Therapeutic Goods Order No. 65 Child-Resistant Packaging for Therapeutic Goods (05/08/2004) (Cth)

Therapeutic Goods Act 1989

THERAPEUTIC GOODS ORDER NO. 65

Child-Resistant Packaging for Therapeutic Goods

I, Terry Slater, delegate of the Minister for Health and Ageing, for the purposes of section 10 of the Therapeutic Goods Act 1989 (the Act) and acting under that section, having consulted with the Therapeutic Goods Committee in accordance with subsection 10(4) of the Act:

(a)     REVOKE the following Orders:

(i) on and from 1 July 2007, Therapeutic Goods Order No. 20 entitled ‘Child Resistant Containers’; and

(ii) on and from 1 July 2007, Therapeutic Goods Order No. 33 entitled ‘Amendment of Schedules to Therapeutic Goods Order No. 20 Child Resistant Containers’; AND

(b)     DETERMINE that, subject to subparagraphs (i), (ii), (iii) and (iv), therapeutic goods to which this Order applies must be packaged in accordance with the requirements of this Order:

(i) therapeutic goods that are included in an application lodged under section 23 of the Act, being an application lodged before 1 July 2005, must, until 30 June 2007, comply with either this Order or Therapeutic Goods Order No. 20 ‘Child Resistant Containers’, as modified by Therapeutic Goods Order No. 33;

(ii) therapeutic goods that are included in an application lodged under section 23 of the Act, being an application lodged before 1 July 2005, must comply with this Order from 1 July 2007;

(iii) therapeutic goods that are included in an application lodged under section 23 of the Act, being an application lodged on or after 1 July 2005, must comply with this Order; and

(iv) therapeutic goods that are subject to this Order but which are not included in an application made under section 23 of the Act must comply with this Order from 1 July 2007.

This Order includes the First Schedule and the Second Schedule to this Order.

This Order commences from the day it is gazetted in the Commonwealth Gazette.

1      Application and exemptions

1(1)   This Order applies to:

(a)     therapeutic goods which contain a substance specified in the First Schedule to this Order or a salt or ester or other derivative of a substance specified in the First Schedule to this Order, except goods:

(i)      that are in a container holding 500 solid dosage units or more (excluding goods packed and labelled for retail supply);

(ii)     intended to be administered by injection;

(iii)     that are solid or semi-solid (excluding solid dosage forms) and are intended to be applied to the skin or mucous membrane;

(iv)    that are liquid or semi-solid and are intended to be applied to the eye or mucous membrane, and are supplied in a container that has a nominal capacity of 20 millilitre or less or that is fitted with a restricted flow insert;

(v)     that are individually wrapped powders;

(vi)    that fall within the description of Item 9(a) of Schedule 5 to the Regulations;

(vii)    that have not reached their final stage of manufacture;

(viii)   supplied to a person whom a healthcare professional, authorised under relevant State or Territory legislation to supply or prescribe the goods, believes would suffer undue hardship through difficulty in opening a container complying with the requirements of this Order;

(ix)    to be used by, or administered to, a patient for treatment in a public hospital, private hospital or nursing home;

(x)     that are solely for export; or

(xi)    intended solely for use in animals; and

(b)     therapeutic goods to which paragraph 1(1)(a) does not apply but which, through their packaging or labelling, state or imply that the goods, as presented, are child-resistant.

2      Interpretation

2(1)   In this Order -

‘Act’ means the Therapeutic Goods Act 1989, as amended from time to time;

‘blister’ means a package in which one or more dosage units are enclosed between a pre-formed tray with individual pockets and a lidding material which may be flat or shaped.  The dosage units can only be extracted from one pocket at a time.  The material of the tray is usually different from that of the lid. It must be cut or torn in order to access the contents;

‘child-resistant packaging’ means packaging that is designed or constructed to be significantly difficult for young children to open, or gain access to the contents of, within a reasonable time but not unduly difficult for adults to use properly, but does not mean packaging which all young children cannot open, or obtain the contents of, within a reasonable time.  Child-resistant is not synonymous with child-proof;

