SCH976.html

DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Notice is hereby given that the Governor in Council, pursuant to section 30 of the Food and Drugs Act , proposes to amend the "Food and Drug Regulations" , in accordance with the schedule hereto marked Schedule No. 976.

The proposed effective date of this amendment will be the date of registration thereof with the Clerk of the Privy Council.

Interested persons may make representations concerning the proposed amendments to Lauraine Begin, Risk Management and Regulatory Affairs Division, Drugs Directorate, Address Locator No.: 0702B1, Health Protection Building, Tunney's Pasture, Ottawa, Ontario, K1A 0L2, within 30 days of the date of publication of this notice. All such representations should cite Canada Gazette Part I, the date of publication of this notice and Schedule No. 976.

The representations should stipulate the parts thereof that should not be disclosed pursuant to the Access to Information Act , in particular, pursuant to section 19 and 20 of that Act , the reason why those parts should not be disclosed and the period during which those parts should remain undisclosed. The representations should also stipulate the parts thereof for which there is no objection to disclosure to the Access to Information Act .

SCHEDULE NO. 976

Part I of Schedule F to the
Food and Drug Regulations is amended by adding the following references in alphabetical order:

Acarbose and its derivatives
Acarbose et ses dérivés
Alendronic acid and its salts
Alendronique (acide) et ses sels
Bicalutamide
Bicalutamide
Colchicine
Colchicine
Docetaxel and its derivatives
Docétaxel et ses dérivés
Famciclovir and its salts
Famciclovir et ses sels
Lamivudine and its salts
Lamivudine et ses sels
Levocarnitine and its salts and derivatives
Lévocarnitine ses sels et dérivés
Losartan and its salts
Losartan et ses sels
Mycophenolic acid and its salts and derivatives
Mycophénolique (acide) ses sels et dérivés
Propofol
Propofol
Sermorelin and its salts
Sermoréline et ses sels
Spironolactone
Spironolactone
Tacrolimus and its derivatives
Tacrolimus et ses dérivés
Tetrabenazine and its salts
Tétrabénazine et ses sels
Tricaine and its salts
Tricaïne et ses sels
Zolpidem and its salts
Zolpidem et ses sels

REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the regulation.)

Description

Drugs for human and veterinary use listed on Part I of Schedule F to the Food and Drug Regulations are required to be sold on prescription given by a practitioner. The review and introduction of new drugs onto the Canadian market necessitates periodic revisions to the schedule. This amendment updates Part I of Schedule F to accurately reflect the regulatory status of seventeen new drugs introduced onto the market as prescription drugs.

The Drug Schedule Status Committee reviews the status of chemical entities proposed for marketing. A decision regarding the necessity for prescription or other status versus non prescription status was made for each of the drugs listed on this schedule on the basis of established and publicly available criteria. These criteria include, but are not limited to, concerns related to toxicity, pharmacologic properties, and therapeutic applications.

Alternatives

This recommended degree of regulatory control coincides with the risk factors associated with each specific drug. The review of these drugs has determined that prescription status is the only acceptable alternative for these drugs at this time.

Any alternatives to the degree of regulatory control would need to be established through additional scientific information and clinical experience.

Benefits and Costs

The amendment will impact on the following sectors:

Public

Prescription access to the previously mentioned drugs will benefit Canadians by decreasing the opportunities for improper use, and by ensuring professional guidance and care.

The pharmaceutical industry

The classification of these drugs as prescription products will limit their sale subject to professional intervention thereby reducing misuse and decreasing liability to the manufacturer.

Health Insurance Plans

These drugs, when assigned prescription status, may be covered by both provincial and private health care plans.

Consultation

Early notice was provided in the 1996 Federal Regulatory Plan , as entry number HCan/R-13-L, although these drugs were not specifically mentioned.

The manufacturers affected by this amendment were informed of the intent to recommend these drugs for inclusion on Schedule F, Part I at the time of market approval. Advance notice of this regulatory proposal was provided to the Provincial Ministries of Health, medical and pharmacy licensing bodies, and industry associations. As well, early notice of this initiative was provided through the Drugs Directorate electronic bulletin board.

No comments have been received to date; any comments received before the end of the part I comment period, will be reviewed together with responses subsequent to this publication. A 30 day comment period will be provided upon prepublication in Canada Gazette Part I.

Compliance and Enforcement

This amendment does not alter existing compliance mechanisms under the provisions of the Food and Drugs Act and Regulations enforced by Drugs Programme Inspectors.

Contact

Lauraine Bégin
Risk Management and Regulatory Affairs Division
Bureau of Drug Policy and Coordination
Drugs Directorate
Health Protection Building
Address Locator 0702B1
Tunney's Pasture
Ottawa, Ontario
K1A 0L2

Telephone: (613) 957-0372
Facsimile: (613) 941-6458

(Other Orders are available to subscribers elsewhere on this site)