DRUG CONTROL AND REGULATION

INTRODUCTION
In all parts of the world, governments have recognised the need to intervene in the supply of drugs.
These notes confine themselves to the controls relating to the legal use of drugs as opposed to the
use and abuse of so-called recreational drugs. Also excluded from discussion is the
Pharmaceutical Benefits Scheme by which residents of Australia can obtain most prescribed
medicines under a government subsidy.
The purpose of the notes is to give you an overview of the main laws that operate in Australia that
relate to the control of drugs. Legislation of this kind is always and everywhere very complicated
and is frequently amended. It is important to remember that these laws are in the public interest
and not to protect the sectional interests of a particular profession or industry.
In Australia, a study of the subject is made difficult because of the operation of both State and
Commonwealth laws and certain Constitutional complications.
The theme is summed up in three words - Quality, Safety and Efficacy.
QUALITY
History
There is a long history of the authorities regulating drugs going back to classical times. From the
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11 century onwards, in Europe, false weights, false measures and deceptive practices such as
adulteration were so common that buyers would not trust the word of sellers, reflecting the low
standard of commercial morality prevalent in those days. It was not until the Middle Ages that the
real history of adulteration and the methods used to cope with the problem began.
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During the 19 century, as newer analytical methods were being developed, more specific tests
could be applied to determine the purity of drugs. The Adulteration of Food Act of 1860 was
extended to drugs in 1868 and this was the forerunner of similar laws throughout the British
Empire. From then until recent times, laws controlling the purity of foods and drugs have been
combined in the one piece of legislation.
The British Pharmacopoeia
In an effort to provide standards, books known as pharmacopoeias gradually emerged. In 1618, the
College of Physicians published the first London Pharmacopoeia. This was followed by the
Edinburgh Pharmacopoeia and two centuries later, the Dublin Pharmacopoeia. The three were
combined to produce the British Pharmacopoeia (BP) in 1864.
Under Australian law, the basic standard for drugs is the BP but the monographs can be modified
by Ministerial Order for Australian use. This power is used rarely. In addition, the European
Pharmacopoeia and the United States Pharmacopeia are also acceptable. Pharmacopoeias are
books of standards of purity. As well as standards for substances, there are also general standards
in the pharmacopoeia for medicines in their final forms such as injections, tablets and ointments.
Code of Good Manufacturing Practice
To manufacture therapeutic goods for supply in Australia or for export, you must have a licence. A
licence will be granted provided that the manufacturer complies with the Code of Good
Manufacturing Practice for Therapeutic Goods. The Code does not tell companies how to
manufacture but does set out the general conditions under which the goods are manufactured. The

aim is to be build quality into the product rather than adopting an after the fact approach. Staff
must be suitably qualified and trained, laboratories and preparation areas properly equipped and
documentation accurately maintained.
SAFETY
History
The control of poisons, in the sense of restricting supply, also goes back a long way. The
possession of aconite was a capital crime in Greece and the specific crime of poisoning was
introduced in Rome in 82 BC - the punishment being exile and confiscation of property or exposure
to wild beasts.
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In 8 century Egypt, laws were passed prohibiting the use of cannabis. The punishment was novel
- tooth extraction!
Shakespeare, in Romeo and Juliet identifies the illegal supply of poisons and its punishment when
the old apothecary says to Romeo, who wants to buy poison, "Such mortal drugs I have; but
Mantua's law is death to any he that utters them".
In the mid 1800s, arsenic was used as a means of despatching unwanted relatives. Its detection by
chemical means was not known and its misuse gave rise in Great Britain, in 1851 to the Arsenic
Act to regulate its sale. Unwanted babies were poisoned and the insurance money collected.
In the late 1700s, soothing syrup for children called Godfrey's Cordial became available. It
contained a number of substances that were known to dispel wind. These are collectively known as
carminatives; examples are caraway, aniseed and coriander. But Godfrey's Cordial also contained
opium. Before then, the poor would give their crying babies gin to settle them but as Godfrey's
Cordial achieved popularity, it was used for the same purpose and this continued for many years. It
was reported in 1855 that in some parts of London, opium tincture - an alcoholic extract of opium was used also for intentionally destroying children. Some shops sold 15 gallons (70 litres) per
week.
In Victoria, a physician and member of the Legislative Council, Daniel Tierney introduced a private
members bill in 1857 to restrict the sale of poisons because of these abuses. The chemists and
druggists of the day opposed the bill. They formed the Pharmaceutical Society of Victoria to oppose
it because they had not been consulted. The bill was withdrawn. There were no restrictions on the
supply of any drug or poison in Victoria until 1877 by which time the Pharmaceutical Society had
changed its view and supported the Sale and Use of Poisons Act 1876. This Act was the
forerunner of all drug control laws throughout Australia, although South Australia had introduced a
very simple act in 1862. The preamble to the 1876 Act stated:
Whereas the unrestricted sale of poisons often leads to fatal accidents and
the commission of crime: And whereas large quantities of arsenic, strychnine,
and other poisons are used in the colony for pastoral, agricultural, and other
purposes, and fatal accidents occur by reason of careless custody and use of
such poisons by the owners thereof or persons in their employ: And whereas it
is expedient for the safety of the public to regulate the sale of poisons and to
make provision for the exercise of proper precautions in the use of the same;
Be it therefore enacted etc...
By the standards of today, the 1876 Act imposed minimal controls. It required the purchaser of a
poison that was named in the Act to be over 18 years of age and to sign a book setting out the
particulars of the purchase including the reason. Sellers had to be registered pharmacists or other
persons who held a licence that was issued by the newly formed Pharmacy Board of Victoria.
Opium, cyanide, strychnine and arsenic are examples of the substances that were controlled. The
1876 Act was amended and re-enacted many times. Its title was simplified to the Poisons Act but in
1981, the name was again changed to the Drugs, Poisons and Controlled Substances Act 1981

