Regulation - LGIC
Proposed Amendment to the Schedule to Ontario Regulation 730 (General) under the Livestock Medicines Act
Regulation Number(s):
R.R.O. 1990, Reg. 730: GENERAL
Instrument Type:
Regulation - LGIC
Bill or Act:
Livestock Medicines Act, R.S.O. 1990, c. L.23
Summary of Decision:
Amendments were filed with the Registrar of Regulations and take effect on December 1, 2018, whereby Regulation 730 under the Livestock Medicines Act will be amended to remove medically important antimicrobials for veterinary use from the designated list of livestock medicines. These drugs have been given prescription status by Health Canada and thereafter are to be sold and distributed like other veterinary prescription drugs. All other livestock medications that are designated by Regulation 730 continue to be allowed to be sold by Livestock Medicines Outlets.
Rather than listing the designated livestock medicines in a Schedule of the Regulation, the regulation now sets out rules for determining what is designated.
Two minor amendments were also made that: 1) revoke livestock medicines that are no longer available for sale in Canada; and 2) accurately reference the updated drug schedules in the Drug and Pharmacies Regulation Act.
Rather than listing the designated livestock medicines in a Schedule of the Regulation, the regulation now sets out rules for determining what is designated.
Two minor amendments were also made that: 1) revoke livestock medicines that are no longer available for sale in Canada; and 2) accurately reference the updated drug schedules in the Drug and Pharmacies Regulation Act.
Analysis of Regulatory Impact:
A costing analysis was carried out by the Ministry, and it was found that the total administrative cost for regulated businesses associated with removing medically important antimicrobials from the list of designated livestock medicines would be approximately $93,130 annually (over two years). The average annual cost per regulated business (i.e., Livestock Medicines Outlets) is estimated at $171.51. Total costs are expressed in present value terms, discounted to the fiscal year in which the regulatory proposal comes into force. An average annual cost in present value terms is $18,000 discounted over 10 years with a discount rate of 2.5%.
Further Information:
R.R.O. 1990, Reg. 730: GENERAL
Proposal Number:
17-MAFRA008
Posting Date:
November 14, 2017
Summary of Proposal:
OMAFRA proposes to amend the Livestock Medicines Act (LMA) Regulation 730 to remove medically-important antimicrobials (MIAs) from the list of prescribed Livestock Medicines, to accurately reference the updated drug schedules in the Drugs and Pharmacies Regulation Act and clearly reference what livestock medicines outlets (LMO) can or cannot sell.
To combat antimicrobial resistance, Health Canada is taking steps to limit access to antimicrobial drugs. In particular, it has indicated its plans to move all medically important antimicrobial drugs currently allowed for sale "over-the-counter" to the Prescription Drug List(PDL). So they can only be obtained with a prescription. Roughly 300 veterinary drugs would be affected, some of which are currently sold pursuant to the LMA. Health Canada expects to implement these changes by December 2018.
The province's LMA and Regulation 730 regulates the sale of medicines to livestock owners for use in livestock from retail outlets licensed under the Act. Listed livestock medicines currently include antimicrobials that will, under the federal proposal be added to the PDL.
OMAFRA supports the federal government efforts to combat antimicrobial resistance and proposes updates to Regulation 730 to align with Health Canada changes. Should the proposed federal and provincial change take effect, Ontario livestock owners would only be able to purchase MIAs with a prescription from a veterinarian. Feed mills may continue to sell MIAs mixed in feed but would require a valid prescription for that sale. Producers should discuss delivery options with their veterinarian if there are concerns about distance or timely treatment/access to MIAs.
Products containing the following active ingredients will no longer be sold at LMOs:
Apramycin
Bacitracin
Erythromycin
Lincomycin
Neomycin
Penicillin G
Spectinomycin
Streptomycin/Dihydrostreptomycin
Sulphonamides
Tetracycline/Chlortetracycline/Oxy tetracycline
Tilmicosin
Tiamulin
Tylosin/Tylvalosin
Virginiamycin
Or their salts or derivatives
Please see the attached draft amendment to the regulation.
