S.I. No. 563/1935 - Therapeutic Substances (Saorstát Eireann) (Amendment) Regulations, 1935.

DEPARTMENT OF LOCAL GOVERNMENT AND PUBLIC HEALTH.

THE THERAPEUTIC SUBSTANCES (SAORSTÁT EIREANN) (AMENDMENT) REGULATIONS, 1935.

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, order as follows:—

1 ..

1.—(1) These Regulations may be cited as the Therapeutic Substances (Saorstát Eireann) (Amendment) Regulations, 1935, and shall be read and construed as one with the Therapeutic Substances (Saorstát Eireann) Regulations, 1934, and may be cited together therewith as the Therapeutic Substances (Saorstát Eireann) Regulations, 1934 and 1935.

(2) The provisions of these Regulations, relating to sterilised surgical catgut, shall come into operation on the 1st day of November, 1935, but save as aforesaid these Regulations shall come into operation on the date hereof.

(3) In these Regulations, the expression "the Principal Regulations" means the Therapeutic Substances (Saorstát Eireann) Regulations, 1934; and the expression "the Minister" means the Minister for Local Government and Public Health.

2 Sterilised Surgical Catgut.

2. Sterilised surgical catgut, that is to say, a ligature or other form of binding material prepared from gut or other animal tissue and offered or intended to be offered for sale as sterile and ready for use in surgical operations upon the human body, being a therapeutic substance 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.

3 ..

3.—(1) The provisions of Part II of the Principal Regulations which relate to licences for manufacture other than sub-paragraphs (b) and (i) of Article 5 thereof shall apply to the manufacture of sterilised surgical catgut.

(2) Every licence for the manufacture of sterilised surgical catgut shall, in addition to being subject to the conditions set forth in Article 5 of the Principal Regulations, as applied by these Regulations, be subject to the further condition that the licensee shall comply with the provisions of these Regulations and with such further requirements, if any, as may be specified in any regulations which may be made under the Therapeutic Substances Act, 1932 , and of which the Minister has given the licensee not less than one month's notice.

4 ..

4. Sterilised surgical catgut shall not be sold or offered for sale unless it has been sealed in a previously sterilised container or packet, in such manner, as will, in the opinion of the Minister, suffice to preclude the access of bacteria.

5 ..

5. If any sterilised surgical catgut is advertised or sold as such, the name "Sterilised surgical catgut" shall appear on the label of the container or packet in the manner prescribed in Article 8 of the Principal Regulations:

Provided that—

(i) it shall only be necessary to print or write on the label the particulars specified in sub-paragraphs (a), (b) and (c) of paragraph (1) and sub-paragraphs (a) and (c) of paragraph (3) of Article 8 of the Principal Regulations ; and

(ii) for the purpose of sub-paragraph (c) of paragraph (3) of the said Article 8, the date on which the test for sterility hereinafter prescribed in these Regulations was completed, shall be treated as the date on which the manufacture of the batch of catgut was completed.

6 ..

6. Before any sterilised surgical catgut is sold or offered for sale, the batch to which it belongs shall have been tested for the presence of living bacteria in the manner specified in the Schedule to these Regulations by the manufacturer or by some institution approved by the Minister for the purpose on his behalf and none of the contents of the batch shall be sold or offered for sale unless the batch has passed the test.

7 ..

7. The provisions of Parts V and VII of the Principal Regulations which relate respectively to licences for the import of therapeutic substances and to therapeutic substances manufactured or imported for export only shall apply to sterilised surgical catgut.

8 ..

8. For the purpose of these Regulations a batch of catgut shall consist entirely of material collected under uniform conditions and simultaneously subjected or intended to be subjected to the same process or series or processes for rendering it sterile.

9 ..

9. Save as in these Regulations expressly provided, the provisions of the Principal Regulations shall not apply to sterilised surgical catgut.

AMENDMENT OF PRINCIPAL REGULATIONS.

10 ..

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

(a) In sub-paragraph (1) of Article 7 of Part I (B) of the Second Schedule the words "These determinations shall be made as follows :—A sample of the vaccine lymph shall be thoroughly mixed with melted nutrient agar medium and a culture plate poured from the mixture, or the sample shall be spread upon the surface of a prepared plate of nutrient agar. The number of colonies appearing on incubation for two days at approximately 37°C. and then for at least three days at approximately 20°C. shall then be enumerated." shall be substituted for the words from "These determinations" to the figures and letter "20°C."

(b) In sub-paragraph (2) of Article 8 of Part I (B) of the Second Schedule, the figures "100" shall be substituted for the figures "1000" and in sub-paragraph (3) of the said Article, the word "hundredfold" shall be substituted for the word "thousandfold."

(c) In Article 3 of Part II (A) of the Second Schedule and in the heading of that Article the word and figures "Article 19" shall be substituted for the word and figures "Article 18."

SCHEDULE.

METHOD OF CARRYING OUT TEST FOR STERILITY.

1. For the purposes of the test a sample of catgut shall be taken from each batch consisting of not less than 1 per cent. of the whole quantity of material constituting the batch. The sample shall, when practicable, be the contents of at least one whole container or packet, and shall be drawn at random from the whole number of containers or packets constituting the batch.

2. The sample shall be subjected to the following processes for testing its sterility :—

(a) The container or packet shall be opened and the sample removed with aseptic precautions.

(b) After all the adherent fluid has been drained off as completely as possible, the sample shall be placed entire in a test tube at least 3’5 cms. in diameter, and 17’5 cms. in length, and containing 50 mils of sterile distilled water. This tube shall then be closed by some method which will preclude the access of bacteria, and placed in an incubator at 37°C. for 24 hours.

(c) After this incubation, the sample shall be aseptically transferred to a similar tube containing a solution of 1 per cent. of sodium thiosulphate and 1 per cent. of sodium carbonate in distilled water, the tube and solution having been previously sterilised in the autoclave. In this solution the sample shall again be incubated for 24 hours at 37°C.

(d) After the second incubation the sample shall be again removed aseptically and, without further washing, shall be examined for the presence of living bacteria and their spores. The sterility tests shall be carried out either—

(i) by placing the sample in a tube at least 3’5 cms. in diameter and 17’5 cms. in length, containing not less than 50 mils of a culture medium prepared by dissolving 0’2 per cent. of prepared agar-agar in a nutrient bacteriological broth,* the mixture being sterilised in the autoclave ; or

(ii) by the method prescribed in Articles 16 (1), (2), (3); and 17 (1) of the Principal Regulations :

Provided that, if a manufacturer satisfies the Minister that he has already in use tests for the purpose of living aerobic or anaerobic bacteria, and that these tests, as applied by him, will detect the presence of such bacteria in the catgut as ready for issue with a certainty at least equal to that afforded by the application of the tests prescribed in the above-mentioned Articles, the Minister may approve the use of such tests in the place of the tests so prescribed ; but, in that event, the Minister may at any time withdraw such approval and require the manufacturer to carry out the prescribed tests.

(e) The tubes of culture medium containing the sample shall be incubated at 37°C. for 12 days, and examined daily for the growth of bacteria.

*Note—The broth may preferably be made by the digestion of meat with trypsin (Douglas' broth or Hartley's modification thereof).

(f) If no such growth is detected during this period, the batch from which the sample was drawn shall be treated as free from living bacteria and their spores, and as having passed the test.

Given under the Official Seal of the Minister for Local Government and Public Health, this Twenty-seventh day of September, One Thousand Nine Hundred and Thirty-five.

(Sighnithe) SEÁN T. O'CEALLAIGH,

Minister for Local Government and Public Health.