Scheduling delegate's final decisions: ACMS, November 2015

Scheduling medicines and poisons

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18 November 2015

Part A - Final decisions on matters referred to an expert advisory committee (1.1-1.4)

1. Scheduling proposals referred to the August 2015 meeting of the Advisory Committee on Medicines Scheduling (ACMS#15)

1.1 Codeine

Scheduling proposal

The medicines scheduling delegate (the delegate) has referred the following scheduling proposal for consideration by and advice from the Advisory Committee on Medicines Scheduling (ACMS):

  • Proposal to delete the Schedule 3 entry for codeine, and reschedule all current Schedule 3 codeine to Schedule 4 due to issues including morbidity, toxicity and dependence.
  • Consideration could include whether all current Schedule 3 preparations should be rescheduled to Schedule 4, or whether any rescheduling to Schedule 4 should only apply to combination analgesic products containing codeine.
  • Consideration could include whether the Schedule 2 entry for codeine should also be amended.
Delegate's interim decision

The delegate's interim decision is available at Reasons for the scheduling delegate's interim decision and invitation for further comment for the ACMS, October 2015.

Delegate's considerations

The delegate considered the following in regards to this proposal:

  • Scheduling proposal;
  • Public submissions received;
  • ACMS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors1;
  • Other relevant information.
Public submissions on the interim decision

127 submissions were received.

113 did not support the proposal. Main Points:

  • Consumers are able to self-manage pain responsibly
  • Upscheduling seen as prevention of accessing pain relief
  • Issues with access to/Cost associated seeing GPs
  • Alternative medications not seen as effective
  • Cost to Medicare
  • Benefits of codeine outweigh "morbidity, toxicity and dependence"
  • The issue of abuse of prescription codeine verses OTC codeine is not addressed by this scheduling change
  • Not able to take Non-Steroidal Anti-Inflammatory Drugs
  • The issue of abuse of prescription codeine verses OTC codeine is not addressed by this scheduling change
  • There has been no increased demand or change in patterns of use of codeine containing cold and flu products since the up-scheduling of codeine containing analgesics in 2010
  • There is no evidence of harm, abuse or dependency associated with codeine containing cold and flu preparations
  • Pharmacists are accessible and suitably qualified to implement an effective risk mitigation strategy to address concerns of misuse or abuse
  • Introduce system similar to pseudoephrine
  • Introduce real time monitoring/reporting system
  • Suggest reducing pack size
  • 1 June 2016 implementation is not adequate time and a longer transition period would be required

14 submissions supported the proposal. Main Points:

  • Seen too many addicts and health problems associated with OTC codeine
  • Ease of access to OTC codeine
  • Other effective alternative medication available
  • Arguments regarding increased cost to public purse are disingenuous as there are alternative analgesics on the market
  • Good evidence now demonstrates that under current arrangements (Schedule 3 Pharmacist Medicine) there is a substantial level of harm from the easy and widespread availability of these opioid medicines
  • Personal accounts of family members addicted to codeine, abusing OTC analgesics and cough syrup

Edited versions of these submissions will be made available at Public submissions on scheduling matters.

Delegate's decision

The delegate has deferred making a final decision at this time regarding the possible rescheduling of codeine. This is due to the large number of submissions received during the most recent consultation period, and the deferral of a decision will allow the submissions and the subsequent information provided to be thoroughly considered. This will also allow the delegate the option available under the legislation to seek further advice, including from the ACMS at its March 2016 meeting, prior to making a final decision, which will not be before 23 June 2016 (the publication date of final decision outcomes of March 2016 meeting). Should the final decision require an implementation date, it will be announced at the time of publication and will not be before 2017.

1.2 Naloxone

Scheduling proposal

The medicines scheduling delegate (the delegate) has referred the following scheduling proposal for consideration by and advice from the Advisory Committee on Medicines Scheduling (ACMS):

  • To create a new Schedule 3 entry for naloxone when in single use prefilled syringe preparations for injection containing 400 µg/mL of naloxone or less.
Substance summary

Naloxone is a specific opioid antagonist that acts competitively at opioid receptors. It is an antagonist of opioids that possesses agonist or mixed agonist­antagonist activity, although larger doses may be needed for compounds with the latter activity. Naloxone is used to reverse opioid central depression, including respiratory depression, induced by natural or synthetic opioids, in the management of known or suspected opioid overdosage, postoperatively after the use of opioids during surgery, and in neonates when opioid analgesics have been given to the mother during labour.

