O. Reg. 173/08: GENERAL

 

ontario regulation 173/08

made under the

drug and pharmacies regulation act

Made: May 3, 2008
Approved: June 4, 2008
Filed: June 4, 2008
Published on e-Laws: June 5, 2008
Printed in The Ontario Gazette: June 21, 2008

Amending O. Reg. 297/96

(General)

1. Section 1 of Ontario Regulation 297/96 is amended by adding the following definition:

“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;

2. Section 2 of the Regulation is revoked and the following substituted:

2. (1) Schedules I, II, III and U are established for the purposes of the Act.

(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).

(3) The substances listed in Schedule II of the Manual are prescribed as being included in Schedule II for the purposes of the Act.

(4) The substances listed in Schedule III of the Manual are prescribed as being included in Schedule III for the purposes of the Act.

(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.

(6) The substances listed in Schedules A and B to this Regulation are not drugs for the purposes of the Act.

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.

(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.

(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.

3. (1) Item 19 of Schedule A to the Regulation is revoked.

(2) Item 23 of Schedule A to the Regulation is amended by striking out “Calcium gluconate” and substituting “Calcium gluconate, except in injectable form for parenteral nutrition”.

(3) Item 34 of Schedule A to the Regulation is amended by striking out “Copper sulfate” and substituting “Copper sulfate, except in injectable form for parenteral nutrition”.

(4) Item 79 of Schedule A to the Regulation is amended by striking out “Pancreatin” and substituting “Pancreatin, except in products for the treatment of established pancreatic insufficiency”.

(5) Item 99 of Schedule A to the Regulation is amended by striking out “Sodium chloride” and substituting “Sodium chloride, except in injectable form for parenteral nutrition or single ingredient solutions for parenteral or ophthalmic use in concentrations of more than 0.9% (note: does not apply to contact lens solutions intended to be rinsed off prior to insertion into eye)”.

(6) Item 100 of Schedule A to the Regulation is amended by striking out “Sodium citrate” and substituting “Sodium citrate, except for parenteral use”.

4. (1) Item 59 of Part I of Schedule B to the Regulation is amended by adding “for use in lozenges only” after “hydrochloride”.

(2) Item 82 of Part I of Schedule B to the Regulation is amended by striking out “Magnesium citrate” and substituting “Magnesium citrate except for cathartics”.

(3) Item 89 of Part I of Schedule B to the Regulation is amended by adding “(in liquid dosage forms in concentrations up to and including 30%)” at the end.

(4) Item 91 of Part I of Schedule B to the Regulation is amended by striking out “Methylene blue” and substituting “Methylene blue except for parenteral use”.

(5) Items 105 and 106 of Part I of Schedule B to the Regulation are revoked.

(6) Item 126 of Part I of Schedule B to the Regulation is revoked.

(7) Item 140 of Part I of Schedule B to the Regulation is revoked.

(8) Item 144 of Part I of Schedule B to the Regulation is amended by striking out “Sodium phosphate” and substituting “Sodium phosphate except for cathartics”.

5. This Regulation comes into force on June 4, 2008.

Made by:

Council of the Ontario College of Pharmacists:

Peter Gdyczynski

President

Deanna Williams

Registrar

Date made: May 3, 2008.