ontario regulation 20/13
made under the
Ontario Drug Benefit Act
Made: January 9, 2013
Filed: January 23, 2013
Published on e-Laws: January 23, 2013
Printed in The Ontario Gazette: February 9, 2013
Amending O. Reg. 201/96
1. Section 1 of Ontario Regulation 201/96 is amended by adding the following subsection:
(1.2) The executive officer shall not, under section 16 of the Act, make the Act apply in respect of a drug that is a drug product described in subsection 12 (9) of this Regulation, unless the conditions set out in that subsection are met.
2. Subsection 12 (9) of the Regulation is revoked and the following substituted:
(9) A strength and dosage form of a drug product that contains oxycodone as the only active ingredient and that is a long-acting product that has been formulated in a solid dosage form for oral administration shall not be designated as a listed drug product unless the following conditions are met:
1. There must be evidence satisfactory to the executive officer that the drug product exhibits one or more physiochemical properties that, when compared to drugs without the property or properties, make the drug product,
i. significantly more difficult to alter, break, crush, chew, dissolve or otherwise manipulate in such a way that it could be misused, abused or put to an intended use that is different than the use for which it is prescribed, or
ii. significantly less effective and less likely to be misused, abused or put to an intended use that is different than the use for which it is prescribed, if the product is altered, broken, crushed, chewed, dissolved or otherwise manipulated.
2. The evidence referred to in paragraph 1 must be demonstrated by,
i. in vitro testing,
ii. in vivo testing,
iii. another form of testing of equivalent reliability, or
iv. a combination of any of the forms of testing mentioned in subparagraphs i to iii.
3. Subparagraph 3 ii of section 27 of the Regulation is amended by striking out “the Drug and Pharmacies Regulation Act” and substituting “the
Drug and Pharmacies Regulation Act, the Narcotics Safety and Awareness Act, 2010”.
4. This Regulation is deemed to have come into force on November 23, 2012.