‘closure’ means the portion(s) of a package that keeps the package closed. A closure may be separately identifiable or an integral component of a package;

‘container’, in relation to therapeutic goods, means the vessel, bottle, tube, ampoule, syringe, vial, sachet, strip pack, blister pack, wrapper, cover or other similar article that immediately covers the goods, but does not include an article intended for ingestion;

‘goods’ means therapeutic goods;

‘non-reclosable package’ means a package that, having been opened, is not capable of being reclosed to its original child-resistant state;

‘packaging’ means a package, including any closure system, being the sum of components that together immediately contain and protect the dosage form.  It includes containers, closures and closure liners.  Packaging may be either reclosable or non-reclosable;

‘Poisons Standard’ has the same meaning as in regulation 2 of the Regulations;

‘reclosable package’ means a package which, once opened, can be reclosed to re-form a child-resistant package;

‘Regulations’ means the Therapeutic Goods Regulations 1990, as amended from time to time;

‘Sponsor’ has the same meaning as in subsection 3(1) of the Act;

‘Standard’ means any of the national or international Standards referred to in paragraph 4(1)(a);

‘strip’ means a package in which one or more dosage units are enclosed individually in a continuous strip made by bonding two layers of material together so that the dosage units are separated and protected and can only be extracted from one pocket at a time.  Each layer may be of the same or different material. It must be cut or torn in order to access the contents;

‘therapeutic goods’ has the same meaning as in subsection 3(1) of the Act; and

‘young children’ means children within the age groups specified in the protocols given in the Standards referred to in paragraph 4(1)(a) for the testing of child-resistance.

3      General requirements

3(1)   The requirements of this Order apply in addition to any other packaging requirements that may be applied under the Act or Regulations.

3(2)   The packaging for goods to which this Order applies must be fit for purpose for the shelf-life of the goods.

3(3)   The packaging for goods to which this Order applies must retain its child-resistant properties for the expected in-use life of the goods.

3(4)   Performance of the child-resistant feature must not be adversely affected by the contents of the package.

3(5)   Sight, unusual strength or unusual dexterity shall not be required to access the contents of the package or, in the case of reclosable packages, to re-engage the child-resistant feature.

4      Reclosable packages

4(1)   Where goods to which this Order applies are in a reclosable package, the package must:

(a)     comply with at least one of the following Standards:

(i)      the International Organization for Standardization Standard ISO 8317:1989 entitled Child-resistant packaging – Requirements and testing procedures for reclosable packages;

(ii)     the British Standards Institution Standard BS EN 28317:1993 entitled Child-resistant packaging – Requirements and testing procedures for reclosable packages;

(iii)     the Canadian Standards Association Standard CSA Z76.1-99 entitled Reclosable Child-Resistant Packages;

(iv)    the United States Code of Federal Regulations, Title 16, Section 1700.15, entitled Poison prevention packaging standards and Section 1700.20, entitled Testing procedure for special packaging, as in effect at the date of this Order;

(v)     the Australian Standard AS 1928-2001 entitled Child-resistant packages; or

(b)     be a container which is fitted with a closure that is specified and described in the Second Schedule to this Order.

4(2)   Where goods to which this Order applies are in a reclosable package that complies with any one of the Standards listed in paragraph 4(1)(a), the Sponsor of the goods is to hold evidence that the package so complies. Such evidence may consist of:

(a)     certification (or appropriately authorised copies of such certification) from a recognised testing authority, attesting that the package complies with a relevant Standard, expressed so as to make it beyond doubt that the certification in fact refers to the package specified by the Sponsor, together with a statement of the protocol used to demonstrate child-resistance;

(b)     where the package is not certified as above, information proving         compliance with a relevant Standard, expressed so as to make it       beyond doubt that the information in fact refers to the package specified by the Sponsor, together with a statement of the protocol used to demonstrate child-resistance; or

(c)     information demonstrating that the package as specified by the Sponsor has been established previously as complying with a relevant Standard.