(DPCS Act) which currently operates. It has been amended nearly every year and is a patchwork
quilt of alterations. It is an Act of the Parliament of Victoria and similar pieces of legislation operate
in other States but with other titles.
What does the DPCS Act do?
Unlike the 1876 Act which had a preamble, the present one does not but the philosophy of the old
Act has not changed although much more emphasis is now placed on drugs. It places various
degrees of restriction on the availability of poisons and controlled substances in recognition of the
fact that dangerous substances do have legitimate medical, agricultural, academic and industrial
uses.
First of all, the Act identifies several classes of professional persons - medical practitioners,
pharmacists, dentists, veterinary practitioners and to a lesser extent, optometrists and nurse
practitioners who have a general authorisation to purchase, possess and supply drugs and poisons
for the lawful practice of their respective professions. As well, the authority so conferred is subject
to the Act and to the regulations made under the Act. For example, it is illegal for a dentist to
prescribe for other than the dental treatment of a patient under his care.
In Victoria, manufacturers and wholesalers must be licensed by the Department of Health & Human
Services. The premises must be suitable, sanitary and adequately equipped for the purpose and
the business must be genuine and not simply a paper operation or tax saving scheme. The
premises are inspected and licences are issued annually for which a fee is payable. Conditions
may be inserted into the licence. This licence is in addition to the licence issued under the
Therapeutic Goods Act 1989 (see below) and although there is some overlap, the poisons licence
places emphasis on security and the maintenance of records of supply whereas the other is more
to do with actual manufacturing practice. The DPCS Act also places restrictions on licensees in
terms of whom they can supply various categories of poisons. For example, a wholesaler is only
allowed to supply prescription drugs to the various authorised persons mentioned above or to
suitably licensed organisations such as hospitals and universities or to other licensees.
Drugs of dependence
A major portion of the DPCS Act relates to creating offences for the unlicensed or unauthorised
manufacture, supply or possession of certain drugs. The Victoria Police rather than the Department
of Health & Human Services administers this part of the Act.
The poisons classification system
For historical reasons, the poisons classification system (known as scheduling) that operates in
Australia embraces medicines for human and animal use, agricultural, laboratory and industrial
chemicals and household substances. The schedules are lists of substances that are subject to
varying degrees of control; a particular schedule determines labelling and packaging and any
limitations on distribution. In many other countries, e.g. the United Kingdom, New Zealand,
Canada and South Africa, there are also graded systems of controls but these are contained in
individual Acts dedicated to the end use of the substance. Thus, the Medicines Act 1968 (UK)
combines a scheduling system together with controls over quality and efficacy.
For pharmaceuticals, there are basically three categories of distribution; namely, prescription only
(Schedules 4 and 8), pharmacy only (Schedules 2 and 3) and unrestricted sale (unscheduled). All
of the countries mentioned above have a more or less similar regime except the USA which omits
the second of these. The rigidity of the American system has prevented the transfer of a number
of drugs from prescription to non-prescription status because supply through an unregulated retail
market without immediate accessibility to, and supervision by, a pharmacist. The Australian
system accommodates such transfers and was designed so to do. Drugs in Schedules 2 and 3
are biologically and legally poisons and this fundamental fact is sometimes overlooked.
Poisons scheduling is a means of balancing risk and benefit to the public. This balance ought not

be subject to untutored, dislocative or precipitate action which could increase the problem of
iatrogenic illness to an unacceptable level. In other words, it is in the public interest to restrict the
sale of medicines only to those who need them and that reduction of consumption to the minimum
is the intention of the controls.
Schedule 1.

