{"id":"F2024L01453","name":"Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Estradiol) Instrument 2024","slug":"therapeutic-goods-serious-scarcity-and-substitutable-medicine-estradiol-instrument-2024","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":105458,"registerId":"commonwealth-F2024L01453-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\nThis instrument is the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Estradiol) Instrument 2024.","sortOrder":0},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\nThis instrument is made under section 30EK of the Therapeutic Goods Act 1989.","sortOrder":1},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 Definitions\n\nNote: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n(a) medicine;\n\n(b) Register;\n\n(c) registered goods;\n\n(b) registration number.\n\nIn this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\ngeneric product has the same meaning as in the Therapeutic Goods Regulations 1990.\n\npatch means transdermal drug delivery system.\n\npharmacist has the same meaning as in subsection 30EK(6) of the Act.\n\nprescriber means the person who:\n\n(a) is authorised under a law of a State or Territory to prescribe medicine, and\n\n(b) prescribed the scarce medicine for the patient.\n\nregistered medicine means a medicine that is included in the part of the Register for goods known as registered goods.\n\nscarce medicine has the meaning given by section 5.\n\nsubstitutable medicine has the meaning given by section 6.","sortOrder":2},{"sectionNumber":"5","sectionType":"section","heading":"Declaration of serious scarcity","content":"#### 5 Declaration of serious scarcity\n\nFor paragraph 30EK(1)(a) of the Act, a serious scarcity of the medicine specified in column 2 of each item in the table in Schedule 1 (the scarce medicine) across the whole of Australia is declared.","sortOrder":3},{"sectionNumber":"6","sectionType":"section","heading":"Substitution of scarce medicine by pharmacists","content":"#### 6 Substitution of scarce medicine by pharmacists\n\nFor paragraph 30EK(1)(b) of the Act, in relation to each item in the table in Schedule 1, the medicine specified in column 3 (the substitutable medicine) is permitted to be dispensed by a pharmacist in substitution for the scarce medicine specified in column 2, in the circumstances specified in:\n\n(a) column 5 of that item (the specific permitted circumstances); and\n\n(b) the table in Schedule 2 (the general permitted circumstances).\n\nNote: Substitution is only permitted where both the specific permitted circumstances and the general permitted circumstances exist.","sortOrder":4},{"sectionNumber":"7","sectionType":"section","heading":"Period instrument in force","content":"#### 7 Period instrument in force\n\n This instrument remains in force until 28 February 2027.","sortOrder":5},{"sectionNumber":"8","sectionType":"section","heading":"Repeals","content":"#### 8 Repeals\n\n Unless repealed earlier, this instrument is repealed at the start of 1 March 2027.\n\n \n\nSchedule 1—Scarce medicine, substitutable medicine, dose unit equivalence and specific permitted circumstances\n\nNote: See sections 5 and 6.\n\n```html\n

Scarce medicine, substitutable medicine, dose unit equivalence and specific permitted circumstances

Column 1

Column 2

Column 3

Column 4

Column 5

Item

Scarce medicine

Substitutable medicine

Dose unit equivalence

Specific permitted circumstances

1

each of the following:

(a) ESTRADERM MX 25 estradiol 25 microgram/24 hours transdermal drug delivery system sachet, registration number 67089;

(b) ESTRADOT 25 estradiol 25 microgram transdermal drug delivery system sachet, registration number 338056

a registered medicine, or a medicine subject to an approval under section 19A of the Act, that:

(a) contains estradiol as the only active ingredient; and

(b) is manufactured in the dosage form of a patch; and

(c) releases 25 micrograms of estradiol per day

one patch of the scarce medicine is equivalent to one patch of the substitutable medicine

the pharmacist has advised the patient, or person acting on behalf of the patient, of:

(a) the number of dose units of substitutable medicine that must be administered to the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified in column 4; and

(b) suitable instructions for administering the substitutable medicine

2

each of the following:

(a) ESTRADERM MX 50 estradiol 50 microgram/24 hours transdermal drug delivery system sachet, registration number 56658;

(b) ESTRADOT 50 estradiol 50 microgram transdermal drug delivery system sachet, registration number 338058

either of the following:

(a) a registered medicine, or a medicine subject to an approval under section 19A of the Act, that:

(i) contains estradiol as the only active ingredient; and

(ii) is manufactured in the dosage form of a patch; and

(iii) releases 50 micrograms of estradiol per day;

(b) a registered medicine, or a medicine subject to an approval under section 19A of the Act, that:

