161 (1) Subject to the approval of the Lieutenant Governor in Council, the Council may make regulations, (a)  establishing Schedules I, II, III and U for the purposes of this Act, and prescribing the substances that are to be included in those Schedules; (b)  naming or identifying substances for the purposes of the definition of “drug” in subsection 1 (1) and specifying the provisions of this Act that shall apply in respect of such substances; (c)  naming substances and preparations that are not drugs for the purposes of the definition of “drug” in subsection 1 (1); (c.1)  naming publications for the purposes of the definition of “drug” in subsection 1 (1) and specifying the provisions of this Act that shall apply in respect of substances named in those publications; (c.2)  governing matters relating to the sale in pharmacies of drugs or other specified substances or preparations; (d)  prescribing the percentage of any substance to be contained in any preparation referred to in any Schedule; (e)  prescribing the manner in which prescriptions shall be given in respect of the drugs referred to in Schedule I and the conditions under which such prescriptions may be given; (f)  authorizing the refilling of prescriptions without further prescription and prescribing the conditions under which prescriptions may be refilled without further prescription; (g)  governing the manner in which records shall be kept of the purchase and sale of drugs or of any category or class of drug; (h)  pertaining to the transfer of prescriptions and the records to be kept by the transferor and the transferee; (i), (j) Repealed:  2007, c. 10, Sched. L, s. 25 (4). (j.1)  governing the designation of designated managers; (k)  providing for the establishment and maintenance of patient record systems; (k.1)  prescribing books and records to be kept and returns to be made and information to be furnished with respect to pharmacies and providing for the examination and audit of such books and records; (k.2)  respecting the promotion or advertising of pharmacies and respecting advertising by operators of pharmacies; (l)  prescribing the types of containers to be used for containing any drug and the designs, specifications and labelling of containers used for containing any drug; (l.1)  establishing one or more separate classes of certificates of accreditation with respect to pharmacies, hospital pharmacies or institutional pharmacies, setting terms, conditions and limitations with respect to such classes, and requiring compliance with those terms, conditions and limitations; (l.2)  respecting the operation of hospital pharmacies and clarifying the application to hospital pharmacies of the provisions set out in section 119; (l.3)  respecting the operation of institutional pharmacies and clarifying the application to institutional pharmacies of the provisions of this Act that apply to them by virtue of their designating regulations; (m)  prescribing standards for accreditation of pharmacies including their operation and the maintenance, space, equipment and facilities required therefor; (m.1)  defining and governing the meaning of “remote dispensing location” for the purposes of this Act and the regulations or any provision of this Act or the regulations; (m.2)  prescribing standards for accreditation applicable to remote dispensing locations, including their operation and the maintenance, space, equipment and facilities required therefore; (m.3)  establishing requirements for and governing remote dispensing locations, their owners and operators and their operation, and clarifying the application of this Act with respect to remote dispensing locations, their owners and operators; (n)  providing for applications for certificates of accreditation of pharmacies, the issuance, suspension, revocation, expiration and renewal of such certificates, and anything ancillary to such issuance, suspension, revocation, expiration and renewal; (o), (p)  Repealed:  1998, c. 18, Sched. G, s. 49 (14). (q)  prescribing standards for the subdivision of premises so that drugs are restricted to a specified area and so that the part of the premises to which the drugs are restricted may be rendered not accessible to the public, while the other part remains open; (r)  regulating the handling, location and storage of drugs in a pharmacy; (s)  regulating the use of containers in which drugs may be dispensed; (t)  designating organizations to test, certify and designate containers that meet standards approved by the Council for such purposes as may be specified in the regulations, and requiring the use of containers that are so certified and designated except under such circumstances as are prescribed; (u)  defining “proprietary misconduct” for the purposes of this Act and governing what constitutes an act of proprietary misconduct.  R.S.O. 1990, c. H.4, s. 161 (1); 1998, c. 18, Sched. G, s. 49 (12-14, 18); 2007, c. 10, Sched. L, s. 25 (1-8); 2009, c. 26, s. 8 (8); 2014, c. 14, Sched. 2, s. 5 (1). Note:  The following applies with respect to regulations respecting fees made under clause 161 (1) (n) and regulations made under clause 161 (1) (o) or (p) that are in force immediately before February 1, 1999.  Despite the coming into force of the Statutes of Ontario, 1998, chapter 18, Schedule G, subsections 49 (13) and (14) (repealing the authority under which the regulations are made), the regulations shall be deemed to continue in force until they are revoked by the authority that made them.  See:  1998, c. 18, Sched. G, ss. 49 (15, 16). Note:  A reference to by-laws in the Act shall be deemed to include a reference to regulations which are deemed to continue in force under the Statutes of Ontario, 1998, chapter 18, Schedule G, subsection 49 (16).  See:  1998, c. 18, Sched. G, s. 49 (17). Incorporation by reference (2) A regulation under subsection (1) may adopt by reference, in whole or in part and with such changes as may be necessary, any document or publication made by a body or organization independent of the College and require compliance with the document or publication adopted.  1998, c. 18, Sched. G, s. 49 (19); 2007, c. 10, Sched. L, s. 25 (9). Note:  The following applies with respect to regulations made under subsection (2) that are in force immediately before February 1, 1999.  Despite the coming into force of the Statutes of Ontario, 1998, chapter 18, Schedule G, subsections 49 (13) and (14) (repealing the authority under which the regulations are made), the regulations shall be deemed to continue in force until they are revoked by the authority that made them.  See:  1998, c. 18, Sched. G, ss. 49 (15, 16). Note:  A reference to by-laws in the Act shall be deemed to include a reference to regulations which are deemed to continue in force under the Statutes of Ontario, 1998, chapter 18, Schedule G, subsection 49 (16).  See:  1998, c. 18, Sched. G, s. 49 (17). Rolling incorporation (3) If a regulation under subsection (2) so provides, a  document or publication adopted by reference shall be a reference to it, as amended from time to time, and whether the amendment was made before or after the regulation was made.  1998, c. 18, Sched. G, s. 49 (19). Copies available for inspection (4) A copy of a document or publication adopted by reference under subsection (2) shall be available for public inspection during normal business hours in the office of the College and shall, if it exists in electronic format, be posted on the College’s website or made available through a hyperlink at the College’s website.  1998, c. 18, Sched. G, s. 49 (19); 2007, c. 10, Sched. L, s. 25 (10). Circulation (5) A regulation shall not be made under subsection (1) unless the proposed regulation is circulated to every person who holds a valid certificate of accreditation at least 60 days before it is approved by the Council. 2014, c. 14, Sched. 2, s. 5 (2). Same (6) Subsection (5) does not apply to a regulation if the Minister required that the Council make the regulation under clause 5 (1) (c) of the Regulated Health Professions Act, 1991. 2014, c. 14, Sched. 2, s. 5 (2). Exception (7) Despite subsection (5), the Council may, with the approval of the Minister, exempt a regulation from the requirement that it be circulated or abridge the 60-day period referred to in subsection (5) to such lesser period as the Minister may determine. 2014, c. 14, Sched. 2, s. 5 (2). Section Amendments with date in force (d/m/y) 1998, c. 18, Sched. G, s. 49 (12-14, 18, 19) - 01/02/1999 2007, c. 10, Sched. L, s. 25 (1-4) - 04/06/2008; 2007, c. 10, Sched. L, s. 25 (5-10) - 04/06/2007 2009, c. 26, s. 8 (8) - 14/03/2011 2014, c. 14, Sched. 2, s. 5 (1, 2) - 01/08/2016 Enforcement