S.I. No. 284/1937 - Therapeutic Substances (Amendment) Regulations, 1937.

STATUTORY RULES AND ORDERS. 1937. No. 284.

THERAPEUTIC SUBSTANCES (AMENDMENT) REGULATIONS, 1937.

DEPARTMENT OF LOCAL GOVERNMENT AND PUBLIC HEALTH.

THE THERAPEUTIC SUBSTANCES (AMENDMENT) REGULATIONS, 1937.

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 and make the following regulations, that is to say:—

1.—(1) This Order may be cited as the Therapeutic Substances (Amendment) Regulations, 1937, and shall be read and construed as one with the Therapeutic Substances Regulations, 1934 to 1936, and may be cited together therewith as the Therapeutic Substances Regulations, 1934 to 1937.

(2) This Order shall come into operation on the First day of January, 1938.

2. The Therapeutic Substances (Saorstát Eireann) (Amendment) Regulations, 1935, shall be amended as follows:—

(1) Sub-paragraph (2) of Article 1 shall be read and construed as if the word "sterilised" were omitted therefrom and as if for the date "1st day of November, 1935", there were substituted therein, the date of the coming into operation of this Order.

(2) The heading which immediately precedes Article 2 shall be amended by the deletion of the word "sterilised".

(3) Article 2 (which declares that sterilised surgical catgut as defined therein shall be a therapeutic substance to which the Therapeutic Substances Act, 1932 , applies as being a therapeutic substance the purity of which cannot in the opinion of the Minister be adequately tested by chemical means) shall be amended by the deletion of the words "sterilised" and "as sterile and ready".

(4) Articles 3, 4, 6, 7 and 9 shall be amended by the deletion of the word "sterilised" where it occurs in these regulations.

(5) Article 5 shall be revoked and the following Article shall be substituted in its place :—

5.—(1) If any surgical catgut is advertised or sold as such, and as sterile and ready for use, the name "sterilised surgical catgut" shall be indelibly marked on the sealed container of surgical catgut or printed or written in indelible ink on a label enclosed therein and there shall also be indelibly marked on such container or printed or written in indelible ink on such label the particulars specified in sub-paragraphs (a), (b) and (c) of paragraphs (1) and sub-paragraphs (a) and (c) of paragraph (3) of Article 8 of the Principal Regulations: provided that 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.

(2) The provisions of this Article shall not until the First day of April, 1939, apply to surgical catgut the manufacture of which has been completed before the First day of January, 1938.

(6) The following provisions shall be added after Article 9 :—

Non-Sterile Surgical Catgut.

9A.—(1) Every container of and wrapper enclosing surgical catgut other than surgical catgut offered or intended to be offered for sale as sterile and ready for use shall bear a label on which are printed or written in a conspicuous manner in indelible red ink the words "non-sterile surgical catgut—not to be used for operations upon the human body unless efficiently sterilised."

(2) Surgical catgut to which the provisions of the preceding paragraph apply shall not except for the purposes of that paragraph be deemed to be a therapeutic substance to which the Therapeutic Substances Act, 1932 , applies.

Given under the Official Seal of the Minister for Local Government and Public Health,

this 3rd day of December, One Thousand Nine Hundred and Thirty-seven.

(Sighnithe) SEÁN T. O'CEALLAIGH,

Minister for Local Government and Public Health.