volume is lidocaine (or similar drugs for local anesthesia) where
the product may be ordered and administered by percentage (e.g., 1% or 2%). In such cases, the
percentage strength as well as the quantity per total volume followed in close proximity by quantity per
milliliter enclosed by parentheses must be used.
Example 1: 1%
(100 mg/10 mL)
(10 mg/mL)
Example 2: 2%
(1000 mg/50 mL)
(20 mg/mL)
Dry solids that must be constituted should follow the same format with the exception that only the
quantity of the drug in the container should be listed as the primary expression of strength, not the quantity
per total volume or quantity per milliliter (quantity/mL).
Example: 500 mg/vial
Ratio Expression of Strength
Single-entity injectable drug products must be labeled in terms of quantity per milliliter (quantity/mL) and
not as a ratio expression.
Examples:
Epinephrine Injection, 1:1000 must be expressed as 1 mg/mL.
Epinephrine Injection, 1:10,000 must be expressed as 0.1 mg/mL.
Isoproterenol Hydrochloride Injection, 1:5000 must be expressed as 0.2 mg/mL.
Neostigmine Methylsulfate Injection, 1:1000 must be expressed as 1 mg/mL.
Single-entity injectable drug products greater than 1 mL should be formatted as quantity per total volume
on the principal display panel of the label followed in close proximity by quantity per milliliter (quantity/mL)
enclosed by parentheses.
When combined with a local anesthetic, the concentration of epinephrine will be expressed as a ratio.
Examples:
Lidocaine Hydrochloride and Epinephrine Injection 1%/1:100,000
or
Lidocaine Hydrochloride 1%
and
Epinephrine Injection 1:100,000
Pharmacy Bulk Package
Where a container is offered as a Pharmacy Bulk Package, the label must: 1) state prominently “Pharmacy
Bulk Package—Not for Direct Infusion”; 2) contain or refer to information on proper techniques to help
assure safe use of the product; and 3) 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〉).
Imaging Bulk Package
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Where a container is offered as an Imaging Bulk Package, the label must: 1) state prominently “Imaging
Bulk Package” and, in juxtaposition with this statement, include the following use statement: “For use only
with an automated contrast injection system, contrast management system, or contrast media transfer set
approved or cleared for use with this contrast agent in this Imaging Bulk Package”; 2) bear a statement
limiting the time frame in which the container may be used once it has been entered, provided it is held
under the labeled storage conditions; 3) bear the statement “See drug and device labeling for information
on devices indicated for use with this Imaging Bulk Package and techniques to help assure safe use.” (See
〈659〉.)
Ferrules and Cap Overseals
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:
1. Only cautionary statements may appear on the top (circle) surface of the ferrule and cap overseal of a
vial containing an injectable product. The cautionary statement should appear on both the ferrule and
cap, but may appear solely on the ferrule if the cap overseal is transparent and the cautionary
statement beneath the cap is readily legible. A cautionary statement is one intended to prevent an
imminent life-threatening situation and may include instructional statements that provide potency or
other safety-related instructions if warranted. Examples of such statements include, but are not limited
to: “Warning—Paralyzing Agent” and “Dilute before Using”. The cautionary statement should be printed
in a contrasting color and should be clearly visible under ordinary conditions of use.
2. If no cautionary statement is necessary, the top surface of the vial, including the ferrule and cap
overseal, must remain blank.
3. Other statements or features including, but not limited to, identifying numbers or letters, such as code
numbers, lot numbers, company names, logos, or product names, etc., may appear on the side (skirt)
surface of the ferrule on vials containing injectable products, but not on the top (circle) surface of the
ferrule or cap overseal. The appearance of such statements or features on the skirt surface of the
ferrule should not detract from, or interfere with, the cautionary statement on the top surface.
Potassium Chloride for Injection Concentrate
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 ampule is
prohibited, except for Potassium Chloride for Injection Concentrate (see
〈659〉).
Neuromuscular Blocking and Paralyzing Agents
All injectable 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.
Aluminum in Large-Volume Injections (LVIs), Small-Volume Injections (SVIs), and Pharmacy Bulk Packages (PBPs)
Used in Parenteral Nutrition (PN) Therapy
2
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1. The aluminum content of LVIs used in PN therapy must not exceed 25 mcg/L.