[This Schedule is intentionally blank.]

Schedule 2.

Pharmacy Medicine Substances, the safe use of which may require advice from a
pharmacist and which should be available from a pharmacy or, where a pharmacy
service is not available, from a licensed person. [e.g. many cough medicines; some
analgesics.]

Schedule 3.

Pharmacist Only Medicine Substances, the safe use of which requires professional
advice but which should be available to the public from a pharmacist without a
prescription. [e.g. some aerosols for prevention and relief of asthma; analgesics that
contain codeine; emergency hormonal contraception.]

Schedule 4.

Prescription Only Medicine, or Prescription Animal Remedy Substances, the use

of which should be by or on the order of persons permitted by State or Territory
legislation to prescribe and should be available from a pharmacist on prescription. [e.g.
antibiotics; antidepressants; cardiovascular drugs; oral contraceptives; tranquillisers.]

Schedule 5.

Caution Substances with a low potential for causing harm, the extent of which can be
reduced through the use of appropriate packaging with simple warnings and safety
directions on the label. [e.g. garden sprays; weed killers; dilute acids.]

Schedule 6.

Poison Substances with a moderate potential for causing harm, the extent of which
can be reduced through the use of distinctive packaging with strong warnings and safety
directions on the label. [e.g. strong acids; strong alkalis; stronger pesticides.]

Schedule 7.

Dangerous Poison Substances with a high potential for causing harm at low
exposure and which require special precautions during manufacture, handling or use.
These poisons should be available only to specialised or authorised users who have the
skills necessary to handle them safely. Special regulations restricting their availability,
possession, storage or use may apply. [e.g. strychnine; arsenicals; highly toxic
pesticides.]

Schedule 8.

Controlled Drug Substances which should be available for use but require restriction
of manufacture, supply, distribution, possession and use to reduce abuse, misuse and
physical or psychological dependence. [e.g. morphine; pethidine; methadone;
amphetamines.]

Schedule 9.

Prohibited Substance Substances which may be abused or misused, the

manufacture, possession, sale or use of which should be prohibited by law except when
required for medical or scientific research, or for analytical, teaching or training purposes
with approval of Commonwealth and/or State or Territory Health Authorities. [e.g. heroin;
cannabis; hallucinogenic drugs.]

EFFICACY
Efficacy is a word that refers to the ability of the medicine to do what the manufacturer says it will
do in terms of the label and in any advertising.
Of the three criteria - safety, quality and efficacy - it is efficacy that generates the most
controversy. It is quite possible for a medicine to be safe and for it to be made under hygienic
conditions with good quality materials but be therapeutically useless; in other words, an elegant
placebo or perhaps a fraud. When we buy a medicine, we take it for the benefits that it will confer
on us by curing the condition, preventing it or alleviating the symptoms.
The regulatory system that operates in Australia, while good on quality and safety for all
medicines, is mixed when it comes to efficacy. For all prescription medicines and many that are
available without a prescription, all three criteria are met. For many medicines, however, there is

