Commonwealth legislation

National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021

In ForceCTH

Jurisdiction

Commonwealth

Collection

legislative instrument

Plain English Summary

5/10 complexity

This Determination lets an approved pharmacist supply a specific listed PBS medicine as a substitute without a new prescription when the prescribed product is unavailable and the patient needs it sooner than a prescriber can be seen. The pharmacist must be working at an approved premises, may only substitute items listed in the table, inform the patient of permitted PBS charges and any alternative charges, keep a record of the decision, and notify the original prescriber within 72 hours. It affects approved pharmacists, PBS prescribers and patients who use the listed medicines.

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Deep Dive

5,490 words · generated 13/06/2026

What it does

This Determination (PB 84 of 2021) authorises a narrow form of pharmacist-led, prescription-free supply of specific listed PBS medicines during shortages. It is made under subsection 89A(3) of the National Health Act 1953 (see s 3). The instrument creates a statutory pathway, applicable only where the conditions in s 5 are satisfied, under which an approved pharmacist may supply a specified substitute pharmaceutical benefit without a fresh prescription to a person who presents a prescription for the prescribed benefit (s 5(1)(a) and (8)). The pathway is conditional and tightly circumscribed by the Determination.

Mechanically, the Determination does the following.

It permits supply without a new prescription only where the person presents an existing prescription for a prescribed pharmaceutical benefit listed in Column 1 of the table in s 5(8) (s 5(1)(a) and (8)).
It limits substitution to the precise substitute pharmaceutical benefits listed in Column 2 of the table in s 5(8). The table pairs particular strengths, forms, manners of administration and brand entries for listed drugs (s 5(8)).
It requires an approved pharmacist acting at premises in respect of which they are approved to meet several conditions before supplying a substitute without prescription: the pharmacist must be unable to supply the prescribed benefit (s 5(2)); must be satisfied it is not practicable for the person to obtain a prescription for the substitute from a PBS prescriber before the person needs the supply (s 5(3)); the substitute must be one that may be dispensed in accordance with s 30EL of the Therapeutic Goods Act 1989 (s 5(4)); the pharmacist must inform the person of substitute options and specific cost information before supply (s 5(5)); the pharmacist must record specified information and statements justifying the substitution (s 5(6)); and the pharmacist must have arrangements to notify the original PBS prescriber in writing within 72 hours of the supply (s 5(7)).

Current sections

Direct links to the current provisions in National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021.

Name

1 Name

(1) This instrument is the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021. (2) This instrument may also be cited as PB 84 of 2021.

Authority

3 Authority

This instrument is made under subsection 89A(3) of the National Health Act 1953.

Definitions

4 Definitions

Note: The expression premises that is used in this instrument is defined in the Act.

In this instrument:

Act means the National Health Act 1953.

approved pharmacist has the same meaning as in Part VII of the Act.

listed drug has the same meaning as in Part VII of the Act.

PBS prescriber has the same meaning as in Part VII of the Act.

pharmaceutical benefit has the same meaning as in Part VII of the Act.

