STATUTORY RULES.
1961. No. 134.
REGULATIONS
UNDER THE COMMONWEALTH SERUM LABORATORIES ACT 1961.*
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 Commonwealth Serum Laboratories Act 1961.
Dated this 26th day of October, 1961.
DE L’ISLE
Governor-General.
By His Excellency’s Command,
(Sgd.) Donald A. Cameron
Minister of State for Health.
COMMONWEALTH SERUM LABORATORIES
REGULATIONS.
Citation.
1. These Regulations may be
cited as the Commonwealth Serum Laboratories Regulations.
Prescribed biological products.
2. The biological products
specified in the Schedule to these Regulations are prescribed for the purposes
of section 19 of the Commonwealth Serum Laboratories Act 1961.
THE SCHEDULE.
REGULATION 2.
Item No. | Biological Products. |
PART 1.—BIOLOGICAL PRODUCTS DERIVED FROM ANIMALS. |
1. | Blood products, namely— |
(1) Blood
|
(2) Blood cellular components
|
(3) Plasma
|
(4) Plasma fractions
|
(5) Serum
|
2. | Endocrine products, namely— |
(1) Corticotrophin
|
(2) Insulin
|
(3) Pituitary preparations
|
(4) Thyroid extract
|
* Notified in the
Commonwealth Gazette on 27th October, 1961.
8486/61.—PRICE 3D. 10/18.10.1961.
THE SCHEDULE—continued.
Item No. | Biological Products. |
PART 1.—BIOLOGICAL PRODUCTS DERIVED
FROM ANIMALS—continued. |
3. | Other products from animal tissues or secretions, namely— |
(1) Cell cultures
|
(2) Cell layers
|
(3) Cell preparations
|
(4) Cell suspensions
|
(5) Enzymes from animal tissues or secretions
|
(6) Heparin
|
(7) Preparations being or containing tissue;
extracts prepared from tissue or of tissue secretions
|
(8) Protein hydrolysates
|
PART 2.—BIOLOGICAL PRODUCTS DERIVED FROM HUMANS.
4. | Blood products, namely— |
(1) Blood
|
(2) Blood cellular components
|
(3) Plasma
|
(4) Plasma fractions
|
(5) Serum
|
5. | Products from human tissues or secretions, namely— |
(1) Cell cultures
|
(2) Cell layers
|
(3) Cell preparations
|
(4) Cell suspensions
|
Part 3.—BIOLOGICAL PRODUCTS
DERIVED FROM, OR BY THE USE OF, MICRO-ORGANISMS.
6. | Antibiotic preparations, namely— |
(1) 6-amino penicillanic acid
|
(2) Benzyl penicillin
|
(3) Dihydrostreptomycin
|
(4) Phenoxymethyl penicillin
|
(5) Streptomycin
|
7. | Antibiotic preparations comprising a derivative, compound or salt of
any of the following:— |
(1) 6-amino penicillanic acid
|
(2) Benzyl penicillin
|
(3) Dihydrostreptomycin
|
(4) Penicillamine
|
(5) Phenoxymethyl penicillin
|
(6) Streptomycin
|
8. | Antigens,
toxins, toxoids and sera for the diagnosis, prevention, cure or alleviation
of disease caused by the following bacterial agents:—
|
(1) Bacillae
|
(2) Bordetellae
|
(3) Brucellae
|
(4) Clostridia
|
(5) Corynebacteriae
|
(6) Diplococci
|
(7) Erysipelothrix
|
(8) Fusibacteriae
|
(9) Haemophilus
|
(10) Klebsiellae
|
(11) Leptospirae
|
(12) Mycobacteriae
|
(13) Neisseriae
|
(14) Pasteurellae
|
(15) Salmonellae
|
(16) Staphylococci
|
(17) Streptococci
|
(18) Vibrio
|
THE SCHEDULE—continued.
Item No. | Biological Products. |
PART 3.—BIOLOGICAL PRODUCTS DERIVED FROM, OR BY THE USE OF, MICRO-ORGANISMS—continued.
9. | Antigens,
toxins, toxoids and sera for the diagnosis, prevention, cure or alleviation
of disease caused by the following rickettsial agents:—
|
(1) The rickettsia of epidemic typhus fever
|
(2) The rickettsia of murine typhus fever
|
(3) The rickettsia of Q. fever
|
10. | Antigens,
toxins, toxoids and sera for the diagnosis, prevention, cure or alleviation
of disease caused by the following viral agents:—
|
(1) Canine distemper virus
|
(2) Contagious pustular dermatitis virus
|
(3) Fibroma virus
|
(4) Fowl pox virus
|
(5) Infectious laryngotracheitis virus
|
(6) Influenza virus
|
(7) Pigeon pox virus
|
(8) Poliomyelitis virus
|
(9) Sendai virus
|
(10) Vaccinia virus
|
(11) Yellow fever virus
|
11. | Cultures of micro-organisms |
12. | Enzymes of
micro-organisms |
PART 4.—MISCELLANEOUS PRODUCTS.
13. | Allergenic
materials, including those produced from animals, arachnids, insects,
micro-organisms and plants, for the diagnosis, prevention, cure or
alleviation of allergic conditions
|
14. | Fat emulsions
of plant origin |
15. | Microbiological
culture media |
16. | Antivenenes for
the cure or alleviation of bites or stings caused by snakes, insects,
arachnids or fish
|
17. | Diagnostic
agents derived from, or for use in the diagnosis of disease caused by, any of
the following micro-organisms:—
|
(1) Mycoplasmae
|
(2) Proteus
|
(3) Shigellae
|
(4) Treponemae
|
(5) Histoplasmae
|
(6) Toxoplasmae
|
(7) Trichomonas
|
(8) The rickettsia of North Queensland tick typhus
fever
|
(9) The rickettsia of spotted fever
|
(10) Dengue fever virus
|
(11) The virus of enzootic abortion of ewes
|
(12) Herpes simplex virus
|
(13) Lymphogranuloma venereum virus
|
(14) Mumps virus
|
(15) Ornithosis virus
|
(16) West Nile encephalitis virus
|
18. | Other diagnostic agents and outfits, namely— |
(1) Anti-Rh sera
|
(2) Blood grouping agents
|
(3) Blood group specific substances
|
(4) Coombs reagent
|
(5) Diagnostic outfits
|
(6) Precipitin sera
|
(7) Thromboplastin
|
(8) Reagents for Paul-Bunnell test
|
THE SCHEDULE—continued.
Item No. | Biological Products. |
PART 4.—MISCELLANEOUS PRODUCTS—continued.
19. | Infusion fluids
and diluents for the solution and suspension of biological products—
|
(1) Balanced salt solutions
|
(2) Buffered saline extracting fluid
|
(3) Carbolized saline
|
(4) Cholesterol solution
|
(5) Coca’s extracting fluid
|
(6) Formalinized distilled water
|
(7) Glucose-citrate solution
|
(8) Glycerolized saline
|
(9) Phenolized distilled water
|
(10) Sodium chloride injection
|
(11) Water for injection
|
20. | Biological
products composed of two or more of the products specified in this Schedule.
|
By Authority: A. J. ARTHUR, Commonwealth Government Printer, Canberra.