R.R.O. 1990, REGULATION 551

GENERAL

Consolidation Period: From June 4, 2008 to the e-Laws currency date.

Last amendment: O. Reg. 172/08.

Definitions

1. In this Regulation,

“controlled drug” means a substance referred to in Part I, II or III of the schedule to Part G of the Food and Drug Regulations (Canada);

“controlled drug preparation” means a substance that contains one controlled drug, and one or more active medicinal ingredients, in a recognized therapeutic dose, that are not controlled drugs;

“internal use” means local or systemic absorption upon introduction into the body by the parenteral route or through a body orifice;

“narcotic drug” means a substance referred to in the schedule to the Narcotic Control Regulations (Canada);

“sell” includes offer to sell, dispense, distribute, give away and supply;

“verbal prescription narcotic” means a substance,

(a) that contains one narcotic drug,

(b) that also contains, in a recognized therapeutic dose, two or more medicinal ingredients that are not narcotic drugs,

(c) that is not intended for parenteral administration, and

(d) that does not contain diacetylmorphine (heroin), hydrocodone, methadone, oxycodone or pentazocine. O. Reg. 172/08, s. 1.

2.-40. Revoked: O. Reg. 784/94, s. 3.

41. Revoked: O. Reg. 172/08, s. 2.

42. Revoked: O. Reg. 120/97, s. 1.

43. The owner of a pharmacy shall at the request of the Council complete and file with the Registrar within thirty days after the request a return in Form 1. R.R.O. 1990, Reg. 551, s. 43.

44. The Council may at any time require an examination and audit to be made by a public accountant designated by it for the purpose of ascertaining and reporting to the Council whether the information furnished by the owner of a pharmacy in a return in Form 1 is correct and the owner shall provide to the public accountant all the evidence, vouchers, records, books and papers that may be required by the public accountant for the purpose of the examination and audit and the public accountant shall report to the Council in the manner required by the Council. R.R.O. 1990, Reg. 551, s. 44.

45. Revoked: O. Reg. 784/94, s. 3.

46. (1) The practice of pharmacy shall not be carried on by a member where there is a conflict of interest.

(2) It is a conflict of interest for a member to,

(a) knowingly operate or be associated as owner, manager, employee or corporate director, in the operation of a pharmacy that is supplying drugs to a nursing home owned or operated by the same person that owns or operates the pharmacy unless the drugs are supplied to not more than twenty persons who are not more than 40 per cent of the residents of the nursing home;

(b) knowingly be involved in the operation of a pharmacy where the owner or a partner, shareholder or director of the owner of the pharmacy owns, controls or has a beneficial interest in 25 per cent or more of the ownership of an entity that manufactures drugs;

(c) participate in an arrangement by reason of which the interest of the member or any person associated with the member in the operation of a pharmacy influences, or is likely to influence adversely, the discharge of the member’s professional obligation as a pharmacist. R.R.O. 1990, Reg. 551, s. 46.

47.-51. Revoked: O. Reg. 784/94, s. 3.

52. An application for a certificate of accreditation of a pharmacy shall be in Form 3. R.R.O. 1990, Reg. 551, s. 52.

53. A certificate of accreditation of a pharmacy shall be in Form 4 and shall be displayed in the pharmacy. R.R.O. 1990, Reg. 551, s. 53.

54. Every certificate of accreditation expires with the 9th day of March in each year. R.R.O. 1990, Reg. 551, s. 54.

55. An application for renewal of a certificate of accreditation of a pharmacy shall be in Form 5. R.R.O. 1990, Reg. 551, s. 55.

56. (1) A verbal prescription for a drug referred to in Schedule I established by Ontario Regulation 297/96 (General) made under the Act shall only be accepted by,

(a) a pharmacist;

(b) an intern; or

(c) a registered pharmacy student under the direct supervision of a pharmacist. O. Reg. 172/08, s. 3 (1).

(2) A verbal prescription referred to in subsection (1) shall be reduced to writing forthwith by the person receiving the prescription from the prescriber. R.R.O. 1990, Reg. 551, s. 56 (2); O. Reg. 172/08, s. 3 (2).

(3) A prescription for a narcotic drug, other than a verbal prescription narcotic, shall be in writing. O. Reg. 172/08, s. 3 (3).