Supply of pharmaceutical benefits by approved pharmacist without prescription

5 Supply of pharmaceutical benefits by approved pharmacist without prescription

(1) A pharmaceutical benefit (the substitute benefit) described in column 2 of an item of the table in subsection (8) may be supplied without a prescription to a person by an approved pharmacist, at or from premises in respect of which the pharmacist is approved, if: (a) a prescription for a pharmaceutical benefit (the prescribed benefit) described in column 1 of the item is presented to the approved pharmacist; and (b) subsections (2), (3), (4), (5), (6) and (7) apply. Approved pharmacist cannot supply prescribed benefit (2) This subsection applies if the approved pharmacist cannot supply the prescribed benefit. Person cannot obtain prescription for substitute benefit in time (3) This subsection applies if the approved pharmacist is satisfied that it is not practicable for the person to obtain a prescription for the substitute benefit from a PBS prescriber before the person needs the supply of the prescribed benefit. Substitution permitted under Therapeutic Goods Act (4) This subsection applies if the substitute benefit may be dispensed in accordance with section 30EL of the Therapeutic Goods Act 1989. Person presenting prescription has been informed of cost implications (5) This subsection applies if the approved pharmacist has informed the person presenting the prescription of: (a) each substitute benefit that the approved pharmacist can supply instead of the prescribed benefit; and (b) for each substitute benefit that the approved pharmacist can supply: (i) the amount (which may be a nil amount) that the approved pharmacist would, if the approved pharmacist supplied the substitute benefit to the person for whom the prescribed benefit was prescribed, be permitted by Part VII of the Act to charge that person for that supply; and (ii) the amount that the approved pharmacist would, if the approved pharmacist supplied the substitute benefit otherwise than under Part VII of the Act to the person for whom the prescribed benefit was prescribed, charge that person for that supply; and (c) the amount (which may be a nil amount) that the approved pharmacist would, if the approved pharmacist supplied the prescribed benefit to the person for whom it was prescribed, be permitted by Part VII of the Act to charge that person for that supply. Record of information justifying supply of substitute benefit (6) This subsection applies if the approved pharmacist records the information that the approved pharmacist used to support the decision to supply the substitute benefit, including the following statements: (a) a statement that the substitute benefit supplied is a pharmaceutical benefit determined under paragraph 89A(3)(a) of the Act; (b) a statement that the conditions in this section are satisfied; (c) a statement that the approved pharmacist is satisfied that the substitute benefit needs to be supplied because: (i) the approved pharmacist cannot supply the prescribed benefit; and (ii) it is not practicable for the person to obtain a prescription for the substitute benefit from a PBS prescriber before the person needs the supply of the prescribed benefit. Arrangements to inform PBS prescriber of substitution (7) This subsection applies if the approved pharmacist has in place arrangements for giving, to the PBS prescriber who wrote the prescription for the prescribed benefit, written notice of the supply of the substitute benefit, within 72 hours after that supply. Table of prescribed and substitute pharmaceutical benefits (8) For the purposes of subsection (1), the table is as follows.