Naloxone hydrochloride is usually given intravenously for the most rapid action, with onset within two minutes. The onset of action is only slightly less rapid when it is given intramuscularly or subcutaneously. Other routes of administration, including endotracheal, have also been used. The duration of action of naloxone is dependent on the dose and route, but is generally in the range of 1 to 4 hours. An intravenous infusion may be used for a sustained response; commonly, 2 mg of naloxone hydrochloride is added to 500 mL of sodium chloride 0.9% or glucose 5% to obtain a concentration of 4 micrograms/mL.

In the management of known or suspected opioid overdosage, the initial dose of naloxone hydrochloride is 0.4 to 2 mg given intravenously and repeated if necessary at intervals of 2 to 3 minutes. If no response has been seen after a total dose of 10 mg then the diagnosis of overdosage with drugs other than opioids should be considered. If the intravenous route is not feasible the intramuscular or subcutaneous route can be used. When sustained opioid antagonism is needed, an intravenous infusion may be used. Dosage regimens have not been well established, and the rate of infusion must be titrated according to the patient's response.

Some have recommended an infusion of 60% of the initial dose per hour given via an infusion pump, either undiluted, or diluted to a concentration of 200 micrograms/mL in glucose. Others have suggested an initial intravenous loading dose of 400 micrograms, followed by a continuous infusion at an initial rate of 400 micrograms/hour. Alternatively, an intravenous loading dose of 5 micrograms/kg has been suggested, followed by a continuous infusion of 2.5 micrograms/kg per hour.

Scheduling status

Naloxone is currently listed in Schedule 4.

Scheduling history
National Health and Medical Research Council - Poisons Scheduling Sub-committee: March 1973

The committee recommended that the Schedule 4 entry for Morphine antagonists should be amended to include naloxone, and that the Schedule 8 entry for Oxymorphone should be amended to specify "Oxymorphone except when included in Schedule 4" (as naloxone and some other morphine antagonists were derivatives of oxymorphone).

National Health and Medical Research Council – Poisons Scheduling Sub-committee: August 1985

The committee decided to delete the general Schedule 4 entry for Morphine antagonists, and create a new Schedule 4 entry for Naloxone.

Pre-meeting public submissions

96 individual submissions were received (57 as a part of a campaign).

All submissions supported the proposal to down-schedule naloxone in single use pre-filled syringes for injections to Schedule 3. Main points:

  • Schedule 3 entry will remove barriers to access;
  • Naloxone is safe and has no effect on anyone without opioids in their system;
  • Low to no abuse potential.

One submission, while supporting down-scheduling of naloxone, did not support the wording of the proposal. This submission suggested new wording to restrict Schedule 3 listing to a single dose form:

  • To amend the scheduling of naloxone to include single doses containing 2 mg or less and a recommended total dose of 10 mg or less.

Edited versions of these submissions are available at Public submissions on scheduling matters.

ACMS advice to the delegate

The ACMS recommended a new Schedule 3 entry for naloxone when packaged and labelled for the treatment of opioid overdose.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: a) the risks and benefits of the use of the substance; b) the purposes for which a substance is to be used and the extent of use of a substance; d) the dosage, formulation labelling, packaging and presentation of a substance; and f) any other matters that the Secretary considers necessary to protect public health.

The reasons for the recommendation comprised the following:

  • Naloxone is a well-tolerated life-saving medicine with minimal side effects.
  • The benefits of increasing availability of naloxone outweigh the risks.
  • Naloxone is used as an antidote to opioid overdose.
  • The dose form, labelling and packaging of Schedule 3 naloxone must be made suitable for consumer use.
  • Naloxone does not replace other resuscitation treatments and procedures.

ACMS recommended an implementation date of 1 February 2016.

Delegate's interim decision

The delegate's interim decision is that a new Schedule 3 entry for naloxone when used for the treatment of opioid overdose be created.

The proposed implementation date for the new Schedule 3 entry is 1 February 2016.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: a) the risks and benefits of the use of the substance; b) the purposes for which a substance is to be used and the extent of use of a substance; c) the toxicity of the substance; d) the dosage, formulation, labelling, packaging and presentation of a substance; and f) any other matters that the Secretary considers necessary to protect public health.

