S.I. No. 345/1947 - Therapeutic Substances (Amendment) Regulations, 1947.

STATUTORY RULES AND ORDERS. 1947. No. 345.DEPARTMENT OF HEALTH. THERAPEUTIC SUBSTANCES ACT, 1932.

THERAPEUTIC SUBSTANCES (AMENDMENT) REGULATIONS, 1947.

The Minister for Health in exercise of the powers vested in him by the Therapeutic Substances Act, 1932 , after consultation with the Therapeutic Substances Advisory Committee, hereby orders and declares as follows :—

1. These Regulations may be cited as the Therapeutic Substances (Amendment) Regulations, 1947, and shall be read and construed as one with the Therapeutic Substances Regulations, 1934 to 1946, and may be cited collectively therewith as the Therapeutic Substances Regulations, 1934 to 1947.

2. In these Regulations—

the expression " the Principal Regulations " means the Therapeutic Substances (Saorstát Éireann) Regulations, 1934, and the expression " the Minister " means the Minister for Health.

3. Each of the following substances, being substances the purity of which cannot in the opinion of the Minister be adequately tested by chemical means, is hereby declared to be a therapeutic substance to which the Therapeutic Substances Act, 1932 , applies, that is to say, any anti-infective acid produced by Penicillium notatum, whether obtained from Penicillium notatum or not, any salt or derivative of any such acid and any solution containing any such acid, salt or derivative.

4.—(1) The substances declared by Article 3 of these Regulations to be therapeutic substances to which the Therapeutic Substances Act, 1932 , applies shall be issued only in the form of a dry salt or other dry substance or in a form approved by the Minister.

(2) The word " Penicillin " in these Regulations and in the Principal Regulations as amended by these Regulations means any such substance as aforesaid in any such form as aforesaid.

5. Paragraph (d) of sub-article 3 of Article 8 of the Principal Regulations shall not apply to Penicillin.

6. The following amendments shall be made in the Principal Regulations :—

(1) The following words shall be inserted at the end of sub-article (1) of Article 7 :—

" Provided that in the case of penicillin the container may be of some substance other than glass."

(2) The following words shall be inserted at the end of Article 10 :—

" Provided that in the case of penicillin in any form such of the tests may be applied at such earlier stage in the manufacture as may be approved by the Minister in respect of penicillin in that form."

(3) The following paragraph shall be inserted in Article 13 after paragraph (g) :—

" (h) penicillin intended for use by parenteral injection."

(4) In proviso (i) in Article 13, after the word " insulin " there shall be inserted the words " and penicillin."

(5) The following schedule shall be substituted for the Seventh Schedule to the Principal Regulations :—

" SEVENTH SCHEDULE.

PENICILLIN.

Proper Name.

1. The proper name of penicillin is " penicillin " followed by a word or words indicating the nature of the preparation, as, for example, " penicillin (sodium salt)."

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.

Quality.

4.—(1) Penicillin shall be tested for potency 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 milligramme in the case of penicillin in solid form and in units per millilitre in the case of solutions.

(2) Penicillin intended for use by parentaral injection with a potency, in the case of penicillin in solid form, of less than 300 units per milligramme, or, in the case of a solution, of less than 2,000 units per millilitre shall not be issued :

Provided that the Minister may authorise, with or without conditions, the issue for specified purposes of penicillin which does not satisfy the said standards.

(3) A preparation of penicillin containing the living organism of Penicillium notatum shall not be issued.

Tests for Sterility.

5. The provisions of Articles 14 to 18 of these regulations 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 for Freedom from Abnormal Toxicity.

6. 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 millilitre 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.

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

There shall be injected intravenously into each of three normal healthy rabbits each weighing not less than 1·5 kilograms a quantity of the penicillin containing not less, in the case of each rabbit, than 2,000 units per kilogram of the rabbit's weight, dissolved, in the case of penicillin in solid form, in not more than 5 millilitres of water or physiological saline. The body temperature of the rabbits shall be recorded either continuously from one hour before until three hours after the injection, or at least once during the hour before, and three times in the three hours after, the injection, one of which shall be between seventy-five and ninety minutes after the injection. The sample shall be treated as having passed the test if the average maximum increase of temperature shown by the three rabbits does not exceed 0·6° C.

Container.

8. The materials of which a container (including the closure) of penicillin is made shall be materials as to which the licensee has satisfied himself that they do not lead to the destruction of penicillin.

Labelling.

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

(2) If penicillin as issued for sale is mixed with any substance the label on the container shall state the nature of that substance and the minimum number of units of penicillin per gramme of the mixture in the case of penicillin in solid form or per millilitre thereof in the case of a solution.

10. The Therapeutic Substances (Amendment) Regulations, 1945, and the Therapeutic Substances (Amendment) (No. 2) Regulations, 1945, are hereby revoked but such revocation shall not affect anything duly done thereunder and in particular any licence granted thereunder shall continue in force and have effect as if it were a licence granted under the Principal Regulations as amended by these Regulations.

GIVEN under the Official Seal of the Minister for Health this eighteenth day of August, One Thousand Nine Hundred and Forty-seven.

(Signed) SEAMAS Ó RIAIN,

Minister for Health.