4(3)   In addition to the requirement referred to in subclause 4(2), where goods to which this Order applies are in a reclosable package, the Sponsor of the goods is to hold evidence demonstrating that the package will remain fit for purpose for the shelf-life of the goods, will retain its child-resistant properties for the expected in-use life of the goods, and that performance of the child-resistant feature will not be adversely affected by the contents of the package.

4(4)   Where a change in specifications for a package occurs, the Sponsor of the goods is to hold additional evidence demonstrating that the child-resistant properties of the package and operation of the closure have not been adversely affected.

4(5)   In addition to the requirements referred to in subclauses 4(1), 4(2), 4(3), and 4(4), where goods to which this Order applies are in a reclosable package, the Sponsor of the goods is to hold information in relation to:

(a)     the types and sizes of container to which a specified closure may be applied;

(b)     the suitability of the package for the type of goods;

(c)     instructions appropriate to the particular packaging system to ensure correct application of the closure to the container after filling and engagement of the child-resistant mechanism; and

(d)     the quality control tests applied to demonstrate that production lots of the package are of consistent and satisfactory quality and appropriate for use.

4(6)   When goods to which this Order applies are in a reclosable package, adequate directions for opening and effectively reclosing the package shall be conspicuously marked or written on the package or on a label securely affixed or attached to the package.

4(7)   Any directions on the package or label for goods to which this Order applies concerning the correct operation of the child-resistant mechanism must be written in the English language or clearly demonstrated in graphics.

4(8)   Where goods to which this Order applies contain a substance specified in the First Schedule, and are packaged together with a separate dropper or applicator that is reasonably expected to replace the original closure on the goods once the goods are in use, then that configuration also must comply with the requirements of this Order.

5      Non-Reclosable Packages

5(1)   Subject to subclause 5(2), when goods to which this Order applies are in a package which is a non-reclosable package, the package must be in the form of a blister or other sealed unit formed from paper, film, plastic material, metal foil or other sheet or strip material or a combination of these in which a single dosage unit is enclosed, whether as part of a continuous series comprising a strip or sheet of like material or not.

5(2)   A non-reclosable package referred to in subclause 5(1) shall not be formed from cellulose film or unlaminated paper.

Dated this fifth day of August 2004

Terry Slater

National Manager

Therapeutic Goods Administration

Delegate of the Minister for Health and Ageing

First Schedule

ANTI-ARRHYTHMICS – All preparations containing one or more ANTI-ARRHYTHMIC ingredients including but not limited to the following:

Amiodarone	Disopyramide	Flecainide
Mexiletine	Procainamide	Quinidine
Sotalol	Verapamil

ANTICONVULSANTS - All preparations containing one or more ANTICONVULSANT ingredients  including but not limited to the following:

Carbamazepine	Clonazepam	Ethosuximide
Gabapentin	Lamotrigine	Levetiracetam
Methylpheno-barbitone	Oxcarbazepine	Phenytoin
Primidone	Sodium valproate	Sulthiame
Tiagabine	Topiramate	Vigabatrin

ANTIHISTAMINES - All preparations containing one or more ANTIHISTAMINE ingredients including but not limited to the following:

Antazoline	Astemizole	Azatadine
Brompheniramine	Cetirizine	Chlorpheniramine
Clemizole*	Cyproheptadine	Dexchlorpheniramine
Dimenhydrinate	Diphenhydramine	Doxylamine
Fexofenadine	Hydroxyzine	Loratadine
Mepyramine	Methdilazine	Pheniramine
Promethazine	Terfenadine	Trimeprazine

* in dosage forms other than ointment or suppository

ASPIRIN

BETA BLOCKERS - All preparations containing one or more BETA BLOCKER ingredients including but not limited to the following:

Atenolol	Carvedilol	Esmolol
Metoprolol	Oxprenolol	Pindolol
Propranolol	Sotalol	Timolol

CALCIUM ANTAGONISTS - All preparations containing one or more CALCIUM ANTAGONIST ingredients including but not limited to the following:

Amlodipine	Diltiazem	Felodipine
Lercanidipine	Nifedipine	Nimodipine
Perhexiline	Verapamil

CAMPHOR (including CAMPHORATED OIL) in liquid preparations when included in Schedule 4, 5 or 6 of the Poisons Standard.