(i) contains estradiol as the only active ingredient; and

(ii) is manufactured in the dosage form of a patch; and

(iii) releases 25 micrograms of estradiol per day

one patch of the scarce medicine is equivalent to:

(a) one patch of the substitutable medicine in paragraph (a) in column 3; or

(b) two patches of the substitutable medicine in paragraph (b) in column 3

all of the following:

(a) when substituting with the substitutable medicine in paragraph (b) in column 3—the pharmacist:

(i) does not have access to the substitutable medicine in paragraph (a) of column 3; and

(ii) dispenses patches that are of the same brand;

(b) the pharmacist has advised the patient, or person acting on behalf of the patient, of:

(i) the number of dose units of substitutable medicine that must be administered to the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified in column 4; and

(ii) suitable instructions for administering the substitutable medicine

3

each of the following:

(a) ESTRADERM MX 75 estradiol 75 microgram/24 hr transdermal drug delivery system sachet, registration number 76117;

(b) ESTRADOT 75 estradiol 75 microgram transdermal drug delivery system, registration number 338059

either of the following:

(a) a registered medicine, or a medicine subject to an approval under section 19A of the Act, that:

(i) contains estradiol as the only active ingredient; and

(ii) is manufactured in the dosage form of a patch; and

(iii) releases 75 micrograms of estradiol per day;

(b) a registered medicine, or a medicine subject to an approval under section 19A of the Act, that:

(i) contains estradiol as the only active ingredient; and

(ii) is manufactured in the dosage form of a patch; and

(iii) releases 37.5 micrograms of estradiol per day

one patch of the scarce medicine is equivalent to:

(a) one patch of the substitutable medicine in paragraph (a) in column 3; or

(b) two patches of the substitutable medicine in paragraph (b) in column 3

all of the following:

(a) when substituting with the substitutable medicine in paragraph (b) of column 3—the pharmacist:

(i) does not have access to the substitutable medicine in paragraph (a) of column 3; and

(ii) dispenses patches that are of the same brand;

(b) the pharmacist has advised the patient, or person acting on behalf of the patient, of:

(i) the number of dose units of substitutable medicine that must be administered to the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified in column 4; and

(ii) suitable instructions for administering the substitutable medicine

4

each of the following:

(a) ESTRADERM MX 100 estradiol 100 microgram/24 hours transdermal drug delivery system sachet, registration number 67090;

(b) ESTRADOT 100 estradiol 100 microgram transdermal drug delivery system, registration number 338060

either of the following:

(a) a registered medicine, or a medicine subject to an approval under section 19A of the Act, that:

(i) contains estradiol as the only active ingredient; and

(ii) is manufactured in the dosage form of a patch; and

(iii) releases 100 micrograms of estradiol per day;

(b) a registered medicine, or a medicine subject to an approval under section 19A of the Act, that:

(i) contains estradiol as the only active ingredient; and

(ii) is manufactured in the dosage form of a patch; and

(iii) releases 50 micrograms of estradiol per day

one patch of the scarce medicine is equivalent to:

(a) one patch of the substitutable medicine in paragraph (a) in column 3; or

(b) two patches of the substitutable medicine in paragraph (b) in column 3

all of the following:

(a) when substituting with the substitutable medicine in paragraph (b) of column 3—the pharmacist:

(i) does not have access to the substitutable medicine in paragraph (a) of column 3; and

(ii) dispenses patches that are of the same brand;

(b) the pharmacist has advised the patient, or person acting on behalf of the patient, of:

(i) the number of dose units of substitutable medicine that must be administered to the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified in column 4; and

(ii) suitable instructions for administering the substitutable medicine

\n```\n\nSchedule 2—General permitted circumstances\n\nNote: See section 6.\n\n```html\n

General permitted circumstances

Column 1

Column 2

Item

Circumstances

1

the patient, or person acting on behalf of the patient, has evidence of a valid prescription for the scarce medicine, unless otherwise permitted by law

2

the pharmacist does not have access to the scarce medicine

3

the prescriber has not indicated on the prescription for the scarce medicine that substitution is not permitted

4

the pharmacist has exercised professional judgement and determined that the patient is suitable to receive the substitutable medicine

5

the amount of substitutable medicine dispensed would result in the patient receiving sufficient medicine to ensure an equivalent dosage regimen and duration to that prescribed in relation to the scarce medicine

6

the patient, or person acting on behalf of the patient, has consented to receiving the substitutable medicine

7

the pharmacist makes a record of dispensing the substitutable medicine in substitution of the scarce medicine at the time of dispensing

