jswizzle3737/ontario_laws_and_regs huggingface dataset:
“Remote dispensing location”
 2. For purposes of the Act and this Regulation, “remote dispensing location” means a premises where drugs are dispensed or sold by retail to the public and that is operated by, but is not at the same location as, a pharmacy whose certificate of accreditation permits its operation.  O. Reg. 58/11, s. 2. Part II   DRUG SCHEDULES
Schedules and special cases
 3. (1) Schedules I, II, III and U are established for the purposes of the Act.  O. Reg. 58/11, s. 3 (1). (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
under the Food and Drugs Act (Canada). 3. The substances listed in Schedules I, II, III, IV, V, VI, VII and VIII of the Controlled Drugs and Substances Act (Canada).  O. Reg. 58/11, s. 3 (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. 58/11, s. 3 (3). (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. 58/11, s. 3 (4). (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. 58/11, s. 3 (5). (6) The substances listed in Schedules A and B to this Regulation are not drugs for the purposes of the Act.  O. Reg. 58/11, s. 3 (6). (7) Despite clause (f) of the definition of “drug” in subsection 1 (1) of the Act, any substance that is a natural health product containing pseudoephedrine or its salts, or ephedrine or its salts, or any combination of any of them, is a drug for the purposes of the Act.  O. Reg. 58/11, s. 3 (7).
Schedule I, conditions on sale
 4. The following conditions apply to the sale in a pharmacy of a drug referred to in Schedule I: 1. Subject to paragraph 2, a pharmacist must be physically present in the pharmacy. 2. Where the drug is sold in a remote dispensing location, a pharmacist must be physically present either in the remote dispensing location or in the pharmacy that operates the remote dispensing location. 3. There must be a prescription for the drug. 4. The sale of the drug must be approved by a pharmacist. 5. Subject to paragraph 6, the drug shall only be available for sale from the dispensary. 6. Where the drug is sold in a remote dispensing location, the drug shall only be available for sale from the dispensary or from an automated pharmacy system. O. Reg. 58/11, s. 4; O. Reg. 301/12, s. 1.
Schedule II, conditions on sale
 5. The following conditions apply to the sale in a pharmacy of a drug referred to in Schedule II: 1. Subject to paragraph 2, a pharmacist must be physically present in the pharmacy. 2. Where the drug is sold in a remote dispensing location, a pharmacist must be physically present either in the remote dispensing location or in the pharmacy that operates the remote dispensing location. 3. The sale of the drug must be approved by a pharmacist. 4. Subject to paragraph 5, the drug shall only be available for sale from the dispensary. 5. Where the drug is sold in a remote dispensing location, the drug shall only be available for sale from the dispensary or from an automated pharmacy system.  O. Reg. 58/11, s. 5.
Schedule III, conditions on sale
 6. The following conditions apply to the sale in a pharmacy of a drug referred to in Schedule III: 1. Subject to paragraph 2, a pharmacist must be physically present in the pharmacy. 2. Where the drug is sold in a remote dispensing location, a pharmacist must be physically present either in the remote dispensing location or in the pharmacy that operates the remote dispensing location. 3. A pharmacist or intern must be available for consultation with the patient. 4. Subject to paragraph 5, the drug shall only be available for sale in the pharmacy from the dispensary or from an area within 10 metres of the dispensary. 5. Where the drug is sold in a remote dispensing location, the drug shall only be available for sale from an automated pharmacy system, or from an area in the remote dispensing location to which the public does not have access.  O. Reg. 58/11, s. 6. Part III   CERTIFICATES OF ACCREDITATION: ISSUANCE AND RENEWAL
PART III CERTIFICATES OF ACCREDITATION: ISSUANCE AND RENEWAL
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Definition
 7. In this Part, “applicant” means each proposed owner of the pharmacy and, where any proposed owner is, (a) a corporation, other than a non-profit corporation referred to in subsection 142 (5) of the Act, includes each officer and director of the corporation and each shareholder of the corporation who is a member, if that member owns, directly or indirectly, five per cent or more of the voting shares of the corporation, (b) a non-profit corporation as referred to in subsection 142 (5) of the Act, includes each officer and director of that corporation.  O. Reg. 58/11, s. 7.
Additional requirements, remote dispensing location
 9. (1) A person is qualified for the issuance of a certificate of accreditation to establish and operate a pharmacy that permits the operation of remote dispensing locations if all of the following requirements, in addition to those set out in section 8, are met: 1. The additional fees required to be paid for the issuance of a certificate of accreditation that permits the operation of remote dispensing locations have been submitted to the College. 2. Where requested by the Registrar or the Accreditation Committee, an applicant has provided additional information sufficient to determine whether permission to operate remote dispensing locations should be granted. 3. There are reasonable grounds for the belief that the pharmacy will be able to supervise all aspects of the operation of the proposed remote dispensing locations, properly and effectively.  O. Reg. 58/11, s. 9 (1). (2) It is an additional condition for the issuance of a certificate of accreditation that permits the operation of remote dispensing locations that the Registrar or the Accreditation Committee be satisfied that each remote dispensing location meets the additional standards for accreditation as referred to in subsection 20 (3).  O. Reg. 58/11, s. 9 (2).