2. The package insert of LVIs used in PN therapy must state that the drug product contains no more than
25 mcg of aluminum per liter. This information must be contained in the Precautions section of the
labeling of all LVIs used in PN therapy.
3. If the maximum amount of aluminum in SVIs and PBPs is 25 mcg/L or less, instead of stating the
exact amount of aluminum that each contains, as in paragraph (4), the immediate container label for
SVIs and PBPs used in the preparation of PN admixtures or formulations (with exceptions as noted
below) may state: “Contains no more than 25 mcg/L of aluminum.” If the SVI or PBP is a lyophilized
powder, the immediate container label may state the following: “When reconstituted in accordance
with the package insert instructions, the concentration of aluminum will be no more than 25 mcg/L.”
4. The maximum level of aluminum at expiry must be stated on the immediate container label of all SVIs
and PBPs used in the preparation of PN admixtures or formulations. The aluminum content must be
stated as follows: “Contains no more than ___ mcg/L of aluminum.” The immediate container label of
all SVIs and PBPs that are lyophilized powders used in the preparation of PN solutions must contain
the following statement: “When reconstituted in accordance with the package insert instructions, the
concentration of aluminum will be no more than ___ mcg/L.” This maximum amount of aluminum
must be stated as the highest one of the following three levels:
The highest level for the batches produced during the past 3 years
The highest level for the latest 5 batches
The maximum level in terms of historical levels, but only until completion of production of the
first 5 batches.
The package insert for all LVIs, SVIs, and PBPs used in the preparation of PN admixtures or formulations
must contain the following statement in the Warnings section of the labeling:
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, which 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 mcg/kg/day, accumulate aluminum at levels associated
with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of
administration.
Change to read:
LABELS AND LABELING FOR PRODUCTS IN OTHER CATEGORIES
Labels and Labeling of Liquids and Constituted Products
The labels
1
and labeling state the following information:
1. In the case of a liquid product, the percentage content of each active moiety or drug substance or the
amount of each active moiety or drug substance in a specified volume.
2. In the case of a product to which a diluent must be added before use, the amount of each active
moiety or drug substance, the name and volume of diluent to be added, the final volume of solution,
the concentration after the diluent is added (e.g., quantity/mL or quantity/5 mL), directions for proper
storage of the constituted solution, and an expiration or BUD (see Expiration Date and Beyond-Use
Date).
Amount of Active Moiety or Drug Substance per Dosage Unit
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
C226732-M4908-NL2015, rev. 00 20200731
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 must be labeled to express the quantity of each
active moiety or drug substance contained in each unit. Unit-dose oral solutions or suspensions (whether
supplied as liquid products or as liquid products that are constituted from solids upon addition of a
designated volume of a specific diluent) must be labeled to express the quantity of each active moiety or
drug substance delivered under the conditions prescribed in
Deliverable Volume 〈698〉. Official drug products
not in unit-dose packaging must be labeled to show the quantity of each active moiety or drug substance in
each milliliter or in each gram, or to express the percentage of each such ingredient (see
General Notices,
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 required by regulation [e.g., over-the-counter (OTC) regulation 21 CFR §201.62(b)] or
indicated in a monograph or chapter, declarations of strength or quantity must be stated only in metric units
[see also
General Notices, 5.50.10 Units of Potency (Biological)].
Expiration Date and Beyond-Use Date
▲
▲ (IRA 1-S-2023)
The label of an official drug product
▲
must
▲ (IRA 1-Sep-2023)
bear an expiration date. All products
▲
must
▲
(IRA 1-Sep-2023)
display the expiration date so that it can be read by an ordinary individual under customary
conditions of purchase and use. The expiration date
▲
must
▲ (IRA 1-Sep-2023)
be prominently displayed in high
contrast to the background
▲
and it must
▲ (IRA 1-Sep-2023)
be
▲
printed or
▲ (IRA 1-Sep-2023)
sharply embossed
▲
or debossed,
▲ (IRA 1-Sep-2023)
and
▲
be clear to the user. The term “expiration date” may be abbreviated on
the drug package label in a manner that allows the reader to understand the abbreviation to mean
“expiration date” (e.g., EXP, Exp Date). The year must always be in a 4-digit format.
