Section 56 Class Exemption for Pharmacists

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To enable implementation of the Interim Policy for the Provision of Methadone in Ontario issued by the Ontario College of Pharmacists (OCP) on March 16, 2006 and its replacement Methadone Maintenance Treatment and Dispensing Policy which will come into effect on June 1, 2011, the pharmacists in the province of Ontario are exempted pursuant to section 56 of the Controlled Drugs and Substances Act (CDSA) from the application of subsections 5(1) of the CDSA with respect to methadone, and from subsection 8(1) of the Narcotic Control Regulations (NCR).

This exemption is being issued on the understanding that the OCP and the College of Physicians and Surgeons of Ontario (CPSO) continue to work together for the provision of Methadone in Ontario to ensure that an adequate accountability framework is in place for this non-traditional approach to the provision of methadone and to make it clear to pharmacists and exempted physicians involved in this model share responsibility and accountability.

In respect of this exemption,

• Methadone means the substance listed under subitem 5(4), Schedule I to the CDSA and listed under subitem 5(4) in the Schedule to the NCR. Methadone includes the salts of methadone.
• Pharmacist means, as defined in section 2 of the NCR, a person who is registered and entitled under the laws of a province
  • (i) to practise pharmacy, and
  • (ii) to operate a pharmacy or dispensary
  and who is operating a pharmacy or dispensary and is practising pharmacy thereunder in that province, and,
  • (b) includes, for the purpose of sections 3, 31 to 39, subsections 44(1), 45(1) and (2), section 46 and subsections 65(3) and (4), a person who is registered and entitled under the laws of a province to practise pharmacy and who is practising pharmacy in that province.
• Exempted Physician means a physician who has been granted an exemption pursuant to s.56 of the CDSA to administer, prescribe, provide or sell methadone.
• Delegate means a person who meets the qualifications set out in the Policy of the College of Physicians and Surgeons of Ontario in Respect of Methadone Administration (February 2006) and is under the direction and control of an exempted physicians who has been authorized by his/her exemption to delegate to these qualified persons the administering or giving of methadone to patients at the treatment location.

In addition to the authority provided to pharmacists under s. 31(3) of the NCR in respect of methadone, this exemption gives authority to pharmacists in the province of Ontario, subject to the terms and conditions of this exemption, to transport, send, or deliver individually labelled doses of methadone dispensed pursuant to a prescription issued by an exempted physician to that physician or his/her delegate at a treatment location.

This exemption is only applicable under the following conditions:

1. the pharmacist adheres to all Criteria for Authorized Dispensing of Methadone by Pharmacists set out in the OCP Interim Policy for the Provision of Methadone in Ontario issued on March 16, 2006 and the Requirements for Dispensing Methadone in a Pharmacy outlined in the OCP Methadone Maintenance Treatment and Dispensing Policy when it takes effect on June 1, 2011;
2. Before transferring custody of methadone doses to any physician or delegate, the pharmacist has confirmed with the College of Physicians and Surgeons of Ontario that the receiving physicians has been granted the appropriate exemption by Health Canada; and
3. The Ontario College of Pharmacists has appropriate mechanisms in place to ensure that all pharmacists providing methadone are in compliance with the terms and conditions of this exemption and that any breach by a pharmacist or pharmacy of this or any other College policy with respect to the provision of methadone may be characterized as an act of professional misconduct.

This exemption may be suspended without prior notice if the Minister deems that such a suspension is necessary to protect public health, safety or security including, without limiting the generality of the foregoing, to prevent controlled substances from being trafficked or otherwise diverted within or from a treatment location the site for illicit purposes or if any of the conditions outlined above are not met.

Notwithstanding the conditions above or the ability to suspend, the Minister may revoke the exemption if he believes that it is no longer in the public interest.

The Minister may at any time change the terms and conditions of this exemption where deemed necessary by the Minister

This exemption will remain in effect until December 31, 2013 or until revoked. Failure to comply with the terms and conditions of this class exemption may, among other things, result in immediate suspension of this exemption, and ultimately, in its revocation.

Acting Director, Office of Controlled Substances, CSTD/HECSB, for and on behalf of the Minister of Health

Date of Issuance: December 22, 2010