(1)  Subject to subregulations (2) and (3) and to regulation 48 , a person must not supply a restricted substance otherwise than on, and in accordance with, a prescription issued, or a direction given, in accordance with regulation 41 .

Penalty:  Fine not exceeding 10 penalty units.

(2)  A person may dispense not more than once a prescription for a restricted substance that conforms in all other respects with regulation 41(4) but does not specify a maximum number of times the dispensing of the prescription may be repeated if, upon dispensing the prescription, that person cancels it in accordance with subregulation (12) .

(3)  Where –

(a) the dispensing of a prescription for a declared restricted substance is authorised, by the terms of the prescription, to be repeated but the prescription does not specify the minimum intervals at which the dispensing of the prescription may be repeated; and

(b) the prescription conforms in all other respects with regulation 41(4)  –

a person may dispense that prescription if –

(c) the person –

(i) ascertains, in accordance with subregulation (4) , the earliest date on which the dispensing of the prescription may be repeated; and

(ii) upon dispensing the prescription, marks on it, over the person's signature and the date, a note that specifies both the date so ascertained and how it was ascertained; or

(d) upon dispensing the prescription, the person cancels it in accordance with subregulation (12) .

(4)  The date referred to in subregulation (3)(c)(i) is to be ascertained by reference to either or both of the following:

(a) specific directions for the use by the patient of the declared restricted substance, being directions incorporating a dosage rate, that are included in the prescription;

(b) information obtained directly from the prescriber as to the minimum interval between occasions on which the declared restricted substance should be dispensed to the patient.

(5)  If the date referred to in subregulation (3)(c)(i) is ascertained by reference only to the information referred to in paragraph (a) of subregulation (4) , that date is to be a date not earlier than 4 days before the day on which the quantity of the declared restricted substance being dispensed would be exhausted if used strictly in accordance with the directions referred to in that paragraph.

(6)  A person, other than a pharmaceutical chemist or an assistant under the direct personal supervision of a pharmaceutical chemist, must not dispense a prescription for a restricted substance.

Penalty:  Fine not exceeding 10 penalty units.

(7)  A pharmaceutical chemist or an assistant under the direct personal supervision of a pharmaceutical chemist, subject to this regulation, is authorised to dispense a prescription for a restricted substance.

(8)  A person must not dispense any prescription for a restricted substance or supply a restricted substance on or in accordance with any prescription unless the person complies with the following provisions:

(a) the dispensing of the prescription must not be repeated more than the maximum number of times indicated on it and, if an interval of times is specified, at a shorter interval than that specified, and on each occasion upon which it is dispensed there is to be stamped or marked in writing or clearly shown on the prescription –

(i) the date upon which it is dispensed; and

(ii) the signature of the pharmaceutical chemist by whom it is dispensed or by whom its dispensing is supervised; and

(iii) the address of the place at which it is dispensed;

(b) where the occasion of the dispensing of the prescription is, in accordance with the terms of the prescription, the last occasion on which it may be dispensed, the person, upon dispensing it, must cancel it in accordance with subregulation (12) ;

(c) before completion of the supply of the restricted substance, the person must make or cause to be made, in the approved recording system relating to the pharmacy at which that supply is effected, an entry that, subject to subregulation (9) , sets out –

(i) the date on which the restricted substance is dispensed; and

(ii) whether the authority for the dispensing by the person of the restricted substance is a prescription issued under regulation 41 or 42 or an instruction given under regulation 43 ; and

(iii) the name of the person by whom that prescription was issued or that direction was given; and

(iv) the name and address of the person for the treatment of whom, or of the owner of the animal for the treatment of which, the restricted substance was dispensed; and

(v) the material part of the prescription or instruction, including particulars of any specification in respect of the repeated dispensing of the prescription; and

(vi) the text of any note marked, under subregulation (3)(c)(ii) , on the prescription (if any) on the authority of which that person dispensed the restricted substance;

(d) the label on the container of the restricted substance is to be marked with the identifying letter or number of the prescription appearing in the approved recording system and with such other particulars as are prescribed in regulation 84(2) ;

(e) the approved recording system is to be kept at the place at which the restricted substance was dispensed and is produced on demand to an inspector.

