National Health (Pharmaceutical Benefits) Regulations (Amendment) (Cth)

Statutory Rules 1981 No. 521

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National Health (Pharmaceutical Benefits)

Regulations2(Amendment)

WHEREAS it is provided by sub-section 101 (4) of the National Health Act 1953 that a drug or medicinal preparation that was not a pharmaceutical benefit under that Act immediately before the commencement of that sub-section shall not be prescribed as a pharmaceutical benefit in accordance with section 85 of that Act unless the Pharmaceutical Benefits Advisory Committee has recommended to the Minister that it be so prescribed:

 AND WHEREAS the Pharmaceutical Benefits Advisory Committee has recommended to the Minister that each drug and medicinal preparation the name of which is specified in Schedule 3 to the following Regulations be prescribed as a pharmaceutical benefit in accordance with section 85 of the National Health Act  1953:

AND WHEREAS it is desirable, amongst other things, to prescribe, for the purpose of section 85 of the National Health Act 1953, each drug and medicinal preparation so recommended by the Pharmaceutical Benefits Advisory Committee:

 NOW THEREFORE I, the Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, hereby make the following Regulations under the National Health Act 1953.

 Dated 25 March 1981.

 ZELMAN COWEN

 Governor-General

 By His Excellency’s Command,

MICHAEL MACKELLAR

Minister of State for Health

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Commencement

 1. These Regulations shall come into operation on 1 April 1981.

Pharmaceutical benefits that may be prescribed only for specified persons, diseases, &c.

 2. Regulation 14 of the National Health (Pharmaceutical Benefits) Regulations is amended—

• (a)

  by omitting from paragraph (d) of sub-regulation (2) “writing of a prescription for the supply of the pharmaceutical benefit has been made by the medical practitioner intending to write the prescription” and substituting “supply of the pharmaceutical benefit has been made by a medical practitioner”; and

• (b)

  by omitting sub-regulation (3) and substituting the following sub-regulation:

  • “(3)

    Where a medical practitioner makes an application under paragraph (2) (d) and the Permanent Head approves the application, the Permanent Head shall record his approval on a numbered authority and—

    • (a)

      where, in the approval, the Permanent Head requires the medical practitioner to vary the prescription for the supply of the pharmaceutical benefit-return the approval to the medical practitioner; or

    • (b)

      in any other case-forward the approval to the person to whom the pharmaceutical benefit is to be supplied.”.

Supply of pharmaceutical benefits on prescriptions

 3. Regulation 21 of the National Health (Pharmaceutical Benefits) Regulations is amended by omitting from paragraph (e) of sub-regulation (1) “accompanied by a numbered” and substituting “written upon an”.

Repeat authorizations

 4. Regulation 26 of the National Health (Pharmaceutical Benefits) Regulations is amended by omitting from paragraph (e) of sub-regulation (1) “accompanied by a numbered” and substituting “written upon an”.

Schedule 1

 5. Schedule 1 to the National Health (Pharmaceutical Benefits) Regulations is amended as set out in Schedule 1.

Schedule 2

 6. Schedule 2 to the National Health (Pharmaceutical Benefits) Regulations is amended as set out in Schedule 2.

Schedule 3

 7. Schedule 3 to the National Health (Pharmaceutical Benefits) Regulations is amended as set out in Schedule 3.

Schedule 4

 8. Schedule 4 to the National Health (Pharmaceutical Benefits) Regulations is amended as set out in Schedule 4.

Schedule 5

 9. Schedule 5 to the National Health (Pharmaceutical Benefits) Regulations is amended as set out in Schedule 5.

SCHEDULE 1

Regulation 5

AMENDMENTS OF SCHEDULE 1 TO THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS

• 1.

  After item 54 insert the following item:

  “54A Benzalkonium Chloride Solution”.

• 2.

  After item 64 insert the following item:

  “64A Borax”.

• 3.

  After item 65 insert the following item:

  “65A Brilliant Green”.

• 4.

  After item 92 insert the following item:

  “92A Cardamom Tincture, Compound”.

• 5.

  After item 136 insert the following item:

  “136A Cocaine”.

• 6.

  After item 235 insert the following item:

  “235A Disodium Edetate”.

• 7.

  Omit item 244.

• 8.

  After item 252 insert the following item:

  “252A Ephedrine Hydrochloride Tablets”.

• 9.

  After item 282 insert the following item:

  “282A Ferric Ammonium Citrate”.

• 10.

  Omit item 305.

• 11.

  After item 309 insert the following items:

“309A Ginger Tincture, Strong

309B Ginger Tincture, Weak”.