Deemed reasonable grounds for belief
 10. For the purposes of paragraph 5 of subsection 8 (1), and without limiting its generality, there shall be deemed to be reasonable grounds for the belief that the pharmacy will not be operated with decency, honesty and integrity and in accordance with the law where any one or more of the following has occurred: 1. An applicant made a false or misleading statement or representation in the application or in any information provided to the College in respect of the application. 2. An applicant failed or refused to provide information requested under paragraph 3 or 4 of subsection 8 (1).  O. Reg. 58/11, s. 10.
Issuance, name and address
 11. A certificate of accreditation shall be issued in the specific name of the owner of the pharmacy and for the specific municipal address at which the pharmacy is to be operated.  O. Reg. 58/11, s. 11.
Amendment for remote dispensing locations
 12. (1) A pharmacy whose certificate of accreditation does not permit the operation of remote dispensing locations may apply for an amended certificate of accreditation that permits the operation of remote dispensing locations.  O. Reg. 58/11, s. 12 (1). (2) A pharmacy whose certificate of accreditation permits the operation of remote dispensing locations may apply for an amended certificate of accreditation that permits the operation of additional remote dispensing locations.  O. Reg. 58/11, s. 12 (2). (3) A pharmacy that applies under this section is qualified for the issuance of an amended certificate of accreditation if the requirements set out in subsections 8 (1) and 9 (1) are met, and the conditions set out in subsections 8 (2) and 9 (2) apply to the issuance of an amended certificate of accreditation under this section.  O. Reg. 58/11, s. 12 (3).
Remote dispensing certificate
 13. (1) A certificate of accreditation that permits the operation of remote dispensing locations shall specify the locations of the permitted remote dispensing locations.  O. Reg. 58/11, s. 13 (1). (2) A pharmacy whose certificate of accreditation permits the operation of remote dispensing locations may only operate remote dispensing locations at the specific locations referred to in the certificate of accreditation.  O. Reg. 58/11, s. 13 (2). (3) Only the specific pharmacy whose certificate of accreditation permits the operation of a remote dispensing location at a specific location may operate that remote dispensing location.  O. Reg. 58/11, s. 13 (3). (4) The permission granted in a certificate of accreditation for a pharmacy to operate a remote dispensing location shall be deemed to have been revoked if there is a permanent discontinuance of service at, or closure of, the pharmacy or the remote dispensing location.  O. Reg. 58/11, s. 13 (4).
Expiry of certificates of accreditation
 14. Subject to section 15, every certificate of accreditation automatically expires on the 10th day of May in each year unless renewed on or before that date.  O. Reg. 58/11, s. 14.
Renewal of certificates of accreditation
 15. (1) The Registrar may renew the certificate of accreditation where the Registrar is satisfied that the requirements for renewal have been met or substantially met.  O. Reg. 58/11, s. 15 (1). (2) Where the Registrar is not satisfied that the requirements for renewal have been met or substantially met, or where the Registrar proposes that terms, conditions or limitations be attached to the certificate, the Registrar shall refer the application for renewal to the Accreditation Committee.  O. Reg. 58/11, s. 15 (2). (3) Where the Registrar refers an application for renewal to the Accreditation Committee, the Registrar shall provide to the person responsible for the filing of the application notice in writing of that fact and notice that the holder of the certificate has the right to make a submission in writing to the Accreditation Committee within 30 days of the receipt of the notice by the person responsible for filing.  O. Reg. 58/11, s. 15 (3). (4) Where notice is given by the Registrar under subsection (3), the Registrar shall also provide along with the notice, the reasons why the Registrar, (a) has proposed to refuse to renew the certificate of accreditation; or (b) has proposed that terms, conditions or limitations should be attached to the certificate of accreditation.  O. Reg. 58/11, s. 15 (4). (5) Where the Registrar refers an application for the renewal of a certificate of accreditation to the Accreditation Committee, the certificate of accreditation does not expire until the decision of the Accreditation Committee becomes final.  O. Reg. 58/11, s. 15 (5). (6) After considering the application for renewal and any submission made on behalf of the pharmacy, the Accreditation Committee shall either, (a) direct the Registrar to renew the certificate of accreditation, which renewal may be subject to such terms, conditions and limitations as the Committee considers appropriate; or (b) direct the Registrar not to renew the certificate of accreditation.  O. Reg. 58/11, s. 15 (6). (7) Where the Accreditation Committee directs the Registrar not to renew the certificate of accreditation of a pharmacy, the certificate of accreditation shall be deemed to have expired and be revoked as of the date the decision of the Accreditation Committee becomes final.  O. Reg. 58/11, s. 15 (7). (8) Nothing in this Regulation affects in any way the right to revoke or suspend a certificate of accreditation for non-payment of fees as provided for under subsection 140 (4) of the Act.  O. Reg. 58/11, s. 15 (8).
