Ontario Drug Benefit Act

Bills that amended this Act0

No published amendment links yet for this Act.

Sections67

• 0.1Principles

  0.1 In this Act, the following principles are recognized: 1. The public drug system aims to meet the needs of Ontarians, as patients, consumers and taxpayers. 2. The public drug system aims to involve consumers and patients in a meaningful way. 3. The public drug system aims to operate transparently to the extent possible for all persons with an interest in the system, including, without being limited to, patients, health care practitioners, consumers, manufacturers, wholesalers and pharmacies. 4. The public drug system aims to consistently achieve value-for-money and ensure the best use of resources at every level of the system. 5. Funding decisions for drugs are to be made on the best clinical and economic evidence available, and will be openly communicated in as timely a manner as possible. 2006, c. 14, s. 5. Section Amendments with date in force (d/m/y) 2006, c. 14, s. 5 - 01/10/2006

• 1.
• 1Definitions

  1 (1) In this Act, “authorized prescriber” means a physician, registered nurse in the extended class, a prescribed person or a member of a prescribed class; (prescripteur autorisé) “designated” means designated in the Formulary by the executive officer; (“désigné”) “drug” means a drug as defined in the Drug and Pharmacies Regulation Act, and includes, (a) any substance designated as a listed drug product before section 16 of the Traditional Chinese Medicine Act, 2006 came into force, and (b) any substance that was supplied under this Act by virtue of section 16 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 section 1.1; (“administrateur”) “Formulary” means the Formulary that the executive officer is required to keep, maintain and publish und…

• 2.
• 1.1Executive officer

  1.1 (1) The Lieutenant Governor in Council shall appoint an executive officer for the Ontario public drug programs. 2006, c. 14, s. 7. Functions and powers (2) Subject to this Act and the regulations, it is the function of the executive officer, and he or she has the power, to perform any functions or duties that he or she may have under this Act and the regulations, under the Drug Interchangeability and Dispensing Fee Act and its regulations and under any other Act or regulation, and without in any way restricting the generality of the foregoing, (a) to administer the Ontario public drug programs; (b) to keep, maintain and publish the Formulary; (c) to make this Act apply in respect of the supplying of drugs that are not listed drug products as provided for in section 16; (d) to designate products as listed drug products, listed substances and designated pharmaceutical products for the …

• 3.
• 1.2Formulary

  1.2 (1) The executive officer shall keep, maintain and publish a Formulary. 2006, c. 14, s. 7. Contents (2) The Formulary shall set out, (a) the listed drug products and listed substances for the purposes of this Act; (b) the drug benefit price for listed drug products, listed substances and designated pharmaceutical products; (c) the products that are designated as interchangeable for the purposes of the Drug Interchangeability and Dispensing Fee Act; and (d) any other information required under this or any other Act. 2006, c. 14, s. 7. Other information (3) In addition to anything mentioned in subsection (2), the Formulary may set out any other information or material the executive officer considers necessary or advisable. 2006, c. 14, s. 7. Publication (4) The executive officer shall publish the Formulary on the website of the Ministry and may publish it in any other format the execut…

• 4.
• 1.3Listing

  1.3 (1) A drug product becomes a listed drug product on the effective date of its being designated in the Formulary as a listed drug product, and ceases to be a listed drug product on the effective date of that designation being removed. 2006, c. 14, s. 7. Requirements for listing (2) The executive officer may designate a drug product in the Formulary as a listed drug product where the executive officer considers it to be in the public interest to do so, but shall not do so if the prescribed conditions under clause 18 (1) (b) have not been met. 2006, c. 14, s. 7. Modification (3) 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. 7. Transitional (4) A drug product that was a listed drug product immediately before October 1, 2006 continues to be a listed drug product until it is removed from the F…

• 5.
• 1.4Repealed

  1.4 Repealed: 2021, c. 25, Sched. 18, s. 1. Section Amendments with date in force (d/m/y) 2006, c. 14, s. 7 - 01/10/2006 2021, c. 25, Sched. 18, s. 1 - 01/01/2022