When all-numeric dates are used, they must be formatted using the year, the month, and, if applicable,
the day, separated by hyphens or forward slashes in one of the following formats:
YYYY-MM-DD (e.g., 2019-06-30, 2019/06/30)
YYYY-MM (e.g., 2019-06, 2019/06)
When alphanumeric dates are used, months must be displayed using at least three letters in one of the
following formats:
YYYY-MMM-DD (e.g., 2019-JUN-30, 2019/JUN/30)
YYYY-MMM (e.g., 2019-JUN, 2019/JUN)
If an expiration date is stated only in terms of the year and the month, then the intended expiration date
is the last day of the stated month.
For containers that have insufficient space on the primary container to accommodate the full expiration
date format described previously (e.g., topical ophthalmic ointment container crimps, blow-fill-seal
ampules), use the all-numeric format YYYY-MM or the alphanumeric format YYYYMMM (without a hyphen or
forward slash to accommodate space constraints). If there is a lack of space in close proximity to the
expiration date, the term designated to represent “expiration date” (e.g., EXP) may be omitted if the
specific alphanumeric format, YYYYMMM, is used. However, all other packaging, including but not limited to
a carton, tray, or overwrap, must have the full expiration date format as described previously.
▲ (IRA 1-Sep-
2023)
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The monographs for some
▲
drug products
▲ (IRA 1-Sep-2023)
state how the labeled expiration date
▲
must
▲
(IRA 1-Sep-2023)
be determined. In the absence of a specific requirement in the individual monograph for a
drug product,
▲
▲ (IRA 1-Sep-2023)
the label
▲
must
▲ (IRA 1-Sep-2023)
bear an expiration date assigned for the
particular formulation and package of the product.
▲
The
▲ (IRA 1-Sep-2023)
label need not show an expiration
date
▲
for the following exception: if the product is a human OTC drug product for which the labeling states
no dosage limitations, it is packaged in a container that is intended for sale without prescription, and if the
product is stable for not less than (NLT) 3 years when stored under the prescribed conditions. Refer to 21
CFR 211.137(h).
▲ (IRA 1-Sep-2023)
If an official
▲
drug
▲ (IRA 1-Sep-2023)
product is required to bear an expiration date, the product
▲
must
▲
(IRA 1-Sep-2023)
be dispensed solely in or from a container labeled with an expiration date, and the date on
which the article is dispensed
▲
and intended to be used must
▲ (IRA 1-Sep-2023)
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
▲
labeled
▲ (IRA 1-Sep-2023)
storage
conditions. The expiration date limits the time during which the article may be dispensed
▲
and
▲ (IRA 1-Sep-
2023)
used.
▲
The label of a dietary supplement product recognized in USP and that claims conformance with USP
must bear an expiration date for the specific dosage form formulation and package of the product, unless
otherwise specified in the individual monograph. See General Notices, 3.10.20 Applicability of Standards to
Medical Devices, Dietary Supplements, and Their Components and Ingredients for applicability of USP
dietary supplement standards.
-
▲ (IRA 1-S-2023)
The beyond-use date (BUD) is the date after which a product
▲
or preparation must
▲ (IRA 1-Sep-2023)
not be
used. The dispenser
▲
must
▲ (IRA 1-Sep-2023)
place on the label of the prescription container a suitable BUD
to limit the patient's use of the article based on any information supplied by the manufacturer or this
subsection. The BUD
▲
must
▲ (IRA 1-Sep-2023)
not be later than the expiration date on the manufacturer's
container. Also see the Labels and Labeling for Compounded Preparations section.
For articles that require constitution before use, a suitable BUD for the constituted product
▲
must
▲ (IRA 1-
Sep-2023)
be identified in the labeling.
For all other dosage forms, in determining a BUD the dispenser
▲
must
▲ (IRA 1-Sep-2023)
take into account,
in addition to any other relevant factors:
Nature of the drug
Container in which it was packaged by the manufacturer and the expiration date thereon
Characteristics of the patient's container, if the article is repackaged for dispensing
Expected storage conditions to which the article may be exposed
Unusual storage conditions to which the article may be exposed
Expected length of the course of therapy.