Removal of terms, conditions and limitations
 17. Where terms, conditions and limitations are imposed on the certificate of accreditation, the Registrar may remove any or all of them, (a) where the Registrar is satisfied that the terms, conditions or limitations have been complied with; or (b) with the approval of the Accreditation Committee.  O. Reg. 58/11, s. 17.
Revocation
 18. (1) The Registrar may propose to the Accreditation Committee the revocation of a certificate of accreditation where the Registrar is satisfied that the certificate was issued or renewed based on the false or misleading information of an applicant.  O. Reg. 58/11, s. 18 (1). (2) Where the Registrar makes a proposal to the Accreditation Committee under subsection (1), the Registrar shall give written notice to the holder of the certificate including, the reasons why the Registrar proposes that the certificate of accreditation be revoked.  O. Reg. 58/11, s. 18 (2). (3) The holder of a certificate that receives a notice referred to in subsection (2) may make a written submission to the Accreditation Committee within 15 days of receiving the notice or such greater period of time as shall be agreed to by either the Registrar or the Accreditation Committee.  O. Reg. 58/11, s. 18 (3). (4) If the requirements of subsections (2) and (3) have been met, the Accreditation Committee may direct the Registrar to revoke a certificate of accreditation where it is satisfied that it was issued or renewed based on the false or misleading information of an applicant and where it is satisfied that it is appropriate to do so.  O. Reg. 58/11, s. 18 (4). PART IV   STANDARDS FOR ACCREDITATION AND OPERATION
PART IV STANDARDS FOR ACCREDITATION AND OPERATION
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Remote dispensing locations
 19. For greater clarity, every standard for accreditation that applies to a pharmacy applies to a remote dispensing location, unless the standard provides otherwise.  O. Reg. 58/11, s. 19.
Standards for accreditation
 20. (1) The standards for accreditation are those set out in sections 21 to 26.  O. Reg. 58/11, s. 20 (1). (2) Every pharmacy shall maintain the standards for accreditation.  O. Reg. 58/11, s. 20 (2). (3) The additional standards for accreditation relative to a remote dispensing location are those set out in sections 27 to 37.  O. Reg. 58/11, s. 20 (3). (4) Every pharmacy whose certificate of accreditation permits the operation of remote dispensing locations shall maintain the additional standards for accreditation.  O. Reg. 58/11, s. 20 (4).
Other requirements
 22. (1) Subject to subsections (2) to (5), every pharmacy must, (a) have a floor area of sufficient size for the safe and orderly operation of the pharmacy, but in any event a floor area of not less than 18.6 square metres; (b) have been constructed and finished in a manner which permits the effective cleaning of all surfaces including the walls, floors and ceilings; (c) have a clearly defined designated area not extending beyond 10 metres from the dispensary for the purposes of facilitating compliance with the condition in paragraph 4 of section 6; (d) have a separate and distinct patient consultation area in the pharmacy offering acoustical privacy in which pharmacists may engage their patients in dialogue about their medications and related matters; and (e) have sufficient shelving, drawers or other suitable fixtures or facilities to allow for the appropriate storage in the pharmacy of all drugs, natural health products and substances and preparations referred to in Schedule U.  O. Reg. 58/11, s. 22 (1). (2) The requirements of clause (1) (a) do not apply to a pharmacy until May 11, 2012, if a certificate of accreditation was issued in respect of the pharmacy before that clause came into force.  O. Reg. 58/11, s. 22 (2). (3) The Accreditation Committee may exempt a pharmacy from meeting the requirements of clause (1) (a) for a specified period of time if the pharmacy satisfies the Accreditation Committee that despite all reasonable efforts the pharmacy is unable to meet those requirements.  O. Reg. 58/11, s. 22 (3). (4) The requirements of clause (1) (a) do not apply to a remote dispensing location in which all drugs are dispensed or distributed from an automated pharmacy system.  O. Reg. 58/11, s. 22 (4). (5) The requirements of clause (1) (c) do not apply to a remote dispensing location.  O. Reg. 58/11, s. 22 (5).
Sterile compounding
 23. Every pharmacy in which sterile products are compounded must have, (a) a well lit and appropriately ventilated preparation area, (i) which is not accessible to the public, (ii) which is specifically designed for sterile compounding, and (iii) which contains a counter constructed of a non-porous surface capable of being appropriately cleaned; (b) a sink with a supply of hot and cold running water located in close proximity to the sterile compounding area; (c) adequate and secure storage space to keep drugs, medications and equipment used in sterile compounding segregated from the balance of the drugs, medications and equipment used in the dispensary; and (d) such other facilities and equipment as are reasonably necessary in the circumstances to allow the members engaged in the practice of the profession in the pharmacy to compound sterile products.  O. Reg. 58/11, s. 23.