The LMA has worked well since the 1950s in allowing the sale of specific veterinary drugs for use in raising livestock as an exception to rules for human health and as an alternative to other animal health drugs sold by pharmacies and veterinarians. In 2017 drugs can be bought and sold through the internet, drug risks have changed and lists get out of date. Other jurisdictions have updated their regulations and Ontario is considering doing the same. A review of the LMA is needed for its currency, scope and ability to manage the risks.
We are looking for your input to identify issues and potential solutions for government consideration, including:
1. Who should be able to sell over-the-counter veterinary drugs (including vaccines and other biologics) and with what restrictions?
a) Veterinarians only
b) Pharmacists
c) Licensed retail outlets (LMOs)
d) Any retail store
e) Other (please specify)
Currently LMA sets out requirements related to expiry dates, refrigeration requirements, sales records, and allows sale of livestock medicines to livestock owners only (beef, poultry, etc.), not for aquaculture or beekeeping.
2. Are these restrictions adequate? If Yes, please explain. If No, Please explain.
Please identify most appropriate ways to manage risks related to the sale of over-the-counter veterinary drugs.
To combat antimicrobial resistance, Health Canada is taking steps to limit access to antimicrobial drugs. In particular, it has indicated its plans to move all medically important antimicrobial drugs currently allowed for sale "over-the-counter" to the Prescription Drug List(PDL). So they can only be obtained with a prescription. Roughly 300 veterinary drugs would be affected, some of which are currently sold pursuant to the LMA. Health Canada expects to implement these changes by December 2018.
The province's LMA and Regulation 730 regulates the sale of medicines to livestock owners for use in livestock from retail outlets licensed under the Act. Listed livestock medicines currently include antimicrobials that will, under the federal proposal be added to the PDL.
OMAFRA supports the federal government efforts to combat antimicrobial resistance and proposes updates to Regulation 730 to align with Health Canada changes. Should the proposed federal and provincial change take effect, Ontario livestock owners would only be able to purchase MIAs with a prescription from a veterinarian. Feed mills may continue to sell MIAs mixed in feed but would require a valid prescription for that sale. Producers should discuss delivery options with their veterinarian if there are concerns about distance or timely treatment/access to MIAs.
Products containing the following active ingredients will no longer be sold at LMOs:
Apramycin
Bacitracin
Erythromycin
Lincomycin
Neomycin
Penicillin G
Spectinomycin
Streptomycin/Dihydrostreptomycin
Sulphonamides
Tetracycline/Chlortetracycline/Oxy tetracycline
Tilmicosin
Tiamulin
Tylosin/Tylvalosin
Virginiamycin
Or their salts or derivatives
Please see the attached draft amendment to the regulation.
The LMA has worked well since the 1950s in allowing the sale of specific veterinary drugs for use in raising livestock as an exception to rules for human health and as an alternative to other animal health drugs sold by pharmacies and veterinarians. In 2017 drugs can be bought and sold through the internet, drug risks have changed and lists get out of date. Other jurisdictions have updated their regulations and Ontario is considering doing the same. A review of the LMA is needed for its currency, scope and ability to manage the risks.
We are looking for your input to identify issues and potential solutions for government consideration, including:
1. Who should be able to sell over-the-counter veterinary drugs (including vaccines and other biologics) and with what restrictions?
a) Veterinarians only
b) Pharmacists
c) Licensed retail outlets (LMOs)
d) Any retail store
e) Other (please specify)
Currently LMA sets out requirements related to expiry dates, refrigeration requirements, sales records, and allows sale of livestock medicines to livestock owners only (beef, poultry, etc.), not for aquaculture or beekeeping.
2. Are these restrictions adequate? If Yes, please explain. If No, Please explain.
Please identify most appropriate ways to manage risks related to the sale of over-the-counter veterinary drugs.
Contact Address:
Vicky Grahovac
Food Safety and Environmental Policy Branch
1 Stone Road W, Guelph ON N1G 4T6
519-826-3837
Food Safety and Environmental Policy Branch
1 Stone Road W, Guelph ON N1G 4T6
519-826-3837
Effective Date:
December 1, 2018
Decision:
Approved