Vol. 145, No. 25 — December 7, 2011
Registration
SOR/2011-274 November 24, 2011
FOOD AND DRUGS ACT
Regulations Amending the Food and Drug Regulations (1651 — Schedule F)
P.C. 2011-1352 November 24, 2011
His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act (see footnote b), hereby makes the annexed Regulations Amending the Food and Drug Regulations (1651 — Schedule F).
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1651 — SCHEDULE F)
AMENDMENTS
1. The reference to
Dopamine and its salts
Dopamine et ses sels
in Part Ⅰ of Schedule F to the Food and Drug Regulations (see footnote 1) is replaced by the following:
Dopamine and its salts, when sold for administration by injection
Dopamine et ses sels, s’ils sont vendus pour administration par injection
2. The reference to
Gold and its salts
Or et ses sels
in Part Ⅰ of Schedule F to the Regulations is replaced by the following:
Gold and its salts and derivatives, when sold for administration by injection
Or et ses sels et dérivés, s’ils sont vendus pour administration par injection
3. The reference to
Uracil and its salts
Uracile et ses sels
in Part Ⅰ of Schedule F to the Regulations is replaced by the following:
Uracil and its salts, when sold for the treatment of cancer
Uracile et ses sels, s’ils sont vendus pour le traitement du cancer
COMING INTO FORCE
4. These Regulations come into force on the day on which they are registered.
REGULATORY IMPACT
ANALYSIS STATEMENT
(This statement is not part of the Regulations.)
Issue and objectives
This amendment to Part Ⅰ of Schedule F to the Food and Drug Regulations revises the listings for three naturally sourced medicinal ingredients to retain prescription status for specific strengths, uses, routes of administration or dosages while providing exemptions to allow nonprescription status.
The three medicinal ingredients are dopamine and its salts, gold and its salts and uracil and its salts. These three medicinal ingredients are currently in Schedule F to the Food and Drug Regulations without any qualifying phrases or exceptions, and are therefore currently available by prescription only.
The initial proposal for this project also had included a fourth medicinal ingredient, lovastatin. However, in response to information submitted following publication of a Notice of Intent for this project, Health Canada is reviewing the proposed amendment to the Schedule F listing for lovastatin. As a result, lovastatin has been removed from Project 1651. This allows the amendments for the three remaining medicinal ingredients to be finalized while allowing further consideration of the issues raised regarding the proposal for lovastatin.
Sections C.01.041 to C.01.049 of the Food and Drug Regulations control the sale of medicinal ingredients that are listed in Schedule F. Part Ⅰ of Schedule F lists ingredients that require a prescription for human use and for veterinary use. Part Ⅱ of Schedule F lists ingredients that require a prescription for human use, but do not require a prescription for veterinary use if so labelled or if in a form unsuitable for human use.
Since the coming into force of the Natural Health Products Regulations in 2004, all naturally sourced ingredients meeting the definition of a natural health product are governed by these regulations. However, products containing ingredients listed in Schedule F to the Food and Drug Regulations are explicitly excluded from the Natural Health Products Regulations.
Description and rationale
Health Canada undertook a review of the naturally sourced medicinal ingredients listed in Schedule F. As part of this undertaking, the Department’s Drug Schedule Status Committee (“the Committee”) reviewed science assessments for 11 naturally sourced medicinal ingredients and recommended that these medicinal ingredients be regulated (in whole or in part) as nonprescription natural health products under the Natural Health Products Regulations. The Committee recommends prescription status or exemption from prescription status for medicinal ingredients on the basis of established and publicly available factors. These factors include, but are not limited to, toxicity, pharmacological properties and therapeutic uses of the ingredients. Three of these eleven medicinal ingredients are presented in this project.
These three naturally sourced medicinal ingredients were added to Schedule F prior to the Natural Health Products Regulations coming into force in 2004. Following the review of the naturally sourced medicinal ingredients in Schedule F, the Committee recommended that the listings in Schedule F to the Food and Drug Regulations for the following three naturally sourced medicinal ingredients be revised to allow nonprescription status for strengths, doses, dosage forms or uses that do not meet the factors for listing in Schedule F.
Manufacturers will be able to apply for market authorization for products containing the exempted strengths, uses, routes of administration or dosages of these medicinal ingredients as natural health products pursuant to the Natural Health Products Regulations once the regulatory amendment comes into force. There are no known market-authorized health products containing these medicinal ingredients whose status will be affected by this regulatory amendment.
Description of the medicinal ingredients:
Dopamine and its salts — The current listing for dopamine and its salts is revised to retain prescription status for dopamine and its salts when sold for administration by injection. All other dosage forms and routes of administration at any strength and for any use are exempt from prescription status.
Dopamine is inactive in the body when administered orally. Therefore, there are no oral drug products containing dopamine on the market in Canada. Revising the prescription status of dopamine mitigates issues with the licensing of orally administered natural health products with ingredients that might naturally contain trace amounts of dopamine.
