Guidance on veterinary drug labelling: Annexes

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Annex A: Regulatory labelling requirements checklist

This checklist covers the requirements that apply to most of the veterinary drug labels. For labelling information for package insert, refer to the package insert section. For more details on particular product types, refer to Annex C.

Label elements (as applicable) Principal display panel Any panel Inner label Outer label

Proper or common name (brand name is not required)

Y

N/A

Y

Y

Standards of manufacture (quality standards)

Y

N/A

Y

Y

"Sterile"

Y

N/A

Y

Y

Scheduling symbols

Y

N/A

Y

Y

Drug identification number (DIN)

Y

N/A

Y

Y

"Veterinary Use Only"

Y

N/A

Y

Y

Therapeutic classification

R

N/A

R

R

Warnings (refer to the warnings section for PDP)

Y

N/A

Y

Y

Name and address of manufacturer (Canadian importer if foreign manufacturer)

N/A

Y

Y

Y

For questions or to report an adverse event: contact information

N/A

R

R

R

Lot number

N/A

Y

Y

Y

Adequate directions for use

  • indications for use
  • intended species
  • directions for use (dosage, duration, route of administration and instructions, as applicable)
  • safety information (contraindications, cautions and warnings, as applicable)
  • storage conditions

N/A

Y

Y

Y

Quantitative list of medicinal (active) ingredients

N/A

Y

Y

Y

List of non-medicinal (inactive) ingredients

Preservatives for parenteral drugs

N/A

Y

R

Y

Other non-medicinal ingredients

N/A

N/A

N/A

N/A

Expiration date

N/A

Y

Y

Y

Net amount

N/A

Y

R

Y

Annex B: Sample veterinary drug label (outer label)

Side (any) panel Principal display panel Side (any) panel

Indications

For use in the treatment of <insert disease> in <insert species>

Medicinal ingredients

<complete proper/common name> XX g per YY

Directions for use

Administer X tablet(s) orally every Y hours for Z days. See package insert for complete directions for use.

Cautions

The safety of this drug in <insert species> less than <X> months of age has not been established.

Storage

Store between X-Y°C. Protect from light and from freezing.

Manufactured by

Animal Drug GmbH. Germany
321 Strasse Way, Berlin
12345 Germany

Imported by

Animal Drug Co.
123 Veterinary Way
Animalville ON A1B 2C3

For questions or to report an adverse event, call 1-800-XXX-XXXX or email at report@animaldrugco.ca.

Lot A1B2C3

Exp. 2022SE

DIN XXXXXXXX

Pr Brand Name/Nom commercial

Proper/common name
Nom propre/nom usuel

Veterinary use only/Usage vétérinaire seulement

Antimicrobial/Antimicrobien
Net XX g

Warnings

Treated animals must not be slaughtered for use in food for at least XX days after the latest treatment with this drug.

Keep out of reach of children.

See package insert for complete warnings.

Mises en garde

Les animaux traités ne doivent pas être abattus à des fins alimentaires avant XX jours après le dernier traitement avec ce médicament.

Garder hors de la portée des enfants.

Voir la notice d'accompagnement pour les Mises en Garde complète.

Indications

À utiliser pour le traitement de <insérer la maladie> chez <insérer l'espèce>

Ingrédients médicinaux

<nom propre / usuel complet> XX g par YY

Mode d'emploi

Administrer X comprimé(s) par voie orale toutes les Y heures pendant Z jours. Voir la notice pour le mode d'emploi complet.

Précautions

L'innocuité de ce médicament n'a pas été établie chez <insérer l'espèce> âgés de moins de <X> mois.

Entreposage

Entreposer entre X-Y°C. Protéger de la lumière et du gel.

Fabriqué par

Animal Drug GmbH. Germany
321 Strasse Way, Berlin
12345 Germany

Importé par

Animal Drug Co.
123 Veterinary Way
Animalville (Ontario) A1B 2C3 Canada

Pour des questions ou pour signaler un effet secondaire, appelez le 1-800-XXX-XXXX ou envoyez un courriel à report@animaldrugco.ca.

Lot A1B2C3

Exp. 2022SE

Annex C: Requirements for particular product types

Non-parenteral products requiring dilution

For non-parenteral products that must be diluted before use (for example, powders for reconstitution), the labelling should include the following:

If percentages are used, they should be specified as % w/w, w/v or v/v.