• 6.
• 1.5Repealed

  1.5 Repealed: 2021, c. 25, Sched. 18, s. 2. Section Amendments with date in force (d/m/y) 2006, c. 14, s. 8 - 01/10/2006 2021, c. 25, Sched. 18, s. 2 - 01/01/2022

• 7.
• 2Eligible persons

  2 (1) A person who is a member of a prescribed class of persons is an eligible person. R.S.O. 1990, c. O.10, s. 2 (1); 2006, c. 14, s. 9. Persons deemed eligible persons (2) This Act applies to persons entitled to receive drug benefits under the Ontario Disability Support Program Act, 1997 and the Ontario Works Act, 1997 as if those persons were eligible persons. 1997, c. 25, Sched. E, s. 9; 2017, c. 11, Sched. 4, s. 2. Section Amendments with date in force (d/m/y) 1997, c. 25, Sched. E, s. 9 - 01/07/1998 2006, c. 14, s. 9 - 01/10/2006 2017, c. 11, Sched. 4, s. 2 - 01/07/2017

• 8.
• 3Application of this Act

  3 This Act applies in respect of the supplying of listed drug products for eligible persons unless that supplying is an insured service as defined in the Health Insurance Act. R.S.O. 1990, c. O.10, s. 3; 1996, c. 1, Sched. G, s. 3. Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 3 - 27/05/1996

• 9.
• 10.
• 4Billing restricted

  4 (1) No operator of a pharmacy shall charge, or accept payment from, a person other than the executive officer in respect of supplying a listed drug product for an eligible person pursuant to a prescription except as provided under this Act. 1996, c. 1, Sched. G, s. 4; 2006, c. 14, s. 10 (1). Same (2) No physician shall charge, or accept payment from, a person other than the executive officer in respect of supplying a listed drug product for an eligible person except as provided under this Act. 1996, c. 1, Sched. G, s. 4; 2006, c. 14, s. 10 (2). Billing permitted, co-payment (3) An operator of a pharmacy may charge, or accept payment from, a person in respect of supplying a listed drug product in an amount not greater than the maximum co-payment the executive officer is permitted to subtract under subsection 6 (1). 1996, c. 1, Sched. G, s. 4; 2006, c. 14, s. 10 (3). Exception (4) If the…

• 11.
• 4.1Billing privileges

  4.1 (1) If an operator of a pharmacy or a physician wishes to receive payment from the executive officer under this Act, the operator or physician shall apply to the executive officer for billing privileges. 2009, c. 26, s. 19 (1). Granting of privileges (2) The executive officer may grant billing privileges to an operator or physician who has applied under subsection (1) where the executive officer is of the opinion it is in the public interest to do so, after considering any matter that he or she considers to be appropriate. 2009, c. 26, s. 19 (1). Agreements (3) The executive officer may make it a condition of granting billing privileges under subsection (2) that the operator or physician enter into an agreement with the executive officer containing any provisions that the executive officer considers necessary or desirable in the public interest in the particular case. 2009, c. 26, s.…

• 5Payment of claim of operator

  5 (1) Subject to subsection (2), an operator of a pharmacy who has been granted billing privileges under subsection 4.1 (2) and who submits to the executive officer a claim for payment in respect of supplying a listed drug product for an eligible person pursuant to a prescription is entitled to be paid by the executive officer the amount provided for under section 6. 2009, c. 26, s. 19 (2). Alternative payments (2) The executive officer may pay the operator of a pharmacy an amount different from the amount provided for under section 6 in respect of a claim or claims under subsection (1) for prescribed classes of eligible persons, subject to any prescribed requirements. 2006, c. 14, s. 11 (1). Transitional (2.1) Any agreement that was in place under subsection (2), as it existed before October 1, 2006, that was in effect immediately before that date continues in force, with the executive …

• 6Amount executive officer to pay

  6 (1) The amount the executive officer shall pay under subsection 5 (1) in respect of a listed drug product is the amount calculated by adding the amounts determined under paragraphs 1, 2 and 3, subtracting from that total the maximum co-payment that may be charged in respect of the supplying of a listed drug product for an eligible person, as provided for in the regulations, and by further subtracting from that amount any additional amount determined by the executive officer in accordance with the regulations: 1. The dispensing fee determined under subsection (2). 2. The drug benefit price for the drug product, but, if there are other listed drug products that are interchangeable with the drug product, the drug benefit price shall be deemed to be the lowest of the drug benefit prices for the drug product and the listed drug products that are interchangeable with it. 3. The applicable pr…