• 12.

  After item 380 insert the following item:

  “380A Isoprenaline Hydrochloride Injection”.

• 13.

  After item 449 insert the following item:

  “449A Methoin Tablets”.

• 14.

  After item 496 insert the following item:

  “496A Noradrenaline Acid Tartrate”.

• 15.

  After item 605 insert the following item:

  “605A Potassium Hydroxide Solution”.

• 16.

  After item 658 insert the following item:

  “658A Reserpine”.

• 17.

  After item 659 insert the following items:

“659A Rhubarb

659B Rhubarb Tincture, Compound”.

• 18.

  After item 676 insert the following item:

  “676A Smallpox Vaccine”.

• 19.

  After item 679 insert the following item:

  “679A Sodium Acid Phosphate”.

• 20.

  After item 718 insert the following item:

  “718A Sucrose”.

• 21.

  After item 726 insert the following item:

  “726A Sulphamethoxydiazine Tablets”.

• 22.

  After item 727 insert the following item:

  “727A Sulphamethoxypyridazine Tablets”.

• 23.

  After item 737 insert the following items:

“737A Tannic Acid

737B Tar”.

SCHEDULE 2Regulation 6

AMENDMENTS OF SCHEDULE 2 TO THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS

• 1.

  After item 7 insert the following items:

“7A	Aluminium Hydroxide Gel B.P.	Magnesium Hydroxide with Aluminium  Hydroxide Gel, B.P.
Magnesium Hydroxide with Oxethazaine  and Aluminium Hydroxide Gel, B.P.
Light Kaolin, B.P. or Light Kaolin (Natural) B.P.   with Aluminium Hydroxide Gel
7B	Aluminium Hydroxide Gel Dried B.P.	Magnesium Hydroxide with Aluminium Hydroxide  Gel Dried B.P. Magnesium Trisilicate with Magnesium Hydroxide  and Aluminium Hydroxide Gel Dried, B.P.
7C	Aluminium Hydroxide and Magnesium Carbonate Co-dried Gel	—”.

• 2.

  After item 9 insert the following item:

“9A Aminacrine Hydrochloride, B.P. 1968 —”.

• 3.

  Omit item 13.

• 4.

  Omit item 19, substitute the following item:

“19 Atropine Methonitrate —”.

• 5.

  After item 40 insert the following item:

“40A Camphor Compound Linctus —”.

• 6.

  Omit item 44.

• 7.

  After item 57 insert the following item:

“57A Codeine, Linctus, A.P.F. —”.

• 8.

  After item 84 insert the following item:

“84A Epicillin Purified Water, B.P. with Epicillin”.

• 9.

  After item 106 insert the following item:

“106A Gelatin Sodium Carboxymethyl cellulose with Pectin and Gelatin”

• 10.

  After item 110 insert the following items:

“110A	Glycerophosphate Compound Syrup A.P.F. 1964	—
110B	Glyceryl Trinitrate	—”

• 11.

  Omit item 123.

• 12.

  After item 139 insert the following item:

“39A Morphine Sulphate Atropine Sulphate with Morphine Sulphate Tacrine Hydrochloride with Morphine Sulphate”

• 13.

  Omit item 147.

• 14.

  Omit item 159, substitute the following item:

“59 Pectin Gelatin with Sodium Carboxymethylcellulose and Pectin Kaolin Light B.P. or Light Kaolin (Natural) B.P. with Pectin”.

• 15.

  After item 182 insert the following item:

“82A Senega and Ammonia Mixture, A. P.F. —”

SCHEDULE 3

Regulation 7

AMENDMENTS OF SCHEDULE 3 TO THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS

• 1.

  Omit item 3.

• 2.

  After item 13 insert the following item:

“13A Aluminium Hydroxide and Magnesium Carbonate Co-dried Gel”.

• 3.

  Omit item 17, substitute the following items:

“17	Amaranth Solution, A.P.F. 1964
17A	Amaranth Solution, A.P.F.
17B	Amaranth Solution Compound, A.P.F.”.

• 4.

  Omit item 33.

• 5.

  Omit item 51.

• 6.

  After item 56 insert the following item:

“56A Calcitriol”.

• 7.

  Omit item 60, substitute the following item:

“60 Camphor Compound Linctus, A.P.F.”.

• 8.

  Omit item 62.

• 9.

  Omit item 63.

• 10.

  Omit item 66.

• 11.

  After item 85 insert the following item:

“85A Codeine Linctus, A.P.F.”.

• 12.

  Omit item 87.

• 13.

  Omit item 130.

