Schedule 4 Appendix B drugs - Special restricted substances

​Appendix B of the Poisons and Therapeutic Goods Regulation 2008 (Regulation) lists Schedule 4 substances (prescription-only medicines) that have more stringent controls on possession and supply because they are liable to abuse, misuse and diversion. These substances are referred to under the Regulation as special restricted substances, and are more commonly referred to as Schedule 4 Appendix B (S4B) medicines.

S4B medicines are a subset of medicines listed in Appendix D of the Regulation (S4D medicines) and have more stringent dispensing requirements than other S4D medicines. For more information about S4D medicines see Schedule 4 Appendix D drugs - Prescribed restricted substances.

The following additional restrictions apply to prescribing and dispensing of S4B medicines:

• Paper prescriptions (handwritten or computer-generated, printed prescriptions):
• A prescription for a S4B medicine with repeats must have an interval for repeats, in the same way as a prescription for a Schedule 8 (S8) medicine.
• A pharmacist who supplies a S4B medicine must keep the prescription whether or not the prescription authorises more than one supply of the substance. This means paper repeats for a S4B medicine must be kept at the pharmacy, separately from other prescriptions (except S8 and other S4B prescriptions), and must not be given to the patient.
• If the prescriber has not clearly specified an interval for repeats on a S4B medicine paper prescription, the pharmacist dispensing the first supply must write the word CANCELLED in ink across the prescription. Directions for any repeat supplies are invalid and no repeats can be dispensed.
• Paper form of the National Residential Medication Chart/chart equivalents:
• The prescriber must issue a separate paper-based prescription (as above) for a S4B medicine with an interval for repeats as well as writing the order to administer the medicine on the medication chart. The paper-based prescription must be kept at the pharmacy separate to other prescriptions (except S8 and other S4B prescriptions).
• Electronic prescriptions from conformant electronic prescribing systems (other than for electronic forms of medication chart prescriptions on an approved National Residential Medication Chart/chart equivalent):
• An electronic prescription for a S4B medicine with repeats must have an interval for repeats, in the same way as a prescription for a S8 medicine. This includes all electronic prescriptions in the community. The prescriber must ensure the instruction is entered. If no repeat intervals appear on the electronic prescription, directions for any repeat supplies are invalid and no repeats can be dispensed. The pharmacist may only dispense a single supply. The prescription should be electronically cancelled to prevent a new token from being issued.
• Conformant systems retain details of dispensed prescriptions therefore there is no need for a pharmacist to keep any paper copies of dispensed S4B medicine prescriptions.

List of substances in Appendix B of the Poisons and Therapeutic Goods Regulation 2008

Anabolic and androgenic steroidal agents that are not listed individually are included in their classes. The substances are listed by generic name. Some may have more than one medicine brand name.

• Amylobarbital (amylobarbitone) ^[1]
• Anabolic and androgenic steroidal agents ^[2]
• Drostanolone
• Ethyloestrenol
• Fluoxymesterone
• Mesterolone
• Methandienone
• Methandriol
• Methenolone
• Methylandrostanolone
• Methyltestosterone
• Mibolerone
• Nandrolone
• Norethandrolone
• Oxandrolone
• Oxymesterone
• Oxymetholone in preparations for therapeutic use
• Pentobarbitone ^[1]
• Stanolone
• Stanozolol
• Testosterone ^[3]

References

1. when included in Schedule 4 of the Poisons List* (i.e. when for injection)
2. included in Schedule 4 of the Poisons List*, except when referred to elsewhere in the Appendix
3. except when included in Schedule 6 of the Poisons List* (i.e. when in implants for animals)

*For infomation on the NSW Poisons List refer to Legislation.