• 7Repealed

  7 Repealed: 1996, c. 1, Sched. G, s. 7 (1). Note: No process under section 7 initiated or under way on or before January 30, 1996 shall continue after that day. See: 1996, c. 1, Sched. G, s. 7 (2). Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 7 (1) - 30/01/1996

• 12.
• 8Repealed

  8 Repealed: 2006, c. 14, s. 13. Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 8 (1, 2) - 27/05/1996 2006, c. 14, s. 13 - 01/10/2006

• 13.
• 9Agreement re listed substance

  9 (1) The executive officer may make an agreement with a supplier of a listed substance, providing for payment of a specified amount for supplying the listed substance to an eligible person under the direction of an authorized prescriber. R.S.O. 1990, c. O.10, s. 9 (1); 2006, c. 14, s. 14 (1); 2017, c. 11, Sched. 4, s. 3. Supplier not to charge (2) Except as the agreement authorizes, the supplier shall not charge, or accept payment from, any person other than the executive officer for supplying the listed substance to an eligible person under the direction of an authorized prescriber. R.S.O. 1990, c. O.10, s. 9 (2); 2006, c. 14, s. 14 (2); 2017, c. 11, Sched. 4, s. 3. Exception (3) Subsection (2) does not apply to a supplier of a listed substance who supplies the listed substance to an eligible person without knowing or having reasonable grounds to believe that the person is an eligible …

• 10Refusal to dispense prohibited

  10 No operator of a pharmacy shall refuse to supply a listed drug product for an eligible person in order to avoid the operation of a provision of this Act but an operator may refuse to supply a listed drug product for an eligible person if the proper exercise of professional judgment so requires. R.S.O. 1990, c. O.10, s. 10; 1996, c. 1, Sched. G, s. 9. Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 9 - 27/05/1996

• 14.
• 11Opting out

  11 (1) An operator of a pharmacy who has been granted billing privileges under subsection 4.1 (2) may notify the executive officer that the operator elects not to accept payment from the executive officer under section 5. R.S.O. 1990, c. O.10, s. 11 (1); 2006, c. 14, s. 15 (1); 2009, c. 26, s. 19 (6). Idem (2) Beginning ninety days after the day the executive officer receives the notice under subsection (1), the operator is not entitled to payment from the executive officer under section 5 and is not required to supply listed drug products for eligible persons under section 10. R.S.O. 1990, c. O.10, s. 11 (2); 1996, c. 1, Sched. G, s. 10; 2006, c. 14 s. 15 (2). Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 10 - 27/05/1996 2006, c. 14, s. 15 (1, 2) - 01/10/2006 2009, c. 26, s. 19 (6) - 15/03/2010

• 15.
• 11.1Order suspending operator’s right to payment

  11.1 (1) If the executive officer believes on reasonable grounds that with respect to a pharmacy there has been a breach of a condition that is prescribed by the regulations or agreed to by the operator of the pharmacy, the executive officer may make an order suspending the operator of the pharmacy from being entitled to receive payment from the executive officer under this Act. 1996, c. 1, Sched. G, s. 11; 2006, c. 14, s. 16 (1). Effect of order (2) Beginning on the day set out in the order, the operator is not entitled to payment by the executive officer under this Act. 1996, c. 1, Sched. G, s. 11; 2006, c. 14, s. 16 (2). Same (3) Beginning on the day set out in the order, the operator may charge, or accept payment from, a person other than the executive officer in an amount not exceeding the sum of, (a) the amount the executive officer would have paid under this Act, absent the order;…

