NEWSLETTER

Ontario Drug Interchangeability and Dispensing Fee Act

R.S.O. 1990, Chapter P.23

Amended by: 1996, c. 1, Sched. G, ss. 19-26; 2004, c. 7, s. 7.

Definitions

1.  In this Act,

“designated” means designated by the regulations; (“désigné”)

“dispenser” means a person who dispenses a drug pursuant to a prescription; (“préposé à la préparation”)

“drug” means a drug as defined in subsection 117 (1) of the Drug and Pharmacies Regulation Act; (“médicament”)

“inspector” means a person appointed under section 12 of this Act; (“inspecteur”)

“interchangeable product” means a drug or combination of drugs in a particular dosage form and strength identified by a specific product name or manufacturer and designated as interchangeable with one or more other such products; (“produit interchangeable”)

“operator of a pharmacy” means the holder of a certificate of accreditation for the operation of a pharmacy under section 139 of the Drug and Pharmacies Regulation Act; (“exploitant d’une pharmacie”)

“prescription” means a direction from a person authorized to prescribe drugs within the scope of his or her practice of a health discipline directing the dispensing of a drug or mixture of drugs for a specified person; (“ordonnance”)

“Registrar” means the Registrar of the Ontario College of Pharmacists; (“registrateur”)

“regulations” means the regulations made under this Act. (“règlements”) R.S.O. 1990, c. P.23, s. 1; 1996, c. 1, Sched. G, s. 20.

Application of this Act

2.  This Act does not apply to the dispensing of a drug in or by a hospital approved as a public hospital under the Public Hospitals Act if the drug is dispensed for a patient or an out-patient of the hospital. R.S.O. 1990, c. P.23, s. 2.

Over the counter drugs excepted

3.  Subsections 4 (2) and (3) and sections 5, 6, 7, 9 and 10 do not apply in respect of an interchangeable product that does not require a prescription for sale. R.S.O. 1990, c. P.23, s. 3; 1996, c. 1, Sched. G, s. 26 (1).

Substitution where named product

4.  (1)  If a prescription directs the dispensing of a specific interchangeable product, the dispenser may dispense in its place another product that is designated as interchangeable with it. R.S.O. 1990, c. P.23, s. 4 (1); 1996, c. 1, Sched. G, s. 26 (1, 2).

Request for interchangeable product

(2)  If a prescription directs the dispensing of a specific interchangeable product, the dispenser, on the request of the person for whom the product was prescribed or the person presenting the prescription, shall dispense in its place another product that is designated as interchangeable with it. R.S.O. 1990, c. P.23, s. 4 (2); 1996, c. 1, Sched. G, s. 26 (1, 2).

Inform customer

(3)  If a prescription directs the dispensing of a specific interchangeable product, the dispenser shall not supply that product without informing the person for whom the product was prescribed or the person presenting the prescription, in the manner prescribed by the regulations, of the right to request an interchangeable product. R.S.O. 1990, c. P.23, s. 4 (3); 1996, c. 1, Sched. G, s. 26 (1).

Exceptions

(4)  Subsection (3) does not apply if,

(a) the amount to be charged for supplying the product specified in the prescription is not more than the least amount that would have been charged for supplying a product that is interchangeable with it and available in the dispenser’s inventory; or

(b) Repealed: 1996, c. 1, Sched. G, s. 21.

(c) the product is being supplied pursuant to a repeat of the prescription. R.S.O. 1990, c. P.23, s. 4 (4); 1996, c. 1, Sched. G, ss. 21, 26 (3).

Selection of interchangeable product

(5)  If a prescription directs the dispensing of a product that is not designated as an interchangeable product and there is an interchangeable product that contains a drug or drugs in the same amounts of the same active ingredients in the same dosage form as the product prescribed, the dispenser may dispense the interchangeable product. R.S.O. 1990, c. P.23, s. 4 (5); 1996, c. 1, Sched. G, s. 26 (1).

Exception

(6)  Subsections (1), (2), (3) and (5) do not apply to a prescription that includes,

(a) in the case of a written prescription, the handwritten words “no sub”, “pas de rempl.”, “no substitution” or “pas de remplacement”; or

(b) in any other case, a direction recorded by the dispenser that there be no substitution. R.S.O. 1990, c. P.23, s. 4 (6).