Standards for operation
 24. (1) The pharmacy including all rooms and passage ways must be, (a) kept in a clean and orderly fashion; (b) maintained in a good state of repair; and (c) kept well lit and ventilated.  O. Reg. 58/11, s. 24 (1). (2) All equipment including the appliances in the pharmacy must be, (a) kept in a clean and orderly fashion; and (b) maintained in a good state of repair.  O. Reg. 58/11, s. 24 (2). (3) All furniture and fixtures including storage facilities in the pharmacy must be, (a) kept clean; and (b) maintained in a good state of repair.  O. Reg. 58/11, s. 24 (3). (4) The dispensary and every room where drugs and other medications are compounded, dispensed or stored must be kept in an orderly fashion and free from materials and equipment not regularly used in the compounding, dispensing or storage of drugs and other medications.  O. Reg. 58/11, s. 24 (4). (5) The pharmacy must be designed, constructed and maintained so as to ensure the integrity, and the safe and appropriate storage, of all drugs and other medications.  O. Reg. 58/11, s. 24 (5). (6) The pharmacy must have and maintain a program to ensure, (a) the regular cleaning of the pharmacy including all premises, furniture, equipment and appliances, including automated pharmacy systems; (b) the regular maintenance of all equipment and appliances, including automated pharmacy systems; (c) the safe and appropriate disposal of waste and expired consumables, including drugs and other medications; and (d) the appropriate hygienic behaviour of all persons performing dispensing or compounding activities including, (i) the wearing of suitable attire and protective coverings, and (ii) procedures for appropriate hand washing.  O. Reg. 58/11, s. 24 (6). (7) The program referred to in subsection (6) must be set out in writing and must comply in all respects with this Regulation as well as with any applicable federal, provincial or municipal laws.  O. Reg. 58/11, s. 24 (7).
Availability of publications
 25. (1) The pharmacy must provide members working in the pharmacy with access to a current edition of the following publications: 1. A Compendium of Pharmaceutical Specialties or other comparable compendium approved by the Council. 2. A drug interaction publication approved by the Council. 3. A pharmacotherapeutics publication approved by the Council. 4. Publications approved by the Council from a subscription maintained by the pharmacy in respect to drug information services. 5. A patient counselling publication approved by the Council. 6. The Act and its regulations. 7. The Regulated Health Professions Act, 1991 and its regulations. 8. The Pharmacy Act, 1991 and its regulations. 9. The Ontario Drug Benefit Act and its regulations. 10. The Drug Interchangeability and Dispensing Fee Act and its regulations. 11. The Controlled Drugs and Substances Act (Canada) and its regulations. 12. The Food and Drugs Act (Canada) and its regulations. 13. Any other publication reasonably required by members to meet the standards of practice of the profession.  O. Reg. 58/11, s. 25 (1). (2) If any of the publications in subsection (1) are not readily available through a computer system, a current edition must be made physically available in the pharmacy.  O. Reg. 58/11, s. 25 (2). (3) This section does not apply to a remote dispensing location in which all drugs are dispensed or distributed from an automated pharmacy system.  O. Reg. 58/11, s. 25 (3).
Point of Care
 26. Each pharmacy must have the College’s Point of Care symbol in its unaltered trademarked form prominently and appropriately displayed so as to be easily visible to the public either before entering the pharmacy or immediately after entering.  O. Reg. 58/11, s. 26.
Location and access, remote dispensing locations
 27. Every remote dispensing location must be, (a) located indoors, in a well-lit and well-ventilated area that is appropriate for the provision of health care services; and (b) accessible to the public only during the hours that a pharmacist is physically present either in the remote dispensing location or in the pharmacy that operates the remote dispensing location.  O. Reg. 58/11, s. 27.
Safety and security, remote dispensing locations
 28. (1) Every automated pharmacy system that is located in a remote dispensing location must be designed, constructed and maintained so as to ensure that, (a) all drugs and other medications requiring refrigeration are refrigerated at a temperature between 2 degrees Celsius and 8 degrees Celsius; and (b) any refrigerator has the facility to accurately display the temperature inside the refrigerator or alternatively have maintained in it a device which accurately displays the temperature inside of the refrigerator.  O. Reg. 58/11, s. 28 (1). (2) Every remote dispensing location must be designed, constructed and maintained so as to prevent unauthorized access.  O. Reg. 58/11, s. 28 (2). (3) Every remote dispensing location must be protected by an alarm system that will provide immediate notification to the designated manager or his or her delegate of, (a) any theft or attempted theft of the drugs or other medications; (b) any tampering or attempted tampering with, or alteration or attempted alteration of, the remote dispensing location or any of its equipment; or (c) any reduction below 2 degrees Celsius, or any increase above 8 degrees Celsius, of the temperature inside any of its refrigerators.  O. Reg. 58/11, s. 28 (3). (4) Upon the receipt of notification referred to in subsection (3), all dispensing at the remote dispensing location shall cease immediately and shall not resume until the designated manager is satisfied that the remote dispensing location, including any automated pharmacy system, has been fully secured and is fully operational.  O. Reg. 58/11, s. 28 (4).