<table cellspacing="0" cellpadding="0" style="width:100%; border-collapse:collapse"><thead><tr><td colspan="3" style="width:415.65pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span style="font-weight:bold">Prescribed and substitute pharmaceutical benefits</span></p></td></tr><tr><td style="width:46.5pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span style="font-weight:bold">Item</span></p></td><td style="width:148.05pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; line-height:normal"><span style="font-size:10pt; font-weight:bold">Column 1</span><br><span style="font-size:10pt; font-weight:bold">Prescribed pharmaceutical benefit</span></p></td><td style="width:199.5pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top; background-color:#ffffff"><p style="margin-top:3pt; line-height:normal"><span style="font-size:10pt; font-weight:bold">Column 2</span><br><span style="font-size:10pt; font-weight:bold">Substitute pharmaceutical benefit</span></p></td></tr></thead><tbody><tr style="height:89.7pt"><td style="width:46.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:36pt; text-indent:-18pt; line-height:normal"><span>1.</span></p></td><td style="width:148.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 390 micrograms, 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span></span><span>Estradot 25</span></p></td><td style="width:199.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 750 micrograms (as hemihydrate), 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand: Estraderm MX 25</span></p></td></tr><tr style="height:89.7pt"><td style="width:46.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:36pt; text-indent:-18pt; line-height:normal"><span>2.</span></p></td><td style="width:148.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 750 micrograms (as hemihydrate), 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand: Estraderm MX 25</span></p></td><td style="width:199.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 390 micrograms, 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span></span><span>Estradot 25</span></p><p style="margin-top:3pt; line-height:normal"><span></span></p></td></tr><tr style="height:34.95pt"><td style="width:46.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:36pt; text-indent:-18pt; line-height:normal"><span>3.</span></p></td><td style="width:148.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 780 micrograms, 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span></span><span>Estradot 50</span></p></td><td style="width:199.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 1.5 mg (as hemihydrate), 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span></span><span></span><span>Estraderm MX 50</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span></span></p></td></tr><tr style="height:34.95pt"><td style="width:46.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:36pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>4.</span></p></td><td style="width:148.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 780 micrograms, 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span></span><span>Estradot 50</span></p></td><td style="width:199.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 390 micrograms, 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand: Estradot 25</span></p></td></tr><tr style="height:34.95pt"><td style="width:46.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:36pt; text-indent:-18pt; line-height:normal"><span>5.</span></p></td><td style="width:148.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 780 micrograms, 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span></span><span>Estradot 50</span></p></td><td style="width:199.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 750 micrograms (as hemihydrate), 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand: Estraderm MX 25</span></p></td></tr><tr style="height:89.7pt"><td style="width:46.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:36pt; text-indent:-18pt; line-height:normal"><span>6.</span></p></td><td style="width:148.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 1.5 mg (as hemihydrate), 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span></span><span></span><span>Estraderm MX 50</span></p></td><td style="width:199.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 780 micrograms, 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand: Estradot 50</span></p></td></tr><tr style="height:89.7pt"><td style="width:46.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:36pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>7.</span></p></td><td style="width:148.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 1.5 mg (as hemihydrate), 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span></span><span></span><span>Estraderm MX 50</span></p></td><td style="width:199.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 390 micrograms, 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand: Estradot 25</span></p></td></tr><tr style="height:89.7pt"><td style="width:46.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:36pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>8.</span></p></td><td style="width:148.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 1.5 mg (as hemihydrate), 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span></span><span></span><span>Estraderm MX 50</span></p></td><td style="width:199.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 750 micrograms (as hemihydrate), 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand: Estraderm MX 25</span></p></td></tr><tr style="height:89.7pt"><td style="width:46.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:36pt; text-indent:-18pt; line-height:normal"><span>9.</span></p></td><td style="width:148.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 1.17 mg, 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span></span><span></span><span>Estradot 75</span></p></td><td style="width:199.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 585 micrograms, 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand: any of the following:</span></p><p style="margin-top:3pt; margin-left:18pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>(a)</span><span> </span><span>Estradot 37.5</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>(b)</span><span> </span><span>Estradiol Transdermal System (Sandoz, USA)</span></p></td></tr><tr style="height:89.7pt"><td style="width:46.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:36pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>10.</span></p></td><td style="width:148.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 1.56 mg, 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span></span><span></span><span>Estradot 100</span></p></td><td style="width:199.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 3 mg (as hemihydrate), 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand: Estraderm MX 100</span></p></td></tr><tr style="height:89.7pt"><td style="width:46.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:36pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>11.</span></p></td><td style="width:148.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 1.56 mg, 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span></span><span></span><span>Estradot 100</span></p></td><td style="width:199.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 780 micrograms, 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand: Estradot 50</span></p></td></tr><tr style="height:89.7pt"><td style="width:46.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:36pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>12.</span></p></td><td style="width:148.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 1.56 mg, 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span></span><span></span><span>Estradot 100</span></p></td><td style="width:199.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 1.5 mg (as hemihydrate), 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand: Estraderm MX 50</span></p></td></tr><tr style="height:89.7pt"><td style="width:46.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:36pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>13.</span></p></td><td style="width:148.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 3 mg (as hemihydrate), 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span></span><span></span><span>Estraderm MX 100</span></p></td><td style="width:199.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 1.56 mg, 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand: any of the following:</span></p><p style="margin-top:3pt; margin-left:18pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>(a)</span><span> </span><span>Estradot 100</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>(b)</span><span> </span><span>Estradiol Transdermal System (Sandoz, USA)</span></p></td></tr><tr style="height:89.7pt"><td style="width:46.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:36pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>14.</span></p></td><td style="width:148.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 3 mg (as hemihydrate), 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span></span><span></span><span>Estraderm MX 100</span></p></td><td style="width:199.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 780 micrograms, 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand: Estradot 50</span></p></td></tr><tr style="height:89.7pt"><td style="width:46.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:36pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>15.</span></p></td><td style="width:148.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 3 mg (as hemihydrate), 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span></span><span></span><span>Estraderm MX 100</span></p></td><td style="width:199.