The reasons for the decision comprise the following:

  • Naloxone is a well-tolerated life-saving medicine with minimal side effects. The benefits outweigh the risks.
  • Naloxone is used as an antidote to opioid overdose. The dose form, labelling and packaging of Schedule 3 naloxone must be made suitable for consumer use. Naloxone does not replace other resuscitation treatments and procedures.
  • International experience and the outcomes of a trial conducted in the Australian Capital Territory support the view that easier availability of naloxone is likely to decrease the proportion of opioid overdoses which result in death.
  • Benefits of rescheduling naloxone for reversal of opioid overdose to Schedule 3 include that products would be supplied labelled with full and clear instructions for use, understandable by consumers. People who need naloxone would be able to obtain it more easily, which is likely to decrease the proportion of (deliberate or accidental, usually illicitly obtained) opioid overdoses that result in death. Increased accessibility would also potentially reduce morbidity due to opioid overdose, such as hypoxic brain damage.
  • Risks of rescheduling include an incentive for supply when not necessary, that opioid users may use opioids in a riskier manner knowing that an antidote is available (although there is no evidence that this is the case), that bystanders may be less likely to call an ambulance, and risks of unsafe administration.
  • However, there are few inherent risks with use of naloxone. There is no risk of abuse of naloxone itself. Adverse events are rare, there are no major adverse effects if naloxone is given wrongly or not absorbed, and naloxone has no effect in the absence of an opioid.
Delegate's considerations

The delegate considered the following in regards to this proposal:

  • Scheduling proposal;
  • Public submissions received;
  • ACMS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors2;
  • Other relevant information.
Public submissions on the interim decision

13 submissions were received, which all supported the delegate's interim decision.

Edited versions of these submissions will be made available at Public submissions on scheduling matters.

Delegate's final decision

The delegate notes the submissions received in response to publication of the interim decision and confirms the interim decision as no evidence has been received to alter the interim decision. The delegate has confirmed that the reasons for the final decision are in keeping with those for the interim decision.

The implementation date is 1 February 2016.

Schedule entry
Schedule 3 - New entry

NALOXONE when used for the treatment of opioid overdose.

Schedule 4 - Amendment

NALOXONE except when in Schedule 3.

1.3 Orlistat

Scheduling proposal

The medicines scheduling delegate (the delegate) has referred the following scheduling proposal for consideration by and advice from the Advisory Committee on Medicines Scheduling (ACMS):

  • To amend the scheduling of orlistat to down-schedule oral preparations for weight control purposes containing 120 mg or less of orlistat per dosage unit from Schedule 3 to Schedule 2.
Substance summary

Orlistat is a gastric and pancreatic lipase inhibitor that limits the absorption of dietary fat. It is used together with dietary modification in the management of obesity, i.e. in patients with a BMI of 30 kg/m2 or greater. It may also be used in overweight patients with a BMI of 27 kg/m2 or more, if there are associated risk factors. Orlistat is given orally in a usual dose of 120 mg three times daily, immediately before, during, or up to 1 hour after meals. The patient’s diet should be reduced in calories and nutritionally balanced with 30% of calories obtained from fat, and the daily intake of the major nutrients spread over the three main meals. If a meal is missed or contains no fat, the dose should be omitted. Orlistat may also be used at a lower dose of 60 mg three times daily by the same patient group.

Scheduling status

Orlistat is currently listed in Schedules 3 and 4.

Schedule 3

ORLISTAT in oral preparations for weight control purposes containing 120 mg or less of orlistat per dosage unit.

Schedule 4

ORLISTAT except when included in Schedule 3.

Scheduling history
National Drugs and Poisons Schedule Committee: August 1999

The NDPSC recommended that orlistat should be included in Schedule 4.

National Drugs and Poisons Schedule Committee: June 2002

The NDPSC considered an application to reschedule orlistat for the treatment of obesity from Schedule 4 to Schedule 3. At that time, the NDPSC decided that the existing scheduling of orlistat (Schedule 4) remained appropriate.

National Drugs and Poisons Schedule Committee: February 2003

The NDPSC considered a further application to reschedule orlistat for the treatment of obesity from Schedule 4 to Schedule 3. The NDPSC decided that the application did not resolve the concerns raised at the June 2002 meeting, and reconfirmed the inclusion of orlistat in Schedule 4.

