jswizzle3737/ontario_laws_and_regs huggingface dataset:
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 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”) “Minister” means the Minister of Health and Long-Term Care; (“ministre”) “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; 2006, c. 19, Sched. L, s. 1; 2006, c. 14, s. 1 (1, 2); 2006, c. 27, s. 15. No therapeutic substitution (2) Nothing in this Act shall be construed to permit therapeutic substitution.  2006, c. 14, s. 1 (3). Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 19 - 27/05/1996; 1996, c. 1, Sched. G, s. 20 (1-3) - 27/05/1996 2006, c. 14, s. 1 (1-3)
- 01/10/2006; 2006, c. 19, Sched. L, s. 1 - 22/06/2006; 2006, c. 27, s. 15 - 20/12/2006 2007, c. 10, Sched. L, s. 30 - 04/06/2007
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 under clause 14 (1) (a) have not been met.  2006, c. 14, s. 2. Similar active ingredients (4) In clause (3) (a), “similar active ingredients” means different salts, esters, complexes or solvates of the same therapeutic moiety.  2006, c. 14, s. 2. Ceasing to be interchangeable (5) The executive officer may remove a product’s interchangeability designation, (a) where authorized to do so under subsection 12.1 (8); (b) if one of the conditions prescribed under clause 14 (1) (b) has been breached; or (c) in any case, if he or she considers it advisable in the public interest to do so.  2006, c. 14, s. 2. Modification (6) Any modification of a designation takes place on the effective date of its being designated in the Formulary as a modification.  2006, c. 14, s. 2. Non-application of SPPA (7) The Statutory Powers Procedure Act does not apply to anything done by the executive officer under this Act.  2006, c. 14, s. 2. Transitional (8) A product that was interchangeable with another product immediately before October 1, 2006 continues to be interchangeable with that product until its interchangeability designation is removed by the executive officer.  2006, c. 14, s. 2. Section Amendments with date in force (d/m/y) 2006, c. 14, s. 2 - 01/10/2006
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.
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
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 written 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); 2016, c. 6, Sched. 1, s. 2. Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 21 - 27/05/1996; 1996, c. 1, Sched. G, s. 26 (1-3) - 27/05/1996 2016, c. 6, Sched. 1, s. 2 - 03/06/2016
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
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). Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 22 (1-4) - 27/05/1996; 1996, c. 1, Sched. G, s. 26 (1) - 27/05/1996
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. Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 23 - 27/05/1996
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
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).
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.
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.
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).
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 or notice may be served by leaving a copy of the document with the person if the person is an individual, or with an officer, director or agent of the person, or with an individual at any place of business of the person mentioned in subsection 12.1 (3) who appears to be in control or management of the place of business. 5. An order must specify the time period with respect to which the order is made, which may include a time period with respect to which a previous order was made, if the previous order has not been complied with. 6. An order must set out the time period in which the manufacturer or person mentioned in subsection 12.1 (3) is required to comply with the order. 7. An order must specify the consequences for failing to comply with the order.  2006, c. 14, s. 3. Same, publication of enforcement action (2) The executive officer may publish on the Ministry’s website the corporate names of manufacturers or any other persons against whom the executive officer has taken action under section 12.1 and may also publish any information he or she considers appropriate about the action that has been taken.  2006, c. 14, s. 3. No appeal (3) There is no appeal from a decision or action of the executive officer under section 12.1, except as provided for in that section.  2006, c. 14, s. 3. Section Amendments with date in force (d/m/y) 2006, c. 14, s. 3 - 01/10/2006
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). Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 24 - 27/05/1996; 1996, c. 1, Sched. G, s. 26 (1) - 27/05/1996