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Estradiol</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Transdermal patches 1.5 mg (as hemihydrate), 8</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Transdermal</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand: Estraderm MX 50</span></p></td></tr><tr style="height:89.7pt"><td style="width:46.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:36pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>16.</span></p></td><td style="width:148.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Insulin isophane</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Injections (human), cartridges, 100 units per mL, 3 mL, 5</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Injection</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span></span><span>Protaphane InnoLet</span></p></td><td style="width:199.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Insulin isophane</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Injections (human), cartridges, 100 units per mL, 3 mL, 5</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Injection</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand: Protaphane Penfill 3 mL</span></p></td></tr><tr style="height:89.7pt"><td style="width:46.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:36pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>17.</span></p></td><td style="width:148.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Nicorandil</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Tablets 10 mg, 60</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Oral</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span>APO</span><span>‑</span><span>Nicorandil</span></p></td><td style="width:199.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Nicorandil</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Tablets 20 mg, 60</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Oral</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span>any of the following:</span></p><p style="margin-top:3pt; margin-left:18pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>a)</span><span style="width:10.23pt; text-indent:0pt; display:inline-block"> </span><span>APO</span><span>‑</span><span>Nicorandil</span></p><p style="margin-top:3pt; margin-left:18pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>b)</span><span style="width:9.67pt; text-indent:0pt; display:inline-block"> </span><span>Ikotab</span></p></td></tr><tr style="height:89.7pt"><td style="width:46.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:36pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>18.</span></p></td><td style="width:148.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Nicorandil</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Tablets 10 mg, 60</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Oral</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span>Ikotab</span></p></td><td style="width:199.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Nicorandil</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Tablets 20 mg, 60</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Oral</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span>any of the following:</span></p><p style="margin-top:3pt; margin-left:18pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>a)</span><span style="width:10.23pt; text-indent:0pt; display:inline-block"> </span><span>APO</span><span>‑</span><span>Nicorandil</span></p><p style="margin-top:3pt; margin-left:18pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>b)</span><span style="width:9.67pt; text-indent:0pt; display:inline-block"> </span><span>Ikotab</span></p></td></tr><tr style="height:89.7pt"><td style="width:46.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:36pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>19.</span></p></td><td style="width:148.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Nicorandil</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Tablets 20 mg, 60</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Oral</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span>APO</span><span>‑</span><span>Nicorandil</span></p></td><td style="width:199.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Nicorandil</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Tablets 10 mg, 60</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Oral</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span>any of the following:</span></p><p style="margin-top:3pt; margin-left:18pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>a)</span><span style="width:10.23pt; text-indent:0pt; display:inline-block"> </span><span>APO</span><span>‑</span><span>Nicorandil</span></p><p style="margin-top:3pt; margin-left:18pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>b)</span><span style="width:9.67pt; text-indent:0pt; display:inline-block"> </span><span>Ikotab</span></p></td></tr><tr style="height:89.7pt"><td style="width:46.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:36pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>20.</span></p></td><td style="width:148.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Nicorandil</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Tablets 20 mg, 60</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Oral</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span>Ikotab</span></p></td><td style="width:199.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Nicorandil</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Tablets 10 mg, 60</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Oral</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span>any of the following:</span></p><p style="margin-top:3pt; margin-left:18pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>a)</span><span style="width:10.23pt; text-indent:0pt; display:inline-block"> </span><span>APO</span><span>‑</span><span>Nicorandil</span></p><p style="margin-top:3pt; margin-left:18pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>b)</span><span style="width:9.67pt; text-indent:0pt; display:inline-block"> </span><span>Ikotab</span></p></td></tr><tr style="height:89.7pt"><td style="width:46.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:36pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>21</span></p></td><td style="width:148.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Simvastatin</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Tablet 5 mg</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Oral</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span>Zimstat</span></p></td><td style="width:199.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:18pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>Listed drug: Simvastatin</span></p><p style="margin-top:3pt; margin-left:18pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>Form: Tablet 10 mg</span></p><p style="margin-top:3pt; margin-left:18pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>Manner of administration: Oral</span></p><p style="margin-top:3pt; margin-left:18pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span>any of the following:</span></p><p style="margin-top:3pt; margin-left:18pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>a)</span><span style="width:10.23pt; text-indent:0pt; display:inline-block"> </span><span>APO-Simvastatin</span></p><p style="margin-top:3pt; margin-left:18pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>b)</span><span style="width:9.67pt; text-indent:0pt; display:inline-block"> </span><span>SIMVASTATIN-WGR</span></p><p style="margin-top:3pt; margin-left:18pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>c)</span><span style="width:10.23pt; text-indent:0pt; display:inline-block"> </span><span>Simvar 10</span></p><p style="margin-top:3pt; margin-left:18pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>d)</span><span style="width:9.67pt; text-indent:0pt; display:inline-block"> </span><span>Simvastatin Sandoz</span></p><p style="margin-top:3pt; margin-left:18pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>e)</span><span style="width:10.23pt; text-indent:0pt; display:inline-block"> </span><span>Zimstat</span></p></td></tr><tr style="height:89.7pt"><td style="width:46.5pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:36pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>22</span></p></td><td style="width:148.05pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Clonidine</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Tablet containing clonidine hydrochloride 150 micrograms</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Oral</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span>Catapres</span></p></td><td style="width:199.5pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Listed drug: Clonidine</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Form: Tablet containing clonidine hydrochloride 100 micrograms</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Manner of administration: Oral</span></p><p style="margin-top:3pt; line-height:normal; font-size:10pt"><span>Brand:</span><span> </span><span>any of the following:</span></p><p style="margin-top:3pt; margin-left:18pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>a)</span><span style="width:10.23pt; text-indent:0pt; display:inline-block"> </span><span>APO-Clonidine</span></p><p style="margin-top:3pt; margin-left:18pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>b)</span><span style="width:9.67pt; text-indent:0pt; display:inline-block"> </span><span>Catapres 100</span></p><p style="margin-top:3pt; margin-left:18pt; text-indent:-18pt; line-height:normal; font-size:10pt"><span>c)</span><span style="width:10.23pt; text-indent:0pt; display:inline-block"> </span><span>Clonidine Lupin</span></p></td></tr></tbody></table>

