South Australian Numbered Regulations

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CONTROLLED SUBSTANCES (POISONS) REGULATIONS 2011 (NO 140 OF 2011) - REG 35

35—Dispensing prescriptions

        (1)         A pharmacist or medical practitioner who dispenses a drug

            (a)         must endorse on the prescription for the drug or, in the case of a prescription given by fax that is endorsed with the name and address of a single pharmacy at which the prescription may be dispensed, on the faxed copy of the prescription—

                  (i)         his or her name, business name and business address; and

                  (ii)         the date on which the drug is dispensed; and

                  (iii)         the unique identifier applicable to the drug; and

            (b)         must, on the day on which the drug is dispensed, record

                  (i)         the unique identifier applicable to the drug dispensed on the prescription; and

                  (ii)         his or her name as the dispenser; and

                  (iii)         the date; and

                  (iv)         the trade name or the approved name of the drug, or, if it does not have either a trade or approved name, its ingredients; and

                  (v)         —

                        (A)         the full name and address of the person for whose use the drug is dispensed; or

                        (B)         if the drug is intended for an animal—the species of animal for which it is intended, the name and address of the owner of the animal and the name (if any) of the animal; and

                  (vi)         the form, strength and quantity of the dispensed drug; and

                  (vii)         the directions given for the safe and proper use of the dispensed drug; and

                  (viii)         the name, address and business telephone number of the person who prescribed the drug; and

                  (ix)         the number of times the prescription may be dispensed and (if the prescription so specifies) the intervals at which the drug may be dispensed; and

            (c)         if the prescription is for an S4 poison and does not specify the number of times the drug is to be dispensed, must—

                  (i)         dispense it once only pursuant to that prescription; and

                  (ii)         endorse the word "CANCELLED" on the prescription or, in the case of a prescription given by fax that is endorsed with the name and address of a single pharmacy at which the prescription may be dispensed, on the faxed copy of the prescription; and

                  (iii)         unless the prescription is for any reason forwarded to the Department or the Minister—retain the original or duplicate prescription or, in the case of a prescription given by fax that is endorsed with the name and address of a single pharmacy at which the prescription may be dispensed, the faxed copy of the prescription (as the case may be) for at least 1 year and have it readily available for inspection during that period; and

            (d)         if the prescription specifies the number of times and the intervals at which the drug may be dispensed—must not dispense the drug more times than the number specified or at intervals less than those specified; and

            (e)         if the prescription specifies the number of times but not the intervals at which the drug may be dispensed—must not dispense the drug more frequently than he or she considers appropriate; and

            (f)         in the case of a prescription for a drug of dependence, must, each time the drug is dispensed, except if the drug is fully dispensed, forward a copy of the prescription to the CE no later than the 7th day of the month following the month in which the drug was so dispensed or such later date as the CE may, on application by the pharmacist or medical practitioner, authorise; and

            (g)         if a drug is fully dispensed, must—

                  (i)         on the day on which the prescription is fully dispensed, endorse the word "CANCELLED" on the prescription or, in the case of a prescription given by fax that is endorsed with the name and address of a single pharmacy at which the prescription may be dispensed, on the faxed copy of the prescription; and

                  (ii)         —

                        (A)         in the case of a prescription for a drug of dependence—forward to the CE the prescription or, in the case of a prescription given by fax that is endorsed with the name and address of a single pharmacy at which the prescription may be dispensed, the faxed copy of the prescription, not later than the 7th day of the month following the month in which the drug was so dispensed (or such later date as the CE may, on the application by the pharmacist or medical practitioner, authorise); or

                        (B)         in any other case—retain the original or duplicate prescription or in the case of a prescription given by fax that is endorsed with the name and address of a single pharmacy at which the prescription may be dispensed, the faxed copy of the prescription for at least 2 years and have it readily available for inspection during that period.

Maximum penalty: $5 000.

        (2)         A pharmacist in charge of a pharmacy at which no drugs of dependence are dispensed for a period of 30 consecutive days must, no later than the 7th day of the month following the month during which the 30th day of that period falls, notify the CE of that fact in writing.

Maximum penalty: $5 000.

        (3)         If a prescription has been issued in duplicate and the original is retained by the pharmacist or medical practitioner, it is sufficient compliance with this regulation if the required information is marked on the duplicate prescription.

        (4)         Despite subregulation (1)(d), if a pharmacist or medical practitioner is satisfied that a person—

            (a)         has lost a previously dispensed supply of a drug; or

            (b)         will, through absence from the State or otherwise, find it unduly difficult to have future supplies of a drug dispensed as needed,

he or she may (but is not obliged to) dispense a prescription for the person at an interval earlier than that specified on the prescription.