Dopamine is administered by intravenous injection to treat kidney failure, septic shock and acute heart failure resulting from a heart attack. Administration of dopamine by injection requires direct supervision by a practitioner and can cause serious adverse effects in the therapeutic dosage range.
Dopamine and its salts are sold as a prescription medicinal ingredient in the United States (US), the United Kingdom (UK) and Australia. It is available in drug products that are administered by injection.
Gold and its salts — The current listing for gold and its salts is revised to retain prescription status for gold and its salts and derivatives when sold for administration by injection. The revised listing is worded so that it does not change the status of auranofin, an orally administered gold derivative that is listed separately in Schedule F. Gold and its salts and derivatives when sold in any other dosage form or route of administration at any strength and for any use are exempt from prescription status.
Gold is naturally occurring in trace amounts in nature, so it is appropriate to add qualifiers to the listing in Schedule F to avoid unintentionally subjecting products containing trace amounts of gold to prescription requirements where it is not necessary.
As prescription drugs, gold compounds are administered by injection to treat rheumatoid arthritis in patients for whom other treatments have been unsuccessful. Gold compounds administered by injection can have undesirable side effects at normal therapeutic dosage levels and require direct practitioner supervision and routine laboratory monitoring.
In the US, gold can be sold as a dietary supplement. In the UK, gold is not found in the Medicines and Healthcare Products Regulatory Agency’s listings of medicines (prescription only, pharmacy only or general sale). In Australia, gold may be used as a nonmedicinal ingredient in listed prescription or nonprescription medicines.
Uracil and its salts — The current listing for uracil and its salts is revised to retain prescription status for uracil and its salts when sold for the treatment of cancer. Uracil and its salts when sold for other uses at any strength, dosage form or route of administration are exempt from prescription status. Uracil is found in all living organisms so its listing in Schedule F without qualifiers is inappropriate.
Uracil has been used as a prescription drug in conjunction with other anti-cancer drugs to enhance antitumor activity and to reduce adverse effects; however, this therapeutic use is not currently in practice in Canada. If uracil were used in the treatment of cancer it would require the supervision of a practitioner and laboratory monitoring.
In the US, there are no approved drugs containing uracil. In the UK, uracil is not found in the Medicines and Healthcare Products Regulatory Agency’s listings of medicines (prescription only, pharmacy only or general sale). In Australia, uracil is a prescription-only medicine.
The availability of these three naturally sourced medicinal ingredients as nonprescription products may provide consumers with potential access to licensed natural health products. Potential safety concerns for products containing these nonprescription medicinal ingredients would be considered during the premarket review process under the Natural Health Products Regulations.
Manufacturers may benefit by being provided an opportunity to apply for product licences for natural health products containing these ingredients. There is no immediate impact on manufacturers as there are currently no known market-authorized health products containing these medicinal ingredients on the market in Canada whose status will be affected by this regulatory amendment.
There is no change in costs to provincial or privately funded drug benefit plans for the authorized drugs containing these medicinal ingredients on the market in Canada. Should natural health products containing these medicinal ingredients receive market authorization from Health Canada, there would be no anticipated additional costs to provincial or privately funded drugs benefit plans since at this time most do not cover the cost of natural health products.
Consultation
Direct notice of this regulatory proposal was provided to external stakeholders including provincial and territorial departments of Health, medical and pharmacy licensing bodies, and industry, consumer and professional associations in a Notice of Intent sent out on December 29, 2009, and published in the Canada Gazette, Part Ⅰ, on December 26, 2009, with a 75-day comment period. It was also posted on the Health Canada and Consulting With Canadians Web sites. The process for this consultation with stakeholders is described in the Memorandum of Understanding (MOU) to streamline regulatory amendments to Schedule F. The MOU, signed by Health Canada, the Privy Council Office and the Department of International Trade on February 23, 2005, is posted on the Health Canada Web site.
Comments were received from five respondents who addressed the proposed listings for the medicinal ingredients individually as follows:
Dopamine and its salts; gold and its salts; uracil and its salts
All respondents supported the proposed revisions to the Schedule F listings. No respondents objected to the proposed amendments for these three medicinal ingredients.
Lovastatin
Two respondents did not support the proposed Schedule F listing for lovastatin. To provide time to assess these comments, lovastatin will proceed as part of a separate proposal (project 1668) to amend the Schedule F listing. The comments and Health Canada’s responses will be addressed in this separate proposal.
Implementation, enforcement and service standards
These Regulations come into force on the day on which they are registered.
This amendment does not alter existing compliance mechanisms under the provisions of the Food and Drugs Act, the Food and Drug Regulations and the Natural Health Products Regulations enforced by the Health Products and Food Branch Inspectorate.
Contact
Refer to Project No. 1651
Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
1600 Scott Street, Holland Cross, Tower B, 2nd Floor
Address Locator: 3102C5
Ottawa, Ontario
K1A 0K9
Telephone: 613-948-4623
Fax: 613-941-6458
Email: regaff-affreg@hc-sc.gc.ca
Footnote a
S.C. 2005, c. 42, s. 2
Footnote b
R.S., c. F-27
Footnote 1
C.R.C., c. 870