• 16.
• 11.2Order suspending physician’s right to payment

  11.2 (1) If the executive officer believes on reasonable grounds that a physician has breached a condition that is prescribed by the regulations or agreed to by the physician with respect to dispensing drugs, the executive officer may make an order suspending the physician from being entitled to receive payment under this Act. 1996, c. 1, Sched. G, s. 11; 2006, c. 14, s. 17 (1). Effect of order (2) Beginning on the day set out in the order, the physician is not entitled to payment by the executive officer under this Act. 1996, c. 1, Sched. G, s. 11; 2006, c. 14, s. 17 (2). Same (3) Beginning on the day set out in the order, the physician may charge, or accept payment from, a person other than the executive officer in an amount not exceeding the sum of, (a) the amount the executive officer would have paid under this Act, absent the order; and (b) the amount the physician could have charge…

• 17.
• 11.3Claim from eligible person

  11.3 (1) Where an eligible person obtains a listed drug product from a pharmacy or a physician and, for any reason, the operator of the pharmacy or the physician is not entitled to payment from the executive officer under this Act, the eligible person may submit to the executive officer a claim for payment in respect of the supply of a listed drug product and is entitled to be paid by the executive officer the amount the executive officer would have otherwise paid to an operator of a pharmacy or a physician who was entitled to payment. 2009, c. 26, s. 19 (7). Same (2) The entitlement of an eligible person under subsection (1) is subject to this Act and the regulations to the same extent as the entitlement of an operator of a pharmacy or a physician would be, subject to any necessary modification. 2009, c. 26, s. 19 (7). Submission of claim (3) A person’s entitlement under subsection (1) …

• 18.
• 11.4Supply to be at drug benefit price

  11.4 (1) A manufacturer shall not sell a listed drug product, for the purpose of supplying a drug product under this Act, for a price that is higher than its drug benefit price as listed in the Formulary. 2006, c. 14, s. 19. Agreement not to exceed drug benefit price (2) A manufacturer, in agreeing to a drug benefit price with the executive officer under section 22, shall agree to comply with subsection (1). 2006, c. 14, s. 19. Executive officer may make order (3) If the executive officer believes, on reasonable grounds, that a manufacturer is not complying with subsection (1), the executive officer may make an order requiring the manufacturer to pay to the Minister of Finance the amount calculated under subsection (4). 2006, c. 14, s. 19. How amount calculated (4) The amount that the manufacturer is required to pay under subsection (3) is the amount determined by the formula: A = Q (P –…

• 19.
• 11.5Rebates, etc.

  11.5 (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 listed drug product or listed substance; or (b) for any drug in respect of which the manufacturer has made an application to the executive officer for designation as a listed drug product, while that application is being considered. 2006, c. 14, s. 19. Extended definition of “manufacturer” (2) For the purposes of this section and in section 11.6, unless the context requires otherwise, and in section 13.1 and subsection 14 (3), “manufacturer” includes a supplier, distributor, broker or agent of a manufacturer, except in, (a) clause (1) (b) of this section, (b) subsection (6) of this section, (c) paragraph 2 of subsection (9) of this section, and (d) subsection (11) of this secti…

• 20.
• 11.6Rules re ss. 11.4 and 11.5

  11.6 (1) The following rules apply with regard to an order made or a notice given by the executive officer under section 11.4 or 11.5: 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, and specify any right of reconsideration that is available and the time within which the reconsideration is available. 3. In the case of an order or notice under section 11.4 or an order or notice under section 11.5 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 11.5 that applies…

• 21.
• 12Minister and executive officer to consult

  12 The Minister and the executive officer may consult with persons or organizations representing eligible persons, manufacturers, operators of pharmacies, physicians, suppliers of listed substances, wholesalers and companies that own, operate or franchise pharmacies with respect to the amounts payable under this Act and other matters of mutual concern arising out of this Act and the regulations, and the Drug Interchangeability and Dispensing Fee Act and its regulations. 2006, c. 14, s. 20. Section Amendments with date in force (d/m/y) 2006, c. 14, s. 20 - 01/10/2006