National Drugs and Poisons Schedule Committee: October 2003

The NDPSC recommended inclusion in Schedule 3 of orlistat in oral preparations for weight control purposes containing 120 mg or less of orlistat. The NDPSC's decision was made on the following grounds: Safety profile of orlistat based on the low incidence of adverse effects; Orlistat was reasonably efficacious for gradual and long term weight loss when used in conjunction with exercise and dietary restriction; Obesity is a disease which can be easily recognised by consumers; Pharmacists in Australia have good training and experience in providing advice and consultation in relation to management of weight loss and treatment of obesity; and Orlistat for use in weight loss has low potential for abuse or overdose.

Pre-meeting public submissions

Five submissions were received.

Two submissions supported the proposal to down-schedule orlistat in oral preparations for weight control purposes containing 120 mg or less of orlistat per dosage unit from Schedule 3 to Schedule 2.

Main points:

  • Ease supply restriction; and
  • Safe medicine to use.

Three submissions opposed the rescheduling of orlistat.

Main point:

  • Potential for abuse.

Edited versions of these submissions are available at Public submissions on scheduling matters.

ACMS advice to the delegate

The ACMS recommended that the current scheduling of orlistat remains appropriate.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: a) the risks and benefits of the use of the substance; b) the purposes for which a substance is to be used and the extent of use of a substance; c) the toxicity of the substance; and e) the potential for abuse of a substance.

The reasons for the recommendation comprised the following:

  • Risks include decreased absorption of fat-soluble vitamins; some drug interactions; renal failure.
  • Orlistat is used for the management of obesity.
  • Orlistat has minimal toxicity, due to minimal absorption from oral administration.
  • However, risks of rescheduling include the potential for misuse, decreased absorption of fat-soluble vitamins, some drug interactions and renal failure.
Delegate's interim decision

The delegate's interim decision is that the current scheduling of orlistat remains appropriate.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: a) the risks and benefits of the use of the substance; b) the purposes for which a substance is to be used and the extent of use of a substance; c) the toxicity of the substance; and e) the potential for abuse of a substance.

The reasons for the decision comprised the following:

  • Rescheduling orlistat to Schedule 2 is inconsistent with the SPF criterion for Schedule 2 that use is substantially safe for short-term treatment.
  • Orlistat has minimal toxicity, due to minimal absorption from oral administration.
  • However, there is a risk of misuse if orlistat is down-scheduled to Schedule 2 as professional advice is required to ensure appropriate use of over-the-counter (OTC) orlistat. Inclusion in Schedule 2 could increase the potential for inappropriate use or misuse of orlistat by people with anorexia, bulimia or other mental health issues.
  • There are also concerns that advertising of orlistat (if included in Schedule 2) may encourage misuse or inappropriate use.
  • There are risks of decreased absorption of fat-soluble vitamins, some drug interactions and renal failure.
Delegate's considerations

The delegate considered the following in regards to this proposal:

  • Scheduling proposal;
  • Public submissions received;
  • ACMS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors3;
  • Other relevant information.
Public submissions on the interim decision

No public submissions were received.

Delegate's final decision

The delegate notes the submissions received in response to publication of the interim decision and confirms the interim decision as no evidence has been received to alter the interim decision. The delegate has confirmed that the reasons for the final decision are in keeping with those for the interim decision.

1.4 Hydrocortisone

Scheduling proposal

The medicines scheduling delegate (the delegate) has referred the following scheduling proposal for consideration by and advice from the Advisory Committee on Medicines Scheduling (ACMS):

  • To amend the scheduling of hydrocortisone and hydrocortisone acetate to include preparations for dermal human therapeutic use containing 1% or less of hydrocortisone when combined with an antifungal substance (and no other therapeutically active substance) in Schedule 2 under the following conditions:
    • in packs containing 15 g or less; and
    • for the treatment of tinea (tinea pedis, tinea cruris, tinea corporis) and other fungal skin infections; and
    • not labelled for the treatment of children under 12 years.
Substance summary

Hydrocortisone is a corticosteroid with both glucocorticoid and to a lesser extent mineralocorticoid activity. Hydrocortisone is used, usually with a more potent mineralocorticoid, for replacement therapy in adrenocortical insufficiency. It may also be used for its glucocorticoid properties in other conditions for which corticosteroid therapy is indicated but drugs with fewer mineralocorticoid effects tend to be preferred for the long-term systemic therapy of auto-immune and inflammatory disease. Hydrocortisone and its esters (including hydrocortisone acetate) may be used in creams, ointments or lotions, at concentrations ranging from 0.1 to 2.5%, for topical application in the treatment of skin disorders.