57. A prescription for a narcotic drug or verbal prescription narcotic shall not be refilled. O. Reg. 172/08, s. 4.

58. A person shall refill a prescription for a drug referred to in Schedule I established by Ontario Regulation 297/96 (General) made under the Act, other than a narcotic drug or verbal prescription narcotic only where a prescriber so directs and specifies the number of times it may be refilled. R.R.O. 1990, Reg. 551, s. 58; O. Reg. 172/08, s. 5.

59. Every person who receives, subsequent to the time the prescription is issued, a verbal direction to refill a prescription for a drug referred to in Schedule I, established by Ontario Regulation 297/96 (General) made under the Act, other than a narcotic drug or verbal prescription narcotic, shall forthwith record on the original prescription,

(a) the date the refill direction is received;

(b) the number of times specified that it may be refilled; and

(c) the name and address of the prescriber issuing the direction if the prescriber of the refill is not the prescriber of the original prescription,
or record in a record of prescriptions kept under the name of each patient,

(d) the name and quantity of drug prescribed and where applicable the strength of the drug;

(e) the date the refill direction is received;

(f) the number of times specified that the prescription may be refilled; and

(g) the name and address of the prescriber issuing the direction if the prescriber of the refill is not the prescriber of the original prescription,
and the person shall sign the prescription or the record of prescriptions, as the case may be. R.R.O. 1990, Reg. 551, s. 59; O. Reg. 172/08, s. 6.

60. A person shall only refill a prescription for a substance referred to in Part I of the schedule to Part G of the Food and Drug Regulations (Canada) where the prescriber, at the time the prescription is issued,

(a) directs in writing that the prescription be refilled; and

(b) specifies the number of times it may be refilled and the dates for or intervals between refilling it. R.R.O. 1990, Reg. 551, s. 60; O. Reg. 172/08, s. 7.

61. A prescription, except for a narcotic drug or verbal prescription narcotic, shall only be refilled where the person refilling the prescription records,

(a) on the original prescription therefor,

(i) the date of the refill,

(ii) the quantity of the drug dispensed, and

(iii) his or her signature; or

(b) in a record of prescriptions kept under the name of each patient,

(i) the date of the refill,

(ii) the identification number that is on the prescription therefor,

(iii) the name, strength where applicable, and quantity of the drug dispensed,

(iv) the identity of the manufacturer of the drug dispensed,

(v) the name of the prescriber,

(vi) the price charged, and

(vii) the signature of the person refilling the prescription. R.R.O. 1990, Reg. 551, s. 61; O. Reg. 172/08, s. 8.

62. (1) A pharmacist may transfer a prescription to another pharmacist for the purpose of refilling the prescription, except with respect to a prescription for a controlled drug or a controlled drug preparation or a narcotic drug or a verbal prescription narcotic, where,

(a) the prescriber has authorized the prescription to be refilled a specific number of times and there are authorized refills remaining;

(b) the pharmacist transferring the prescription gives a copy of the prescription either,

(i) in writing to the person named in the prescription, his or her agent or a pharmacist acting on behalf of such person or agent, or

(ii) verbally to a pharmacist acting on behalf of the person named in the prescription;

(c) the transferred prescription is marked “transferred copy”;

(d) the transferred copy contains,

(i) the name and address of the person for whom the drug is prescribed,

(ii) the name and quantity of the drug prescribed and where applicable the strength of the drug,

(iii) the quantity of the drug dispensed if different from the quantity prescribed,

(iv) the directions for use as prescribed,

(v) the name and address of the prescriber,

(vi) the identity of the manufacturer of the drug dispensed,

(vii) the identification number of the prescription,

(viii) the name and address of the pharmacy transferring the prescription,

(ix) the date the prescription was issued by the prescriber,

(x) the number of refills authorized originally,

(xi) the number of authorized refills remaining,

(xii) the date of the last refill, and

(xiii) the name of the pharmacist transferring the prescription; and

(e) the pharmacist transferring the prescription records on the original prescription or in a record of prescriptions kept under the name of each patient that the prescription has been transferred, the date of the transfer and his or her signature. R.R.O. 1990, Reg. 551, s. 62 (1); O. Reg. 172/08, s. 9 (1, 2).

(2) A prescription that has been transferred from a pharmacist shall not be refilled in the transferring pharmacy and shall not be transferred further. R.R.O. 1990, Reg. 551, s. 62 (2).

