ARCHIVED — Vol. 146, No. 6 — March 14, 2012

Registration

SOR/2012-27 March 2, 2012

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1652 — Schedule F)

P.C. 2012-220 March 1, 2012

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 (1652 — Schedule F).

REGULATIONS AMENDING THE FOOD AND DRUG
REGULATIONS (1652 — SCHEDULE F)

AMENDMENT

1. The reference to

L-Asparaginase

L-Asparaginase

in Part Ⅰ of Schedule F to the Food and Drug Regulations (see footnote 1) is replaced by the following:

Asparaginase, when sold for administration by injection

Asparaginase, si elle est vendue pour administration par injection

COMING INTO FORCE

2. 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

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 medicinal ingredients that require a prescription for human use and for veterinary use. Part Ⅱ of Schedule F lists medicinal 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.

Asparaginase is currently listed in Part Ⅰ of Schedule F to the Food and Drug Regulations as “L-asparaginase” without any qualifying phrases or exceptions and is therefore currently available by prescription only.

Health Canada has determined that the current listing of the naturally sourced ingredient L-asparaginase in Schedule F is overly broad. This amendment clarifies Health Canada’s intent that only injectable dosage forms merit prescription status.

Description and rationale

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, which means if a naturally sourced medicinal ingredient is listed on Schedule F without any exemptions, the ingredient could not be considered for use in a natural health product.

This amendment to Part Ⅰ of Schedule F to the Food and Drug Regulations amends the listing for the naturally sourced medicinal ingredient L-asparaginase to

  1. — maintain prescription status for injectable dosage forms while providing an exemption from prescription status for other dosage forms; and
  2. — revise the name from “L-asparaginase” to “Asparaginase” for consistency in terminology within the Food and Drug Regulations. L-asparaginase and asparaginase are synonyms for the same substance. “Asparaginase” is the recognized common name while “L-asparaginase” is one of several synonyms.

Asparaginase is an enzyme that breaks down the amino acid asparagine in the body and is used as an injectable drug to treat some forms of cancer. Asparaginase does not occur naturally in humans, but it is found in bacteria, plants and many animals. Currently, asparaginase is only used therapeutically as an injectable drug and not in any other dosage forms (asparaginase is not given orally to treat cancer because it is broken down in the stomach and therefore not absorbed by the body). Therefore, Health Canada has determined that prescription status is required only for the injectable dosage form of asparaginase.

With this amendment, Canada continues to be in line with the regulatory approaches of the United States, the United Kingdom and Australia, where the prescription status of asparaginase is also focused on the injectable forms. These three jurisdictions also allow the use of asparaginase as a food additive.

When used as a food additive, the enzyme asparaginase acts on food to reduce the amount of the amino acid asparagine. Adding asparaginase to food to reduce the amount of asparagine can reduce the risk of formation of the chemical acrylamide which occurs during processing and is a potential human carcinogen. It should be emphasized that it is not possible for asparaginase, when used in food, to have a therapeutic effect on the human body. In order to act as a chemotherapeutic agent, asparaginase must be in its active form to be effective and it must be injected into muscle or veins and not given orally. When used in manufacturing food, asparaginase exerts its effect before the food is cooked. The heat from cooking inactivates the enzyme asparaginase that is present. Inactive asparaginase, consumed as part of a food, is digested in the stomach like other proteins (including other enzymes) in food and would not have any therapeutic effects on the body.

This amendment enables manufacturers to apply for market authorization of non-injectable forms of asparaginase for use in natural health products under the Natural Health Product Regulations. There is no immediate impact on manufacturers as there are currently no products on the market in Canada for the prescription exempt forms. The status of currently marketed prescription drugs containing asparaginase does not change with this amendment.

The Canadian public will continue to benefit from prescription status and oversight by a practitioner for injectable dosage forms of asparaginase, which are used in the treatment of cancer.

There is no change in costs to drug benefit plans for prescription drugs containing this naturally sourced medicinal ingredient as their status does not change.

Consultation

Direct notice of this regulatory proposal was provided to external stakeholders including provincial and territorial ministries of health, medical and pharmacy licensing bodies, and industry, consumer and professional associations on December 24, 2009, followed by a 75-day comment period. This initiative was also published as a Notice of Intent in the Canada Gazette, Part Ⅰ, on December 19, 2009. It was also posted on the Health Canada Web site and the Consulting With Canadians Web site. 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.

No stakeholder comments were received expressing either support or concern regarding the use of asparaginase as a drug. Two comments were received concerning the use of asparaginase as a food additive. As these comments relate to a regulatory amendment proposed by Health Canada’s Food Directorate (Project 1611), they are addressed in Project 1611. Requests for information on Project 1611 can be sent by email to the Food Directorate at sche-ann@hc-sc.gc.ca.

Implementation, enforcement and service standards

This amendment will come into force on the day on which it is 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 Number: 1652
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