Poisons Act 1966 Regulation relating to the labelling of dispensed medicines and to other matters (1992-345) [GG No 75 of 26.6.1992] (NSW)

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1992—No. 345

POISONS ACT 1966—REGULATION

(Relating to the labelling of dispensed medicines and to other matters)

NEW SOUTH WALES

[Published in Gazette No. 75 of 26 June 1992]

HIS Excellency the Governor, with the advice of the Executive Council, and in pursuance of the Poisons Act 1966, has been pleased to make the Regulation set forth hereunder.

RON PHILLIPS

for Minister for Health and Community Services.

Commencement

1. This Regulation commences on 26 June 1992.

Amendments

2. The Poisons Regulations are amended:

(a)

by omitting from Regulation 2 the definitions of “Nursing home” and “Private hospital” and by inserting instead the following definitions:

“Nursing home” means premises licensed as a nursing home

under the Nursing Homes Act 1988.

“Private hospital” means premises licensed as a private hospital under the Private Hospitals and Day Procedures Centre Act 1988.

(b)

by omitting from Regulation 8A (1) (b) the matter “1.5 metres” and by inserting instead the matter “ 1.2 metres”;

(c)

by omitting from Regulation 10A (1) the words “the container” where secondly occurring and by inserting instead the words “that container”;

1992—No. 345

(d) by omitting from Regulation 10A (2) the words “the primary pack” and by inserting instead the words “, that primary pack”;
(e) by inserting in Regulation 17 after the words “any State” the words “or Territory”;
(f) by inserting in Regulation 20 (1) after the word “labelled” the words “in the English language in durable characters”;
(g) by omitting from Regulation 25 the words “or by telegram” wherever occurring and by inserting instead the words “, lettergram or facsimile”;
(h) by omitting from Regulation 27 (7) and (8) the words “the date of its presentation” wherever occurring and by inserting instead the words “the date on which its dispensing or supply upon the prescription is requested”;

(i)  by omitting from Regulation 31D (1) the words “whose pages are numbered consecutively” and by inserting instead the words “, being a book which is bound in such a way that its pages (which must be numbered consecutively) cannot be removed or replaced without trace”;

(i)  by omitting from Regulation 40A (6) (a) the words “the Minister for Health of the Commonwealth” and by inserting instead the words “the Secretary of the Department of Health, Housing and Community Services of the Commonwealth”;

(k)

by omitting from Regulation 42 (6) the words “permission in writing of the Minister for Health of the Commonwealth of Australia” and by inserting instead the words “approval in writing of the Secretary of the Department of Health, Housing and Community Services of the Commonwealth”;

(l)

by omitting from Regulation 46A (3) the word “registered” and by inserting instead the words “security post”;

(m)

by inserting in Regulation 56 (3) and (3A) after the word “telephone” wherever occurring the words “or facsimile’’;

(n)

by omitting from Regulation 56B (1) and (2) the word “registered” wherever occurring and by inserting instead the word “ security ” ;

(o)

by omitting from Regulation 58 (1) the words “the pages being numbered consecutively and” and by inserting instead the words “being a book which is bound in such a way that its pages (which must be numbered consecutively) cannot be removed or replaced without trace and which is”;

(p)

by omitting from Regulation 63 the words “or by telegram” and by inserting instead the words “or by lettergram or by facsimile”;

1992—No. 345

(q)

by omitting from Regulation 63 the words “or telegram” and by inserting instead the words “, lettergram or facsimile”;

(r)

by omitting from Regulations 67 (2) and 67A (3) the words “with pages numbered consecutively and containing the particulars in or to the effect of Form 9” wherever occurring and by inserting instead the words “, being a book which is bound in such a way that its pages (which must be numbered consecutively) cannot be removed or replaced without trace and which contains the particulars required by Form 9,”;

(s)

by inserting in Regulation 67 (2) (b) and 67A (3) (b) after the word “drug” wherever occurring the words “or by a person who witnessed its administration”;

(t) by inserting at the end of Regulation 70B the following clause:

(2) When the authority is restored, the Director-General must

cause notice of its restoration to be published in the Gazette.

EXPLANATORY NOTE

The amendments to the Poisons Regulations made by this Regulation are amendments for the purposes of clarification, amendments by way of law revision and miscellaneous amendments.

Amendments made for the purposes of clarification are contained in paragraphs (c), (d), (f), (h), (i), (o) and (r). Paragraphs (c) and (d) single out a particular container and a particular primary pack (respectively) from others referred to in Regulation 10A. Paragraph (f) makes it clear that containers of dispensed medicines must be labelled in the English language if they are to obtain exemption from certain other labelling requirements of the Regulations. Paragraph (h) clarifies what is meant by the date of “presentation” of a prescription by omitting the term and, instead, setting out its meaning. Paragraphs (i), (o) and (r) make it clear that registers relating to the receipt, supply, etc. of certain substances must take the form of books whose pages cannot be removed or replaced without trace.

The amendments by way of law revision concern the following:

• the repeal of Acts referred to in the Regulations and the enactment of replacement Acts—paragraph (a)
• the abolition of certain methods of communication—paragraphs (g), (l),

(n), (p) and (q)

• the use of a modern form of communication for certain purposes— paragraphs (g), (m), (p) and (q)

Miscellaneous amendments are made by paragraphs (b), (e), (j), (k), (s) and (t). At present, certain poisons kept for retail sale must be kept at least 1.5 metres from particular areas open to the public. Paragraph (b) reduces that distance to 1.2 metres.

1992—No. 345

Paragraph (e) extends a concession regarding the labelling requirements of certain substances to such manufacturers or distributors of those substances as are companies incorporated under the law of any Territory of Australia.

Regulations 40A (6) (a) and 42 (6) require that certain written authorities be obtained from the Minister of Health of the Commonwealth. Paragraphs (j) and (k) amend those requirements so that the authority (now an “approval” in the case of Regulation 42 (6)) is to be obtained from the Secretary of the relevant Commonwealth Department.

A person who administers a drug of addiction must sign the register relating to such drugs. A second signature is also required—at present, that of the person who supervised or authorised the administration. The amendment made by paragraph (s) allows a person who wihessed the administration. to provide the second signature.

When a person’s authority to possess, supply, prescribe etc. a drug of addiction is

withdrawn, notice of the withdrawal must be published in the Government Gazette. The amendment made by paragraph (t) requires publication of notice of the restoration of that authority (when that occurs).

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