A number of antifungal agents are scheduled as OTC medicines for the topical treatment of fungal skin diseases (e.g. bifonazole, clotrimazole, econazole, ketoconazole, miconazole, terbinafine).

Scheduling status

Hydrocortisone is currently listed in Schedules 2, 3 and 4, and Appendix F.

Hydrocortisone acetate is currently listed in Schedules 2 and 3.

Schedule 2

HYDROCORTISONE and HYDROCORTISONE ACETATE, but excluding other salts and derivatives, in preparations for human therapeutic use containing 0.5 per cent or less of hydrocortisone:

  1. for dermal use, in packs containing 30 g or less of such preparations, containing no other therapeutically active constituent other than an antifungal substance; or
  2. for rectal use when combined with a local anaesthetic substance but no other therapeutically active constituent except unscheduled astringents:
    1. in undivided preparations in packs of 35 g or less; or
    2. in packs containing 12 or less suppositories.
Schedule 3

HYDROCORTISONE and HYDROCORTISONE ACETATE, but excluding other salts and derivatives, in preparations for human therapeutic use containing 1 per cent or less of hydrocortisone:

  1. for dermal use, in packs containing 30 g or less of such preparations, containing no other therapeutically active constituent other than an antifungal substance; or
  2. for rectal use when combined with a local anaesthetic substance but no other therapeutically active constituent except unscheduled astringents:
    1. in undivided preparations in packs of 35 g or less; or
    2. in packs containing 12 or less suppositories,
  3. except when included in Schedule 2.
Schedule 4

HYDROCORTISONE:

  1. for human use except when included in Schedule 2 or 3; or
  2. for the treatment of animals.
Scheduling history
National Drugs and Poisons Scheduling Committee: February 1999

The NDPSC agreed to include hydrocortisone in Schedule 2 in dermal preparations containing 0.5% or less of hydrocortisone in packs containing 30 g or less, and containing no other active ingredient or an antifungal as the only other active constituent. The NDPSC also amended the Schedule 3 entry to include dermal preparations containing 1% or less of hydrocortisone in packs containing 30 g or less, and containing no other active ingredient or an antifungal as the only other active constituent (except when included in Schedule 2).

National Drugs and Poisons Scheduling Committee: February 2007

The NDPSC agreed to amend the scheduling of preparations containing 0.5% of hydrocortisone in combination with an anaesthetic for rectal use from Schedule 3 to Schedule 2. The NDPSC noted that this would also harmonise scheduling of the substances with New Zealand. Editorial amendments were made in June and October 2007, to limit the Schedule 2 and 3 entries to human use only.

Advisory Committee on Medicines Scheduling: March 2013

The ACMS considered an application to down-schedule hydrocortisone and hydrocortisone in preparations containing 1% or less of hydrocortisone when combined with antifungal substances for dermal use from Schedule 3 to Schedule 2. The ACMS advised the delegate that the current scheduling remained appropriate.

Pre-meeting public submissions

Five submissions were received.

Three submissions supported the rescheduling proposal.

Main point:

  • Ease restrictions.

Two submissions opposed the rescheduling proposal.

Main points:

  • Current scheduling is appropriate
  • Potential for inappropriate consumer self-treatment of skin conditions caused by an underlying contraindicated condition.

Edited versions of these submissions are available at Public submissions on scheduling matters.

ACMS advice to the delegate

The ACMS recommended that hydrocortisone 1% when combined with antifungal substances for dermal use in packs containing 15 g or less be down scheduled from Schedule 3 to Schedule 2 - specifically, hydrocortisone and hydrocortisone acetate should be included in Schedule 2 in preparations for dermal use containing 1% or less of hydrocortisone when combined with an antifungal substance (and no other therapeutically active substance), under the following conditions:

  • in packs containing 15 g or less; and
  • for the treatment of tinea (tinea pedis, tinea cruris, tinea corporis) and fungal skin infections; and
  • not labelled for the treatment of children under 12 years.