CHLOROQUINE

CINEOLE in a volume of 2 litres or less, when included in Schedule 6 of the Poisons Standard.

CLONIDINE

CLOZAPINE

COLCHICINE

DEXAMPHETAMINE

DEXTROPROPOXYPHENE

DIGITALIS GLYCOSIDES

DIPHENOXYLATE HYDROCHLORIDE WITH ATROPINE SULPHATE

ESSENTIAL OILS in a volume of 200 millilitres or less, when included in Schedule 5 or 6 of the Poisons Standard, including but not limited to the following:

Anise oil	Basil oil	Bay oil
Cajuput oil	Cassia oil	Cinnamon bark oil
Cinnamon leaf oil	Clove oil	Marjoram oil
Nutmeg oil	Pennyroyal oil	Sage (Dalmatian) oil
Thyme oil

EUCALYPTUS OIL in a volume of 2 litres or less, when included in Schedule 6 of the Poisons Standard.

FLUORIDE SALTS in packs containing the equivalent of more than 100 milligrams of elemental fluorine.

HYDROXYCHLOROQUINE

IRON COMPOUNDS - All solid dosage forms except preparations containing the equivalent of 5 milligrams or less of elemental iron in each dosage unit; and in liquid preparations containing the equivalent of more than 250 mg of elemental iron in the total contents of the container.

LITHIUM CARBONATE

MELALEUCA OIL (Tea-tree Oil) in a volume of 200 millilitres or less, when included in Schedule 6 of the Poisons Standard.

METHADONE

METHYLPHENIDATE

METHYL SALICYLATE in liquid preparations containing more than 50 per cent volume in volume of methyl salicylate, in a volume of 200 mL or less.

MINOXIDIL in liquid preparations or preparations for oral administration.

MONOAMINE OXIDASE INHIBITORS - All preparations containing one or more MONOAMINE OXIDASE INHIBITOR ingredients including but not limited to the following:  

Phenelzine Tranylcypromine

NARCOTIC ANALGESICS - All preparations containing one or more NARCOTIC ANALGESIC ingredients including but not limited to the following:

Buprenorphine	Codeine	Dextromoramide
Dihydrocodeine	Diphenoxylate	Fentanyl
Hydromorphone	Morphine	Oxycodone
Pentazocine	Pethidine

NATEGLINIDE

ORPHENADRINE

PARACETAMOL - All solid dosage forms and liquid preparations.

PHENOTHIAZINES - All preparations containing one or more PHENOTHIAZINE ingredients including but not limited to the following:

Chlorpromazine	Fluphenazine	Pericyazine
Perphenazine	Prochlorperazine	Promazine*
Promethazine	Thioridazine	Trifluoperazine
Trimeprazine

  * other than liquid for injection

PIOGLITAZONE

QUININE

SULPHONYLUREAS - All preparations containing one or more SULPHONYLUREA ingredients including but not limited to the following:

Glibenclamide	Gliclazide	Glipizide
Tolazamide	Tolbutamide

THEOPHYLLINE

TRICYCLIC, TETRACYCLIC AND OTHER ANTIDEPRESSANTS - All preparations containing one or more TRICYCLIC, TETRACYCLIC AND/OR OTHER ANTIDEPRESSANT ingredients including but not limited to the following:

Amitriptyline	Clomipramine	Desipramine
Dothiepin	Doxepin	Fluoxetine
Fluvoxamine	Imipramine	Mianserin
Moclobemide	Nefazodone	Nortriptyline
Paroxetine	Reboxetine	Sertraline
Trimipramine	Venlafaxine