Dispensing generic drug

5.  If a prescription directs the dispensing of a drug for which there are interchangeable products without identifying a specific product name or manufacturer, the dispenser shall dispense an interchangeable product of that drug. R.S.O. 1990, c. P.23, s. 5; 1996, c. 1, Sched. G, s. 26 (1).

Maximum dispensing fee

6.  (1)  Every operator of a pharmacy shall set a single specific amount as a usual and customary dispensing fee and shall file a statement with the Registrar setting out that fee. R.S.O. 1990, c. P.23, s. 6 (1); 1996, c. 1, Sched. G, s. 22 (1).

Change of fee

(2)  An operator of a pharmacy may change the usual and customary dispensing fee by filing a statement with the Registrar setting out the new fee. R.S.O. 1990, c. P.23, s. 6 (2); 1996, c. 1, Sched. G, s. 22 (2).

Effective date of fee

(3)  The usual and customary dispensing fee becomes effective on the day the statement is received by the Registrar. R.S.O. 1990, c. P.23, s. 6 (3); 1996, c. 1, Sched. G, s. 22 (3).

Notify customers

(4)  Every operator of a pharmacy shall post in the pharmacy, in the manner prescribed by the regulations, a notice containing the usual and customary dispensing fee filed with the Registrar and any other information prescribed by the regulations respecting the charge for interchangeable products. R.S.O. 1990, c. P.23, s. 6 (4); 1996, c. 1, Sched. G, ss. 22 (4), 26 (1).

Limit re dispensing fee

7.  (1)  A dispenser shall not charge, as a dispensing fee for supplying a drug product, more than the dispenser’s usual and customary dispensing fee, unless a greater amount is provided for by the regulations. 1996, c. 1, Sched. G, s. 23.

Additional limit

(2)  If a dispenser supplies a drug product that is an interchangeable product under this Act, the dispenser shall not charge, in addition to the dispensing fee, more than the lowest amount the dispenser would charge for the product dispensed or the products that are interchangeable with it in the dispenser’s inventory. 1996, c. 1, Sched. G, s. 23.

Exception

(3)  Subsection (2) does not apply if the person presenting the prescription has requested the dispensing of a particular interchangeable product or if the prescription includes a direction that there be no substitutions. 1996, c. 1, Sched. G, s. 23.

Same

(4)  This section does not apply with respect to the supplying of a drug to which the Ontario Drug Benefit Act applies. 1996, c. 1, Sched. G, s. 23.

No liability for dispensing interchangeable products

8.  If an interchangeable product is dispensed in accordance with this Act, no action or other proceeding lies or shall be instituted against the person who issued the prescription, the dispenser or any person who is responsible in law for the acts of either of them on the grounds that an interchangeable product other than the one prescribed was dispensed. R.S.O. 1990, c. P.23, s. 8; 1996, c. 1, Sched. G, s. 26 (1).

Dispense entire quantity

9.  (1)  Every person who dispenses a drug pursuant to a prescription shall dispense the entire quantity of the drug prescribed at one time unless before the drug is dispensed the person presenting the prescription in writing authorizes the dispensing of the drug in smaller quantities. R.S.O. 1990, c. P.23, s. 9 (1).

Exception

(2)  Despite subsection (1), the regulations may authorize dispensing a drug in less than the entire quantity prescribed under specified conditions. R.S.O. 1990, c. P.23, s. 9 (2).

Idem

(3)  The regulations may designate specific drugs that are to be exempt from the application of subsection (1). R.S.O. 1990, c. P.23, s. 9 (3).

Inform customer of cost of drugs

10.  Every person who dispenses a drug pursuant to a prescription shall provide with the drug, in the manner prescribed by the regulations, particulars of the amount charged. R.S.O. 1990, c. P.23, s. 10.

Enforcement

11.  The Ontario College of Pharmacists is responsible for the enforcement of this Act in respect of operators of pharmacies and dispensers in pharmacies. R.S.O. 1990, c. P.23, s. 11.

Inspectors

12.  (1)  The Ontario College of Pharmacists may appoint inspectors for the purpose of enforcing this Act. R.S.O. 1990, c. P.23, s. 12 (1).

