Registration
SOR/2008-35 February 7, 2008

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1551 — Schedule F)

P.C. 2008-0245 February 7, 2008

Her 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, hereby makes the annexed Regulations Amending the Food and Drug Regulations (1551 — Schedule F).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1551 — SCHEDULE F)

AMENDMENT

1. Part I of Schedule F to the Food and Drug Regulations (see footnote 1) is amended by adding the following in alphabetical order:

Lanthanum salts, when sold for the treatment of hyperphosphatemia
Sels de lanthane vendus pour le traitement de l’hyperphosphatémie

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.)

Description

This amendment adds one medicinal ingredient to Part I of Schedule F to the Food and Drug Regulations.

Schedule F is a list of medicinal ingredients, the sale of which is controlled under sections C.01.041 to C.01.049 of the Food and Drug Regulations. 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.

The Drug Schedule Status Committee determines the necessity for prescription status for medicinal ingredients on the basis of established and publicly available criteria. These criteria include, but are not limited to, concerns related to toxicity, pharmacological properties and therapeutic uses of the ingredients.

Description of the medicinal ingredient:

1. Lanthanum salts when sold for the treatment of hyperphosphatemia are phosphate binders used to reduce blood levels of phosphate in patients with kidney disease who are receiving dialysis treatment. Lanthanum salts act in the digestive system to prevent absorption of phosphate that is released from food during digestion. Individualized instructions or direct supervision by a practitioner are required. The patient may also require treatment with other drugs and routine laboratory monitoring. This medicinal ingredient may cause undesirable or severe side effects at normal therapeutic dosage levels.

The degree of regulatory control afforded by Schedule F (prescription drug) status coincides with the risk factors associated with this medicinal ingredient. Oversight by a practitioner is necessary to ensure that appropriate risk/benefit information is considered before the drug containing the medicinal ingredient is administered and that the drug therapy is properly monitored.

Alternatives

Any alternatives to the degree of regulatory control provided by this amendment would have to be established through additional scientific information and clinical experience.

No other alternatives were considered.

Benefits and c osts

The amendment impacts on the following sectors:

• Public

Prescription access to drug products containing this medicinal ingredient will benefit Canadians by decreasing the opportunities for improper use and by ensuring the guidance and care of a practitioner.

Another benefit is that drug products for human use containing medicinal ingredients listed on Schedule F may be covered by both provincial and private health care plans.

• Health Insurance Plans

Drug products for human use containing medicinal ingredients listed on Schedule F may be a cost covered by both provincial and private health care plans.

• Provincial Health Care Services

The provinces may incur costs to cover practitioners’ fees for services. However, the guidance and care provided by the practitioners would reduce the need for health care services that may result from improper use of drug products for human use that contain medicinal ingredients listed on Schedule F. The overall additional costs for health care services should therefore be minimal.

Consultation

The manufacturer affected by this amendment was made aware of the intent to recommend this medicinal ingredient for inclusion on Schedule F during the review of the drug submission.

Direct notice of the regulatory proposal was provided to provincial and territorial Ministries of Health, medical and pharmacy licensing bodies, and industry, consumer and professional associations on May 25, 2007 with a 75-day comment period. This initiative was also posted on the Health Canada Web site and the Consulting With Canadians Web site. No comments were received.

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 22, 2005, is posted on the Health Canada Web site.

Compliance and e nforcement

This amendment does not alter existing compliance mechanisms under the provisions of the Food and Drugs Act and the Food and Drug Regulations enforced by the Health Products and Food Branch Inspectorate.

Contact

Refer to Project No. 1551
Policy Division
Bureau of Policy, Sciences and International Programs
Holland Cross, Therapeutic Products Directorate
1600 Scott Street
Tower B, 2nd Floor
A. L. 3102C5
Ottawa, Ontario
K1A 0K9
Telephone: 613-948-4623
Fax: 613-941-6458
Email: regaff-affreg@hc-sc.gc.ca

Footnote a
 S.C. 1999, c. 33, s. 347

Footnote 1
 C.R.C., c. 870

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