Safety and security, remote dispensing locations
 29. Every automated pharmacy system that is contained in a remote dispensing location must, (a) at all times be locked by key, combination or other mechanical or electronic means so as to prevent unauthorized access; (b) be sufficiently affixed within the remote dispensing location so that it cannot be moved by unauthorized persons; (c) use bar-coding, micro chips or other technologies that ensure that drugs are accurately loaded into the automated pharmacy system, and that verify that the correct drugs are selected robotically during the dispensing process and that correct labels are affixed to the containers for the drugs; and (d) employ technology for the creation and transmission of a digitally scanned image of a paper-based prescription, which technology must have been approved by the Council as, (i) enabling a member who is practising at the pharmacy that receives the transmission to authenticate the prescription, including the prescriber’s signature, and to verify that the prescription has not been altered; (ii) employing reasonable technical and administrative safeguards, including strong encryption of data during transmission or storage on mobile media, to ensure the confidentiality and integrity of all personal information contained in the prescription or its accompanying data streams of audio-visual communications; and (iii) employing reasonable technical and administrative safeguards, including strong encryption and authentication, to ensure that only the pharmacy that operates the remote dispensing location can exercise remote control of the automated pharmacy system.  O. Reg. 58/11, s. 29.
Accountability, remote dispensing locations
 30. (1) Only the designated manager of a pharmacy that operates a remote dispensing location, or his or her delegate, shall load drugs into an automated pharmacy system.  O. Reg. 58/11, s. 30 (1). (2) The designated manager is responsible to ensure the accurate loading, integrity, and safe and appropriate storage, of all drugs that are loaded into an automated pharmacy system.  O. Reg. 58/11, s. 30 (2).
Drug distribution, remote dispensing locations
 31. Every pharmacy that operates one or more remote dispensing locations must, (a) have systems in place to track and maintain an audit trail of the acquisition and all movement of inventory of drugs and other medications between and among the pharmacy and its remote dispensing locations; and (b) maintain records and other documents of all such acquisition and movement of inventory.  O. Reg. 58/11, s. 31.
Audio-Visual link, remote dispensing locations
 32. (1) Every remote dispensing location at which a pharmacist is not physically present must be equipped with a live, two-way audio-visual link that permits dialogue and communication between the patient and a pharmacist who is physically present in the pharmacy that operates the remote dispensing location.  O. Reg. 58/11, s. 32 (1). (2) In the event of any disruption of the audio-visual link between a remote dispensing location and the pharmacy that operates it, all remote dispensing at the remote dispensing location shall cease immediately and shall not resume until the audio-visual link has been fully restored.  O. Reg. 58/11, s. 32 (2).
Controlled drugs, narcotic drugs and targeted substances, remote dispensing locations
 33. No controlled drugs, narcotic drugs, verbal prescription narcotics or targeted substances shall be located at or available from a remote dispensing location.  O. Reg. 58/11, s. 33.
Signage
 34. The following shall be prominently and appropriately displayed in every remote dispensing location, so as to be easily visible to the public either before entering the remote dispensing location or immediately after entering: 1. The College’s Point of Care symbol, as required by section 26. 2. The name, address, accreditation number and telephone number of the pharmacy that operates the remote dispensing location, as well as the name of the pharmacy’s designated manager. 3. Notification that the patient records for every patient who purchases drugs at the remote dispensing location are located at the pharmacy mentioned in paragraph 2. 4. The notices required by the regulations under the Drug Interchangeability and Dispensing Fee Act.  O. Reg. 58/11, s. 34.
Marking of containers, remote dispensing locations
 35. In addition to what is required under applicable legislation and regulations, the container in which a drug is dispensed from a remote dispensing location pursuant to a prescription must be marked with, (a) the name, address and telephone number of the pharmacy that operates the remote dispensing location; (b) a unique identifier, attached to the prescription number, that identifies the drug as having been dispensed from a remote dispensing location that is operated by the pharmacy; (c) the municipal address of the remote dispensing location; and (d) a toll-free telephone number at which the patient may contact the pharmacy that operates the remote dispensing location regarding the drug, during business hours.  O. Reg. 58/11, s. 35.