(3) A pharmacist to whom a prescription has been transferred shall not dispense a drug pursuant thereto until he or she has obtained from the pharmacist transferring the prescription the information set out in clause (1) (d) and, where the prescription has been transferred verbally, reduced the prescription to writing indicating therein the information specified in clause (1) (d). R.R.O. 1990, Reg. 551, s. 62 (3); O. Reg. 172/08, s. 9 (3).

63. Every manager of a pharmacy shall keep or cause to be kept a record of every purchase of a controlled drug or a narcotic drug by entering or causing to be entered in a register or other record maintained for that purpose forthwith upon such purchase,

(a) the date of the purchase;

(b) the name, strength where applicable, and quantity of the drug; and

(c) the name and address of the person from whom the drug was purchased or received. R.R.O. 1990, Reg. 551, s. 63; O. Reg. 172/08, s. 10.

64. Every manager of a pharmacy shall keep or cause to be kept a record of every sale of a controlled drug, other than a controlled drug preparation, or of a narcotic drug, other than a verbal prescription narcotic, by entering or causing to be entered in a register maintained for that purpose forthwith upon the sale,

(a) the date of the sale;

(b) the name, strength where applicable, and quantity of the drug;

(c) the name and address of the purchaser or person named in the prescription,
and, where applicable,

(d) the name and address of the prescriber; and

(e) the identification number on the prescription. R.R.O. 1990, Reg. 551, s. 64; O. Reg. 172/08, s. 11.

65. Every manager of a pharmacy shall keep or cause to be kept a record of every sale of a controlled drug preparation or a verbal prescription narcotic other than by prescription, by entering or causing to be entered in a register or other record maintained for that purpose forthwith upon such sale,

(a) the date of the sale;

(b) the name, strength where applicable, and quantity of the drug; and

(c) the name and address of the purchaser. R.R.O. 1990, Reg. 551, s. 65; O. Reg. 172/08, s. 12.

66. The prescriptions and other records required by this Regulation shall be retained for not less than six years and shall be open to inspection by an inspector appointed under a by-law of the Council and an inspector may make copies of or take extracts from the prescriptions and other records. R.R.O. 1990, Reg. 551, s. 66.

67. Revoked: O. Reg. 172/08, s. 13.

68. Revoked: O. Reg. 179/99, s. 2.

69., 70. Revoked: O. Reg. 172/08, s. 13.

71. (1) A container in which a drug specified in this section is dispensed pursuant to a prescription and in a form intended for systemic or internal use shall bear the following words legibly and conspicuously displayed on the outer surface of the container:

“WARNING: Do not exceed the dose prescribed by your physician. If difficulty in breathing persists, contact your physician immediately.”

(2) The following drugs are specified for the purposes of subsection (1):

1. Ephedrine and its salts.

2. Epinephrine and its salts.

3. Ethylnorepinephine and its salts.

4. Fenoterol and its salts.

5. Ipratropium and its salts.

6. Isoetharine and its salts.

7. Isoproterenol (Isoprenaline) and its salts.

8. Metaproterenol (Orciprenaline) and its salts.

9. Salbutamol (Albuterol) and its salts.

10. Terbutaline and its salts. R.R.O. 1990, Reg. 551, s. 71 (2).

72. Every pharmacy shall be so constructed that,

(a) it contains a prescription laboratory in which drugs are stored and prescriptions compounded or dispensed, located in a well defined area having a floor area adequate for the efficient operation of the pharmacy but of not less than 9.3 square metres;

(b) it is free from every condition that may,

(i) be dangerous to health,

(ii) injuriously affect its efficient operation, or

(iii) injuriously affect the drugs prepared, compounded, dispensed or stored therein;

(c) a separate room, compartment, locker or cupboard is provided for keeping the wearing apparel of employees;

(d) floors and floor coverings may be readily cleaned in rooms where,

(i) drugs are prepared, compounded, dispensed or stored,

(ii) equipment is washed, or

(iii) washing fixtures and toilet fixtures are located;

(e) the walls and ceilings of rooms and passageways may be readily cleaned and the painting or decorating maintained in good condition;

(f) all rooms and passageways are well lighted and ventilated; and

(g) suitable areas are provided for the storage and controlled sale of drugs by the pharmacist. R.R.O. 1990, Reg. 551, s. 72.

