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.