Draft guidance on veterinary drug labelling: Labelling unique types of packages

On this page

• Drugs in pressurized containers and flammability
• Drugs in small containers
• Co-packaged products
  • Co-packaging scenarios

This section outlines the requirements for labelling special packages, including labelling drugs in pressurized containers and flammability, drugs in small containers and drugs in co-packaging.

Drugs in pressurized containers and flammability

Drugs packaged in a disposable metal container that have a manually operated valve are designed to release pressurized contents. These should show the cautionary statements, hazard symbols and signal words as outlined in the Regulations.

Drugs packaged in unpressurized containers operated by a manual pump spray device or any other containers that contain flammable ingredients should have the proper hazard symbol. There should also be a cautionary warning indicating the contents are flammable. Appropriate directions for use (for example, "do not use near an open flame") must be provided.

Drugs in small containers

The labelling requirements for drugs apply to most container sizes.

Some containers are too small to carry all the information required. The inner label requirements do not apply to the drug in that container as long as:

• the outer label complies with the labelling requirements of the Regulations and
• the inner label shows the following:
  • proper name of the drug or common name if there's no proper name or, for a drug with more than 1 medicinal ingredient, the brand name
  • potency, except where, in the case of a drug with more than 1 medicinal ingredient, the name used (refer to the first sub-bullet above) for that drug is unique for a particular potency of the drug
  • net content if the drug is not in a discrete dosage form
  • route of administration if other than oral
  • lot number
  • name of the manufacturer
  • expiration date
  • identification of special characteristics of the dosage form if they're not evident from the name of the drug
  • product's DIN

You may contact us to discuss potential approaches in case 1 of the following scenarios applies:

• drugs in containers that are still too small to accommodate the information noted above (for example, multiple- and single-dose packs)
• drugs in small containers where the packaging may be destroyed during use (for example, blister packs with label information stamped on the backing of the packaging)

Contact us at vdd.vetdrugs-medsvet.dmv@hc-sc.gc.ca.

Co-packaged products

The 2 main scenarios of co-packaging for veterinary drugs are outlined below. If you have questions about co-packaging, contact us at vdd.vetdrugs-medsvet.dmv@hc-sc.gc.ca.

Co-packaging scenarios

• separate containers of ingredients, which are co-packaged together and have 1 DIN, must be used together (for example, mixed together to form the final drug product)
• separate containers of distinct drug products, which are co-packaged together with each having its own DIN (for example, kits where products are sold/packaged together as a unit)

For these scenarios, the product labelling (including package insert) must comply with the Regulations. When separate containers of distinct drug products are packaged together, each product must meet the labelling requirements and have approved labelling. This means:

• no new claims/recommendations for use
• no reference to concurrent use
• no new brand name added to any labelling or advertising
• no safety concerns related to concurrent use

If claims for the co-packaged products exceed the authorized claims for the components or new claims are made on their concomitant administration, you must file another drug submission.