If the diluent for reconstitution is included with the drug, it's considered a medicinal ingredient and should be declared quantitatively on the label. If the diluent is sterile water, it should be declared as "sterile water".

Single-ingredient preparations

When a drug product contains a single medicinal ingredient, you may include a declaration of the quantity of medicinal ingredient immediately following or preceding the proper or common name. However, the amount must refer to the medicinal ingredient in the form mentioned in the name.

For example:

The declaration of the medicinal ingredient in terms of the active moiety is also allowed, provided that both are identified. For example, if the proper name is Pyrantel Pamoate Oral Suspension and the strength is expressed in terms of mg per mL of pyrantel, an acceptable quantitative declaration of the medicinal ingredient would be "Pyrantel 50 mg/mL as Pyrantel Pamoate".

Parenteral preparations

Along with the general requirements for labelling, there is specific information that applies to parenteral drug products. If there's no proper name for a single-ingredient parenteral preparation, write the common name as follows:

Refer to the subsection on the proper or common name of the product for how to express substance X.

Sterile products for injection should include the statement "single-dose vial" or "multi-dose vial" on the label.

Single-dose containers are container closure systems that hold a sterile medication for parenteral administration (injection or infusion) and do not need to meet antimicrobial effectiveness testing requirements. They are to be used for a single patient as a single injection/infusion. Examples of single-dose containers are vials, ampules and prefilled syringes. Labels should include appropriate discard statements. (Refer to USP <659> packaging and storage requirements.)

Multi-dose containers are container closure systems that hold a sterile medication for parenteral administration (injection or infusion) and include an antimicrobial agent or a combination of antimicrobial agents. They either have met the antimicrobial effectiveness testing requirements or are excluded from such testing requirements. They contain more than 1 dose of a drug product. An example of a multi-dose container is a vial.

Unless multi-dosing equipment is used (for example, automatic dosing device, multi-dose syringe, draw-off spike/needle), the maximum number of punctures should be stated along with appropriate administration instructions under the "directions for use" section of the label for new veterinary drugs. The beyond-use date for an opened or entered (for example, needle-punctured) multi-dose container is typically 28 days unless otherwise specified on the label. (Refer to USP <659> packaging and storage requirements.)

Products for injection requiring dilution

The inner and outer labels of concentrated liquid drugs or powdered or special products meant for dilution or that must be reconstituted before injection should include a statement. This statement should state "Concentrate - must be diluted before use” or “Reconstitute before use", as appropriate. For small inner labels of these products, where space is limited, you may use an abbreviated statement such as "dilute before use".

Declaring medicinal ingredients

For liquid preparations

For preparations intended for reconstitution

The potency of medicinal ingredients may be declared in terms of the total compound or the active moiety, provided the whole compound is identified by name. The dosage recommendations should follow the chosen method of potency declaration. For a drug product available in different potencies, the method of declaration should be identical for all potencies.

Electrolyte preparations

For parenteral and oral products, the labelling should indicate the quantity of each electrolyte as mEq or mmol per 100 mL or per 1 L of solution.

The labelling of products for oral administration that contain salts (such as potassium gluconate) or a combination of salts should also indicate:

Drug premixes

Declare the quantity of medicinal ingredients as grams per kilogram of medicated premix. You may also use percentages.

The quantitative declaration format used must reflect the guaranteed level in the product formulation. Use the heading 'Active Ingredient(s)' instead of 'Guaranteed Analysis', which is normally reserved for feed products.

Products containing vitamins

The inner and outer labels must indicate the amount of each vitamin, with the vitamin's proper name used, as follows:

Combination immediate release/modified-release ingredients

A combination drug product may contain an immediate release medicinal ingredient along with an extended release ingredient in the same pharmaceutical form (for example, tablet). In these instances, label the dosage form clearly to reflect the combination.

Transdermal patches

The inner and outer labels (pouch and carton, for example) of transdermal patches should declare the total quantity of the medicinal ingredients per patch, the mean dose delivered per unit of time (for example, X mg/day, X mg/hour) and the duration of patch use (Y hours, Y days).

Label the patch with the following minimum information:

Implants

For labelling implants, include the total quantitative declaration of the medicinal ingredients per implant, the duration of use (Y days) and the mean dose delivered per unit of time (X mg/day), as applicable.

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