ZIPRASIDONE

Second Schedule

Name of Closure	Approved Sizes	For Use With	Known Australian Distributor	Manufacturer	Date of Acceptance in Australia	Standard Complied With
ANCHOR CR	28 mm	Glass or plastic standard thread containers	Anchor Plastics Pty Ltd 5 Marshall Road KIRRAWEE NSW 2232 [phone]	Anchor Plastics Pty Ltd	February 1992	AS 1928-1982 (certified Dec 91)
ARGUS-LOC I	28, 33, & 38 mm 24 mm	Glass, polyethylene terephthalate (PET) or high density polyethylene (HDPE) containers with Glass Packaging Institute (GPI) or Society of the Plastics Industry (SPI) 400/405 neck finish	ACI Plastics Packaging 4 Kingsway MOORABBIN VIC 3189 [phone]	Owens-Illinois (USA)	Original approval pre-1985 July 2002	Unknown US16 CFR 1700 for Senior Adult Use Effectiveness (certified Apr 96)
ARGUS-LOC TAMPERTEL	24, 28, & 38 mm with Tampertel T/E[1] break band	Glass, PET or HDPE containers with Tampertel neck finish	ACI Plastics Packaging 4 Kingsway MOORABBIN VIC 3189 [phone]	ACI Plastics Packaging	July 2002	Approval based on equivalence of CR mechanism to previously approved Argus-Loc
BORMIOLI	28 mm with T/E feature 18, 24, 28 & 35 mm	Glass PFP finish or plastic BMP finish bottles	Unspecified	Bormioli Rocco E Figlio (Italy)	November 2000 June 2002	US 16CFR 1700 (certified Aug 98) Plus ISO 8317:1989 (certified Mar 2000)
CLIC-LOC II (previously known as Clic-Loc)	28 & 38 mm 24 mm	Standard thread glass or plastic containers	ACI Plastics Packaging 4 Kingsway MOORABBIN VIC 3190 [phone]	ACI Plastics Packaging under licence from Owens-Illinois (USA)	February 1991 May 1991	Approval based on equivalence to US manufactured Clic-Loc II closures and certification of these against US 16CFR 1700 (certified Oct 73 / Dec 74)
CLIC-LOC III	33 mm	Standard thread glass or plastic containers	ACI Plastics Packaging 4 Kingsway MOORABBIN VIC 3190 [phone]	ACI Plastics Packaging under licence from Owens-Illinois (USA)	Unknown	US 16CFR 1700 (certified Jan 96)
CORMACK/ KERR CRIII	Closures within size ranges 16-30  mm & 31-50 mm	Glass or plastic containers with standard Standard Plastic 400 (SP-400) neck finish	Cormack Packaging Pty Ltd 20-26 Harley Crescent CONDELL PARK  NSW 2200 [phone]	Cormack Packaging Pty Ltd under licence from Kerr (USA)	December 1999	AS 1928-1982
DUMA Twist-Off 35	35 mm with T/E feature	Duma Twist-Off or Duma Twist-Off Q HDPE containers with standard neck finish	Unspecified	Superfos Pharma Pack (Denmark)	May 2002	ISO 8317:1989 US 16CFR 1700 for Senior Adult Use Effectiveness (certified Jul 97)
EASY LOK	28 and 38 mm	Alto Plastics Ltd 19 Keeling Road PO Box 21308 Henderson, Auckland New Zealand [phone]	Alto Plastics Ltd (New Zealand)	July 1983	Unknown
GAPLAST	36 mm continuous thread closure	60K or 30K polypropylene Gaplast round bottles	Unspecified	Gaplast GmbH (Germany)	February 1999	ISO 8317:1989 (certified Nov 98) plus US 16CFR 1700 for Senior Adult Use Effectiveness (certified Nov 98)
KERR CR-1	20, 22, 24, 28, 30, 33 & 38 mm	Glass or plastic containers with standard SP-400 neck finish	Cormack Packaging 20-26 Harley Crescent CONDELL PARK  NSW 2200 [phone]	Cormack Packaging	Pre-1980	Unspecified