        (5)         If, pursuant to subregulation (4), a pharmacist or medical practitioner dispenses a drug of dependence at an earlier interval than that specified on the prescription, the pharmacist or practitioner must notify the prescriber of that fact in writing.

Maximum penalty: $5 000.

        (6)         If a prescription given by fax is endorsed with the name and address of a single pharmacy at which the drug may be dispensed, a pharmacist must not dispense the drug unless he or she is on duty at that pharmacy.

Maximum penalty: $5 000.

        (7)         A pharmacist or medical practitioner must not dispense a drug

            (a)         if the prescription for the drug

                  (i)         is presented or otherwise sought to be dispensed

                        (A)         in the case of a drug of dependence—more than 6 months after the date on which it was written; or

                        (B)         in any other case—more than 12 months after the date on which it was written; or

                  (ii)         has been cancelled; or

                  (iii)         is partly or wholly illegible; or

                  (iv)         does not comply with the Act or these regulations; or

            (b)         if there are reasonable grounds for suspecting that the prescription has been altered, forged or obtained by false pretences; or

            (c)         unless—

                  (i)         in the case of a drug that is to be dispensed for the first or only time—

                        (A)         an original prescription for the drug is presented; or

                        (B)         the prescription for the drug is given by fax and is endorsed with the name and address of a single pharmacy at which the drug may be dispensed; or

                  (ii)         in the case of a drug that is to be dispensed for the second or subsequent time—

                        (A)         the original prescription for the drug and a written record (whether made on the prescription or on a separately attached repeat authorisation) of the number of times the drug has been dispensed are presented; or

                        (B)         a duplicate or copy of the prescription for the drug and a written record (made both on the duplicate or copy (as the case may be) and on a separately attached repeat authorisation) of the number of times the drug has been dispensed are presented; or

            (d)         if the prescription has been transmitted electronically—unless the drug is able to be dispensed by the pharmacist or medical practitioner in accordance with the terms of an exemption under subregulation (9).

Maximum penalty: $5 000.

        (8)         A pharmacist or medical practitioner must not, in respect of a drug of dependence—

            (a)         dispense more than 2 days supply of the drug unless at least 1 of the following applies:

                  (i)         the person for whose use the drug is prescribed is known to the pharmacist or practitioner;

                  (ii)         the pharmacist or practitioner recognises the signature on the prescription as that of the prescriber who purportedly gave the prescription;

                  (iii)         the pharmacist or practitioner has verified with the prescriber who purportedly gave the prescription that the prescription was in fact given by that prescriber; or

            (b)         hand over the dispensed drug until—

                  (i)         the person for whose use the drug is dispensed

                        (A)         has signed and dated the prescription or, if the prescription was given by fax, the faxed copy of the prescription; and

                        (B)         has, unless the person is known to the pharmacist or practitioner, produced satisfactory evidence of his or her identity; or

                  (ii)         the person for whose use the drug is dispensed

                        (A)         has signed a computer-generated printed copy of the prescription that includes all the information required to be provided on a written prescription; and

                        (B)         has, unless known to the pharmacist or practitioner, produced satisfactory evidence of his or her identity; or

                  (iii)         an agent acting on behalf of the person for whose use the drug is intended—

                        (A)         has signed and dated the prescription or, if the prescription was given by fax, the faxed copy of the prescription; and

                        (B)         has, unless the agent is known to the pharmacist or practitioner, produced satisfactory evidence of his or her identity; or

                  (iv)         an agent acting on behalf of the person for whose use the drug is intended—

                        (A)         has signed a computer-generated printed copy of the prescription that includes all the information required to be provided on a written prescription; and

                        (B)         has, unless known to the pharmacist or practitioner, produced satisfactory evidence of his or her identity.

Maximum penalty: $5 000.

        (9)         The Minister may exempt a pharmacist or medical practitioner, or a class of pharmacists or medical practitioners from this regulation, or specified provisions of this regulation, if satisfied that the pharmacist or medical practitioner, or class of pharmacists or medical practitioners, has adequate arrangements for dispensing drugs on prescriptions that have been transmitted electronically.

        (10)         An exemption under subregulation (9)—

            (a)         may be subject to such conditions as the Minister thinks fit; and

            (b)         may be varied or revoked by the Minister at any time by notice in writing.

        (11)         For the purposes of this regulation, a prescription for a drug is "fully dispensed" if—

            (a)         in the case of a prescription authorising dispensing of the drug once only—the drug has been dispensed on 1 occasion; or

            (b)         in the case of a prescription authorising dispensing of the drug more than once—the drug has been dispensed for the last time.



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