You're using an outdated browser. This website will not display correctly and some features will not work.
Learn more about the browsers we support for a faster and safer online experience.

Important: This version of the e-Laws website will be upgraded to a new version in the coming weeks.
You can try the beta version of the new e-Laws at ontario.ca/laws-beta.

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

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

Skip to content
Versions
current March 7, 2024 (e-Laws currency date)
April 6, 2020 March 6, 2024
January 1, 2020 April 5, 2020
December 13, 2019 December 31, 2019
October 1, 2016 December 12, 2019
September 23, 2016 September 30, 2016
October 1, 2015 September 22, 2016
September 18, 2015 September 30, 2015
April 1, 2013 September 17, 2015
January 23, 2013 March 31, 2013
April 1, 2012 January 22, 2013
April 1, 2011 March 31, 2012
July 1, 2010 March 31, 2011
June 7, 2010 June 30, 2010
October 16, 2008 June 6, 2010
July 12, 2007 October 15, 2008
July 4, 2007 July 11, 2007
April 1, 2007 July 3, 2007
December 14, 2006 March 31, 2007
October 1, 2006 December 13, 2006
September 28, 2006 September 30, 2006
September 6, 2006 September 27, 2006
August 24, 2006 September 5, 2006
August 22, 2006 August 23, 2006
August 10, 2006 August 21, 2006
July 17, 2006 August 9, 2006
July 5, 2006 July 16, 2006
June 15, 2006 July 4, 2006
June 14, 2006 June 14, 2006
May 31, 2006 June 13, 2006
May 19, 2006 May 30, 2006
May 5, 2006 May 18, 2006
April 19, 2006 May 4, 2006
April 4, 2006 April 18, 2006
March 21, 2006 April 3, 2006
March 3, 2006 March 20, 2006
March 1, 2006 March 2, 2006
February 15, 2006 February 28, 2006
January 24, 2006 February 14, 2006
January 12, 2006 January 23, 2006
January 10, 2006 January 11, 2006
December 9, 2005 January 9, 2006
December 6, 2005 December 8, 2005
November 22, 2005 December 5, 2005
November 8, 2005 November 21, 2005
October 25, 2005 November 7, 2005
October 6, 2005 October 24, 2005
September 27, 2005 October 5, 2005
September 22, 2005 September 26, 2005
September 16, 2005 September 21, 2005
September 1, 2005 September 15, 2005
August 30, 2005 August 31, 2005
August 19, 2005 August 29, 2005
August 5, 2005 August 18, 2005
July 14, 2005 August 4, 2005
June 29, 2005 July 13, 2005
June 13, 2005 June 28, 2005
May 30, 2005 June 12, 2005
May 25, 2005 May 29, 2005
May 2, 2005 May 24, 2005
April 28, 2005 May 1, 2005
March 31, 2005 April 27, 2005
March 23, 2005 March 30, 2005
February 24, 2005 March 22, 2005
February 22, 2005 February 23, 2005
February 16, 2005 February 21, 2005
February 3, 2005 February 15, 2005
January 25, 2005 February 2, 2005
January 21, 2005 January 24, 2005
December 21, 2004 January 20, 2005
December 9, 2004 December 20, 2004
November 16, 2004 December 8, 2004
November 10, 2004 November 15, 2004
November 4, 2004 November 9, 2004
October 14, 2004 November 3, 2004
October 8, 2004 October 13, 2004
October 6, 2004 October 7, 2004
September 14, 2004 October 5, 2004
September 3, 2004 September 13, 2004
August 11, 2004 September 2, 2004
August 4, 2004 August 10, 2004
July 20, 2004 August 3, 2004
June 28, 2004 July 19, 2004
April 6, 2004 June 27, 2004
March 12, 2004 April 5, 2004
September 4, 2003 March 11, 2004
83 more

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. 337/03

GENERAL

Historical version for the period September 4, 2003 to March 11, 2004.

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. 38) dated January 30, 2003, and includes the following amendments to the publication:

1. Amendments dated April 16, 2003.

2. Amendments dated September 4, 2003;

“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.

(2) For the purposes of this Regulation, items 255 and 256 of Part III of the Formulary are deemed to read as follows:

255

5mg Tab

   

4.5900

 

02232043

Aricept

PFI

4.5900

256

10mg Tab

   

4.5900

 

02232044

Aricept

PFI

4.5900

 

Reason for Use Code

Clinical criteria

 

347

For the initial trial for patients with mild to moderate Alzheimer’s disease (Mini-Mental State Exam [MMSE] 10-26), patients will be reimbursed for a period of up to three months after which continued treatment must be reassessed.

 

348

For continuation of therapy, further reimbursement will be made available to those patients whose disease has not progressed or deteriorated while on this drug. Patients must continue to have a MMSE score of 10-26.

O. Reg. 173/01, s. 1 (2).

(3) For the purposes of this Regulation, items 301 and 309 of Part III of the Formulary shall be deemed to have been revoked and item 309 shall be deemed to read as follows:

SALBUTAMOL 4.6400

309

100mcg/Met Dose Inh-200 dose Pk

     
 

00790419

Apo-Salvent (Not a Benefit)

APX

 
 

00851841

Salbutamol Inhaler (Not a benefit)

KNR

 
 

00874086

Novo-Salmol (Not a benefit)

NOP

 
 

02213478

Ventolin (Not a benefit)

GLW

 
 

02232570

Airomir HFA

MMH

4.6500

 

02244914

Ratio-Salbutamol HFA

RAI

4.6400

 

02245669

+Apo-Salvent CFC Free

APX

4.6400

O. Reg. 374/02, s. 1.

(4) For the purposes of this Regulation, the reference in Part III of the Formulary to 022441914 Alti-Salbutamol HFA 100mcg/MET Dose Inh-200 Dose Pk SALBUTAMOL SULFATE ALT 4.64 shall be read as if it did not exist. O. Reg. 374/02, s. 1.

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. Revoked: O. Reg. 204/96, s. 1.

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 of 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 of 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; and

(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).

(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).

(6) Clause (1) (c) does not apply with respect to a product that has been designated as bioequivalent to the original product by Health Canada unless the product is described in subsection (5). O. Reg. 496/00, s. 1 (10).

(7) Clauses (1) (c) and (h) do 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 will be designated as interchangeable. O. Reg. 337/03, s. 1 (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.