STATUTORY RULES.

1956. No. .

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REGULATIONS UNDER THE THERAPEUTIC SUBSTANCES ACT 1953.*

I, THE GOVERNOR-GENERAL in and over the Commonwealth of Australia, acting with the advice of the Federal Executive Council, hereby make the following Regulations under the Therapeutic Substances Act 1953.

Dated this eighteenth day of January, 1956.

W. J. Slim

Governor-General.

By His Excellency’s Command,

Minister of State for Health.

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THERAPEUTIC SUBSTANCES REGULATIONS.

Part I.—Preliminary.

Citation.

1. These Regulations may be cited as the Therapeutic Substances Regulations.

Commencement.

2.—(1.) Parts I., III. and IV. of these Regulations shall come into operation on the first day of February, 1956.

(2.) Part II. of these Regulations shall come into operation on the first day of August, 1956.

Parts.

3. These Regulations are divided into Parts, as follows :—

Part I.—Preliminary (Regulations 1-4).

Part II.—Controlled Therapeutic Substances which are Imported into Australia or which become the Subject of Interstate Trade (Regulations 5-6).

Part III.—Examination, Testing and Analysing of Goods (Regulations 7-17).

Part IV.—Committees (Regulations 18-26).

Definitions.

4. In these Regulations, unless the contrary intention appears—

“ official analyst ” means an analyst appointed under regulation 12 of these Regulations ;

“ the Act ” means the Therapeutic Substances Act 1953 ;

“ the Director-General ” means the Director-General of Health.

* Notified in the Commonwealth Gazette on , 1956.

3569/55.—Price 5d. 9/11.1.1956.

Part II.—Controlled Therapeutic Substances which are Imported into Australia or which become the Subject of Interstate Trade.

Packaging and labelling of controlled therapeutic substances.

5.—(1.) Goods that consist of a controlled therapeutic substance which is the subject of a monograph in the British Pharmacopoeia shall, for the purposes of sections 7 and 9 of the Act, be packed and labelled in accordance with the requirements, if any, in the British Pharmacopoeia which are applicable to the packaging and labelling of that substance.

(2.) Goods that consist of a controlled therapeutic substance which is the subject of a monograph in the British Pharmaceutical Codex, but not the subject of a monograph in the British Pharmacopoeia, shall, for the purposes of sections 7 and 9 of the Act, be packed and labelled in accordance with the requirements, if any, in the British Pharmaceutical Codex which are applicable to the packaging and labelling of that substance.

(3.) If goods that consist of a controlled therapeutic substance bear the manufacturer’s trade name for that substance, the goods shall, for the purposes of sections 7 and 9 of the Act, be so labelled that—

(a) the manufacturer’s trade name immediately precedes or follows the official name of the substance, whether on the same line or succeeding lines ; and

(b) the size of the letters or symbols comprising the official name of the substance are not less than half the size of the letters or symbols comprising the manufacturer’s trade name of the substance.

Prescribed particulars to be set out on therapeutic substances imported into Australia or made the subject of interstate trade.

6. The particulars which, under sub-paragraph (ii) of paragraph (c) of sub-section (1.) of section 7 of the Act, and sub-paragraph (ii) of paragraph (c) of sub-section (1.) of section 9 of the Act, goods that consist of, or are represented to consist of, a controlled therapeutic substance are required to bear are—

(a) a number or mark capable of being used to identify, in the records of the manufacturer of the goods, the batch of goods in which those first-mentioned goods were manufactured ;

(b) the strength of the goods by reference to a numerical count, percentage or number of units ; and

(c) where the goods consist of, or are represented to consist of, a controlled therapeutic substance the name or formula of which is specified in the Schedule to these Regulations—a statement to the effect that the goods should not be used after a date specified in the statement, being a date not later than the date after which, if the goods are kept under such conditions of storage as are specified in relation to the goods in the British Pharmacopoeia or the British Pharmaceutical Codex, the goods will have ceased to conform to the standard for the substance of which the goods consist.

Part III.—Examination, Testing and Analysing of Goods.

Definition.

7. In this Part, “ authorized person ” means a person appointed by the Director-General under the next succeeding regulation to be an authorized person.