• 12. #24
• 22.
• 13Collection of personal information

  13 (1) The Minister and the executive officer may directly or indirectly collect personal information, subject to such conditions as may be prescribed, for purposes related to the administration of this Act or for such other purposes as may be prescribed. 1996, c. 1, Sched. G, s. 12; 2006, c. 14, s. 21 (1). Use of personal information (2) The Minister and the executive officer may use personal information, subject to such conditions as may be prescribed, for purposes related to the administration of this Act or for such other purposes as may be prescribed. 1996, c. 1, Sched. G, s. 12; 2006, c. 14, s. 21 (2). Disclosure (3) The Minister and the executive officer shall disclose personal information, subject to such conditions as may be prescribed, if the disclosure is necessary for purposes related to the administration of this Act or for such other purposes as may be prescribed, but shall…

• 23.
• 13.1Requirement to provide information

  13.1 (1) For the purposes of determining compliance with this Act or the regulations or with the Drug Interchangeability and Dispensing Fee Act and its regulations, the executive officer may require a manufacturer, wholesaler, supplier of a listed substance, operator of a pharmacy or a company that owns, operates or franchises pharmacies to provide information other than personal information to the executive officer, either in response to a specific request, or at regular intervals. 2006, c. 14, s. 22. Time and form (2) The executive officer may specify the time at which and the form in which the information must be provided. 2006, c. 14, s. 22. Publication (3) Where the executive officer requires that information be provided at regular intervals, the executive officer shall publish the manner and form that are required on the website of the Ministry, and may publish them in any other fo…

• 14Inspectors

  14 (1) The Minister may appoint inspectors for the purposes of this section. R.S.O. 1990, c. O.10, s. 14 (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 or a physician, if the inspector believes on reasonable grounds that the records will assist the inspector in determining the accuracy and completeness of a claim for payment of the operator or physician or of information they are required to submit under this Act or the regulations, or in determining whether they have complied with this Act and the regulations. R.S.O. 1990, c. O.10, s. 14 (2). Same (3) An inspector may examine records, in whatever form, in the possession or under the control of a wholesaler, manufacturer, supplier of a listed substance, operator of a pharmacy or a company that owns, operates or franchises pharmacies, if th…

• 15Offence

  15 (1) A person is guilty of an offence if the person, (a) charges a person more than is permitted under this Act; (b) submits to the executive officer a claim for payment where the executive officer is not required to make any payment or where the claim is in excess of the amount the executive officer is required to pay; (c) contravenes subsection 9 (2) (supplier charges contrary to agreement); (d) contravenes section 10 (refuses to dispense); (e) refuses to submit information required to be submitted under this Act or knowingly furnishes false or incomplete information to the Ministry in connection with the administration of this Act or the Drug Interchangeability and Dispensing Fee Act; or (f) obstructs a person carrying out an inspection under section 14. 2002, c. 18, Sched. I, s. 18; 2006, c. 14, s. 24 (1, 2). Penalty, individual (2) Subject to subsections (5) and (6), an individual…

• 16Unlisted drugs, special case

  16 (1) If an authorized prescriber informs the executive officer that the proper treatment of a patient who is an eligible person requires the administration of a drug for which there is not a listed drug product, the executive officer may make this Act apply in respect of the supplying of that drug as if it were a listed drug product by so notifying the prescriber. 2017, c. 11, Sched. 4, s. 4. Same (2) The drug benefit price of a drug referred to in subsection (1) shall be the amount determined by the executive officer in accordance with the regulations. 2006, c. 14, s. 25. Listed drugs, special case (3) If an authorized prescriber informs the executive officer that the proper treatment of a patient who is an eligible person requires the administration of a drug for which there are one or more listed drug products but for which the conditions for payment under section 23 are not satisfi…

• 16. #30
• 17Pharmaceutical products

  17 (1) This Act applies with necessary modifications in respect of designated pharmaceutical products and, for the purpose, a designated pharmaceutical product shall be deemed to be a listed drug product. R.S.O. 1990, c. O.10, s. 17 (1). Determination of drug benefit price (2) The executive officer has the authority to, (a) determine the conditions which must be met before a pharmaceutical product, including an extemporaneous preparation, is designated as a designated pharmaceutical product; and (b) determine the drug benefit price of a designated pharmaceutical product, including determining a formula by which the drug benefit price may be calculated. 2006, c. 14, s. 26. Section 22 does not apply (3) Section 22 does not apply for the purposes of this section. 2006, c. 14, s. 26. Publication (4) The executive officer shall publish, on the Ministry’s website and in any other format the ex…

