South Australian Current Regulations South Australian Current Regulations21—Exemptions from section 18 of Act
(1) A council,
council subsidiary or health service facility is exempt from
section 18(1c)(d) of the Act in respect of the supply of an S4 drug
under an immunisation program run by the council, council subsidiary or
health service facility.
(2) A pharmacist who
sells or supplies an S4 drug without dispensing a prescription is exempt
from section 18(1b)(a) and (1c)(a) of the Act in relation to that
sale or supply if—
(a) the
drug is sold or supplied to a council, council subsidiary or
health service facility for use in an immunisation program delivered by the
council, council subsidiary or health service facility and the pharmacist has
received a written order for the drug from the council, council subsidiary or
health service facility; or
(b) the
drug is for use by a person who holds a licence to sell, supply or administer
an S4 drug and the pharmacist has received a written order for the drug
from the licensee; or
(c) the
drug is sold or supplied for the mass treatment of certain animals to the
owner of the animals and—
(i)
the pharmacist has received a written order for the drug
from a veterinary surgeon; or
(ii)
—
(A) the drug is an antibiotic; and
(B) the pharmacist has received a written
order for the drug from an inspector appointed under the
Livestock Act 1997 ; and
(C) the written order is on a form approved
by the Chief Inspector of Stock under that Act and has been countersigned by
the Chief Inspector; or
(d) the
drug is sold or supplied to a registered health practitioner or veterinary
surgeon authorised to sell, supply or administer S4 drugs and the
pharmacist has received a written order for the drug from that practitioner or
veterinary surgeon; or
(e) the
drug is authorised or required by the law of any place to be carried on board
a ship and the pharmacist has received a written order for the drug from the
master or medical officer of the ship; or
(f) the
drug is not one listed in the table in regulation 19(1) for the purposes
of section 18(2) of the Act and the pharmacist—
(i)
is satisfied that—
(A) the person for whom it is to be sold or
supplied is being medically treated with the drug; and
(B) the continued sale or supply of that
drug is essential to the health of that person; and
(C) there is good reason for the person's
inability to produce a prescription for the drug; and
(A) where the pharmacist is satisfied that
the person for whom it is to be sold or supplied is affected by an emergency
specified by the Minister by notice under subregulation (2a) and the sale
or supply occurs during the period specified in relation to that emergency in
the same notice—
• for drugs that
are on the Pharmaceutical Benefits Scheme—no more than the standard
Pharmaceutical Benefits maximum quantity; or
• for drugs that
are not on the Pharmaceutical Benefits Scheme—the quantity that is
contained in the smallest standard pack in which the drug is generally
available; or
(B) in any other case—
• if the drug is
a cream, ointment or liquid or one that is packaged in such a manner as to
promote the safe and proper use of the drug—the smallest standard
package or container made by the manufacturer; or
• if the drug is
not a cream, ointment or liquid or other drug described above—no more
than 3 days dosage of the drug; and
(iii)
on the day on which the drug is sold or supplied,
records—
(A) his or her name as the seller or
supplier of the drug; and
(B) the date; and
(C) the trade name or the approved name of
the drug, or, if it does not have either a trade name or approved name, its
ingredients; and
(D) the name and address of the person for
whom the drug is sold or supplied; and
(E) the form, strength and quantity of the
drug; and
(F) the directions given for the safe and
proper use of the drug, including (where appropriate) the route of
administration of the drug; or
(g) the
drug is a prescribed (continued dispensing) pharmaceutical benefit and the
sale or supply is made in accordance with the conditions specified in the
National Health (Continued Dispensing) Determination; or
(h) the
drug is sold or supplied to a person in accordance with a scheme determined by
the Minister from time to time for the purposes of this paragraph by notice in
the Gazette.
(2a) If the Minister
is satisfied that an emergency (within the meaning of the Emergency
Management Act 2004 ) is occurring in an area of the State, the Minister
may, by notice in the Gazette, specify the emergency and a period of time in
relation to that emergency for the purposes of
subregulation (2)(f)(ii)(A).
(2b) A notice under
subregulation (2a)—
(a) may
specify the emergency by reference to any factor the Minister thinks fit
(including, without limitation, by a description of the circumstances of the
emergency, the area within which the emergency is occurring or by any
description by which the emergency is commonly known); and
(b) may,
from time to time as the Minister thinks fit, be varied or substituted by a
new notice or be revoked.
(3) The holder of a
licence under the Commonwealth Act to manufacture goods is exempt from
section 18(1e) of the Act in respect of the manufacture of those goods.
(4) In this
regulation—
"Pharmaceutical Benefits Scheme" means the Pharmaceutical Benefits Scheme
under the National Health Act.