S.I. No. 46/1936 - Therapeutic Substances (Saorstát Eireann) (Amendment) (No. 2) Regulations, 1936.

1. Diphtheria Prophylactic is diphtheria toxin (the sterile filtrate from a culture on nutrient broth of

Corynebacterium diphtheriœ

), or material derived therefrom, the specific toxicity of which has been reduced to a low value by the action of chemical substances in such a manner that it retains efficient properties as an immunising antigen. To it may be added diphtheria antitoxin. Its proper name is "Diphtheria Prophylactic."

No preparations containing unmodified diphtheria toxin shall be issued for the prophylaxis of diphtheria.

Labelling.

2. The label on the container shall bear a statement of the dose (hereinafter referred to as the "human dose") appropriate for administration at one injection to a human subject.

Tests.

3. Diphtheria Prophylactic shall be submitted to the following tests:—

(

a

)

Tests to determine that the, specific toxicity of the toxin used in its preparation has been so reduced that it does not exceed the prescribed maximum.

—Five human doses of the Diphtheria Prophylactic under test shall be injected into each of five normal guinea-pigs each weighing 250 to 350 grammes. This injection must not cause the death of any of the guinea-pigs within six days following the injection. If all the guinea-pigs injected survive for six days but any of them die within thirty days following the injection from the specific toxæmia, one human dose of the Diphtheria Prophylactic under test shall be injected into each of five normal guinea-pigs, each weighing 250 to 350 grammes. This injection must not cause the death of any of the guinea-pigs within 30 days following the injection.

If a batch of Diphtheria Prophylactic is shown by either of these tests to have a greater toxicity than the maximum hereby indicated, it shall not be issued unless and until the toxicity has been so reduced by further treatment that it does not exceed that maximum.

(

b

)

Tests for potency as an immunising antigen.

—A quantity of Diphtheria Prophylactic not exceeding five human doses shall be injected on one occasion into each of at least ten normal guinea-pigs; or, alternatively, a quantity of Diphtheria Prophylactic not exceeding one-tenth of a human dose shall be injected into each of at least ten normal guinea-pigs on each of two occasions, separated by an interval of not more than four weeks. The guinea-pigs shall be tested for immunity to diphtheria toxin, if they have received the single injection hereinbefore prescribed, at a date not later than six weeks after injection, and if they have received the two injections hereinbefore prescribed, at a date not later than three weeks after the second injection, by intracutaneous injection into each guinea-pig of one test dose of Schick Toxin. If more than two out of ten guinea-pigs thus tested, or more than one quarter of the number tested if this is greater than ten, exhibit a positive Schick reaction, the batch of Diphtheria Prophylactic shall be treated as insufficiently potent, and shall not be issued

Provided that in the case of the form of Diphtheria Prophylactic known as Toxoid-Antitoxin Floccules the Prophylactic may be similarly injected into nine or more normal guinea-pigs which may be tested for immunity to Diphtheria Toxin by two separate but simultaneous intracutaneous injections into each of at least nine of these guinea-pigs of one test dose and two test doses, respectively, of Schick Toxin. If two-thirds or more of the guinea-pigs tested do not exhibit a positive reaction to

one

test dose of Schick Toxin; or alternatively, if one-third or more of the guinea-pigs tested do not exhibit a positive reaction to

two

test doses of Schick Toxin, the batch shall be accepted as sufficiently potent.

Given under the Official Seal of the Minister for Local Government and Public Health this 14th day of February, One Thousand Nine Hundred and Thirty-six.

(Signed) SEÁN T. Ó CEALLAIGH,

Minister for Local Government and Public Health.

4. The potency in units of antipneumococcus serum (Type II) shall be determined, in accordance with a method approved by the Minister, by comparison of the activity of the serum under test in protecting animals against the lethal action of a virulent culture of

Diplococcus pneumoniæ

(

Type II

) with the activity under identical conditions of the standard preparation of antipneumococcus serum (Type II).

Unit of Standardisation.

5. The unit of gas-gangrene antitoxin (Vibrion septique) for the purposes of these Regulations is the specific neutralising activity for gas-gangrene (Vibrion septique) toxin contained in such an amount of the standard preparation as the Minister may from time to time indicate as the quantity exactly equivalent to the unit accepted for international use.

Labelling.

6.—(1) The label on the container shall indicate—

(

a

) the minimum total number of units in the container; and

(

b

) either (i) the potency of the preparation expressed as the minimum number of units of antitoxin per c.c. in the case of liquid products, or as the minimum number of units of antitoxin per gramme in the ease of dry products; or

(ii) the total number of c.c. in the container.

(2) The label on the container or the label or wrapper on the package shall indicate the nature of the particular product, that is to say, whether natural serum, a solution of antitoxic globulins, dried natural serum or dried antitoxic globulins.

Mixed Antitoxins.

7. A mixed antitoxin, containing antitoxins against other toxins than that of the

clostridium

commonly known as Vibrion septique shall, with respect to its content in units of gas-gangrene antitoxin (Vibrion septique) conform with paragraphs 4, 5 and 6 of this Part of this Schedule.

PART III.

(B)

PROVISIONS APPLICABLE TO DIPHTHERIA PROPHYLACTIC.

Definition and Proper Name.

DEPARTMENT OF LOCAL GOVERNMENT AND PUBLIC HEALTH.

THE THERAPEUTIC SUBSTANCES (SAORSTÁT EIREANN) (AMENDMENT) (No. 2) REGULATIONS, 1936.

The Minister for Local Government and Public Health in exercise of the powers conferred on him by the

Therapeutic Substances Act, 1932

, does by this his Order, after consultation with the Therapeutic Substances Advisory Committee, make the following Regulations, that is to say:—

1.—(1) These Regulations may be cited as the Therapeutic Substances (Saorstát Eireann) (Amendment) (No. 2) Regulations, 1936, and shall be construed as one with the Therapeutic Substances (Saorstát Eireann) Regulations, 1934 and 1935.

(2) The Therapeutic Substances (Saorstát Eireann) Regulations, 1934 and 1935, and these Regulations may be cited together as the Therapeutic Substances (Saorstát Eireann) Regulations, 1934 to 1936.

(3) In these Regulations, the expression "the Principal Regulations" means the Therapeutic Substances (Saorstát Eireann) Regulations, 1934.

(4) These Regulations shall come into operation on the First day of April, 1936.

2.—The Principal Regulations shall be amended by the addition to the Second Schedule thereof of Parts I and II of the Schedule to these Regulations in manner following, that is to say:—

(

a

) Part I of the Schedule to these Regulations shall be appended to Part II (Toxins and Antigens) of the Second Schedule to the Principal Regulations; and

(

b

) Part II of the Schedule to these Regulations shall be appended to Part IV (Provisions applicable to particular Sera and Antitoxins) of the Second Schedule to the Principal Regulations.

3.—Part II (B) of the Second Schedule to the Principal Regulations is hereby rescinded and Part III of the Schedule to these Regulations shall be substituted therefor.

SCHEDULE.

PART I.

(F)

PROVISIONS APPLICABLE TO STAPHYLOCOCCUS TOXOID.

Definition and proper name.