• 18Regulations

  18 (1) The Lieutenant Governor in Council may make regulations, (0.a) defining any word or expression used in this Act but not defined in this Act; (0.a.1) governing professional services for the purposes of clause 1.1 (2) (j), including defining “professional services”, governing payments that may be made for professional services, including governing to whom payments may be made, and prescribing conditions to which the executive officer is subject in making payments for professional services; (a) prescribing eligible classes of persons for the purposes of section 2; (b) prescribing conditions to be met for a drug product to be designated as a listed drug product; (b.1) prescribing conditions to be met for a listed drug product to continue to be designated as a listed drug product; (c), (d) Repealed: 2006, c. 14, s. 27 (3). (e) respecting physicians charging, or accepting payment from, …

• 19Decisions about listing, delisting

  19 In deciding whether or not to designate a drug product as a listed drug product or to remove such a designation, the executive officer may consider anything he or she considers advisable in the public interest, including, without limiting the generality of the foregoing, the drug benefit price of the drug product or other drug products or the price charged to operators of pharmacies for the drug product or other drug products. 2006, c. 14, s. 28. Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 16 - 27/05/1996 2004, c. 7, s. 14 (2) - 17/06/2004 2006, c. 14, s. 28 - 01/10/2006

• 20Delisting

  20 (1) The executive officer may remove a drug product’s designation as a listed drug product even if none of the conditions prescribed under clause 18 (1) (b.1) are breached, if he or she considers it advisable in the public interest to do so. 2006, c. 14, s. 28. Effect of breach of continuing conditions (2) Despite a breach of a condition prescribed under clause 18 (1) (b.1), a drug product does not cease to be a listed drug product until its designation as a listed drug product is removed. 2006, c. 14, s. 28. Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 16 - 27/05/1996 2004, c. 7, s. 14 (2) - 17/06/2004 2006, c. 14, s. 28 - 01/10/2006

• 19. #34
• 21Advisors

  21 The Minister, the executive officer or any body or official who advises the Minister, the executive officer or the Lieutenant Governor in Council with respect to anything under this Act may, in formulating such advice, consider anything the Minister, the executive officer or Lieutenant Governor in Council may consider. 2006, c. 14, s. 28. Section Amendments with date in force (d/m/y) 1996, c. 1, Sched. G, s. 16 - 27/05/1996 2006, c. 14, s. 28 - 01/10/2006

• 22Drug benefit price

  22 (1) The drug benefit price for a drug product when it becomes a listed drug product shall be the amount agreed to by the executive officer and the manufacturer, subject to any conditions that may be prescribed. 2006, c. 14, s. 28. Executive officer’s agreement (2) In deciding whether to agree to an amount under subsection (1), the executive officer may consider any matter the executive officer considers advisable in the public interest, including, without limiting the generality of the foregoing, the drug benefit price of other drug products or the price charged to operators of pharmacies for the drug product or other drug products. 2006, c. 14, s. 28. Request for change (3) A manufacturer may request, in writing, that the executive officer change a drug benefit price, but the executive officer is not obligated to act on the request. 2006, c. 14, s. 28. Criteria for requesting change …

• 20. #36
• 23Conditions of payment

  23 (1) The executive officer may require that, in respect of a specified drug product or class of drug products, specified clinical criteria must be met for the executive officer to pay an amount in respect of the supplying of that drug product or class of drug products for particular patients or a particular class of patients. 2006, c. 14, s. 28. Publication (2) Where the executive officer specifies anything under subsection (1), he or she shall publish it in the Formulary. 2006, c. 14, s. 28. Clinical criteria (3) Without limiting the generality of subsection (1), clinical criteria may include, (a) considerations relating to the use or the possibility of the use of other drug products or therapies for particular patients or a particular class of patients; (b) a requirement that the use of a drug product for particular patients or a particular class of patients require a prescription fr…

• 21. #38
• 22. #40
• 23. #42