Authorized persons for the purposes of section 13 of the Act.

8. The Director-General may appoint a person to be an authorized person for the purposes of this Part.

Powers of authorized person.

9. An authorized person may, in accordance with this Part—

(a) take, and enter upon premises for the purpose of taking, samples of goods to which section 13 of the Act applies ;

(b) make examinations and inquiries with respect to matters relating to goods to which section 13 of the Act applies.

Testing of goods for standard.

10. The tests for the purposes of ascertaining whether goods that consist of a controlled therapeutic substance and to which section 13 of the Act applies conform to the standard for that substance are—

(a) where the controlled therapeutic substance is the subject of a monograph in the British Pharmacopoeia—the tests applicable to that substance in the British Pharmacopoeia ; and

(b) where the controlled therapeutic substance is not the subject of a monograph in the British Pharmacopoeia but is the subject of a monograph in the British Pharmaceutical Codex—the tests applicable to that substance in the British Pharmaceutical Codex.

Appointment of laboratories.

11. The following laboratories are appointed as laboratories for the examination, testing and analysing of goods to which section 13 of the Act applies :—

The laboratory controlled by the Department of Pharmacology at the University of Sydney.

The laboratory controlled by the Department of Pharmacology at the University of Melbourne.

The Commonwealth Laboratory, Department of Customs and Excise, Melbourne.

The Commonwealth Serum Laboratories, Melbourne.

Appointment of official analysts.

12. The Director-General may appoint an analyst to be an official analyst for the purposes of these Regulations.

Taking of samples for testing.

13.—(1.) Where an authorized person has taken a sample of goods to which section 13 of the Act applies, the authorized person—

(a) shall forthwith notify the person from whom the sample was taken of his intention to submit the sample to an official analyst for examination, testing and analysing in accordance with the tests prescribed in regulation 10 of these Regulations for the purposes of ascertaining whether the goods conform to the standard ;

(b) shall thereupon, if practicable, divide the sample into three parts and fasten and seal each part, or, if not so divided, fasten and seal the whole sample, in accordance with the next succeeding sub-regulation ; and

(i) where the sample is divided into three parts—forward one part of the sample to the person from whom it was taken, forward another part of the sample to an official analyst for examination, testing and analysing and retain the remaining part ; and

(ii) where the sample is not divided into three parts—forward the whole sample to an official analyst for examination, testing and analysing.

(2.) Where, under the last preceding sub-regulation, a sample is required, or parts of a sample are required, to be fastened and sealed, the sample or parts of a sample shall be fastened and sealed in a vessel or package marked with the name and address of the person from whom the sample was taken in such a manner as will prevent the opening of the vessel or package or the removal of that name and address without breaking the seal.

Examination, &c., and certificates of official analysts.

14.—(1.) An official analyst shall, as soon as practicable after the receipt by him of a sample of goods forwarded to him by an authorized person, examine, test and analyse at a laboratory appointed under regulation 11 of these Regulations the part of the sample forwarded to him, or, if the sample has not been divided into three parts, the whole sample, and shall forward—

(a) a certificate signed by the official analyst in accordance with a form determined by the Director-General to that authorized person setting out the results of the examination, testing and analysing ;

(b) a copy of that certificate signed by the official analyst to the person from whom the sample was taken ; and

(2.) In any legal proceedings, a document which purports to be a certificate of an official analyst under this regulation, or a copy of such a certificate, and to be signed by an official analyst shall, until the contrary is proved, be deemed to be a certificate, or a copy of a certificate, under this regulation signed by an official analyst and a document so signed is, except where the examination, testing and analysing by that official analyst is reviewed under the next succeeding regulation, evidence of the facts stated in the document.

Review of examination, &c., of official analyst.

15.—(1.) Where a sample of goods that consist of a controlled therapeutic substance, being goods to which section 13 of the Act applies, has been examined, tested and analysed by an official analyst in accordance with this Part and the official analyst certifies that the goods do not conform to the standard in relation to that controlled therapeutic substance, the person from whom the sample of the goods was taken may, within twenty-one days after the receipt by him of the certificate of the official analyst, submit to the Director-General evidence in writing that the goods do conform to the standard.