73. (1) Every pharmacy shall be provided with,

(a) a supply of hot and cold water adequate for the efficient operation of the pharmacy;

(b) facilities for washing utensils used in the preparation, service or storage of drugs;

(c) separate hand-washing facilities available for employees and located in a convenient location in the pharmacy;

(d) a system for filing prescriptions;

(e) a typewriter in good working condition;

(f) a prescription counter adequate for the efficient operation of the prescription laboratory with not less than 1.12 square metres of free working space;

(g) a refrigerator for the exclusive storage of drugs requiring refrigeration;

(h) sufficient containers for storing refuse in a sanitary manner; and

(i) the compounding and dispensing equipment set out in the following Table:
TABLE

1. Bottles with caps.

2. Tablet vials (glass or plastic with caps).

3. Labels.

4. Filter papers.

5. Weighing papers.

6. Ointment jars with caps.

7. Distilled or de-ionized water.

8. Dropper bottles.

9. Child-resistant packages;

(k) a library including as a minimum, the following texts, pharmacopoeias, periodicals and other books:

1. A current edition of,

i. A Compendium of Pharmaceutical Specialties.

ii. A Drug Interaction Publication.

iii. A Pharmacology or Therapeutics Text.

iv. Parts I and VI of the Health Disciplines Act and the regulations and amendments.

v. The Narcotic Control Act (Canada), the regulations thereunder and amendments.

vi. The Food and Drugs Act (Canada), the regulations thereunder and amendments, pertinent to the sale of drugs, devices and vitamins.

i. A Pharmaceutics Text.

ii. A Dispensatory.

iii. A Medical Dictionary; and

(2) Only a potable water supply shall be used in any room where drugs are prepared, compounded, dispensed or stored. R.R.O. 1990, Reg. 551, s. 73 (2).

(3) All drugs stored in a pharmacy shall be stored on or in shelves, drawers or fixtures provided for that purpose. R.R.O. 1990, Reg. 551, s. 73 (3).

(4) Every pharmacy shall maintain,

(a) furniture, equipment and appliances used in the interior of the pharmacy so that thorough cleaning of all areas is possible;

(b) in a clean and sanitary condition,

(i) all furniture, equipment and appliances, and

(ii) all rooms in the pharmacy, whether used for the storage, compounding or dispensing of drugs or not; and

(c) the painting and decorating of the interior and exterior of the pharmacy in good condition. R.R.O. 1990, Reg. 551, s. 73 (4).

(5) Every room where drugs are prepared, compounded, dispensed or stored in a pharmacy shall be kept free from materials and equipment not regularly used in the room. R.R.O. 1990, Reg. 551, s. 73 (5).

(6) Refrigerators for the storage of drugs in a pharmacy shall,

(a) be maintained at a temperature between 1.3^o Celsius and 10^o Celsius;

(b) be kept clean and in a sanitary condition; and

(c) be located in an area not accessible to the public. R.R.O. 1990, Reg. 551, s. 73 (6).

(7) All refuse and waste materials in a pharmacy,

(a) shall be removed from the premises at least twice weekly and more often if necessary to maintain a sanitary condition; and

(b) contained in filled containers shall be removed from any room in which drugs are prepared, compounded, dispensed or stored. R.R.O. 1990, Reg. 551, s. 73 (7).

74. (1) Every pharmacist, at the time of payment of his or her annual fee and at any other time within seven days after a request by the Registrar, shall file with the Registrar a signed statement setting out,

(a) the pharmacist’s residential address; and

(b) the location of the place of practice of the pharmacist. R.R.O. 1990, Reg. 551, s. 74 (1).

(2) Every pharmacist shall notify the Registrar in writing of any change in the information required by subsection (1) within seven days of the change. R.R.O. 1990, Reg. 551, s. 74 (2).

75. (1) Every owner of a pharmacy at the time of payment of the fee for renewal of a certificate of accreditation of the pharmacy, or at any other time within seven days after a request by the Registrar, shall file with the Registrar a signed statement setting out,

(a) the full name of the owner of the pharmacy and, where the owner is a corporation, the full name and residential addresses of the directors of the corporation;

(b) the address of the owner of the pharmacy;

(c) the name by which the pharmacy is known to the public;

(d) the location of the pharmacy;

(e) the full name of the manager of the pharmacy;

(f) the residential address of the manager of the pharmacy; and

(g) the names of the pharmacists, interns and registered pharmacy students employed in the pharmacy. R.R.O. 1990, Reg. 551, s. 75 (1).