After considering these factors, the dispenser
▲
must
▲ (IRA 1-Sep-2023)
label a container with a suitable BUD
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 BUD
▲
must
▲ (IRA 1-Sep-2023)
be
▲
no
▲ (IRA 1-Sep-2023)
later than
C226732-M4908-NL2015, rev. 00 20200731
(a) the expiration date on the manufacturer's container; or (b) 1 year from the date the drug is
▲
packaged
and/or labeled by the dispenser,
▲ (IRA 1-Sep-2023)
whichever is earlier, unless stability data or the
manufacturer's labeling indicates otherwise.
Labels and Labeling for Compounded Preparations
The labels and labeling state the following information:
In the case of a compounded preparation, list the name(s) and amount(s) or concentrations of active
moiety(ies) or drug substance(s) on the immediate container (see
Pharmaceutical Compounding—Sterile
Preparations 〈797〉 and Pharmaceutical Compounding—Nonsterile Preparations 〈795〉.)
In the case of a compounded preparation prepared in 503A facilities as defined by FDCA §503A, the
labeling should indicate that “this is a compounded preparation.”
The label on the container or package of a compounded preparation must bear a BUD. The BUD is
determined from the date the preparation is compounded. Because compounded preparations are intended
for administration immediately or following short-term storage, their BUDs may be assigned based on
criteria different from those applied to assigning expiration dates to manufactured drug products.
The monograph for an official compounded preparation typically includes a BUD that states the time period
following the date of compounding during which the preparation, properly stored, may be used. For guidance
regarding the BUD for compounded sterile and nonsterile preparations, see
〈797〉 and 〈795〉, respectively.
The label on the official compounded preparation must include the word “compounded” after the drug
portion of a non-proprietary name (e.g., "Baclofen Compounded Oral Suspension").
Dialysis, Hemofiltration, and Irrigation
Solutions that are intended for use as dialysis, hemofiltration, or irrigation, and are packaged in a
container with a volume of more than 1 L, must be labeled to indicate that the contents are not to be
administered either intravenously or intra-arterially.
Use of Leading and Terminal Zeros
To help minimize the possibility of errors in drug dispensing and administration, when the quantity of
active moiety or drug substance is expressed in whole numbers it must 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 or drug
substance is expressed as a decimal number smaller than 1, it must be shown with a zero preceding the
decimal point (e.g., express as 0.2 mg, not .2 mg).
Units
Abbreviations for the terms “Units” or “International Units” must not be used for labeling or prescribing
purposes. Examples include “U”, “u”, and “IU”. Medication errors have occurred when these abbreviations
have been used. See
General Notices, 9.10 Use of Metric Units.
Alcohol
The alcohol content in a liquid formulation must be stated on the label as a percentage (v/v) of alcohol
(C H OH).
Botanicals
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.”
Electrolytes
The concentration of each electrolyte for replacement therapy (e.g., sodium, potassium, chloride) must be
stated on the label in milliequivalents per volume (mEq/volume). Phosphorus containing injections must be
expressed in milliMoles per volume (e.g., mM/volume). The label of the product must also indicate the
quantity of ingredient(s) in terms of weight or percentage concentration.
Non-Oral Products
2 5
C226732-M4908-NL2015, rev. 00 20200731
Non-oral product labels and labeling must state the names of added substances (as defined in General
Notices, 5.20 Added Substances) in compliance with 21 CFR §201.100(b)(5).
Salts of Drugs
It is an established principle that official articles must have only one official title (see
General Notices, 2.20
Official Articles and compendial nomenclature requirements in 〈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).
Special Capsules and Tablets
The label of any form of capsule or tablet intended for administration other than by swallowing intact must
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).
Products That Contain Vitamins
The vitamin content of a drug product must 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).
Controlled Room Temperature
Articles may be labeled for storage at “controlled room temperature” or at “20° to 25°”, or other
equivalent wording based on the same mean kinetic temperature. All three labeling options must ensure not
to exceed the mean kinetic temperature of 25° with excursions between 15° and 30° (see
〈659〉).