(2.) The Director-General may, if, in his opinion, the evidence so submitted justifies a review of the examination, testing or analysis by the official analyst, direct—

(a) where the sample of the goods has been divided into three parts in accordance with regulation 13 of these Regulations—the authorized person who took the sample to forward that part of the sample which he has retained ; or

(b) where the sample of the goods has not been so divided—the official analyst to forward so much of the sample, if any, as remains unimpaired by his examination, testing and analysing,

to an analyst agreed upon by the person from whom the sample of those goods was taken and the official analyst or, in the absence of agreement, by an analyst nominated by the Director-General.

(3.) The analyst agreed upon or nominated under the last preceding sub-regulation shall examine, test and analyse the sample of the goods and shall forward a certificate signed by the analyst in accordance with a form determined by the Director-General setting out the results of his examination, testing and analysing to the person from whom the sample was taken and shall forward a copy of the certificate signed by the analyst to the Director-General.

(4.) A certificate stating the results of an examination, testing or analysing forwarded by an official analyst under the last preceding regulation ceases to have effect upon the forwarding of a certificate by an analyst under the last preceding sub-regulation.

(5.) In any legal proceedings, a document which purports to be a certificate under this regulation or a copy of such a certificate, signed by an analyst, shall, until the contrary is proved, be deemed to be a certificate or a copy of a certificate duly forwarded and signed in accordance with this regulation and such a document is evidence of the facts stated in the document.

Payment for samples.

16. Where a sample of goods to which section 13 of the Act applies is taken by an authorized person and the goods taken as the sample conform to the standard for those goods, payment for the quantity of goods taken as the sample shall be made by the Commonwealth to the person from whom the sample was taken at the current market value for which that person could have supplied or sold the goods taken as the sample in the normal course of his business at the time the sample was taken.

Offences.

17. A person engaged in the manufacture, import or export of goods to which section 13 of the Act applies shall not—

(a) make or present to the Minister or to a person performing a function or exercising a power under these Regulations a statement or document which is false or misleading ;

(b) molest, obstruct or endeavour to intimidate or influence an authorized person in the execution of his powers or the performance of his duties under these Regulations ; or

(i) to show the authorized person the place at which those goods are kept ;

(ii) to admit the authorized person into a place at which those goods are kept ;

(iii) to show the authorized person or permit the authorized person to inspect any of those goods kept by him ;

(iv) to give a sample of those goods ; or

(v) to assist the authorized person in the execution of his powers or the performance of his duties under these Regulations.

Penalty : One hundred pounds or imprisonment for six months.

Part IV.—Committees.

Definitions.

18. In this Part—

“ Committee ” means a Committee established under this Part ;

“ the Commonwealth Analyst ” means the Commonwealth Analyst, Department of Customs and Excise, Melbourne.

Therapeutic Substances Advisory Committee.

19.—(1.) There shall be a committee to be known as the Therapeutic Substances Advisory Committee.

(2.) The Committee shall consist of—

(a) the Director-General ;

(b) an officer of the Department of Health appointed by the Minister ;

(d) a member appointed by the Minister from among a group of three persons nominated by the Drug and Allied Trades Council of Australia ;

(e) a member appointed by the Minister from among a group of three persons nominated by the Association of Ethical Pharmaceutical Manufacturers ;

(f) a member appointed by the Minister from among a group of three persons nominated by the Federal Council of the British Medical Association in Australia ;

(g) a member appointed by the Minister from among a group of three persons nominated by the Pharmaceutical Association of Australia ; and

(h) a member appointed by the Minister from among a group of three persons nominated by the Federated Pharmaceutical Service Guild of Australia.

(3.) The Commonwealth Analyst may, from time to time, by writing under his hand appoint a person who is an official analyst to be a member of the Committee in his stead, and the official analyst so appointed shall, until his appointment is revoked, be a member of the Committee.

(4.) The Committee shall inquire into and advise the Minister on any matter relating to the Act or these Regulations referred to the Committee by the Minister.

Biological Products Standards Committee.

20.—(1.) There shall be a committee to be known as the Biological Products Standards Committee.