(2) The owner of a pharmacy shall notify the Registrar in writing of any change in the information required by subsection (1) within seven days of the change. R.R.O. 1990, Reg. 551, s. 75 (2).

76. (1) Every person who proposes to open a new pharmacy, acquire an existing pharmacy or relocate an existing pharmacy shall, within the time prescribed by subsection (2), file with the Registrar a signed statement setting out,

(a) the full name of the owner of the pharmacy;

(b) the address of the owner of the pharmacy;

(c) the name by which the pharmacy will be known to the public;

(d) the location of the pharmacy; and

(e) the proposed date of opening, acquiring or relocating the pharmacy. R.R.O. 1990, Reg. 551, s. 76 (1).

(2) A person who proposes to open a new pharmacy or relocate an existing pharmacy shall file the information required by subsection (1) at least thirty days before opening or relocating the pharmacy and, where the person proposes to operate an existing pharmacy, the person shall file the information before commencing to operate the pharmacy. R.R.O. 1990, Reg. 551, s. 76 (2).

(3) Every person who proposes to open a new pharmacy, acquire an existing pharmacy or relocate an existing pharmacy shall, on or before the day the person commences to operate the pharmacy, notify the Registrar of the name of the manager of the pharmacy. R.R.O. 1990, Reg. 551, s. 76 (3).

77. Every person who permanently closes a pharmacy shall, within seven days of closing the pharmacy, notify the Registrar of the closing and within thirty days of the closing shall file with the Registrar a signed statement setting out,

(a) the full name of the owner of the pharmacy;

(b) the name by which the pharmacy was known to the public;

(c) the location of the pharmacy;

(d) the name of the manager of the pharmacy;

(e) the date of closing;

(f) the disposition of the drugs in stock in the pharmacy at the time of closing;

(g) the disposition of the prescription files, drug registers and other records required to be kept under this Regulation; and

(h) the date on which all signs and symbols relating to the practice of pharmacy either within or outside the premises were removed. R.R.O. 1990, Reg. 551, s. 77.

78. The parts of a pharmacy in which prescriptions are compounded and dispensed for the public or drugs are stored or sold by retail shall be so constructed that they may be locked and made not accessible to the public in the absence of a pharmacist. R.R.O. 1990, Reg. 551, s. 78.

79. Revoked: O. Reg. 179/99, s. 3.

80. Revoked: O. Reg. 298/96, s. 1.
SCHEDULE A Revoked: O. Reg. 179/99, s. 4.

SCHEDULE B Revoked: O. Reg. 179/99, s. 4.

SCHEDULE C Revoked: O. Reg. 179/99, s. 4.

SCHEDULE D Revoked: O. Reg. 179/99, s. 4.

SCHEDULE E Revoked: O. Reg. 179/99, s. 4.

SCHEDULE F Revoked: O. Reg. 179/99, s. 4.

SCHEDULE G Revoked: O. Reg. 179/99, s. 4.

SCHEDULE N Revoked: O. Reg. 179/99, s. 4.

FORM 1
RETURN BY OWNER OF A PHARMACY

Drug and Pharmacies Regulation Act

R.R.O. 1990, Reg. 551, Form 1; O. Reg. 784/94, s. 5.

FORM 2 Revoked: O. Reg. 784/94, s. 6.

FORM 3
APPLICATION FOR CERTIFICATE OF ACCREDITATION OF A PHARMACY

Drug and Pharmacies Regulation Act

R.R.O. 1990, Reg. 551, Form 3; O. Reg. 784/94, s. 7.

FORM 4
CERTIFICATE OF ACCREDITATION OF A PHARMACY — ONTARIO COLLEGE OF PHARMACISTS

Drug and Pharmacies Regulation Act

R.R.O. 1990, Reg. 551, Form 4; O. Reg. 784/94, s. 8; O. Reg. 120/97, s. 2.

FORM 5
APPLICATION FOR RENEWAL OF CERTIFICATE OF ACCREDITATION OF A PHARMACY

Drug and Pharmacies Regulation Act

R.R.O. 1990, Reg. 551, Form 5; O. Reg. 784/94, s. 9.

Drug and Pharmacies Regulation Act
Loi sur la réglementation des médicaments et des pharmacies

R.R.O. 1990, REGULATION 545

No Amendments

CHILD RESISTANT PACKAGES

DPRA Reg 545

This Regulation is made in English only.

