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STANDARD FOR THE UNIFORM SCHEDULING OF MEDICINES AND POISONS

No. 15

November 2016

Reasons for scheduling delegates’ final decisions can be accessed from the TGA website, at https://www.tga.gov.au/reasons-scheduling-delegates-final-decisions  

Further inquiries in relation to this document should be directed to:

The Secretary Chemicals Scheduling Secretariat (MD122) Scheduling and Committee Governance Therapeutic Goods Administration PO Box 100 WODEN ACT 2606  

or by email to Chemicals.Scheduling@tga.gov.au 

The Secretary Medicines Scheduling Secretariat (MD122) Scheduling and Committee Governance Therapeutic Goods Administration PO Box 100 WODEN ACT 2606  

or by email to Medicines.Scheduling@tga.gov.au 

Media Liaison Unit Australian Government Department of Health

Table of Contents

Table of Contents

INTRODUCTION

CLASSIFICATION

PRINCIPLES OF SCHEDULING

READING THE SCHEDULES

AVAILABILITY OF POISONS

PREPARATIONS CONTAINING POISONS LISTED IN TWO OR MORE SCHEDULES

PART 1

INTERPRETATION

PART 2

CONTROL ON MEDICINES AND POISONS

SECTION ONE LABELS

SECTION TWO CONTAINERS

SECTION THREE STORAGE

SECTION FOUR DISPOSAL

SECTION FIVE RECORD KEEPING

SECTION SIX SALE, SUPPLY, POSSESSION, or USE

SECTION SEVEN/Appendix I PAINT OR TINTERS

PART 3

MISCELLANEOUS REGULATIONS

SECTION ONE ADVERTISING

SECTION TWO SALE OR SUPPLY

SECTION THREE STORAGE

PART 4

THE SCHEDULES

SCHEDULE 1

SCHEDULE 2

SCHEDULE 3

SCHEDULE 4

SCHEDULE 5

SCHEDULE 6

SCHEDULE 7

SCHEDULE 8

SCHEDULE 9

SCHEDULE 10

PART 5

THE APPENDICES

APPENDIX A – GENERAL EXEMPTIONS

APPENDIX B – SUBSTANCES CONSIDERED NOT TO REQUIRE CONTROL BY SCHEDULING

APPENDIX C (see SCHEDULE 10)

APPENDIX D – ADDITIONAL CONTROLS ON POSSESSION OR SUPPLY OF POISONS INCLUDED IN SCHEDULE 4 OR 8

APPENDIX E – FIRST AID INSTRUCTIONS FOR POISONS

APPENDIX F – WARNING STATEMENTS AND GENERAL SAFETY DIRECTIONS FOR POISONS

APPENDIX G – DILUTE PREPARATIONS

APPENDIX H – SCHEDULE 3 POISONS PERMITTED TO BE ADVERTISED

APPENDIX I

APPENDIX J – CONDITIONS FOR AVAILABILITY AND USE OF SCHEDULE 7 POISONS

APPENDIX K – DRUGS REQUIRED TO BE LABELLED WITH A SEDATION WARNING

APPENDIX L – REQUIREMENTS FOR DISPENSING LABELS FOR HUMAN AND VETERINARY MEDICINES

INDEX

INTRODUCTION

The Poisons Standard November 2016, which, under section 2 above consists of the Standard for the Uniform Scheduling of Medicines and Poisons (the Standard, or the SUSMP), is made under paragraph 52D(2)(b) of the Therapeutic Goods Act 1989, and is a compilation of decisions made under section 52D of the same Act.  The SUSMP should be read in conjunction with the Scheduling Policy Framework (SPF) of the Australian Health Ministers' Advisory Council.  Further information on the scheduling amendments and the SPF can be accessed at www.tga.gov.au.  Refer to Part 1, Interpretation, on page 2 below for definitions of specific terms used in this document including “medicine” and “poison” (noting that the definition of poison includes medicine).

The SUSMP serves two key purposes.

Firstly, the SUSMP contains the decisions of the Secretary of the Department of Health or the Secretary's delegates regarding the classification of poisons into Schedules, as recommendations to Australian States and Territories.  The scheduling classification sets the level of control on the availability of poisons.  The scheduling of poisons is implemented through relevant State and Territory legislation.  Certain advertising, labelling and packaging requirements may also be a consequence of scheduling, but are the subject of other Commonwealth registration schemes.

Secondly, the SUSMP includes provisions for labelling, containers, storage, disposal, record-keeping, sale, supply and possession of poisons in general which are intended to be adopted for use in each jurisdiction of Australia.  Other government agencies may also impose controls on certain products, for example cosmetics.

The requirements for labelling and containers in the SUSMP are intended to integrate with existing legislative instruments for labelling and containers.  Advertising, labelling and packaging of therapeutic goods and agricultural and veterinary chemicals are also dealt with through the respective product registration schemes provided for in Commonwealth legislation. 

Poisons which are packed and sold solely for industrial, manufacturing, laboratory or dispensary use are exempt from all labelling requirements included in the SUSMP as they are covered by labelling requirements under applicable jurisdictional Work Health and Safety laws, as amended from time to time.  Note, however that this exemption does not extend to controls on supply of these poisons.