• 14.

  Omit item 131.

• 15.

  After item 137 insert the following item:

“137A Glyceryl Trinitrate”.

• 16.

  Omit item 147.

• 17.

  Omit item 178.

• 18.

  Omit item 179, substitute the following item:

“179 Lemon Spirit, A.P.F.”.

• 19.

  Omit item 192.

• 20.

  After item 198, insert the following item:

“198A Metolazone”.

• 21.

  Omit item 202.

• 22.

  Omit item 232.

• 23.

  After item 269, insert the following item:

“269A Senega and Ammonia Mixture, A.P.F.”.

• 24.

  Omit item 272.

• 25.

  After item 273 insert the following item:

“273A Soap Liniment B.P.C.”.

• 26.

  Omit item 299, substitute the following item:

“299 Tamoxifen Citrate”.

• 27.

  After item 304 insert the following item:

“304A Tetrabenazine”.

• 28.

  After item 309 insert the following item:

“309A Thymol Mouth-Wash Compound, A.P.F.”.

SCHEDULE 4

Regulation 8

AMENDMENTS OF SCHEDULE 4 TO THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS

• 1.

  After item 3 insert the following item:

“3A Borax, B.P.”.

• 2.

  Omit item 11.

• 3.

  Omit item 13.

• 4.

  Omit item 21.

SCHEDULE 5

Regulation 9

AMENDMENTS OF SCHEDULE 5 TO THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) REGULATIONS

• 1.

  After item 17 insert the following item:

“17A Calcitriol With the written authority of the Permanent Head— Use in hospitals for hypocalcaemia due to renal disease”.

• 2.

  Omit item 60 substitute the following item:

“60 Dipyridamole With the written authority of the Permanent Head— Supplementing anticoagulants in-Biopsy proven glomerulo-nephritis Mesangiocapillary renal disease Renal allograft Patients with cardiac prosthesis”.

• 3.

  After item 61 insert the following item:

“61A Dydrogesterone Tablets With the written authority of the Permanent Head— Endometriosis, proven by visual means”.

• 4.

  Omit item 79 substitute the following item:

“79 (1) Idoxuridine Eye Drops (2) Idoxuridine Eye Ointment Eye infections caused by Herpes Simplex Virus”.

• 5.

  After item 129 insert the following item:

“129A Pindolol, Tablet 15 mg Hypertension where there is an inadequate response to not less than 15 mg of pindolol daily Frequent disabling angina without evidence of cardiac failure where there is an inadequate response to not less than 15 mg of pindolol daily”.

• 6.

  Omit item 147 substitute the following items:

“147	Sodium Cromoglycate B.P. Capsule 10 mg	With the written authority of the Permanent Head— Allergic rhinitis not responding to other treatment
147A	Sodium Cromoglycate B.P. Eye Drops	With the written authority of the Permanent Head— Vernal kerato-conjunctivitis demonstrated by eosinophils in conjunctival scrapings”.

• 7.

  After item 155 insert the following item:

“155A Tamoxifen Citrate With the written authority of the Permanent Head— Treatment of post-menopausal metastatic breast cancer”.

• 8.

  After item 157 insert the following item:

“157A Tetrabenazine With the written authority of the Permanent Head— Chorea not adequately controlled by other drug therapy”.

• 9.

  Omit item 173, substitute the following item:

“173 Vidarabine Eye infections caused by Herpes Simplex Virus where idoxuridine has proved ineffective”.

 

NOTES

1. Notified in the Commonwealth of Australia Gazette on 31 March 1981.

2. Statutory Rules 1960 No. 17 as amended by 1960 Nos. 90 and 102; 1961 Nos. 59 and 137; 1962 Nos. 34, 101 and 114; 1963 Nos. 34, 69 and 107; 1964 Nos. 12, 57 and 135; 1965 Nos. 51, 151 and 152; 1966 Nos. 80 and 144; 1967 Nos. 67, 116 and 158; 1968 Nos. 44, 76, 88 and 146; 1969 Nos. 44, 107 and 185; 1970 Nos. 39, 94, 119 and 186; 1971 Nos. 44, 101, 136 and 154; 1972 Nos. 32, 121 and 205; 1973 Nos. 15, 57, 139 and 229; 1974 Nos. 37, 126 and 222; 1975 Nos. 50, 148 and 209; 1976 Nos. 84, 150, 195 and 255; 1977 Nos. 39, 125 and 221; 1978 Nos. 47, 142, 153 and 245; 1979 Nos. 51, 55, 144 and 250; 1980 Nos. 69, 213 and 338.