neither an evaluation of efficacy nor of data to support the stability of the product. There are
therefore, two standards operating in this country.
Australian Register of Therapeutic Goods
Under the Therapeutic Goods Act 1989, there is a general requirement that therapeutic goods
intended for supply in Australia must be in included in a computerised register called the
Australian Register of Therapeutic Goods (ARTG). The Register is divided into two parts; one
part is for Registered Goods and the other for Listed Goods. It is an offence to supply goods that
are not entered in the Register, unless the goods are exempted, examples of which are clinical
trial materials and medicines made up for individual and specific persons.
The Therapeutic Goods Act 1989 is an Act of the Commonwealth and is administered by the
Therapeutic Goods Administration (TGA) a part of the Commonwealth Department of Health.
Listed Goods
Certain therapeutic goods are eligible for inclusion in the Part reserved for Listed Goods. Goods
can only be entered in this Part if their active ingredients are published in the Therapeutic Goods
Regulations 1990. The range is extensive but it includes most vitamins and minerals, most amino
acids, most herbal substances, sunscreens and an increasing number of miscellaneous
substances which are considered safe. Examples of the latter are chlorophyll, fish oils, royal jelly,
and shark cartilage. Listed Goods are regarded as being of low risk. If a substance is included in a
poisons schedule (see above), it cannot be listed and defaults to registration.
Manufacturers of Listed Goods must be licensed by the TGA and must comply with the Code of
Good Manufacturing Practice. The products must also be labelled in accordance with usual
labelling requirements.
To obtain listing of the goods, the formulation details and the wording of the label is sent
electronically to the TGA, checked by the computer and if there is nothing incorrect, the Listing
number will be allocated. An application fee is payable.
Because Listed Goods are not evaluated for efficacy, sponsors are free to make whatever claims
they like provided the claims are not specifically prohibited in a document called the Therapeutic
Goods Advertising Code. In this Code, representations about certain diseases are prohibited;
these are usually the more serious medical and physiological conditions such as cancer, epilepsy
and some psychiatric illnesses. Firms that put the product on the market are expected to have
data on file to support their claims but often, the data are poor and irrelevant. It therefore follows
that claims on the labels of, and in advertisements for, Listed Goods may be correct but they can
also be unsubstantiated, theoretical, based on in vitro or animal studies, wishful thinking or plain
nonsense.
Listed Goods are recognised by the symbol AUST L followed by the number on the label.
Registered Goods
If a medicine is not eligible for Listing, it must be included in the part of the Register for Registered
Goods. This is the default category. Unlike Listed Goods, Registered Goods are evaluated
rigorously for quality, safety and efficacy by staff of the TGA. After that, the application, supporting
data and the evaluation report are considered by one of several independent expert committees.
Like Listed Goods, Registered Goods must be manufactured under the Code of GMP in licensed
premises and comply with the legal requirements for labelling. They are identified by the symbol
AUST R on the label.

ADVERTISING and PROMOTION

The excesses of drug advertising are well known as evidenced by history and the scandalous
public health consequences that have occurred in countries where there is no regulation on drug
advertising or when it is not enforced. There are public health reasons for limiting consumption of
pharmaceuticals and it is hard to see the argument that advertising educates the public without
stimulating consumption.

Some practical exercises and questions to ponder

Visit a pharmacy, a health food store and a supermarket and examine some of the medicines
and leaflets. Do the claims stand up to scientific rigour?
What are some examples of alternative/complementary therapies? Why do you think they have
achieved popularity in recent years?
Examine one or two examples of Prescription Only Medicines, Pharmacist Only Medicines,
Pharmacy Medicines.
Ask your pharmacist for a sample of a Consumer Medicine Information [CMI] leaflet. What do
you think about the content and layout, given community literacy standards?
Why do you think the government does not permit advertisements of Prescription Only
Medicines directly to the public? [The exceptions are the USA and NZ].
Carefully consider the claims made for herbal medicines that are marked AUST L.
In most cases, it is easy to decide whether something for consumption or application is a food or
a medicine, or a cosmetic or a medicine, respectively. In others, the classification is blurred.
What are some examples that could give regulators a problem?
Does cannabis have a legitimate role in medical treatment?
Should medicines that contain codeine be available without a prescription?

References and further reading

Bomford J, Newgreen D. The Pharmacy Board of Victoria: a History 1887-2005. Pharmacy
Board of Victoria, Parkville, 2005.
Davies C. Keeping advertisers honest an overview of the advertising of medicines and
medical devices in Australia. Aust Presc 2004;27:124-7.
Dwyer P, Newgreen DB. Regulation of drugs, 20.11. In: The Laws of Australia, Thomson
Law Book Company, Pyrmont, 2008.
Harvey KJ, Korczak VS, Maron LJ, Newgreen DB. Commercialism, choice and consumer
protection: The regulation of complementary medicines in Australia. Med J Aust 2008; 188:
21-25, 189: 52-53 (ltr)
McEwen J, Thompson BR, Purcell PM, Kelly LF. Widespread hyoscine hydrobromide toxicity
due to contract manufacturer malpractice: the Travacalm episode. Drug Saf 2007;30(5):375378.
McEwen, J. A history of therapeutic goods regulation in Australia. 2007.
Moulds RFW. Drugs and poisons scheduling. Aust Prescr 1997;20:12-13.
Penn RG. The state control of medicines; the first 3000 years. Br J Clin Pharmacol
1979;8:293-305.
Toop L, Mangin D. The impact of advertising prescription medicines directly to consumers in
New Zealand: lessons for Australia. Aust Presc 2006;29:30-32.
Vitry A. Is Australia free from direct-to-customer advertising? Aust Presc 2004;27:4-6.

August 2015