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R.R.O. 1990, Reg. 935: GENERAL

under Drug Interchangeability and Dispensing Fee Act, R.S.O. 1990, c. P.23

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Drug Interchangeability and Dispensing Fee Act
Loi sur l’interchangeabilité des médicaments et les honoraires de préparation

R.R.O. 1990, REGULATION 935

Amended to O. Reg. 240/06

GENERAL

Historical version for the period May 31, 2006 to June 13, 2006.

This Regulation is made in English only.

1. (1) In this Regulation,

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

1. Amendments dated January 12, 2006.

2. Amendments dated April 19, 2006;

Note: On June 15, 2006, the definition of “Formulary” is amended by adding the following paragraph:

3. Amendments dated June 15, 2006;

See: O. Reg. 203/06, ss. 1, 2.

“original product” means the original source of a drug product in a particular strength and dosage form that is or was designated as a listed drug product under Ontario Regulation 201/96 or that was listed as a drug product under Regulation 868 of the Revised Regulations of Ontario, 1990 (General) or the Parcost C.D.I. prescribed under Ontario Regulation 839/84 as it read on November 30, 1986;

“production size lot” means the amount of finished product that is made from the minimum quantity of raw materials specified in a formula that can be processed using full sized production equipment into a dosage form that meets the specifications for the finished product.

R.R.O. 1990, Reg. 935, s. 1; O. Reg. 235/92, s. 1; O. Reg. 460/92, s. 1; O. Reg. 757/92, s. 1; O. Reg. 101/93, s. 1; O. Reg. 318/93, s. 1 (1); O. Reg. 453/93, s. 1; O. Reg. 524/93, s. 1; O. Reg. 526/93, s. 1; O. Reg. 735/93, s. 1; O. Reg. 49/94, s. 1 (1); O. Reg. 108/94, s. 1; O. Reg. 452/94, s. 1 (1); O. Reg. 615/94, s. 1; O. Reg. 755/94, s. 1 (1); O. Reg. 792/94, s. 1; O. Reg. 40/95, s. 1; O. Reg. 305/95, s. 1; O. Reg. 371/95, s. 1; O. Reg. 479/95, s. 1 (1); O. Reg. 177/96, s. 1; O. Reg. 337/96, s. 1; O. Reg. 376/96, s. 1; O. Reg. 509/96, s. 1 (1); O. Reg. 28/97 s. 1; O. Reg. 111/97, s. 1; O. Reg. 300/97, s. 1; O. Reg. 613/98, s. 1; O. Reg. 73/99, s. 1; O. Reg. 333/99, s. 1; O. Reg. 402/99, s. 1; O. Reg. 587/99, s. 1; O. Reg. 201/00, s. 1 (1); O. Reg. 367/00, s. 1; O. Reg. 583/00, s. 1; O. Reg. 15/01, s. 1; O. Reg. 173/01, s. 1 (1); O. Reg. 359/01, s. 1; O. Reg. 63/02, s. 1; O. Reg. 215/02, s. 1; O. Reg. 394/02, s. 1; O. Reg. 89/03, s. 1; O. Reg. 335/03, s. 1; O. Reg. 59/04, s. 1; O. Reg. 183/04, s. 1; O. Reg. 215/04, s. 1; O. Reg. 277/04, s. 1; O. Reg. 319/04, s. 1; O. Reg. 358/04, s. 1; O. Reg. 378/04, s. 1; O. Reg. 6/05, s. 1; O. Reg. 13/05, s. 1; O. Reg. 35/05, s. 1; O. Reg. 128/05, s. 1; O. Reg. 188/05, s. 1; O. Reg. 190/05, s. 1; O. Reg. 240/05, s. 1; O. Reg. 418/05, s. 1; O. Reg. 458/05, s. 1; O. Reg. 485/05, s. 1 (1); O. Reg. 488/05, s. 1; O. Reg. 500/05, s. 1 (1); O. Reg. 545/05, s. 1; O. Reg. 54/06, ss. 1 (1).

(1.1) Revoked: O. Reg. 54/06, s. 1 (2).

(1.2) For the purposes of this Regulation, items 17 and 18 of Part III of the Formulary shall be read as follows:

VORICONAZOLE

17

50mg Tab

   

11.8800

 

02256460

Vfend

PFI

11.8800

18

200mg Tab

   

47.5000

 

02256479

Vfend

PFI

47.5000

 

Reason for Use Code

Clinical Criteria

 

399

Outpatient continuation of treatment for documented invasive aspergillosis in patients who have demonstrated a clinical response to either oral or parenteral voriconazole. The first prescription must be written by a physician based at the hospital where the patient was hospitalized. Note: Limited to 3 months of reimbursement. LU Authorization Period: 1 year.

O. Reg. 644/05, s. 1.

(1.3) For the purposes of this Regulation, item 231 of Part III of the Formulary shall be read as follows:

231

2.5 mg Tab

   

4.9500

 

02231384

Femara (Letrozole)

NOV

4.9500

 

Reason for Use Code

Clinical Criteria

 

365

For the treatment of metastatic breast cancer in hormone receptor positive postmenopausal women. LU Authorization Period: Indefinite.