Penalty:  Fine not exceeding 10 penalty units.

(9)  Where the dispensing of a prescription is repeated at a pharmacy at which it was previously dispensed, the entry made under subregulation (8)(c) in relation to the repeat is to set out –

(a) the date of the repeat; and

(b) the name and address of the person for the treatment of whom, or of the owner of the animal for the treatment of which, the dispensing of the prescription was repeated; and

(c) a note of the fact of the repeat by reference to the entry made under subregulation (8)(c) in relation to the first occasion of the dispensing of that prescription in that pharmacy.

(10)  As soon as possible after a prescription written under regulation 43 is received at the pharmacy at which the restricted substance to which it relates was dispensed, a pharmaceutical chemist engaged in the conduct of that pharmacy must –

(a) clearly mark on the prescription a note setting out –

(i) the date on which the restricted substance to which it relates was dispensed; and

(ii) the name of the pharmaceutical chemist by whom, or under whose supervision, it was dispensed; and

(iii) the name and address of the pharmacy at which it was dispensed; and

(iv) the identifying mark relating to the approved recording system entry made in pursuance of subregulation (8)(c) in relation to the dispensing of that restricted substance; and

(b) sign and date that note.

Penalty:  Fine not exceeding 10 penalty units.

(11)  Where the prescription is such that, if it were given otherwise than under regulation 43 , subregulation (2) or (3) of this regulation would apply in relation to it, the pharmaceutical chemist must cancel it, or mark it, as required by whichever of those subregulations would so apply.

Penalty:  Fine not exceeding 10 penalty units.

(12)  Subject to subregulations (13) and (14) , where a person is required by any of the preceding provisions of this regulation to cancel a prescription –

(a) the person must write, stamp or mark in ink in legible letters the word "Cancelled" across the prescription; and

(b) except with the permission in writing of the Secretary, the person must not, within a period of 2 years from the day on which the requirement to cancel the prescription arose, remove or permit the removal of the prescription from the premises at which that requirement arose.

Penalty:  Fine not exceeding 10 penalty units.

(13)  Where the original of a prescription that is prepared in duplicate is required, under a law of the Commonwealth, to be forwarded to a Department or authority of the Commonwealth –

(a) it is sufficient compliance with the requirements of subregulation (3)(c)(ii) , subregulation (8)(a) , subregulation (10) or (12) if the duplicate of the prescription is dealt with in accordance with those requirements; and

(b) a reference in the following provisions of this regulation to a prescription, unless the contrary intention appears, is to be taken to include a reference to such a duplicate.

(14)  Subregulation (12)(b) does not apply in relation to a prescription (other than a prescription that does not comply with regulation 15 ) that is written on the same piece of paper as another prescription that may lawfully subsequently be dispensed.

(15)  A person must not dispense a restricted substance on a prescription which –

(a) is illegible or defaced; or

(b) is marked "cancelled" ; or

(c) appears to have been altered; or

(d) appears to be fraudulent in any respect or forged.

Penalty:  Fine not exceeding 10 penalty units.

(16)  A person to whom a prescription of the kind referred to in subregulation (15) is presented must –

(a) retain the prescription notwithstanding that it has not been dispensed; and

(b) as soon as practicable inform the Secretary or a police officer of the relevant circumstances and the person's reasons for not dispensing the prescription.

Penalty:  Fine not exceeding 10 penalty units.

(17)  A person must not dispense a prescription for a restricted substance or supply a restricted substance upon a prescription if the prescription is presented for dispensing –

(a) in the case of a prescription for a restricted substance other than a declared restricted substance or a specified psychotropic substance, more than 12 months after the date on which the prescription was written; or

(b) in the case of a prescription for a declared restricted substance or a specified psychotropic substance, more than 6 months after the date on which the prescription was written.

Penalty:  Fine not exceeding 10 penalty units.

(18)  For the purposes of this regulation, 2 or more prescriptions issued to the same person in respect of the same declared restricted substance are to be treated as a single prescription that authorises the substance to be dispensed more than once.