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O. Reg. 485/05: GENERAL


Published: 2005-08-30

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ontario regulation 485/05

made under the

drug interchangeability and dispensing fee act

Made: August 29, 2005
Filed: August 30, 2005
Printed in The Ontario Gazette: September 17, 2005


Amending Reg. 935 of R.R.O. 1990

(General)

1. (1) The definition of “Formulary” in subsection 1 (1) of Regulation 935 of the Revised Regulations of Ontario, 1990 is revoked and the following substituted:

“Formulary” means the Ministry of Health and Long-Term Care publication titled “Drug Benefit Formulary/Comparative Drug Index” (No. 39) dated September 27, 2005;

(2) Subsections 1 (2), (3), (4) and (5) of the Regulation are revoked.

(3) Section 1 of the Regulation is amended by adding the following subsections:

(2) For the purposes of this Regulation, Items 1339, 1341, 1342, 1343, 1344, 1345, 1346, 1347, 1348, 1349, 1350, 1351, 1352, 1353, 1354, 1356, 1357, 1360 and 1361 of Part III of the Formulary are revoked.

(3) For the purposes of this Regulation, Items 1330, 1331 and 1332 of Part III of the Formulary shall be read as follows:

 


1330


00030783


Depo-Testosterone 100mg/mL Oily Inj Sol-10mL Pk


UPJ


23.2100




1331


00029246


Delatestryl 1000mg/5mL Oily Inj Sol-5mL Pk


THE


22.8500




1332


00782327


Andriol 40mg Cap


ORG


0.9400




 


Reason for Use Code


Clinical Criteria


 


 




 


397


For male patients with confirmed low morning serum testosterone levels associated with documented, symptomatic hypothalamic, pituitary or testicular disease, or in HIV-infected patients.


 


 




 


 


Note: Older males with nonspecific symptoms of fatigue, malaise, depression who have a low normal random testosterone level do not satisfy these criteria.
LU authorization period:  1 year


 


 




(4) For the purposes of this Regulation, Items 1333, 1334, 1335, 1336, 1337, 1358 and 1359 of Part III of the Formulary shall be read as follows:

 


1333


02242878


Premplus 0.625mg/2.5mg Tab-28 Day Pk


WAY


7.0000




1334


02242879


Premplus 0.625mg/5mg Tab-28 Day Pk


WAY


7.0000




1335


02043394


Premarin 0.3mg Tab


WAY


0.1058




1336


00265470


C.E.S. 0.625mg Tab


ICN


0.0774




 


02043408


Premarin 0.625mg Tab


WAY


0.1215




1337


00265489


C.E.S. 1.25mg Tab


ICN


0.1293




 


02043424


Premarin 1.25mg Tab


WAY


0.2163




1358


02089769


Ogen 1.25 1.5mg Tab


UPJ


0.2804




1359


02089777


Ogen 2.5 3mg Tab


UPJ


0.4435




 


Reason for Use Code


Clinical Criteria


 


 




 


398


For short-term use in women who are experiencing symptoms of menopause.


 


 




 


 


Note: Recent evidence has demonstrated that use of hormone replacement therapy (HRT) increases the rate of coronary events, breast cancer, dementia, stroke, venous thromboembolism and referrals for abnormal vaginal bleeding.  These risks should be discussed with patients and reviewed periodically.
LU authorization period:  1 year


 


 




2. (1) Section 6 of the Regulation is amended by adding the following subsection:

(5.1) For the purposes of subsection (5), if a drug product has been designated by Health Canada as equivalent to the original product or to another listed interchangeable product with which it would be designated as interchangeable, the drug product shall be deemed to be pharmaceutically equivalent to the original product and to demonstrate the same physicochemical properties of the original product.

(2) Subsections 6 (6) and (7) of the Regulation are revoked and the following substituted:

(6) Clause (1) (c) does not apply with respect to a product that has been designated by Health Canada as equivalent to the original product or to another listed interchangeable product with which it would be designated as interchangeable unless the product is described in subsection (5).

(7) Clause (1) (h) does not apply to a product that is a solid oral dosage form for systemic effect and that has been designated by Health Canada as equivalent to the original product or to another listed interchangeable product with which it would be designated as interchangeable.

3.  (1)  Subject to subsections (2) and (3), this Regulation comes into force on filing.

(2)  Subsections 1 (1) and (2) and section 2 come into force on September 27, 2005. 

(3)  Subsection 1 (3) comes into force on March 1, 2006.