On-site inspection by pharmacy of remote dispensing locations
 36. (1) Every pharmacy that operates a remote dispensing location shall conduct an on-site inspection of the remote dispensing location at least once in every 30-day period.  O. Reg. 58/11, s. 36 (1). (2) The on-site inspection shall be carried out by the designated manager of the pharmacy or his or her delegate, who shall be a pharmacist or a pharmacy technician who does not regularly work at the remote dispensing location.  O. Reg. 58/11, s. 36 (2). (3) The inspection shall include, (a) testing of all automated pharmacy systems and other equipment, including audio-visual links, to ensure that the integrity of the system is being maintained; (b) inspection of the inventory of drugs and other medications at the remote dispensing location and prompt removal of any damaged or outdated products from the inventory; and (c) verification that policies and procedures are being followed and that the remote dispensing location is being operated in accordance with the Act and this Regulation.  O. Reg. 58/11, s. 36 (3). (4) The findings from each on-site inspection shall be recorded and shall be maintained at the pharmacy in accordance with the record-keeping requirements under Part X.  O. Reg. 58/11, s. 36 (4).
Policies and procedures, remote dispensing locations
 37. Every pharmacy that operates a remote dispensing location shall establish and maintain written policies and procedures for the remote dispensing location that address, at minimum, (a) operation and maintenance of all equipment and processes including any automated pharmacy systems; (b) accuracy of loading of drugs into the automated pharmacy system; (c) safety; and (d) maintenance of patient confidentiality and privacy of health information and access.  O. Reg. 58/11, s. 37. PART V   LOCK AND LEAVE
PART V LOCK AND LEAVE
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Lock and leave
 38. (1) Subject to subsection (8), a pharmacy that wishes to operate without the supervision of a pharmacist who is physically present, pursuant to subsection 146 (2) of the Act, shall apply to the Registrar for approval to do so by completing an application in the form provided by the Registrar and submitting it together with the requested supporting documentation and the fees set out in the by-laws.  O. Reg. 58/11, s. 38 (1). (2) It is a requirement of the granting of approval under subsection (1) that the pharmacy has the means to completely restrict the public, by physical impediments, from access to any drugs referred to in Schedule I, II or III that are in the pharmacy.  O. Reg. 58/11, s. 38 (2). (3) Upon receipt of an application under subsection (1), the Registrar shall arrange for an inspection of the pharmacy by an inspector of the College, and at that inspection the pharmacy shall demonstrate how it would be able to meet the requirements of subsection (2).  O. Reg. 58/11, s. 38 (3). (4) The inspector shall file an inspection report with the Registrar within a reasonable period of time following the inspection.  O. Reg. 58/11, s. 38 (4). (5) If, after receiving the inspection report, the Registrar is satisfied that the pharmacy has met the requirements of subsection (2), the Registrar shall give the approval required by subsection (1).  O. Reg. 58/11, s. 38 (5). (6) If the Registrar proposes to refuse to give the approval, the Registrar shall refer the application to the Accreditation Committee who, after considering the matter, shall direct the Registrar whether to give or refuse the approval.  O. Reg. 58/11, s. 38 (6). (7) A pharmacy that obtains approval under this section shall only operate without the supervision of a pharmacist who is physically present, in accordance with the provisions of subsection 146 (2) of the Act, if the pharmacy completely restricts the public, by physical impediments, from access to any drugs referred to in Schedule I, II or III that are in the pharmacy.  O. Reg. 58/11, s. 38 (7). (8) A pharmacy that, as of the day this Regulation comes into force, has been operating from time to time without the supervision of a pharmacist who is physically present in accordance with the provisions of subsection 146 (2) of the Act, may continue to so operate without applying to the Registrar for approval under subsection (1), so long as, when it so operates, the pharmacy completely restricts the public, by physical impediments, from access to any drugs referred to in Schedule I, II or III that are in the pharmacy.  O. Reg. 58/11, s. 38 (8). PART VI   PRESCRIPTIONS, REFILLS AND TRANSFERS
PART VI PRESCRIPTIONS, REFILLS AND TRANSFERS
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Federal law prevails
 39. Where the provisions of this Part are inconsistent with a law of Canada governing the dispensing, refilling or transfer of prescriptions, including those related to a targeted substance, the law of Canada shall prevail and the provisions of this Part to the extent they are inconsistent with that law shall not apply.  O. Reg. 58/11, s. 39.
