RG-1 Regulatory Guidance:
Chapter 4 - Labelling and guarantees
4.16 Toll manufacturing extra label drug use veterinary prescription feeds
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Summary of memorandum
This document provides clarification on the acceptability of toll manufacturing extra label drug use veterinary prescription (vet Rx) feeds and further describes the documentary evidence that would be required to manufacture veterinary prescription feeds that meet federal regulatory requirements.
Feed means any substance or mixture of substances containing amino acids, anti-oxidants, carbohydrates, condiments, enzymes, fats, minerals, non-protein nitrogen products, proteins or vitamins, or pelletizing, colouring, foaming or flavouring agents and any other substance manufactured, sold or represented for use
- for consumption by livestock,
- for providing the nutritional requirements of livestock, or
- for the purpose of preventing or correcting nutritional disorders of livestock, or any substance for use in any such substance or mixture of substances; (aliments)
- Toll manufacturing
- An agreement where one facility subcontracts out the manufacture or processing of a feed to another facility, which has specialized equipment or processes that are better suited to manufacture the feed in question.
- Veterinary prescription
- Veterinary prescription means an order prescribing a medicated feed made in writing by a veterinarian licensed to practise in the province in which the feed is to be fed to livestock; (ordonnance)
- Extra Label Drug Use Veterinary prescription feed
- Extra Label Drug Use Veterinary prescription feed is a feed manufactured pursuant to a veterinary prescription which instructs the manufacture of a feed with a medication for a purpose or at a level not indicated in the Compendium of Medicating Ingredients Brochures (CMIB)
The Canadian Food Inspection Agency (CFIA) has received an inquiry from the feed manufacturing industry requesting clarification on whether it is possible by regulation to have an extra label drug use veterinary prescription feed be manufactured and medicated at more than one facility. It is proposed that the premix used to formulate the off label medicated feed be manufactured to include the medication at one facility, while the medicated premix would then be purchased and used by a 2nd commercial feed mill to manufacture the complete feed as directed in the veterinary prescription. This proposal can also include a facility having a second facility complete a specialized processing step (such as pelleting, vacuum coating, etc.), prior to reaching the end user.
Toll manufacturing is an acceptable manufacturing relationship between two feed mills. There is no restriction on the type of feed (premix, supplement or complete feed) that may be toll manufactured. The feeds may also be medicated as long as they are manufactured in accordance with the CMIB or a veterinary prescription.
However, there is a gap in policy related to the manufacture of off-label vet Rx feeds by two different facilities. More specifically in situations where one facility manufactures a medicated component (i.e., premix) to be used as an ingredient in the final feed, it is unclear what prescription and labelling standards must be met at time of sale by this toll manufacturer for the medicated premix.
As per section 5(1) of the Feeds Regulations, all feeds must be registered, except for those feeds described in section 5(2) of the Feeds Regulations. Section 5(2)(g) of the Feeds Regulations identifies the information that is required to be on a veterinary prescription and Section 26 of the same regulations stipulates the information required to be on the label attached to the feed. The following are examples of information for the components of the feed that may not be accurately reflected when manufactured at a toll manufacturer.
On the Veterinary prescription:
- The type (premix, supplement or complete feed) and amount of feed to be manufactured
- Feeding/use instructions
- the name and level of inclusion in the feed of the medicating ingredient prescribed by the veterinarian
On the label attached to the product:
- The name of the feed
- The directions for use as indicated on the veterinary prescription
- Cautions and warnings as indicated on the veterinary prescription
How the requirements of sections 5(2)(g) and 26 are to apply to a toll manufacturer, who is only producing a component of the final extra label drug use veterinary prescription feed, has been unclear. The guidance provided in this policy will clarify the veterinary prescription and labelling requirements when an extra label drug use medicated feed is manufactured by two different facilities in a toll-manufacturing scenario.
The manufacture of an extra label drug use veterinary prescription feed by two or more different feed manufacturers is permissible. Indeed, adding a medication to a premix which is then blended into the final complete feed is considered to be a good manufacturing practice. Additionally, subcontracting the manufacture of a component of the medicated complete feed to another facility which has the specialized equipment and expertise to manufacture or process that component in a medicated formulation is also supported. As with all feed manufacturing, it is the responsibility of the feed manufacturers to be able to trace all components of the feed in the event of a recall.
An inspector must be able to determine whether a toll manufactured extra label drug use prescription feed has been manufactured in compliance with the applicable regulations. As per sub-paragraph 5(2)(g(iii))(v) and sub-section 15(4) of the Feeds Regulations, the manufacturer is required to have the signed veterinary prescription in hand during the manufacturing process in its entirety (i.e., before manufacturing starts). To achieve this, it is necessary for each separate manufacturer to have copies of the veterinary prescription under which the premix and the feed which contains the premix have been manufactured. However, it is not necessary to have multiple veterinary prescriptions issued for separate components of the final feed in a toll manufacturing relationship; only one veterinary prescription is required for the final feed.
For the facility that is toll manufacturing or receiving the premix it is necessary to have documentation available which provides the following information:
- The name of the medicated premix/supplement
- The level of medication in the premix/supplement
- The name of the facility for whom the extra label drug use medicated premix/supplement/complete feed is toll manufactured and sold to.
The toll manufacturer is also required to have in their possession a copy of the veterinary prescription under which the feed was manufactured. Furthermore, a label must be attached to the medicated premix/supplement that provides all the necessary labelling information for a veterinary prescription feed, including:
- the actual amount of medicating ingredient in the premix/supplement
- directions in sufficient detail to permit the safe use of the medicated premix/supplement by the secondary manufacturer that ultimately results in the level of medication indicated on the veterinary prescription
- name and address of the toll manufacturer
- name of the producer to whom the prescription was issued and
- name and address of the feed mill which caused the feed to be toll manufactured
Since the premix component of the toll manufactured feed is intended to be mixed further, the label attached by the premix manufacturer does not need to agree with the type and amount of feed indicated on the prescription.
- This policy does not supersede RG 1: Chapter 3.12 Micro Premixes.
- If non-compliance is identified, corrective actions may have to be conducted at one or all facilities involved in the toll manufacture of the veterinary prescription feed.
- If in doubt, questions and requests for clarification should be directed through the established communication pathways.
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