 

403

For the treatment of hormone receptor positive early breast cancer in postmenopausal women who have received 5 years of adjuvant tamoxifen therapy. LU Authorization Period: 5 Years.

O. Reg. 54/06, s. 1 (3).

(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. O. Reg. 485/05, s. 1 (3).

(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

   

O. Reg. 485/05, s. 1 (3).

(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

   

O. Reg. 485/05, s. 1 (3).

(5) Revoked: O. Reg. 485/05, s. 1 (2).

(6) For the purposes of this Regulation, items 392, 393, 394, 395, 396, 398, 1158, 1285, 1286 and 1287 of Part III of the Formulary shall be read as follows:

392

2265273

Novo-Warfarin 1mg Tab

393

2265281

Novo-Warfarin 2mg Tab

394

2265303

Novo-Warfarin 2.5mg Tab

395

2265311

Novo-Warfarin 3mg Tab

396

2265338

Novo-Warfarin 4mg Tab

398

2265346

Novo-Warfarin 5mg Tab

1158

2246083

Apo-Ipravent 0.03% Nasal Spray

1285

2245456

Sodium Aurothiomalate 10mg/mL Inj Sol-1mL Pk

1286

2245457

Sodium Aurothiomalate 25mg/mL Inj Sol-1mL Pk

1287

2245458

Sodium Aurothiomalate 50mg/mL Inj Sol-1mL Pk

O. Reg. 500/05, s. 1 (2).

2. A product is designated as interchangeable with any other products it is indicated as interchangeable with in Part III of the Formulary. O. Reg. 235/92, s. 2.

3. A product is designated as interchangeable with any other products it is indicated as interchangeable with in the following amendments to Part III of the Formulary:

1. Amendments dated September 30, 2005.

2. Amendments dated October 31, 2005.

3. Amendments dated November 30, 2005.

4. Amendments dated December 30, 2005.

5. Amendments dated February 28, 2006.

6. Amendments dated April 4, 2006.

7. Amendments dated April 28, 2006. O. Reg. 545/05, s. 2; O. Reg. 595/05, s. 1; O. Reg. 5/06, s. 1; O. Reg. 40/06, s. 1; O. Reg. 79/06, s. 1; O. Reg. 185/06, s. 1.

Note: On June 14, 2006, section 3 is amended by adding the following paragraph:

8. Amendments dated May 31, 2006.

See: O. Reg. 240/06, ss. 1, 2.

4. Revoked: O. Reg. 204/96, s. 1.

5. A person may charge more than the person’s usual and customary dispensing fee for a product that is supplied pursuant to a prescription if the person explains why a fee in excess of the usual and customary fee is being charged prior to the dispensing of the prescription and the charging of the additional fee is not an act of professional misconduct under section 1 of Ontario Regulation 681/93 made under the Pharmacy Act, 1991. R.R.O. 1990, Reg. 935, s. 5; O. Reg. 377/94, s. 1.

6. (1) It is a condition for each strength and dosage form of a drug product to be designated as interchangeable with other products that the manufacturer of the drug product submit to the Minister,

(a) evidence that Health Canada has approved the product for sale in Canada, a copy of the product’s drug notification form issued by Health Canada and, subject to subsection (2), a copy of the product monograph approved by Health Canada;

(b) a letter authorizing the Minister to gain access to all information with respect to the product in the possession of Health Canada, the government of any province or territory in Canada or the Canadian Coordinating Office for Health Technology Assessment and authorizing the Minister to disclose any information with respect to the product in the possession of the Ministry to Health Canada, the government of a province or territory in Canada or the Canadian Coordinating Office for Health Technology Assessment;

(c) documentation disclosing the product’s master formulation;

(d) the proposed drug benefit price of the product;

(d.1) Revoked: O. Reg. 496/00, s. 1 (4).

(e) evidence that the manufacturer is able to supply the product at the proposed drug benefit price in a quantity sufficient to meet the anticipated demand for the product;

(f) Revoked: O. Reg. 28/97, s. 2 (2).

(g) Revoked: O. Reg. 496/00, s. 1 (5).

(h) comparative bioavailability studies on humans, comparative clinical studies on humans, or both, or other in vivo studies that will show the interchangeability of the product with the original product.

(i) Revoked: O. Reg. 496/00, s. 1 (6).

O. Reg. 18/96, s. 1; O. Reg. 204/96, s. 2; O. Reg. 28/97, s. 2 (1, 2); O. Reg. 496/00, s. 1 (1-6); O. Reg. 337/03, s. 1 (1); O. Reg. 644/05, s. 2.

(2) If Health Canada has not approved a product monograph for a drug product, the manufacturer of the product may, instead of submitting a copy of the product monograph as required under clause (1) (a), submit to the Minister the following information:

1. Pharmaceutical information.

2. Information with respect to the product’s clinical pharmacology.

3. Information as to the product’s indications and clinical use.

4. A list of any contra-indications, warnings or precautions in the use of the product and of possible adverse reactions to its use.