The ACMS recommended an implementation date of 1 February 2016.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: a) the risks and benefits of the use of the substance; b) the purposes for which a substance is to be used and the extent of use of a substance; c) the toxicity of the substance; d) the dosage, formulation, labelling, packaging and presentation of a substance; and f) any other matters that the Secretary considers necessary to protect public health.

The reasons for the recommendation comprised the following:

  • Hydrocortisone 1% is more effective than 0.5% and the overall adverse reports are similar. The 1% strength does not produce more severe adverse reactions.
  • Tinea and fungal infections are common. Itching and inflammation may occur with these infections.
  • The overall risk of adverse events from topical hydrocortisone use is very small and the relative risk between the 0.5% and 1% strengths are hardly distinguishable. It has a good safety profile in short term dermal use.
  • The proposed 15 g pack size minimises duration of use and the proposed labelling reduces the risk of inappropriate use.
  • Providing easier access to a more effective product may be beneficial for consumers.
Delegate's interim decision

The delegate's interim decision is that hydrocortisone 1% when combined with antifungal substances for dermal use in packs containing 15 g or less be down scheduled from Schedule 3 to Schedule 2 - specifically, hydrocortisone and hydrocortisone acetate should be included in Schedule 2 in preparations for dermal use containing 1% or less of hydrocortisone when combined with an antifungal substance (and no other therapeutically active substance), under the following conditions:

  • in packs containing 15 g or less; and
  • for the treatment of tinea (tinea pedis, tinea cruris, tinea corporis) and other fungal skin infections; and
  • not labelled for the treatment of children under 12 years.

The delegate recommended an implementation date for the Schedule 2 amendment of 1 February 2016.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: a) the risks and benefits of the use of the substance; b) the purposes for which a substance is to be used and the extent of use of a substance; c) the toxicity of the substance; d) the dosage, formulation, labelling, packaging and presentation of a substance; and f) any other matters that the Secretary considers necessary to protect public health.

The reasons for the decision comprised the following:

  • Hydrocortisone 1% is more effective than 0.5% and the overall adverse reports are similar. The 1% strength does not produce more severe adverse reactions.
  • Tinea and fungal infections are common. Itching and inflammation may occur with these infections
  • The overall risk of adverse events from topical hydrocortisone use is very small and the relative risk between the 0.5% and 1% strengths are hardly distinguishable. It has a good safety profile in short term dermal use.
  • The proposed 15 g pack size minimises duration of use and the proposed labelling reduces the risk of inappropriate use.
  • Providing easier access to a more effective product may be beneficial for consumers.
Delegate's considerations

The delegate considered the following in regards to this proposal:

  • Scheduling proposal;
  • Public submissions received;
  • ACMS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors4;
  • Other relevant information.
Public submissions on the interim decision

One submission was received which did not support the delegate's interim decision.

Edited versions of these submissions will be made available at Public submissions on scheduling matters.

Delegate's final decision

The delegate notes the submissions received in response to publication of the interim decision and confirms the interim decision as no evidence has been received to alter the interim decision. The delegate has confirmed that the reasons for the final decision are in keeping with those for the interim decision.

The implementation date will be 1 February 2016.

Schedule entry
Schedule 2 - Amendment

HYDROCORTISONE and HYDROCORTISONE ACETATE, but excluding other salts and derivatives, in preparations for human therapeutic use:

  1. for dermal use in preparations containing 0.5 per cent or less of hydrocortisone, in packs containing 30 g or less of such preparations, containing no other therapeutically active constituent other than an antifungal substance; or
  2. for dermal use in preparations containing 1 per cent or less of hydrocortisone, in packs containing 15 g or less of such preparations, containing an antifungal substance and no other therapeutically active constituent:
    1. for the treatment of tinea (tinea pedis, tinea cruris, tinea corporis) and other fungal skin infections; and
    2. not labelled for the treatment of children under 12 years of age; or
  3. for rectal use in preparations containing 0.5 per cent or less of hydrocortisone, when combined with a local anaesthetic substance but no other therapeutically active constituent except unscheduled astringents:
    1. in undivided preparations in packs of 35 g or less; or
    2. in packs containing 12 or less suppositories.

Footnotes

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