ontario regulation 155/13
made under the
Public Hospitals Act
Made: May 13, 2013
Approved: May 14, 2013
Filed: May 15, 2013
Published on e-Laws: May 15, 2013
Printed in The Ontario Gazette: June 1, 2013
Amending Reg. 965 of R.R.O. 1990
1. Regulation 965 of the Revised Regulations of Ontario, 1990 is amended by adding the following section:
10.1 (1) No hospital shall, directly or indirectly, purchase or otherwise obtain a drug except from,
(a) a pharmacy within the meaning of the Drug and Pharmacies Regulation Act in respect of which a valid certificate of accreditation has been issued under that Act;
(b) a person who, in connection with the place from which the drug is provided, holds a valid establishment licence or other approval that may be required in connection with the manufacture, fabrication, packaging, labelling, distribution, testing or importing of the drug under the Food and Drugs Act (Canada);
(c) a pharmacy accredited in accordance with the applicable governing legislation in a province or territory of Canada;
(d) a person who, in connection with the place from which the drug is provided, operates a drug preparation premises within the meaning of Part IX of Ontario Regulation 202/94 (General) made under the Pharmacy Act, 1991 that passed its latest inspection under that Part;
(e) a person who,
(i) purchased or otherwise obtained the drug from a person or entity mentioned in clause (a), (b), (c) or (d), and
(ii) has not reconstituted, diluted or otherwise prepared the drug, or combined, admixed or mixed it together with another substance;
(f) a person who,
(i) purchases or otherwise obtains goods or services for the hospital, and
(ii) has purchased or obtained the drug from a person or entity mentioned in clause (a), (b), (c), (d) or (e);
(g) the Government of Ontario or the Government of Canada or a person acting on behalf of the Government of Ontario or the Government of Canada;
(h) another hospital;
(i) a person conducting a clinical trial authorized pursuant to Division 5 of Part C of the Food and Drug Regulations under the Food and Drugs Act
(j) a person named in a letter of authorization pursuant to section C.08.010 of the Food and Drug Regulations under the Food and Drugs Act
(k) a patient who supplies their own drug; or
(l) a person approved by the Minister in accordance with subsection (2).
(2) The Minister may approve a person for the purposes of clause (1) (l), where the Minister is satisfied that,
(a) the person has demonstrated that they can supply the drug to a hospital in a safe manner; and
(b) it is in the public interest to do so.
(3) For greater certainty, where a hospital purchases a drug from a party and has it mixed, compounded or otherwise prepared by a third party, it shall be considered to have obtained the drug from the third party for the purposes of this section.
(4) Subsection (1) does not apply to a hospital if a declaration of emergency made under the Emergency Management and Civil Protection Act is in effect in the area in which the hospital is located.
(5) In this section,
“drug” means a substance or a preparation containing a substance referred to in clauses (a) to (d) of the definition of “drug” in subsection 1 (1) of the Drug and Pharmacies Regulation Act, but does not include,
(a) a substance or preparation referred to in those clauses that is manufactured, sold or represented for use in animals or fowl, or
(b) a substance or preparation referred to in clause (e), (f), (g), (h) or (i) of that definition.
2. This Regulation comes into force 120 days after the day it is filed.
Pris par :
La ministre de la Santé et des Soins de longue durée,
Deborah Drake Matthews
Minister of Health and Long-Term Care
Date made: May 13, 2013.
Pris le : 13 mai 2013.