5. A list of symptoms of an overdose of the product and information as to the treatment of an overdose.

6. Information with respect to the dosage and administration of the product.

7. Information regarding the availability of dosage forms for each strength of the product marketed in Canada. O. Reg. 18/96, s. 1; O. Reg. 496/00, s. 1 (7).

(3) Clauses (1) (c) and (h) do not apply to the manufacturer of a drug product if the dosage form, strength, formula and manufacturing process of the product and the testing standards for both the raw materials of the product and the finished product are identical to those of the product with which it seeks to be designated as interchangeable. O. Reg. 18/96, s. 1; O. Reg. 496/00, s. 1 (8).

(4) A manufacturer may satisfy the condition set out in clause (1) (h) for a strength of a drug product by submitting the evidence referred to in clause (1) (h) for another strength of the same dosage form of the drug product if that information is sufficient for the purposes of evaluating the interchangeability of both the strengths of the dosage form of the product. O. Reg. 18/96, s. 1.

(5) Clause (1) (h) does not apply with respect to a drug product that is pharmaceutically equivalent to the original product, demonstrates the same physicochemical properties of the original product, is the same dosage form, packaging format and volume as the original product and is one of the following:

1. A parenteral aqueous solution, or a powder for reconstitution into an aqueous solution, that may be administered in an intravenous, intramuscular, subcutaneous or intrathecal fashion and that is in the same solvent and in the same concentration as the original product.

2. An oral solution, elixir, syrup or other similar solubilized form in the same concentration as the original product and which contains no ingredient that will affect the bioavailability of the active ingredient.

3. An ophthalmic, otic, nasal, rectal, vaginal or inhaled solution that is topical and aqueous. O. Reg. 18/96, s. 1; O. Reg. 496/00, s. 1 (9).

(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. O. Reg. 485/05, s. 2 (1).

(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). O. Reg. 485/05, s. 2 (2).

(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. O. Reg. 485/05, s. 2 (2).

7. (1) This section sets out additional conditions to be met in order for a strength and dosage form of a product to be designated as interchangeable. O. Reg. 299/95, s. 1.

(2) A strength and dosage form of a product shall not be designated as interchangeable with other products unless it meets the following conditions:

1. If the original product is a listed product and there are no other interchangeable products already designated, the drug benefit price of the product proposed to the Minister under clause 6 (1) (d) must be less than or equal to 70 per cent of the drug benefit price, as set out in Part III of the Formulary, of the product with which it would be interchangeable.

2. If the original product is a listed product and there are other interchangeable products already designated, the drug benefit price of the product proposed to the Minister under clause 6 (1) (d) must be,

i. if the original product was listed as a listed drug product on or before March 31, 1994, less than or equal to the greater of the following amounts,

A. 63 per cent of the drug benefit price of the original product, as set out in the Formulary at the time the proposal is made to the Minister under clause 6 (1) (d), or

B. 63 per cent of the best available price of the original drug product, as set out in the Formulary on March 31, 1994, and

ii. if the original product was listed as a listed drug product after March 31, 1994, less than or equal to the greater of the following amounts:

A. 63 per cent of the best available price or drug benefit price, as the case may be, of the original product, as set out in the Formulary at the time the original product was listed, or

B. 63 per cent of the drug benefit price of the original product at the time the proposal is made to the Minister under clause 6 (1) (d),

but in no event shall the drug benefit price of the proposed product be greater than the highest drug benefit price among the drug benefit prices set out in the Formulary for the products with which the proposed product would be interchangeable.

3. If the product is an original product that was but is no longer a listed drug product under Ontario Regulation 201/96 and if there are no other interchangeable products already designated, the drug benefit price of the product proposed to the Minister under clause 6 (1) (d) must be,

i. less than or equal to 70 per cent of the drug benefit price of the original product that was set out in the Formulary immediately before its removal, or

ii. if the original product was removed from the Formulary as a listed drug product before May 27, 1996, less than or equal to 70 per cent of the best available price that was set out in the Formulary immediately before the removal of the original product.

4. If the product is an original product that was but is no longer a listed drug product under Ontario Regulation 201/96 and if there are other interchangeable products already designated, the drug benefit price of the product proposed to the Minister under clause 6 (1) (d) must be,

i. less than or equal to 63 per cent of the drug benefit price of the original product that was set out in the Formulary immediately before its removal, or

ii. if the original product was removed from the Formulary as a listed drug product before May 27, 1996, less than or equal to 63 per cent of the best available price that was set out in the Formulary immediately before the removal of the original product. O. Reg. 220/98, s. 1; O. Reg. 593/98, s. 1; O. Reg. 496/00, s. 2.

8. The following conditions must be met in order for a drug product that has been designated as interchangeable to continue to be designated as interchangeable:

1. The manufacturer of the product shall give the Minister notice of any change made to the product, including a formulation change, and of any change in the ownership of the manufacturer.

2. The product must be authorized for sale under the Food and Drugs Act (Canada).

3. The manufacturer of the product must continue to be able to supply the product at the drug benefit price in a quantity that is sufficient to meet the demand for the product. O. Reg. 28/97, s. 3.