The SUSMP is presented with a view to promoting uniform:

• scheduling of poisons throughout Australia;
• signal headings on labels for poisons throughout Australia;
• labelling and packaging requirements for poisons throughout Australia;
• additional controls on the availability and use of poisons in Australia.

The various Commonwealth Acts, legislative instruments and other documents which integrate with the SUSMP include:

• the Agricultural and Veterinary Chemicals Code Act 1994
• the Agricultural and Veterinary Chemicals Code Regulations 1995
• the Therapeutic Goods Act 1989
• Therapeutic Goods Order 69 – General requirements for labels for medicines
• Therapeutic Goods Order 80 – Child-Resistant Packaging Requirements for Medicines
• the Required Advisory Statements for Medicine Labels (RASML).

CLASSIFICATION

Poisons are classified according to the Schedules in which they are included.  The following is a general description of the Schedules.  For the legal definitions, however, it is necessary to check with each relevant State or Territory authority.

PRINCIPLES OF SCHEDULING

Poisons are not scheduled on the basis of a universal scale of toxicity.  Although toxicity is one of the factors considered, and is itself a complex of factors, the decision to include a substance in a particular Schedule also takes into account many other criteria such as the purpose of use, potential for abuse, safety in use and the need for the substance.

This Standard lists poisons in ten Schedules according to the degree of control recommended to be exercised over their availability to the public.

Poisons for therapeutic use (medicines) are mostly included in Schedules 2, 3, 4 and 8 with progression through these Schedules signifying increasingly restrictive regulatory controls.

For some medicines and agricultural, domestic and industrial poisons, Schedules 5, 6 and 7 represent increasingly stricter container and labelling requirements with special regulatory controls over the availability of the poisons listed in Schedule 7.  Products for domestic use must not include poisons listed in Schedule 7.

Schedule 9 contains substances that should be available only for teaching, training, medical or scientific research including clinical trials conducted with the approval of Commonwealth and/or State and Territory health authorities.  Although appearing as a Schedule in this Standard, the method by which it is implemented in the States and Territories may vary.

Schedule 10 (previously Appendix C) contains a list of substances or preparations, the sale, supply or use of which should be prohibited because of their known dangerous properties. 

Substances in products which have been considered for scheduling, but have been exempted from this Standard, may be listed in either Appendix A (general exemptions) or Appendix B (substances considered not to require control by scheduling).

READING THE SCHEDULES

Schedule entries have been designed to be as simple as possible while retaining readability, legal integrity and as much freedom from ambiguity and contradiction as possible.  As a result, they are expressed in a number of ways, though this number has been kept to a minimum.  It is necessary to keep this variety of expression in mind when searching or interpreting Schedule entries.

Firstly, poisons are scheduled individually using their approved names wherever practicable although exceptions are necessary in some cases.  Some of those are mentioned overleaf.  Older group entries are revised and replaced by individual entries as time permits, although in some of these cases a group term has also been retained to deal with any members of the group or class that may have escaped attention but should be scheduled.

Secondly, Schedule entries have been expressed in either positive or negative terms and care must be taken to distinguish between the two different forms of expression.  Thus, selenium is in Schedule 6 only when one of the clauses in this Schedule entry applies, while fluorides are in Schedule 6 unless one of the exempting clauses applies.

Where exceptions are included in an entry, these have been emphasised by printing the word “except” in bold type.

Where the Schedule entries for a poison make a specific exclusion or exemption, the requirements of this Standard do not apply to that poison within the constraints of that exclusion or exemption although controls under other legislation, such as pesticide registration, may apply.

Where a Schedule entry for a poison requires a specific statement to be included on a label as a condition for a product to qualify for an exemption (‘reverse scheduling’), then in cases where it is impracticable for a supplier to use the exact wording of such a statement, its wording may be varied provided that the full intent and meaning of the statement is not changed.

Where a poison has been included in more than one Schedule, the principal entry, where practicable, has been included in the most restrictive Schedule with references to the other Schedule(s) involved.

It is important to remember that a Schedule entry includes preparations containing the poison in any concentration and all salts and derivatives of the poison unless it specifically states otherwise. (See Part 1, Interpretation, subparagraph 1(2)).

It is important to note that a substance is not classed as a derivative on the basis of a single, prescriptive set of criteria.  Classification of a substance as a derivative of a scheduled poison relies on a balanced consideration of factors to decide if a substance has a similar nature (e.g. structurally, pharmacologically, and toxicologically) to a scheduled poison or is readily converted (either physically or chemically) to a scheduled poison.  However, a substance is only considered a derivative of a scheduled poison if it is not individually listed elsewhere in the Schedules, or captured by a more restrictive group or class entry.  Additionally, some entries specifically exclude derivatives.  Once a substance is determined to be a derivative of a scheduled poison, the same scheduling requirements as the scheduled poison, including limits on access, supply and availability, will apply.

Finally, when using this Standard to determine the scheduling status of a poison, it may be necessary to search each relevant Schedule as well as Appendices A, B and the Index.  In this process, if the poison is not found under its “approved name” it may be shown under a group term s

This is an opening excerpt, not the complete document.