Source text: opening excerpt

Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.

1 Name

3 Authority

This instrument is made under subsection 89A(3) of the National Health Act 1953.

4 Definitions

Note: The expression premises that is used in this instrument is defined in the Act.

In this instrument:

Act means the National Health Act 1953.

approved pharmacist has the same meaning as in Part VII of the Act.

listed drug has the same meaning as in Part VII of the Act.

PBS prescriber has the same meaning as in Part VII of the Act.

pharmaceutical benefit has the same meaning as in Part VII of the Act.

5 Supply of pharmaceutical benefits by approved pharmacist without prescription

This section sets out a practical compliance checklist distilled from the instrument’s mandatory provisions (s 5(1)-(7)) and the table (s 5(8)). Each step cites the relevant subsection of the Determination to ensure traceability to the text.

Confirm approval status and premises

Verify that the pharmacist is an "approved pharmacist" and that the supply will be made at premises "in respect of which the pharmacist is approved", as those terms are used in the instrument (s 5(1); s 4). Do not proceed under the Determination if either approval is absent.

Confirm the prescription presented matches Column 1 of the table

Ensure a prescription for a prescribed pharmaceutical benefit described in Column 1 of an item in s 5(8) is presented to the approved pharmacist (s 5(1)(a), (8)). If the prescription is for a product not listed in Column 1, the Determination does not authorise substitution.

Establish inability to supply the prescribed benefit

Before substitution, confirm and document that the approved pharmacist cannot supply the prescribed benefit (s 5(2)). The Determination makes this inability a condition precedent to substitution.

Establish impracticability of obtaining a new prescription

Form an objective record that it is not practicable for the person to obtain a prescription for the substitute from a PBS prescriber before the person needs the supply (s 5(3)). Document the factual basis for the impracticability finding, for example: prescriber unavailable, urgency of need, clinic closures, or other contemporaneous facts. The Determination requires the pharmacist be satisfied of this element.

Check TGA s 30EL dispensability for the substitute

Verify the substitute "may be dispensed in accordance with section 30EL of the Therapeutic Goods Act 1989" (s 5(4)). Consult the Therapeutic Goods Act text and any relevant TGA guidance for the product to confirm dispensability. Do not rely on the Determination to override TGA dispensing rules.