Rules re dispensing
 40. (1) A drug shall not be dispensed in a pharmacy pursuant to a prescription unless the prescription has been authorized by a prescriber. O. Reg. 58/11, s. 40 (1); O. Reg. 301/12, s. 2 (1). (2) Subject to subsections (3) and (4), the authorization required by subsection (1) may be given verbally or by signature.  O. Reg. 58/11, s. 40 (2). (3) A drug shall not be dispensed in a pharmacy pursuant to a prescription given verbally unless all of the following conditions have been met: 1. The drug is not a narcotic drug. (This does not prevent the dispensing of a verbal prescription narcotic.) 2. The verbal direction was received by a member who was practising at the pharmacy. 3. The member receiving the verbal direction recorded, i. the date the verbal direction was received, ii. the number of refills authorized by the verbal direction, and iii. the name of the member who received the verbal direction. 4. The prescription was recorded and signed by the member receiving the verbal direction.  O. Reg. 58/11, s. 40 (3). (4) A drug shall not be dispensed in a pharmacy pursuant to a prescription given by signature that has been transmitted by means of fax, electronic mail or other form of electronic transmission, except where a member who is practising at the pharmacy either, (a) has received the prescription directly from the prescriber by means of a transmission process that ensures the security, confidentiality and integrity of all personal information contained in the prescription and, before dispensing drugs pursuant to the prescription, has verified that the prescription, including the prescriber’s signature, is authentic and has not been altered; or (b) has received the prescription through an automated pharmacy system that is contained in a remote dispensing location and that employs technology for the creation and transmission of a digitally scanned image of a paper-based prescription that has been approved in accordance with clause 29 (d).  O. Reg. 58/11, s. 40 (4). (5) A drug shall not be dispensed in a pharmacy pursuant to a transferred prescription unless the provisions of section 43 have been complied with.  O. Reg. 58/11, s. 40 (5). (6) For greater certainty, this section also applies where a prescriber authorizes a refill in an original prescription or authorizes a repeat of a prescription previously given. O. Reg. 301/12, s. 2 (2). 41. Revoked: O. Reg. 301/12, s. 3. 42. Revoked: O. Reg. 301/12, s. 3.
PART VII CHILD RESISTANT PACKAGING
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Definition
 44. In this Part, “child resistant package” means a container or a package that meets the standards for child resistant packages prescribed by the Food and Drug Regulations under the Food and Drugs Act (Canada).  O. Reg. 58/11, s. 44.
Child resistant package
 45. Every person who fills a prescription shall dispense the drug in a child resistant package unless, (a) the prescriber or the person who presents the prescription directs otherwise; (b) in the professional judgment of the member who is responsible for the dispensing of the drug, it is advisable not to use a child resistant package given the particular circumstances; or (c) a child resistant package is not suitable because of the physical form of the drug.  O. Reg. 58/11, s. 45. PART VIII   ADVERTISING
PART VIII ADVERTISING
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Definitions
 46. In this Part and for the purposes of section 50, “advertisement” includes an announcement, directory listing or other form of communication similar to an advertisement; “drug services” means one or more of the compounding, dispensing or sale by retail of drugs or the provision of information or advice with respect to drugs.  O. Reg. 58/11, s. 46.
ODBA information
 48. Nothing in this Part prohibits 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. 58/11, s. 48. PART IX   PROPRIETARY MISCONDUCT/CONFLICT OF INTEREST
PART IX PROPRIETARY MISCONDUCT/CONFLICT OF INTEREST
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Definition
 49. In this Part, “prescription information” means information recorded in a pharmacy that relates to the prescribing and dispensing of drugs pursuant to prescriptions, but does not include the name of patients or any information that would be reasonably expected to identify any patient.  O. Reg. 58/11, s. 49.
Disclosure of prescription information
 51. A pharmacy may disclose prescription information if all of the following conditions have been met: 1. The disclosure is made in accordance with a written agreement between the holder of the certificate in respect of the pharmacy and the person to whom the disclosure is made, and that agreement requires that any prescription information that is disclosed will not include anything that would be reasonably expected to identify a patient. 2. The designated manager of the pharmacy is aware of the existence of the written agreement referred to in paragraph 1.  O. Reg. 58/11, s. 51.
Conflict of interest, definitions
 52. In this section and section 53, “benefit” means any incentive or inducement of more than nominal value, whether direct or indirect, and includes a rebate, credit or gift; “child” means a child within the meaning of the Family Law Act; “owner” means the owner of the pharmacy and where the owner of the pharmacy is, (a) a corporation other than a non-profit corporation referred to in subsection 142 (5) of the Act, includes each officer and director of the corporation and each shareholder of the corporation who is a member if that member owns, directly or indirectly, five per cent or more of the voting shares of that corporation, or (b) a non-profit corporation as referred to in subsection 142 (5) of the Act, includes each officer and director of that corporation; “parent” means a parent within the meaning of the Family Law Act; “related corporation” means a corporation wholly or substantially owned or controlled, whether directly or indirectly, by the owner of a pharmacy or a related person of the owner of a pharmacy; “related person” means the owner of the pharmacy and any person who has one of the following relationships to the owner or to the spouse of the owner of the pharmacy, whether based on blood, marriage, common-law or adoption: 1. A child or the spouse of a child. 2. A grandchild or the spouse of a grandchild. 3. A parent or the spouse of a parent. 4. A grandparent or the spouse of a grandparent. 5. A sibling or spouse of a sibling; “spouse” means, (a) a spouse as defined in section 1 of the Family Law Act, or (b) either of two persons who live together in a conjugal relationship outside marriage.  O. Reg. 58/11, s. 52.