KERR TE CR-1	20, 24, 28, 33 & 38 mm with T/E feature	Glass or plastic containers with standard SP-400 neck finish	Cormack Packaging 20-26 Harley Crescent CONDELL PARK  NSW 2200 [phone]	Kerr Group (USA)	October 1993	Approval based on equivalence to Kerr CR-1 (non-TE range)
PP28 CLIC-LOC	28 mm with T/E feature	Glass containers with standard PP28 neck finish, or plastic containers with equivalent neck finish.	Unspecified	United Closures & Plastics Plc (UCP) (England)	September 2001	ISO 8317:1989 (certified May 96)
REXAM Series FG	33 mm 38 mm	For use with HDPE bottles with 33-400 or 38-400 neck finishes	Unspecified	Rexam PLC (USA)	July 2001 October 2000	US 16CFR 1700 full protocol (certified May 2001) US 16CFR 1700 for Senior Adult Use Effectiveness (certified Jun 2000)
SAF-CAP I Dropper Closure	24 mm	For use with HDPE bottles	Cormack Packaging 20-26 Harley Crescent CONDELL PARK  NSW 2200 [phone]	Van Blarcom Cosures Inc. (USA)	July 1992	US 16CFR 1700 (certified Aug 91) plus US 16CFR 1700 for Senior Adult Use Effectiveness (certified Sep 97)
SAF-CAP III	24, 28, 33, 38 & 45 mm	For use with glass or plastic bottles with standard continuous thread	Unspecified	Van Blarcom Closures (USA)	July 1997	US 16CFR 1700 (certified Jan 96) plus Senior Adult Use Effectiveness (certified Feb 96)
SAFE VISTOP	28 mm with T/E feature and Clic-Loc Technology	Glass bottles with standard neck finish PP28S (28 mm o/d thread diameter with Pilfer Proof ring)	Vidchem Pty Ltd 1a/307 Wattletree Road MALVERN  VIC 3144 [phone]	Astra Plastique (France)	May 2000	ISO 8317:1989 (certified Aug 99)
SECRO	·    Secro 92 (18 mm) dropper closure with T/E feature ·    Secro PP24 (24 mm) with T/E feature ·    Secro PP28 (28 mm) with T/E feature	For use with glass or plastic [PET, polypropylene (PP), HDPE] containers with Secro 92, Secro PP24 or Secro PP28 neck finishes	Cormack Packaging Pty Ltd 20-26 Harley Crescent CONDELL PARK  NSW 2200 [phone]	Stella Kunststofftechnik  GmbH (Germany)	December 2000	ISO 8317:1989 (certified Mar 94 / Aug 95)
SUNBEAM FG	28 mm	HDPE containers	Alto Plastics Ltd 19 Keeling Road PO Box 21308 Henderson, Auckland New Zealand [phone]	Alto Plastics Ltd (New Zealand)	July 1984	US 16CFR 1700
TAMPERDISC	24, 28, 33 & 38 mm with T/E feature	Glass or plastic (PET, PP, HDPE) bottles utilising British Standards Institute (BSI) standard thread	Williamson Plastics Pty Ltd 99 Rookwood Road YAGOONA NSW 2199 [phone]	Williamson Manufacturing Pty Ltd	August 1996	Approval based on equivalence to Willsafe closure.
WILLIAMSON 2000 SERIES	·    20, 24 & 28 mm ·    20 and 24 mm dropper closure	Glass or plastic (PET, PP, HDPE) bottles utilising BSI standard thread	Williamson Plastics Pty Ltd 99 Rookwood Road YAGOONA NSW 2199 [phone]	Williamson Manufacturing Pty Ltd	February 2001	AS 1928 – 1982 (certified Dec 2000)
WILLSAFE	24, 33 & 38 mm 28 mm 20 mm	Glass or plastic (PET, PP, HDPE) bottles utilising BSI standard thread	Williamson Plastics Pty Ltd 99 Rookwood Road YAGOONA NSW 2199 [phone]	Williamson Manufacturing Pty Ltd	February 1988 April 1989 November 1993	AS 1928 – 1982 (certified Mar 89)

[1] Tamper-evident