8

the pharmacist has an established procedure to notify the prescriber of the substitution at the time of, or as soon as practical after, dispensing the substitutable medicine

\n```","sortOrder":6}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"},"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"The instrument remains tightly focused on its original purpose: addressing supply shortages of specific estradiol transdermal patches through temporary pharmacist substitution authority. The scope has not expanded beyond the four specified product strengths and their therapeutic equivalents."},"complexity_factors":["Multiple cross-references to the Therapeutic Goods Act 1989 (section 30EK, subsection 3(1)) and Therapeutic Goods Regulations 1990","Nested conditional logic: substitution requires satisfying BOTH specific circumstances (Schedule 1, column 5) AND general circumstances (Schedule 2)","Tiered substitution rules in Items 2-4 of Schedule 1: primary option (same strength) and fallback option (double lower strength) with additional constraints on the fallback","8 separate general conditions in Schedule 2 that must all be satisfied","Dose equivalence calculations required (1:1 or 1:2 ratios depending on available stock)","Defined terms rely on external statutory definitions ('generic product', 'registered goods', 'section 19A approval')","Sunset clause with automatic repeal mechanism (sections 7-8)"],"plain_english_summary":"This instrument declares a shortage of certain estradiol patches and lets pharmacists substitute equivalent-dose estradiol patches (including using two lower‑strength patches when necessary) when the prescribed brand is unavailable, with patient consent and prescriber notification. It aims to prevent treatment interruptions for people using hormone replacement or gender‑affirming care, affecting patients, pharmacists and prescribers; it remains in force until February 2027."},"flash_summary":{"complexity_score":5,"scope_assessment":{"changed":false,"description":"This instrument operates under the delegated power in section 30EK of the Therapeutic Goods Act 1989 (section 3) to declare scarcity (section 5) and permit pharmacist substitution (section 6). It does not amend the Act or create new statutory categories; it sets time‑limited substitution rules for specific registered estradiol patch products (Schedule 1) and conditions for substitution (Schedule 2) until 28 February 2027 (section 7)."},"complexity_factors":["Dual-condition substitution: substitution permitted only where both the specific circumstances in Schedule 1 (see section 6 and Schedule 1, column 5) and the general circumstances in Schedule 2 exist (section 6).","Dose‑unit equivalences mapped for multiple strength conversions (Schedule 1, column 4), requiring conversion calculations at point of dispensing.","Multiple substitutable options including higher/lower strength patches and two‑patch substitutions (Schedule 1, items 2–4), plus brand‑consistency constraints for some substitutions (Schedule 1, column 5).","Pharmacist discretion and clinical judgement requirement for suitability (Schedule 2, item 4), creating professional‑liability and decision‑making burdens.","Prescriber opt‑out and prescription validity checks constrain substitution (Schedule 2, items 1 and 3).","Administrative obligations: patient consent, counselling/instruction, contemporaneous record of substitution and prescriber notification procedure (Schedule 2, items 6–8, Schedule 1 column 5).","Use of delegated regulatory approvals as substitutable options (allows medicines registered or approved under section 19A — Schedule 1, column 3), introducing regulatory-status checks.","Time-limited instrument with explicit expiry/repeal dates (sections 7–8), requiring monitoring and potential re-issuance or transition planning.","Cross-references to statutory definitions and other instruments (section 4), increasing interpretive complexity for implementers."],"plain_english_summary":"Declares a national serious scarcity of particular estradiol transdermal patches and authorises pharmacists to dispense specified alternative estradiol patch medicines in substitution where defined conditions are met. \n\nThis affects patients prescribed those patches, their prescribers, pharmacists and manufacturers. Mechanically it permits pharmacist-led substitution (with consent, counselling and record‑keeping) while the replacement rules and dose equivalences apply, and it remains in force until 28 February 2027."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-serious-scarcity-and-substitutable-medicine-estradiol-instrument-2024","history":"/api/acts/therapeutic-goods-serious-scarcity-and-substitutable-medicine-estradiol-instrument-2024/history","analysis":"/api/acts/therapeutic-goods-serious-scarcity-and-substitutable-medicine-estradiol-instrument-2024/analysis","conflicts":"/api/acts/therapeutic-goods-serious-scarcity-and-substitutable-medicine-estradiol-instrument-2024/conflicts","importantCases":"/api/acts/therapeutic-goods-serious-scarcity-and-substitutable-medicine-estradiol-instrument-2024/important-cases","documents":"/api/acts/therapeutic-goods-serious-scarcity-and-substitutable-medicine-estradiol-instrument-2024/documents"}}