S.I. No. 121/1945 - Therapeutic Substances (Amendment) Regulations, 1945.

STATUTORY RULES AND ORDERS. 1945. No. 121.

THERAPEUTIC SUBSTANCES (AMENDMENT) REGULATIONS, 1945.

Francis Constantine Ward, Parliamentary Secretary to the Minister for Local Government and Public Health, in exercise of the powers vested in the said Minister by the Therapeutic Substances Act, 1932 , and by virtue of the Local Government and Public Health (Delegation of Ministerial Functions) Order, 1945, after consultation with the Therapeutic Substances Advisory Committee, orders and declares as follows, that is to say :—

1. This Order may be cited as the Therapeutic Substances (Amendment) Regulations, 1945, and shall be read and construed as one with the Therapeutic Substances Regulations, 1934 to 1942, and may be cited collectively together therewith as the Therapeutic Substances Regulations, 1934 to 1945.

2. In this Order the expression " the Minister " means the Minister for Local Government and Public Health and includes a Parliamentary Secretary to whom the powers of the Minister under the Therapeutic Substances Act, 1934, are for the time being delegated under Section 9 of the Ministers and Secretaries (Amendment) Act, 1939 .

3. Penicillin (crude filtrate), penicillin (dried crude filtrate) and penicillin salts as defined in the Schedule hereto are hereby declared to be therapeutic substances to which the Therapeutic Substances Act, 1932 , applies, and the Therapeutic Substances Regulations, 1934 to 1942, as amended by this Order shall apply accordingly to such substances.

4. The following Schedule shall be appended as a Seventh Schedule to the Therapeutic Substances (Saorstát Éireann) Regulations, 1934.

"SEVENTH SCHEDULE.

PENICILLIN.

Definitions and Proper Names.

1.—(1) Penicillin (crude filtrate) is the solution obtained by the filtration of cultures containing penicillin, or of extracts from such cultures. Its proper name is ' penicillin (crude filtrate).'

(2) Penicillin (dried crude filtrate) is the substance obtained by reducing pencillin (crude filtrate) to a dry condition. Its proper name is ' penicillin (dried crude filtrate).'

(3) A penicillin salt is the substance separated by the application of chemical and physical processes from the culture medium on or in which a mould producing penicillin has been grown, and reduced to a dry condition. Its proper name is ' penicillin ' followed by a word or words indicating the nature of the preparation, as, for example, ' penicillin (sodium salt).'

(4) In this Schedule ' penicillin ' means the anti-microbic organic acid which is known to be produced by penicillium notatum, and ' preparation of penicillin ' means penicillin (crude filtrate), penicillin (dried crude filtrate) or a penicillin salt or solution thereof.

Standard Preparation.

2. The standard preparation is a quantity of a dry penicillin salt kept in an institution approved by the Minister.

Unit of Standardisation.

3. The unit of penicillin for the purpose of these regulations is the activity contained in such an amount of the standard preparation as may be indicated from time to time by the Minister.

Tests for Potency.

4. Preparations of penicillin shall be tested for potency in units, which shall be determined, by comparative tests in relation to the standard preparation, by a method approved by the Minister. The potency so determined shall be expressed in units per c.c. in the case of liquid preparations and in units per milligramme in the case of solid preparations.

Quality.

5.—(1) Penicillin (crude filtrate) containing less than 10 units per c.c., and penicillin (dried crude filtrate) containing less than 0.75 units per milligramme, shall not be issued.

(2) A preparation of penicillin intended for use in making solutions for parenteral injection shall contain not less than 150 units of penicillin per milligramme.

(3) A preparation containing penicillin intended for local application which contains less than 10 units per c.c. or 10 units per gramme of penicillin shall not be issued.

Tests for Sterility.

6. The provisions of Articles 14 to 18 of these regulation relating to the application of tests for sterility shall apply to preparations of penicillin with such modifications, if any, as the Minister may from time to time approve.

Tests far Freedom from Abnormal Toxicity.

7. Preparations of penicillin intended for use by parenteral injection shall be subjected to the following test for absence of abnormal toxicity :—

A quantity of the preparation containing not less than 1,000 units of penicillin, in a volume not exceeding 0.5 c.c. of a watery solution, shall be injected intravenously into each of five normal mice each weighing approximately 20 grammes.

The sample shall be treated as having passed the test if either—

(a) the injection does not cause death in any of the mice within twenty-four hours from the injection, or

(b) the injection having caused death in one only of the mice within that period, further such injections in five other such mice do not cause the death of any of those mice within twenty-four hours from the injection.

Tests for Freedom from Pyrogenic Substances.

8. Preparations of penicillin intended for use by parenteral injection shall be subjected to the following test for absence of pyrogenic substances :—

A quantity of a solution containing not less than 10,000 units of penicillin, in pyrogen-free water shall be injected intravenously into each of three normal healthy rabbits each weighing not more than 2.5 kilograms. The body temperature of the rabbits shall be recorded one and one-half hours before the injection and either continuously for three hours after the injection or at the end of one, two and three hours after the injection. The sample shall be treated as having passed the test if the average maximum temperature increase of the three rabbits does not exceed 1.2°C.

Container.

9. The licensee shall satisfy himself that the container for liquid preparations of penicillin shall be made of glass which does not cause the destruction of penicillin.

Labelling.

10.—(1) The label on the container shall indicate whether the preparation is suitable for parenteral injection.

(2) In the case of preparations of penicillin intended only for local application, the label on the container and the label or wrapper on the package shall bear the words ' not to be injected ' clearly printed in a distinctive colour.

(3) If a preparation of penicillin as issued for sale is combined with any substance other than a simple diluent, the exact nature and strength of that substance shall be stated on the label on the container."

GIVEN under my hand this seventh day of May, One Thousand Nine Hundred and Forty-five.

(Signed) F. C. WARD,

Parliamentary Secretary to the

Minister for Local Government

and Public Health.