1.  In this Regulation,

"child resistant package" means a container or a package that meets the standards for child resistant packages approved by the Minister. R.R.O. 1990, Reg. 545, s. 1.

2.  The Canadian Standards Association is designated as an organization to test, certify and designate containers that meet standards for child resistant packages. R.R.O. 1990, Reg. 545, s. 2.

3.  Every person who fills a prescription shall dispense the drug in a child resistant package that is certified and designated by the Canadian Standards Association. R.R.O. 1990, Reg. 545, s. 3.

4.  Section 3 does not apply where,

(a) the prescriber or the person who presents the prescription to be filled directs otherwise;

(b) in the professional judgement of the pharmaceutical chemist in the particular circumstances or the particular situation it is advisable not to use a child resistant package;

(c) a child resistant package is not suitable because of the physical form of the drug; or

(d) the person who fills the prescription is unable to obtain a child resistant package because supplies of such packages are unavailable on the market. R.R.O. 1990, Reg. 545, s. 4.

---

ONTARIO REGULATION 297/96

GENERAL

Consolidation Period: From June 4, 2008 to the e-Laws currency date.

Last amendment: O. Reg. 173/08.

1. In this Regulation,

“dispensary” means the area of a pharmacy where drugs referred to in Schedules I and II are stored and prepared for dispensing and distribution and to which the public has no access;

“Manual” means the manual published by the National Association of Pharmacy Regulatory Authorities entitled “Canada’s National Drug Scheduling System” and dated September 25, 1998, as that manual is amended from time to time. O. Reg. 180/99, s. 1; O. Reg. 173/08, s. 1.

2. (1) Schedules I, II, III and U are established for the purposes of the Act. O. Reg. 173/08, s. 2.

(2) The following substances are prescribed as being included in Schedule I for the purposes of the Act:

1. The substances listed in Schedule I of the Manual.

2. The substances listed in Parts I and II of Schedule F to the Food and Drug Regulations (Canada).

3. The substances listed in Schedule I, II, III, IV, V, VI, VII and VIII of the Controlled Drugs and Substances Act (Canada). O. Reg. 173/08, s. 2.

(3) The substances listed in Schedule II of the Manual are prescribed as being included in Schedule II for the purposes of the Act. O. Reg. 173/08, s. 2.

(4) The substances listed in Schedule III of the Manual are prescribed as being included in Schedule III for the purposes of the Act. O. Reg. 173/08, s. 2.

(5) The substances listed in the Unscheduled Category of the Manual are prescribed as being included in Schedule U for the purposes of the Act. O. Reg. 173/08, s. 2.

(6) The substances listed in Schedules A and B to this Regulation are not drugs for the purposes of the Act. O. Reg. 173/08, s. 2.

2.1 (1) The following conditions apply to the sale in a pharmacy of a drug referred to in Schedule I:

1. A pharmacist must be present in the pharmacy.

2. There must be a prescription for the drug, or, in the case of a refill, the refill must be in accordance with Regulation 551 of the Revised Regulations of Ontario, 1990, (General) made under the Act.

3. The sale of the drug must be approved by a pharmacist.

4. The drug shall only be available for sale from the dispensary. O. Reg. 173/08, s. 2.

(2) The following conditions apply to the sale in a pharmacy of a drug referred to in Schedule II:

1. A pharmacist must be present in the pharmacy.

2. The sale of the drug must be approved by a pharmacist.

3. The drug shall only be available for sale from the dispensary. O. Reg. 173/08, s. 2.

(3) The following conditions apply to the sale in a pharmacy of a drug referred to in Schedule III:

1. A pharmacist must be present in the pharmacy.

2. A pharmacist or intern must be available for consultation with the patient.

3. The drug shall only be available for sale in the pharmacy from the dispensary or from an area within 10 metres of the dispensary. O. Reg. 173/08, s. 2.

3. (1) In this section,

“advertisement” includes an announcement, directory listing or other form of communication similar to an advertisement;

“prescription services” means the compounding, dispensing or sale by retail of drugs pursuant to prescriptions and the provision of information or advice with respect to those drugs. O. Reg. 119/97, s. 1.

(2) It is a standard of accreditation of a pharmacy that the owner or operator of the pharmacy ensure that an advertisement of prescription services available in the pharmacy be in compliance with this section. O. Reg. 119/97, s. 1.