Prepare and give the required consumer disclosure

Inform the person presenting the prescription of:
- Each substitute benefit the pharmacist can supply instead of the prescribed benefit (s 5(5)(a)).
- For each substitute, the amount the pharmacist would, if the substitute were supplied under Part VII, be permitted to charge the person (s 5(5)(b)(i)).
- For each substitute, the amount the pharmacist would charge the person if supplied otherwise than under Part VII (s 5(5)(b)(ii)).
- The amount the pharmacist would, if the prescribed benefit were supplied under Part VII, be permitted to charge the person (s 5(5)(c)).
Ensure these amounts are current and supportable. Include "nil" disclosures where relevant.

Make and retain the required record entries

Record the information used to support the decision to supply the substitute (s 5(6)). The record must include:
- A statement that the substitute supplied is "a pharmaceutical benefit determined under paragraph 89A(3)(a) of the Act" (s 5(6)(a)).
- A statement that the conditions in s 5 are satisfied (s 5(6)(b)).
- A statement that the pharmacist is satisfied the substitute needs to be supplied because they cannot supply the prescribed benefit and it is not practicable for the person to obtain a prescription for the substitute from a PBS prescriber before they need the supply (s 5(6)(c)).
Prefer digital records that capture timestamps and supporting metadata. Ensure records are retained in accordance with relevant professional and statutory recordkeeping obligations.

Ensure timely written notification to the PBS prescriber

Have in place robust arrangements to give written notice to the PBS prescriber who wrote the original prescription within 72 hours after supply (s 5(7)). The Determination does not prescribe the method of written notice; use an auditable channel such as secure email, fax with confirmation, or an integrated electronic messaging function that archives delivery confirmation. Record evidentiary proof of notification.

Supply only table‑listed substitutes and follow brand restrictions

Cross‑check the prescription against the table in s 5(8) and supply only the Column 2 substitute listed for the corresponding Column 1 prescribed benefit. Note brand‑specific entries and the "any of the following" options where the table allows multiple brands. Do not improvise substitutes not listed in Column 2.

Implement SOPs, staff training and system support

Update pharmacy standard operating procedures to embed the Determination’s decision points, disclosure scripts, record templates and notification procedures.
Train staff to recognise which prescriptions fall within the table in s 5(8), to calculate the Part VII permitted charge and the non‑Part VII charge accurately, and to capture the required statements in records.
Enhance dispensing software or workflow to include mandatory fields linked to s 5(2)-(7) compliance checks and to capture notification evidence.

Audit and quality control

Regularly audit substitution events to verify: presence of a valid Column 1 prescription, record entries required by s 5(6), evidence of consumer disclosure in line with s 5(5), and proof of notification to the PBS prescriber within 72 hours (s 5(7)). Keep audit trails for regulatory review.

Seek guidance on ambiguous points

Where the pharmacist has doubt about whether a product may be dispensed under TGA s 30EL, or how to determine the Part VII permitted charge in a particular case, seek authoritative guidance from PBS administrators or legal advice. The Determination delegates these technical determinations to the external statutory frameworks it imports.

Following this checklist aligns practice with the Determination’s requirements in s 5(1)-(7) and reduces compliance risk. The two operationally sensitive items to prioritise are the contemporaneous evidence supporting the "cannot supply" and "not practicable" predicates (s 5(2)-(3)), and the 72‑hour written notification to the PBS prescriber (s 5(7)).

National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021

Plain English Summary

Deep Dive

What it does

Current sections

Name

1 Name

Authority

3 Authority

Definitions

4 Definitions

Supply of pharmaceutical benefits by approved pharmacist without prescription

5 Supply of pharmaceutical benefits by approved pharmacist without prescription

Source text: opening excerpt

1 Name

1 Name

3 Authority

3 Authority

4 Definitions

4 Definitions

5 Supply of pharmaceutical benefits by approved pharmacist without prescription

5 Supply of pharmaceutical benefits by approved pharmacist without prescription

Main concepts

Who it affects

Key duties and rights

Penalties and enforcement

How it interacts with other laws

Amendment history

Litigation history

Gotchas

How to comply