(2.) The Committee shall consist of—

(a) the Director-General ;

(b) an officer of the Department of Health appointed by the Minister ; and

(3.) The Committee shall inquire into and advise the Minister on the standards, and matters relating to the standards, of antibiotics, antigens, antitoxins, blood derivatives, insulin products, sera, toxoids, vaccines and other biological products.

Therapeutic Substances Standards Committee.

21.—(1.) There shall be a committee to be known as the Therapeutic Substances Standards Committee.

(2.) The Committee shall consist of—

(a) the Director-General ;

(b) an officer of the Department of Health appointed by the Minister ;

(d) two Professors of Pharmacology appointed by the Minister ;

(e) a legally qualified medical practitioner appointed by the Minister ; and

(f) a person approved as a pharmaceutical chemist under the National Health Act 1953-1955 appointed by the Minister.

(4.) The Committee shall inquire into and advise the Minister on the standards, and matters relating to the standards, of therapeutic substances other than antibiotics, antigens, antitoxins, blood derivatives, insulin products, sera, toxoids, vaccines and other biological products.

Chairman and secretary of a Committee.

22.—(1.) Subject to the next succeeding sub-regulation, the chairman of a Committee shall be the Director-General and the secretary of a Committee shall be the officer of the Department of Health appointed as a member of the Committee by the Minister.

(2.) The Director-General may, from time to time, by writing under his hand, appoint an officer of the Department of Health to act as a member of a Committee in his stead, and the officer so appointed shall, until his appointment is revoked, be a member and the chairman of the Committee in the place of the Director-General.

Members appointed by the Minister.

23. A member of a Committee appointed by the Minister shall hold office during the Minister’s pleasure.

Meetings of Committees.

24.—(1.) Meetings of a Committee shall be held at such times and places as the chairman of the Committee directs.

(2.) At a meeting of the Biological Products Standards Committee three members form a quorum and at a meeting of any other Committee five members form a quorum.

(3.) The chairman of a Committee shall preside at all meetings of the Committee at which he is present.

(4.) In the absence of the chairman of a Committee from a meeting of the Committee, the members of the Committee present at the meeting shall appoint one of their number to preside at that meeting, and the member so appointed shall have and may exercise and perform at that meeting all the powers and functions of the chairman.

(5.) A question arising at a meeting of a Committee shall be determined by a majority of votes of the members present.

(6.) The chairman or other member presiding at a meeting of a Committee has a deliberative vote and, in the event of an equality of votes, also has a casting vote.

Powers and functions of Committees where vacancy occurs.

25. The exercise and performance of the powers and functions of a Committee is not affected by reason only of there being a vacancy in the office of a member of that Committee.

Remuneration and allowances of members of Committees.

26.—(1.) A member of a Committee (other than an officer of the Public Service of the Commonwealth or of a State) shall be paid—

(a) a remuneration at the rate of Five pounds five shillings for each day on which he attends a meeting of the Committee ; and

(b) an allowance at the rate of Three pounds three shillings for each day or part of a day during which he is necessarily absent from his home overnight in connexion with his attendance at a meeting of the Committee.

(2.) The cost of return transport fares actually and necessarily incurred by a member of a Committee in travelling between his place of residence and the place where the meeting of the Committee is held shall be borne by the Commonwealth.

THE SCHEDULE.

Regulation 6.

Amorphous Penicillin.

Aureomycin Hydrochloride.

Benzyl Penicillin.

Chloramphenicol.

Cholera Vaccine.

Cream of Penicillin.

Dihydrostreptomycin.

Dimercaprol.

Diphtheria Prophylactic.

Eye Ointment of Penicillin.

Lozenges of Penicillin.

Ointment of Penicillin.

Old Tuberculin.

Plague Vaccine.

Purified Protein Derivative of Tuberculin.

Schick Control.

Schick Test Toxin.

Streptomycin-Calcium Chloride.

Streptomycin Hydrochloride.

Streptomycin Sulphate.

Sulpharsphenamine.

Tablets of Glyceryl Trinitrate.

Tryparsamide.

Typhoid-Paratyphoid A and B Vaccine.

Typhoid-Paratyphoid A, B and C Vaccine.

Whooping-Cough Vaccine.

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By Authority: A. J. Arthur, Commonwealth Government Printer, Canberra.