Drug Interchangeability and Dispensing Fee Act

Bills that amended this Act0

No published amendment links yet for this Act.

Sections17

• 1.

  1. (1) In this Act, “designated” means designated by the executive officer in the Formulary; (“désigné”) “dispenser” means a person who dispenses a drug pursuant to a prescription; (“préposé à la préparation”) “drug” means a drug as defined in the Drug and Pharmacies Regulation Act, and includes any substance designated as an interchangeable product before section 16 of the Traditional Chinese Medicine Act, 2006 came into force; (“médicament”) “executive officer” means the executive officer of the Ontario public drug programs appointed under the Ontario Drug Benefit Act; (“administrateur”) “Formulary” means the Formulary that the executive officer is required to keep, maintain and publish under the Ontario Drug Benefit Act; (“Formulaire des médicaments”) “inspector” means a person appointed under section 12 of this Act; (“inspecteur”) “interchangeable product” means a drug or combination…

• 1.1

  1.1 (1) The executive officer may designate a product as being interchangeable with another product by designating it as such in the Formulary. 2006, c. 14, s. 2. Formulary and interchangeability (2) A product becomes interchangeable with another product on the effective date of its being designated as interchangeable with that product, and ceases to be interchangeable with that product on the effective date of the removal of its interchangeability designation by the executive officer. 2006, c. 14, s. 2. Requirements for interchangeability (3) The executive officer may designate a product as being interchangeable with another product if it is in the public interest to do so, but shall not do so if, (a) it does not contain a drug or drugs in the same amounts of the same or similar active ingredients in the same or similar dosage form as the other product; or (b) the prescribed conditions …

• 2.

  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.

  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). Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 26 (1) - 27/05/1996 Substitution where named product

• 4.

  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 pr…

• 5.

  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). Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 26 (1) - 27/05/1996 Maximum dispensing fee

• 6.

  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 informa…

• 7.

  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 appl…

• 8.

  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). Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 26 (1) - 27/05/1996 Dispense entire quantity

• 9.

  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.

  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.

  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.

  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 (…

• 12.1

  12.1 (1) A manufacturer shall not provide a rebate to wholesalers, operators of pharmacies, or companies that own, operate or franchise pharmacies, or to their directors, officers, employees or agents, (a) for any interchangeable product; or (b) for any product in respect of which the manufacturer has made an application to the executive officer for designation as an interchangeable product, while that application is being considered. 2006, c. 14, s. 3. Extended definition of “manufacturer” (2) For the purposes of this section and in section 12.2, unless the context requires otherwise, “manufacturer” includes a supplier, distributor, broker or agent of a manufacturer, except in, (a) clause (1) (b) of this section, (b) paragraph 2 of subsection (8) of this section, (c) subsection (10) of this section, and (d) clauses (b) and (c) of the definition of “drug benefit price” in subsection (14)…

• 12.2

  12.2 (1) The following rules apply with regard to an order made or a notice given by the executive officer under section 12.1: 1. The order or notice must be in writing, and set out in brief the reason for which it is made. 2. An order must set out how any amount required to be paid under the order was calculated, specify any right of reconsideration that is available, and the time within which reconsideration is available. 3. In the case of an order or notice under section 12.1 that applies to a manufacturer, the order or notice may be served by leaving a copy of the document with an officer, director or agent of the manufacturer, or with an individual at any place of business of the manufacturer who appears to be in control or management of the place of business. 4. In the case of an order or notice under section 12.1 that applies to a person mentioned in subsection 12.1 (3), the order…

• 13.

  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…

• 14.

  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; (d) defining any word or expression used in this Act but not defined in this Act. 2004, c. 7, s. 7; 2006, c. 14, s. 4 (1). (2)-(5) Repealed: 2006, c. 14, s. 4 (3). 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;…