Medicines, Poisons and Therapeutic Goods Amendment Regulation 2023 (No 3) (ACT)

Medicines, Poisons and Therapeutic Goods Amendment Regulation 2023 (No 3)

Subordinate Law SL2023-34

The Australian Capital Territory Executive makes the following regulation under the Medicines, Poisons and Therapeutic Goods Act 2008.

Dated 23 November 2023.

ANDREW BARR

Chief Minister

RACHEL STEPHEN-SMITH

Minister

Medicines, Poisons and Therapeutic Goods Amendment Regulation 2023 (No 3)

Subordinate Law SL2023-34

made under the

Medicines, Poisons and Therapeutic Goods Act 2008

Contents

Page

1            Name of regulation  1

2            Commencement  1

3            Legislation amended  1

4            Section 532 (1), definition of designated person, new paragraph (d)       1

5            New section 532 (2) (a) (iii)  1

6            Section 532 (2) (b) and (c)  1

7           Section 532 (2) (d)  2

8            New section 532 (2) (e)  2

9            New section 533 (3A) and (3B)  2

10          New section 533A  3

11          Dictionary, note 3  4

1. Name of regulation

   This regulation is the Medicines, Poisons and Therapeutic Goods Amendment Regulation 2023 (No 3).

2. Commencement

   This regulation commences on the day after its notification day.

   NoteThe naming and commencement provisions automatically commence on the notification day (see Legislation Act, s 75 (1)).

3. Legislation amended

   This regulation amends the Medicines, Poisons and Therapeutic Goods Regulation 2008.

4. Section 532 (1), definition of designated person, new paragraph (d)

   before the notes, insert

   (d)a controlled medicines research and education program licence‑holder.

5. New section 532 (2) (a) (iii)

   insert

   (iii)if the controlled medicine is required to be stored in a refrigerator—a locked refrigerator;

6. Section 532 (2) (b) and (c)

   omit

   medicine is kept in a container

   substitute

   controlled medicine is kept in a container or refrigerator

7. Section 532 (2) (d)

   before

   medicine

   insert

   controlled

8. New section 532 (2) (e)

   insert

   (e)if the controlled medicine is required to be stored in a refrigerator—the person must ensure that the refrigerator in which the medicine is kept is used only to store medicines requiring refrigeration.

9. New section 533 (3A) and (3B)

   insert

   (3A)However, if the controlled medicine is required to be stored in a refrigerator, the prescribed person must ensure—

   (a)if the refrigerator has a lock—the refrigerator is kept securely locked when not under the supervision of the prescribed person; and

   (b)if the refrigerator does not have a lock—the room or enclosure where the refrigerator is located is kept securely locked when the room or enclosure is not under the supervision of the prescribed person; and

   (c)if the refrigerator, or the room or enclosure where the refrigerator is located, is unlocked by a combination lock—the prescribed person keeps the combination confidential; and

   (d)if the refrigerator, or the room or enclosure where the refrigerator is located, is unlocked by a key—the prescribed person keeps personal custody of the key; and

   (e)the refrigerator is used only to store medicines requiring refrigeration.

   (3B)If a controlled medicine is stored in a refrigerator, the prescribed person may leave the refrigerator, or the room or enclosure where the refrigerator is located, unlocked if—

   (a)the refrigerator, room or enclosure is under the supervision of the prescribed person; and

   (b)the controlled medicine is kept in a metal container that prevents ready access to the container’s contents and is securely fixed inside the refrigerator; and

   (c)the metal container is kept securely locked when not in immediate use; and

   (d)if the metal container is unlocked by a combination lock—the prescribed person keeps the combination confidential; and

   (e)if the metal container is unlocked by a key—the prescribed person keeps personal custody of the key.

10. New section 533A

    in part 11.4, insert

533AStorage of buprenorphine or methadone by opioid dependency treatment licence-holders etc—Act, s 61 (b) and (c)

(1)This section applies to a pharmacist authorised under an opioid dependency treatment licence to possess buprenorphine or methadone.

NotePossess includes having control over disposition (see Act, s 24).

(2)Despite section 533, the pharmacist may, during the business hours for the pharmacy to which the opioid dependency treatment licence relates, store buprenorphine or methadone that is not for immediate administration in a medicines cupboard or drawer if—

(a)the medicines cupboard or drawer is securely fixed to a wall or floor (or both); and

(b)the medicines cupboard or drawer is kept securely locked when not in immediate use; and

(c)the medicines cupboard or drawer is under the direct supervision of the pharmacist at all times the medicines cupboard or drawer contains buprenorphine or methadone; and

(d)for a medicines cupboard or drawer that is unlocked by a combination lock—the pharmacist keeps the combination confidential; and

(e)for a medicines cupboard or drawer that is unlocked by a key—the pharmacist keeps personal custody of the key; and

(f)the door of the medicines cupboard or drawer is not in direct view of a member of the public attending the pharmacy.

1. Dictionary, note 3

   insert

   ·     medicine (see s 11)

Endnotes

1. Notification

   Notified under the Legislation Act on 11 December 2023.

2. Republications of amended laws

   For the latest republication of amended laws, see align="center">© Australian Capital Territory 2023