Vol. 143, No. 21 — October 14, 2009

Registration

SOR/2009-279 October 1, 2009

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1591 — Schedule F)

P.C. 2009-1630 October 1, 2009

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 (see footnote b), hereby makes the annexed Regulations Amending the Food and Drug Regulations (1591 — Schedule F).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1591 — SCHEDULE F)

AMENDMENTS

1. The reference to

Naltrexone and its salts
Naltrexone et ses sels

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

Naltrexone and its salts and derivatives
Naltrexone, ses sels et ses dérivés

2. Part I of Schedule F to the Regulations is amended by adding the following in alphabetical order:

Ambrisentan
Ambrisentan

Etravirine and its salts
Étravirine et ses sels

Methoxy polyethylene glycol-epoetin beta
Méthoxy polyéthylèneglycol-époétine bêta

Nepafenac
Népafénac

Panitumumab
Panitumumab

Retapamulin
Rétapamuline

Sitagliptin and its salts
Sitagliptine et ses sels

COMING INTO FORCE

3. 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 adds eight medicinal ingredients 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 degree of regulatory control afforded by Schedule F (prescription drug) status coincides with the risk factors associated with each 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.

Drugs can only be sold in Canada once Health Canada has assessed them for safety, efficacy and quality as required by the Food and Drugs Act and the Food and Drug Regulations. Final approval of the regulatory amendment adding a medicinal ingredient to Schedule F and its publication in the Canada Gazette, Part II, means that prescription status for the drug can be enforced under provisions of the Food and Drug Regulations.

Enforcement of prescription status is important as Health Canada has issued market authorization for the sale of drug products containing the medicinal ingredients described in this amendment.

Description and rationale

Health Canada’s Drug Schedule Status Committee recommends 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 ingredients to be added to Schedule F:

1. Ambrisentan is an endothelin receptor antagonist that is used to treat pulmonary arterial hypertension, a condition characterized by high blood pressure in the pulmonary artery. Ambrisentan is used in the treatment of a serious disease that is easily misunderstood by the public. Ambrisentan may cause undesirable or severe side effects at normal therapeutic dosage levels. Patients require routine laboratory monitoring.

2. Etravirine and its salts is an HIV non-nucleoside reverse transcriptase inhibitor. Etravirine and its salts is used in the treatment of human immunodeficiency virus type 1 infection in patients for whom other HIV treatments are not effective. Administration of etravirine and its salts requires direct practitioner supervision and routine laboratory monitoring. In addition, administration may require individualized instructions. Etravirine and its salts may cause undesirable or severe side effects at normal therapeutic dosage levels.

3. Methoxy polyethylene glycol-epoetin beta is a polymer-based erythropoietic compound that increases the number of red blood cells and hemoglobin level in the blood. Methoxy polyethylene glycol-epoetin beta is used for the treatment of anemia in patients with chronic kidney disease. Individualized instructions and direct supervision by a practitioner are required. Routine laboratory monitoring is required. Methoxy polyethylene glycol-epoetin beta may cause undesirable or severe side effects at normal therapeutic dosage levels.

4. The current listing for “naltrexone and its salts” is revised to “naltrexone and its salts and derivatives.” The revised listing is necessary to include the new medicinal ingredient, methylnaltrexone bromide, a derivative of naltrexone. Naltrexone and its salts and derivatives are opioid receptor antagonists, which block or lessen the action of opioid drugs such as morphine without causing a biological response of their own. Methylnaltrexone bromide acts by reducing the effect of opioid drugs on the intestinal tract and is used to treat constipation in patients with advanced illness such as incurable cancer who are receiving opioid drugs on a continuous basis to alleviate pain. Methylnaltrexone bromide is administered by injection under the skin.

5. Nepafenac is a nonsteroidal anti-inflammatory drug that is used for management of eye pain and inflammation associated with cataract surgery. Direct practitioner supervision of drug administration is required. Nepafenac may cause undesirable or severe side effects at normal therapeutic dosage levels.

6. Panitumumab is a monoclonal antibody that acts on certain types of cancer cells and may prevent the cancer cells from growing or dividing. Panitumumab is used to treat cancer of the colon or rectum that has spread to other parts of the body. Panitumumab should be given under the supervision of a practitioner experienced in the use of anti-cancer drugs. Panitumumab may cause undesirable or severe side effects at normal therapeutic dosage levels.

7. Retapamulin is a topical antibiotic ointment that is used to treat bacterial skin infections such as impetigo and small infected cuts, abrasions and sutured wounds. Diagnosis and direct supervision by a practitioner are required. Retapamulin may cause undesirable or severe side effects at normal therapeutic dosage levels.

8. Sitagliptin and its salts is a member of a new class of medicines called dipeptidyl peptidase-4 inhibitors used to treat type II diabetes. Sitagliptin is used to improve blood sugar level in patients with type II diabetes mellitus in addition to diet and exercise. Individualized instructions, treatment with other prescription medications and routine laboratory monitoring are required.

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

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.

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

Consultation

The manufacturers affected by this amendment were made aware of the intent to recommend these medicinal ingredients for inclusion on Schedule F during the review of the drug submissions.

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 31, 2008 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.

Implementation, enforcement and service standards

This amendment will be implemented by notifying the general public through publication in the Canada Gazette, Part II, and by notifying both internal and external stakeholders via email of the date the regulatory amendment will be published in the Canada Gazette, Part II.

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. 1591
Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Holland Cross
1600 Scott Street, 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

NOTICE:
The format of the electronic version of this issue of the Canada Gazette was modified in order to be compatible with extensible hypertext markup language (XHTML 1.0 Strict).