Examine books

(2)  An inspector may examine any records, in whatever form, in the possession or under the control of an operator of a pharmacy if the inspector believes on reasonable grounds that the records will assist the inspector in determining whether this Act and the regulations have been complied with. R.S.O. 1990, c. P.23, s. 12 (2).

Copies

(3)  An inspector may, upon giving a receipt for it, take away a record for the purpose of making a copy, but the copy shall be made and the record shall be returned as promptly as reasonably possible. R.S.O. 1990, c. P.23, s. 12 (3).

Entry

(4)  An inspector may at any reasonable time on producing proper identification enter any business premises where the inspector believes a record referred to in subsection (2) may be located for the purpose of an inspection. R.S.O. 1990, c. P.23, s. 12 (4).

Offence

13.  (1)  Any person who,

(a) contravenes subsection 4 (2) (dispense product requested);

(b) contravenes subsection 4 (3) (inform customer of interchangeable product);

(c) contravenes section 5 (dispense interchangeable when generic prescribed);

(d) contravenes section 6 (usual and customary dispensing fee set and posted);

(e) contravenes section 7 (maximum allowable charge);

(f) contravenes section 9 (dispense entire quantity);

(g) contravenes section 10 (inform person of cost); or

(h) obstructs any person carrying out an inspection under section 12,

and any director or officer of a corporation who authorizes or permits such a contravention by a corporation is guilty of an offence under this Act and liable to a penalty of not more than $25,000. R.S.O. 1990, c. P.23, s. 13 (1); 1996, c. 1, Sched. G, ss. 24, 26 (1).

Idem

(2)  The maximum penalty that may be imposed upon a corporation is $100,000 and not as provided in subsection (1). R.S.O. 1990, c. P.23, s. 13 (2).

Regulations

14.  (1)  The Lieutenant Governor in Council may make regulations,

(a) prescribing conditions to be met by products or by manufacturers of products in order to be designated as interchangeable with other products;

(b) prescribing conditions to be met for a product to continue to be designated as interchangeable;

(c) prescribing circumstances in which persons may charge more than their usual and customary dispensing fees. 2004, c. 7, s. 7.

Same, Minister

(2)  The Minister may make regulations designating a product as interchangeable with one or more other products where the Minister considers it advisable in the public interest to do so, but a product shall not be designated as interchangeable with another product if,

(a) it does not contain a drug or drugs in the same amounts of the same active ingredients in the same dosage form as the other product; or

(b) the product or its manufacturer has not met the conditions described in regulations made under clause (1) (a). 2004, c. 7, s. 7.

Removal of designation

(3)  Only the Lieutenant Governor in Council may make regulations removing the designation made by the Minister under subsection (2) of an interchangeable product. 2004, c. 7, s. 7.

Same

(4)  The Lieutenant Governor in Council may, under subsection (3), remove the designation of an interchangeable product even if none of the conditions prescribed under clause (1) (b) are breached, if the Lieutenant Governor in Council considers it advisable in the public interest to do so. 2004, c. 7, s. 7.

Effect of breach of continuing conditions

(5)  Despite a breach of a condition prescribed under clause (1) (b), a product does not cease to be designated as an interchangeable product until its designation is removed. 2004, c. 7, s. 7.

Regulations by college

(6)  Subject to the approval of the Lieutenant Governor in Council and with prior review by the Minister, the Council of the Ontario College of Pharmacists may make regulations,

(a) prescribing the manner in which persons shall be informed of the right to request an interchangeable product;

(b) prescribing the information to be included in a notice and the manner of posting a notice;

(c) authorizing dispensing a drug in less than the entire quantity prescribed and specifying the conditions under which that authority is to apply;

(d) designating specific drugs that are to be exempt from the application of subsection 9 (1);

(e) prescribing the information concerning cost to be provided on sale and how it is to be provided;

(f) requiring operators of pharmacies to retain specified records respecting their purchase of drugs for the purposes of this Act and prescribing the period of time those records shall be retained. 2004, c. 7, s. 7.

Same

(7)  Where the Minister requests in writing that the Council of the Ontario College of Pharmacists make, amend or revoke a regulation under subsection (6) and the Council has failed to do so within 60 days after the request, the Lieutenant Governor in Council may make the regulation, amendment or revocation specified in the request. 2004, c. 7, s. 7.

General or particular

(8)  A regulation made under this section may be general or particular in its application. 2004, c. 7, s. 7.