This regulation may be cited as the Health (Drugs and Poisons) Amendment Regulation (No. 2) 2020.
This regulation amends the Health (Drugs and Poisons) Regulation 1996.
3Replacement of s 11 (Labelling of controlled or restricted drugs or poisons—Act, s 131I)
Section 11—
omit, insert—11Labelling of controlled or restricted drugs or poisons—Act, ss 131I and 132(n)
(1)For section 131I of the Act, a package containing a controlled drug, a restricted drug or a poison must bear a label that complies with the current Poisons Standard, part 2.(2)For section 132(n) of the Act, a package is exempt from section 131I of the Act if the package is labelled in an alternative way certified for the package under subsection (3).See also the current Poisons Standard, section 1.5 for other labelling exemptions.(3)The chief executive may certify an alternative way of labelling a package if—(a)the package is for containing a controlled drug, a restricted drug, or an S2 or S3 poison; and(b)either—(i)an appropriate authority, for a purpose or in another State, has authorised (whether by approval, exemption or some other way) the package to be labelled in the alternative way for the purpose or other State; orFor the definition appropriate authority, see the current Poisons Standard, part 1.(ii)the chief executive is satisfied the alternative way is unlikely to adversely affect public safety, having regard to the nature of the drug or poison and the purpose for which it is to be used.(4)The chief executive must publish, on the department’s website—(a)the alternative way certified under subsection (3); and(b)the day the certification takes effect; and(c)the period, if any, for which the certification has effect.
4Replacement of s 78A (Medicinal cannabis)
Section 78A—
omit, insert—Subject to section 74(3), a person must not dispense, obtain, prescribe, sell or use a controlled drug that is medicinal cannabis unless the person—(a)is a doctor; and(b)is dispensing, obtaining, prescribing or supplying the drug for another person being medically treated by the doctor.Maximum penalty—80 penalty units.
5Amendment of s 171 (Pharmacists)
(1)Section 171(2), ‘or (5)’—
omit, insert—, (5) or (6)
(2)Section 171—
insert—(5A)A pharmacist is authorised to supply a UTI drug to a person under the pharmacist UTI trial DTP.(3)Section 171(5A) and (6)—
renumber as section 171(6) and (7).(4)Section 171—
insert—(8)In this section—pharmacist UTI trial DTP means the drug therapy protocol called ‘Drug Therapy Protocol—Pharmacist UTI Trial’.UTI drug means a restricted drug that is for the treatment of a urinary tract infection, stated in the pharmacist UTI trial DTP.
6Amendment of s 183 (When endorsement is not needed)
(1)Section 183, heading, ‘needed’—
omit, insert—needed—delivery agents and carers
(2)Section 183(3)—
omit.
After section 183—
insert—184When endorsement is not needed—approved arrangements
(1)A person does not need an endorsement to administer, dispense, issue, manufacture, obtain, possess, prescribe, supply or use a restricted drug for an approved clinical trial.(2)Also, a person does not need an endorsement to issue, obtain, possess, sell by wholesale, supply or use a restricted drug that is a listed immunoglobulin blood product for carrying out the person’s functions or duties under the national blood supply arrangements.
8Amendment of s 194 (Emergency sale of restricted drugs by pharmacist)
(1)Section 194(3)—
omit.(2)Section 194(4), ‘record in the emergency supply book’—
omit, insert—make a record of
(3)Section 194(4)(e), ‘doctor or nurse practitioner’—
omit, insert—prescriber
(4)Section 194—
insert—(5)The pharmacist must keep the record for at least 2 years after the date the restricted drug was sold.Maximum penalty—20 penalty units.
(5)Section 194(4) and (5)—
renumber as section 194(3) and (4).
After section 194—194A Sale of oral hormonal contraceptives by pharmacist for immediate need
(1)Despite section 193(1)(a), a pharmacist may sell a person a restricted drug that is an oral hormonal contraceptive without a prescription if the pharmacist reasonably believes—(a)the person has been treated by a prescriber with the drug for a continuous period of a reasonable length before seeking the drug from the pharmacist; and(b)it is not practicable for the person to obtain a prescription for the drug before needing to continue treatment with the drug; and(c)the person has not, in the year before seeking the drug from the pharmacist, been sold the drug without a prescription from the dispensary at which the drug is sought.(2)The pharmacist must not sell the person more than a manufacturer’s pack of the restricted drug.Maximum penalty—40 penalty units.
(3)The pharmacist must sell the restricted drug in a container that has on it a securely attached label with the following information written on it—(a)‘Keep out of reach of children’ in red on a background of contrasting colour and in bold-faced sans serif capital letters with a face depth of at least 1.5mm;(b)‘Immediate need’ in a colour contrasting with the background colour and in bold-faced sans serif capital letters with a face depth of at least 1.5mm;(c)the name of the person;(d)the name and address of the pharmacy;(e)the date of the sale;(f)the approved name, or the trade name, of the drug.Maximum penalty—40 penalty units.
(4)When selling the restricted drug to the person, the pharmacist must make a record of the following information—(a)the name and address of the person;(b)the date of the sale;(c)the description and quantity of the drug;(d)the directions given for the use of the drug;(e)the name of the prescriber who last prescribed the drug;(f)a brief description of why the pharmacist is selling the drug to the person under this section.Maximum penalty—40 penalty units.
(5)The pharmacist must keep the record for at least 2 years after the date of the sale.Maximum penalty—20 penalty units.
(6)In this section—manufacturer’s pack, of a restricted drug, means a primary pack of the drug supplied by the manufacturer of the drug.For the definition primary pack, see the current Poisons Standard, part 1.oral hormonal contraceptive means an oral preparation of a drug for preventing pregnancy by interrupting ovulation.
10Amendment of s 200 (Authorised persons to obtain restricted drugs on purchase order)
Section 200—
insert—(5)An order placed on a national blood tracking system for a restricted drug that is a listed immunoglobulin blood product is taken to be a purchase order complying with this section.(6)In this section—national blood tracking system means an electronic system for ordering, or authorising orders for, blood or blood-related products, established for facilitating the national blood supply arrangements.
11Amendment of appendix 9 (Dictionary)
Appendix 9—
insert—listed immunoglobulin blood product means an immunoglobulin blood product listed on the national product price list.National Blood Agreement see the National Blood Authority Act 2003 (Cwlth), section 3.national blood supply arrangements means the arrangements under, or mentioned in, the National Blood Agreement.national product price list means the price list for blood products or blood-related products supplied under the National Blood Agreement, approved by the Ministerial Council under that Agreement.