PART X RECORDKEEPING
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Recordkeeping
 54. (1) A pharmacy shall, (a) maintain the records and documents required under the Act and its regulations, in the required manner; (b) maintain the records and documents required to be made by members under the Pharmacy Act, 1991 and its regulations and to meet the standards of practice of the profession, in the required manner; (c) maintain the records and documents required to be made by the pharmacy or members practising at the pharmacy under any federal legislation governing the purchase or sale of drugs in the required manner; (d) make and maintain a scanned electronic copy of every original written prescription pursuant to which a drug is dispensed as well as a copy of the information required by subsection 156 (1) of the Act and retain those copies as part of the patient record; (e) make the original prescriptions and other records referred to in clause (a), (b), (c) or (d) available for inspection by an inspector of the College; and (f) assist the inspector to make or obtain copies of any records or documents referred to in clause (a), (b), (c) or (d), if requested by the inspector.  O. Reg. 58/11, s. 54 (1). (2) The requirements of clause (1) (d) do not apply to a pharmacy until May 11, 2012, if a certificate of accreditation was issued in respect of the pharmacy before that clause came into force.  O. Reg. 58/11, s. 54 (2). (3) A pharmacy shall maintain the records and documents referred to in subsection (1) in a computer system where possible and, where that is not possible, shall maintain them in a systematic manner that allows for their easy retrieval.  O. Reg. 58/11, s. 54 (3).
Length of retention
 55. (1) Subject to subsection (3), records and other documents relating to the care of a patient, other than original written prescriptions, shall be maintained for a period of at least 10 years from the last recorded professional pharmacy service provided to the patient or until 10 years after the day on which the patient reached or would have reached the age of 18 years, whichever is longer.  O. Reg. 58/11, s. 55 (1). (2) All prescription records required to be maintained by the Act shall be maintained for the period specified in the Act or if no period is specified in the Act, for the period set out in subsection (1).  O. Reg. 58/11, s. 55 (2). (3) While an audit or inspection is being performed by or on behalf of the College in respect of the pharmacy or in respect of a member who is practising at the pharmacy, no record or document shall be destroyed until the audit or inspection is completed, except with the written approval of the Registrar.  O. Reg. 58/11, s. 55 (3).
Safeguards
 56. (1) A pharmacy shall ensure that appropriate safeguards are installed and maintained to ensure that the records and documents required to be kept by a pharmacy which contain personal health information are collected, recorded, used, stored, handled and destroyed in a manner that protects confidentiality and privacy.  O. Reg. 58/11, s. 56 (1). (2) The pharmacy shall ensure that all records and documents that are not stored in a computer system, (a) are legible; (b) are made using non-erasable ink; (c) are readily retrievable; and (d) are stored securely and in an appropriate manner to provide reasonable protection from damage.  O. Reg. 58/11, s. 56 (2).
Backup
 57. A pharmacy shall ensure that, (a) it has adequate backup and recovery systems to back up and recover information stored in its computer system; (b) records and documents stored in a computer system are backed up at least once a day, unless the computer system was not used during that day; (c) a copy of the backup is stored off site or in a fireproof and theft-resistant safe; (d) all copies of the backup are kept secure to avoid unauthorized acts, use or disclosure; and (e) one copy of the backup is stored in a manner that allows for its ready retrieval in the event it is required to continue the orderly operation of the pharmacy.  O. Reg. 58/11, s. 57.
Remote dispensing locations
 58. (1) The obligations to which a pharmacy is subject under this Part apply with respect to the records, documents and information of every remote dispensing location that the pharmacy operates.  O. Reg. 58/11, s. 58 (1). (2) In addition, a pharmacy that operates a remote dispensing location shall maintain the following records and documents with respect to the remote dispensing location, (a) a record of all testing done on any automated pharmacy system prior to first use and of all on-site inspections conducted pursuant to section 36; (b) a record of all maintenance done on any automated pharmacy system; (c) a record of all technical malfunctions that occur in any automated pharmacy system that includes the cause of the malfunction, and the amount of time and the steps taken to repair it; (d) all documentation received from the manufacturer or vendor of an automated pharmacy system, including the name of the manufacturer, the model number, a description of how the machine operates and an operating manual; and (e) all written policies and procedures with respect to the operation of automated pharmacy systems at the remote dispensing location.  O. Reg. 58/11, s. 58 (2). PART XI   INFORMATION, EXAMINATION AND AUDIT
PART XI INFORMATION, EXAMINATION AND AUDIT
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Information return
 59. A pharmacy shall, within 30 days of a written request from the Registrar, complete and file with the College a return in Form 1 (Return by Owner of a Pharmacy) as set out on the website of the College.  O. Reg. 58/11, s. 59.