Light-Resistant Container
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 bears a statement that the opaque
covering is needed until the contents are to be used or administered (see
Containers—Performance Testing
〈671〉, Spectral Transmission and 〈659〉).
Single-Unit Container
Each single-unit container must be labeled to indicate the identity; quantity and/or strength; name of the
manufacturer, packer, or distributor; lot number; and expiration date of the article (see
〈659〉).
Single-Dose Container
When space permits a single-dose container must be labeled as such, and should include on the label
appropriate discard instructions (see
〈659〉).
Multiple-Dose Container
When space permits, a multiple-dose container must be labeled as such (see
〈659〉).
Unit-of-Use Container
A unit-of-use container must be labeled as such (see
〈659〉).
Protection from Freezing
The container label must 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
〈659〉).
Prescription Container Labeling
At a minimum, a prescription container must be labeled in a patient-centered manner. The label must
contain essential information that is important for the patient’s safe and effective use of the medicine. Labels
C226732-M4908-NL2015, rev. 00 20200731
should be designed and formatted to optimize readability and understanding (see
Prescription Container
Labeling 〈17〉).
GENERAL LABELING
Users are reminded to always refer to the
General Notices in assessing or applying any compendial
standards.
General Notices addresses a number of labeling-related aspects, including 3.20 Indicating
Conformance (when an article may be labeled USP, NF, or USP–NF, and requirements related to differences
in identity, naming, strength, quality, or purity);
General Notices, 5.20.20 Added Substances (Excipients and
Ingredients) in Official Products; 6.70 Reagents; and 8.240 Weights and Measures (e.g., microgram may be
represented as either µg or mcg. For labeling or prescribing purposes, only “mcg” is to be used).
LABELS AND LABELING FOR ANIMAL DRUG PRODUCTS
This section provides exceptions or additions to the previous requirements in this chapter. The following
requirements are specific to the labeling for animal drug products.
Definitions
The written printed or graphic matter on the outer shipping container for animal drugs is considered to be
part of “labeling”. Shipping labeling for animal drugs should contain, at minimum, product identification, lot
number, expiration date, and conditions for storage and handling.
Labeling for Animal Drug Products
The labeling for animal drugs should identify the animal species and, if applicable, specific subset(s) of the
animal species for which the drug is approved, conditionally approved, or indexed. In the case of a
compounded preparation for animals, the labeling should indicate that “This is a compounded preparation.”
The labeling for prescription animal drug products must include the following statement:
"Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian."
Labeling for Injectable Animal Drug Products
Labeling for injectable animal drug products includes the following information:
A statement limiting the time frame in which the container may be used once it has been entered
(e.g., needle-punctured), provided it is held under the labeled storage conditions.
Quantity and Total Volume for Single- and Multiple-Dose Injectable Animal Drug Products
Because of considerable variability in body weight within and among animal species, most injectable
animal drugs are approved to be dosed on a mg/kg body weight basis. Thus, strength on labeling for single-
and multiple-dose injectable animal drugs should be expressed on the basis of quantity per milliliter
(quantity/mL), usually mg/mL. An exception would be for single-dose injectable animal drugs that are dosed
regardless of the weight of the animal, in which case strength on labeling should be expressed as quantity
per total volume (e.g., 50 mg/5 mL). For single-dose containers holding less than 1 mL, strength on labeling
should be expressed as quantity per fraction of a mL (e.g., 12.5 mg/0.625 mL).
Dry solids that must be constituted should provide on labeling the total quantity followed by the quantity
per milliliter (quantity/mL) after constitution.
Compounded Veterinary Preparations
The label on the official compounded veterinary preparation must include the word “compounded” after
the drug portion of a non-proprietary name and the word “veterinary” at the end of the full official name
(e.g., Atenolol Compounded Oral Suspension, Veterinary).
1
If there are space limitations, see 21 CFR§ 201.10(i), 21 CFR§ 201.105(b), 21 CFR§ 610.60.
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2
See 21 CFR §201.323. USP uses the following terms: large-volume injections (LVIs), small-volume injections (SVIs), and parenteral nutrition (PN), rather than
terminology used in 21 CFR §201.323: large-volume parenterals, small-volume parenterals, and total parenteral nutrition.
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C226732-M4908-NL2015, rev. 00 20200731
