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Livestock Medicines Act

R.R.O. 1990, REGULATION 730

GENERAL

Consolidation Period:  From December 1, 2018 to the e-Laws currency date.

Last amendment: 465/18.

Legislative History: 636/91, 636/92, 291/97, 465/18.

This is the English version of a bilingual regulation.

1. In this Regulation,

“veterinary biologic” has the same meaning as in the Health of Animals Act (Canada). R.R.O. 1990, Reg. 730, s. 1; O. Reg. 465/18, s. 1.

2. (1) Subject to subsections (3) to (5), the following drugs that are manufactured for use in livestock are designated as livestock medicines for the purposes of the Act and this Regulation:

1. Preparations for the control of external and internal parasites and insect pests.

2. Oral preparations for the prevention or treatment of disease of the digestive system, including bloat, colic, indigestion, diarrhea, constipation and impaction.

3. Preparations for the treatment of surface wounds and lacerations, wire cuts and burns.

4. Preparations for the treatment of skin diseases, including topical hoof care products.

5. Vitamins for injection or oral administration, including injectable vitamin A, not to exceed 500,000 International Units per millilitre and injectable vitamin D, not to exceed 75,000 International Units per millilitre.

6. Preparations for the prevention or treatment of deficiencies, including hematinics for horses, containing,

i. minerals for oral administration,

ii. selenium for injection, or

iii. iron for injection.

7. Propylene glycol and preparations, including dextrose, calcium, phosphorus and magnesium preparations, for the treatment and prevention of acetonemia and hypocalcemia or otherwise intended as an aid in the supportive treatment of nutritional deficiencies.

8. Implants and feed additives for use as growth promotants.

9. Anti-cannibalism compounds for use in poultry.

10. Topical preparations for use as liniments, counterirritants and poultices for the treatment of joint pain and swollen ligaments, tendons or muscles.

11. Oral or topical preparations for use as antitussives, decongestants, bronchodilators and expectorants.

12. Acetylsalicylic acid boluses for use in horses and cattle.

13. Disinfectants, udder washes, teat dips and sanitizers.

14. Antimicrobials, including their salts and derivatives. O. Reg. 465/18, s. 2.

(2) Subject to subsection (4), a veterinary biologic is designated as a livestock medicine for the purposes of the Act and this Regulation, unless it is exempted under subsection (5), if the veterinary biologic was,

(a) imported into Canada pursuant to a permit issued under section 121 of the Health of Animals Regulation (Canada); or

(b) manufactured pursuant to a product licence issued under section 124 of the Health of Animals Regulation (Canada) and it is permitted to be sold under that Regulation. O. Reg. 465/18, s. 2.

(3) A drug set out in subsection (1) shall not be designated as a livestock medicine unless it has been assigned a drug identification number pursuant to subsection C.01.014.2 (1) of the Food and Drug Regulations (Canada). O. Reg. 465/18, s. 2.

(4) A drug that is prescribed by subsection 3 (2) of Ontario Regulation 264/16 (General) made under the Drug and Pharmacies Regulation Act as being in Schedule I for the purposes of the Drug and Pharmacies Regulation Act is not designated as a livestock medicine. O. Reg. 465/18, s. 2.

(5) The following veterinary biologics are not designated as livestock medicines:

1. Anthrax vaccine.

2. Brucella vaccine.

3. Rabies vaccine.

4. Modified-live virus and live virus vaccines for use in mammals, except the following veterinary biologics:

i. IBR-PI3 intranasal vaccine for cattle.

ii. Mink distemper vaccine.

iii. Mink enteritis vaccine. O. Reg. 465/18, s. 2.

3. (1) The following classes of licences are established:

1. Class 1.

2. Class 2.  R.R.O. 1990, Reg. 730, s. 3 (1); O. Reg. 291/97, s. 1 (1).

(2) A livestock medicine set out in section 2 is designated as a livestock medicine that may be sold by the holder of a Class 1 licence at the holder’s established place of business. O. Reg. 291/97, s. 1 (2); O. Reg. 465/18, s. 3.

(3) A Class 2 licence authorizes the holder of a Class 1 licence to sell at a temporary place of business the livestock medicines that the holder is authorized to sell at the holder’s established place of business.  O. Reg. 291/97, s. 1 (2).

(4) Revoked:  O. Reg. 291/97, s. 1 (2).

4. (1) The applicant for a Class 1 licence shall send to the Director an application accompanied by payment of the fee of $75.

(2) A Class 1 licence is valid up to and including July 31 after it is issued.  O. Reg. 291/97, s. 2.

5. (1) The holder of a Class 1 licence may obtain a Class 2 licence by sending to the Director an application accompanied by payment of the fee of $50.

(2) A Class 2 licence is valid only for the period shown on it.  O. Reg. 291/97, s. 2.

5.1 A licence is not transferable.  O. Reg. 291/97, s. 2.

6. (1) A licence is issued on the terms and conditions that the licensee,

(a) shall continue to have an established place of business for the storage and sale of livestock medicines;

(b) shall keep for sale or sell livestock medicines only at the established or temporary place of business described on the licence;

(c) shall not keep for sale or sell any livestock medicines after the expiration date indicated by the manufacturer on the label thereof;

(d) shall not repackage or relabel livestock medicines;

(e) shall not deliver a livestock medicine except for dairy sanitizers, teat dips and udder washes to a livestock owner without an order from that owner authorizing the delivery evidenced by an invoice prepared by the licensee in advance of delivery;

(f) shall keep refrigerated all livestock medicines that require refrigeration;

(g) shall store in the manner prescribed by this Regulation all livestock medicines that do not require refrigeration; and

(h) Revoked: O. Reg. 291/97, s. 3 (1).