(3) The owner or operator of a pharmacy shall not, through any medium, publish, display, distribute or use, or permit, directly or indirectly, the publication, display, distribution or use through any medium of, an advertisement relating to prescription services that,

(a) is false, misleading or deceptive, whether as a result of the inclusion of information or the omission of information;

(b) is not readily comprehensible to the persons to whom it is directed;

(c) is not dignified and in good taste;

(d) contains anything that cannot be verified;

(e) contains testimonials, comparative statements or endorsements;

(f) contains a reference to a member’s area of practice or to a procedure or treatment available from a member practising in the pharmacy, unless the advertisement discloses whether or not the member has an area of expertise and, if the member does have such an area of expertise, the particular expertise;

(g) contains references to a particular brand of equipment used to assist in providing prescription services;

(h) contains information that is not relevant to the choice of a pharmacy; or

(i) contains any representations as to the safety or effectiveness or an indication for use of any specified prescription drug. O. Reg. 119/97, s. 1.

(4) An advertisement by the owner or operator of a pharmacy that includes price information relating to prescription drugs shall include the price information for at least 15 different drugs, 10 of which each belong to a different one of the following drug classifications:

1. Anti-infective agents.

2. Antineoplastic agents.

3. Autonomic agents.

4. Blood formation and coagulation drugs.

5. Cardiovascular drugs.

6. Central nervous system drugs.

7. Diagnostic agents.

8. Electrolytic, caloric and water balance drugs.

9. Cough preparations.

10. Eye, ear, nose and throat preparations.

11. Gastrointestinal drugs.

12. Gold compounds.

13. Heavy metal antagonists.

14. Hormones and substitutes.

15. Oxytocics.

16. Skin and mucous membrane preparations.

17. Spasmolytics.

18. Unclassified therapeutic agents.

19. Vitamins. O. Reg. 119/97, s. 1.

(5) If an advertisement by a member includes price information relating to prescription drugs, the advertisement shall include at a minimum the following price information with respect to each drug:

1. The dispensing fee.

2. The sum of the cost to the pharmacy plus the pharmacy’s mark-up.

3. The total cost for the prescription to the purchaser.

4. The time period during which the advertised price will be available. O. Reg. 119/97, s. 1.

(6) The price information referred to in subsection (5) shall be given for the standard reference quantity of each drug. However, if the prescription is supplied to a consumer in the package in which it was supplied to the pharmacy, the price information shall be given for the quantity contained in the package. O. Reg. 119/97, s. 1.

(7) The standard reference quantity for a drug is the reference quantity indicated in the guidelines titled “Standard Reference Quantity Guidelines”, dated January 30, 1997 and available from the College or, if it is not indicated in the College guidelines, the standard reference quantity for a drug is,

(a) for tablets or capsules, 100;

(b) for liquids, 100 millilitres; or

(c) 30 grams for solid dosage forms. O. Reg. 119/97, s. 1.

(8) An advertisement by a member that includes price information relating to prescription drugs shall include, in addition to the price information referred to in subsection (5), the following information with respect to each drug in respect of which price information is included:

1. The generic name of the drug.

2. The strength of the drug.

3. The brand name and the name of the manufacturer of the drug.

4. The dosage form of the drug.

5. The quantity of the drug for which the price information is given.

6. Any of the following services that are included in the price:

i. The establishment of patient medical profiles.

ii. Professional consultation.

iii. Health care services information.

iv. After hours emergency prescription services.

v. Delivery service. O. Reg. 119/97, s. 1.

4. It is a standard of accreditation for a pharmacy that the owner or operator of the pharmacy that advertises price information for a prescription drug ensure that the pharmacy does not charge any purchaser, including the Minister, more, in respect of any fee, cost or amount that is required under subsection 3 (5) to be part of the price information, than the amount set out in the advertisement. O. Reg. 119/97, s. 1.

5. Nothing in this Part prohibits the owner or operator of a pharmacy from publishing, displaying, distributing or using, or permitting, directly or indirectly, the publication, display, distribution or use of, an advertisement that relates solely to the co-payment or dispensing fee charged by the pharmacy for supplying a drug that is a listed drug product under the Ontario Drug Benefit Act to an eligible person under that Act. O. Reg. 119/97, s. 1.
SCHEDULE A

SCHEDULE B
PART I