(i) shall not sell a livestock medicine to any person other than an owner of livestock or for any purpose other than the treatment of livestock.  R.R.O. 1990, Reg. 730, s. 6 (1); O. Reg. 636/91, s. 2 (1, 2); O. Reg. 291/97, s. 3 (1).

(2) A Class 2 licence shall be issued only for a temporary place of business that is located on premises where livestock are assembled in connection with an agricultural exhibition, a horse show or the holding of horse races.  O. Reg. 291/97, s. 3 (2).

7. (1) A licensee who maintains, handles or stores livestock medicines shall keep them in a refrigerator, cabinet or other storage facility that is used solely for that purpose.

(2) A licensee shall ensure that livestock medicines, whether they require refrigeration or not, are maintained at the temperatures prescribed for them by the manufacturer and that they do not come in contact with food or medicine for human consumption.  O. Reg. 636/91, s. 3.

(3) The licensee shall maintain every refrigerator, cabinet or other storage facility in a clean and sanitary condition.  O. Reg. 291/97, s. 4.

8. (1) Every licensee shall,

(a) sell every livestock medicine in the container in which it is received by the licensee;

(b) in the case of any livestock medicine bearing a warning or caution on the label, draw the attention of the purchaser to the warning or caution; and

(c) immediately after the expiration date indicated by the manufacturer on the label of a livestock medicine, remove the livestock medicine from sale and keep it separate from other livestock medicines until it is disposed of in a manner approved by the Director.

(2) No licensee shall engage in any practice by which a livestock medicine is held out as an inducement for the purchase of livestock medicines or other goods, or by which other goods are held out as an inducement for the purchase of livestock medicines.

(3) No licensee shall store or permit to be stored any food or medicine for human consumption in a refrigerator, cabinet or facility used for the storage of livestock medicines.  R.R.O. 1990, Reg. 730, s. 8.

9. (1) Every licensee shall keep accurate records of the livestock medicines sold by the licensee, and the record of each sale shall include,

(a) the date of the sale;

(b) the name and address of the purchaser;

(c) the brand name and quantity; and

(d) the lot numbers of any veterinary biologics. R.R.O. 1990, Reg. 730, s. 9 (1); O. Reg. 465/18, s. 4.

(2) Every record of a sale of livestock medicines shall be kept for a period of at least two years.  R.R.O. 1990, Reg. 730, s. 9 (2).

10. No advertising in respect of livestock medicines by a licensee shall exceed the claims or information set out on the manufacturer’s label.  R.R.O. 1990, Reg. 730, s. 10.

11. (1) Where an inspector seizes, removes or detains any livestock medicine under clause 3 (5) (c) of the Act, the inspector shall,

(a) attach a tag to the livestock medicine bearing a serial number and the words “Ont. Detained/Retenu en Ont.”;

(b) forthwith thereafter notify the owner or the person who had possession thereof in writing of,

(i) the seizure, and

(ii) the grounds on which the seizure was made; and

(c) direct that the livestock medicine be detained in the place where it was found or be removed to another place designated by him or her. R.R.O. 1990, Reg. 730, s. 11 (1); O. Reg. 465/18, s. 5.

(2) Where a livestock medicine is detained, no person shall,

(a) remove the tag attached to it; or

(b) sell, offer to sell, move or allow or cause to be moved such livestock medicine. R.R.O. 1990, Reg. 730, s. 11 (2).

(3) Where an inspector is satisfied that,

(a) the licensee is not contravening the Act or this Regulation with regard to a livestock medicine that is detained; or

(b) the person whose livestock medicine is detained is authorized to sell livestock medicines to owners of livestock for the treatment of livestock,

the inspector shall remove the attached tag and release the livestock medicine from detention. R.R.O. 1990, Reg. 730, s. 11 (3).

(4) Where,

(a) after a hearing, the Director finds,

(i) that there is a contravention of the Act or this Regulation by the licensee whose livestock medicine is detained, or

(ii) that the person whose livestock medicine is detained is not authorized to sell livestock medicines to owners of livestock for the treatment of livestock; or

(b) a person is convicted of an offence against the Act or this Regulation in respect of livestock medicine that is detained,

the Director may direct that the livestock medicine be destroyed or disposed of in such manner as he or she considers advisable. R.R.O. 1990, Reg. 730, s. 11 (4).

(5) Any proceeds realized from the disposal of livestock medicine under subsection (4) shall be paid to the Minister of Finance.  R.R.O. 1990, Reg. 730, s. 11 (5).

12. Where a licence is refused, suspended or revoked, any livestock medicines in the possession of the applicant or licensee shall be removed and disposed of under the supervision of an inspector by,

(a) their sale to a person authorized to sell livestock medicines;

(b) their return to the supplier of the livestock medicines; or

(c) any other method satisfactory to the Director.  R.R.O. 1990, Reg. 730, s. 12.

13. In addition to the grounds mentioned in section 6 of the Act, the Director may refuse to renew or may suspend or revoke a licence where the licensee sells any drug other than a livestock medicine.  R.R.O. 1990, Reg. 730, s. 13.

FormS 1-4 Revoked:  O. Reg. 636/91, s. 4.

Schedule Revoked: O. Reg. 465/18, s. 6.

 

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