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The Controlled Substances Act and the Controlled Substances Poisons Regulations regulate the prescription, supply, and administration of drugs and poisons in South Australia. The following is a non-exhaustive guide to the major legal obligations only. Reference should be made to the legislation for further information. Pharmacists are expected to be familiar and comply with the below information. The Act provides pharmacists with certain privileges not available to the general public. In exchange for these privileges, it expects pharmacists to be aware of the requirements of the Act, to act lawfully and act responsibly at all times. These privileges may be withdrawn by order of the Minister responsible for the Act if a conviction is obtained or an opinion is formed that the pharmacist has acted irresponsibly in handling prescription drugs Section 57 of the Act. See also: Legal requirements when prescribing or supplying drugs of dependence. Pharmacists may manufacture, produce, pack, sell or supply scheduled poisons where such activity is part of ordinary pharmacy practice. Mass production is considered to be manufacturing and requires a licence. Pharmacists are authorised to sell or supply all classes of drugs and poisons but must be satisfied the supply is lawful. A Pharmacist must personally not through an assistant give oral directions, supplemented where practicable with written directions, for the safe and proper use of a schedule 3 medicine to the person who is being supplied the medicine. These medicines are:. Pharmacists must not sell or supply pseudoephedrine either as Schedule 3 or Schedule 4 unless the person presenting for the supply provides a specified form of photo-identification or his or her birth certificate. Accepted forms of photo-identification include a current:. The records of sale or supply must be made in an electronic form that is accessible via the internet to the Chief Executive of the Department for Health and Wellbeing and the Commissioner of Police. Schedule 7 poisons must not be sold to a person under 18 years of age, a person not known to the pharmacist unless evidence of identity is produced or for domestic or garden use. A record of the sale must be kept including the intended use of the poison and the licence number is applicable. The Controlled Substances Controlled Drugs, Precursors and Plants Regulations permits a pharmacist to supply needles, syringes and advice regarding their safe use to drug users. All poisons must be labelled with the original manufacturers label or labelled with the name trade and approved , form and strength of the medicine, directions for safe use including route of administration, name of patient, date dispensed, reference number linking to the prescription record if dispensed, name and address of pharmacy. Warning labels such as a drowsiness warning label may also be required. Schedule 8 drugs must be stored to prevent unauthorised access, for instance generally in a locked safe or vault. Minimum specifications depend on the number of doses stored. The standard 10mm steel pharmacy safe is sufficient if or less doses, or or less doses if there is 24 hour alarm monitoring. Schedule 8 drugs must be transported in a manner consistent with the Code of Practice for the Storage and Transport of Drugs of Dependence. Using Australia Post to transport Schedule 8 drugs is prohibited, unless the particular distribution program is exempted under the Crimes Act Where it is necessary to transport Schedule 8 drugs, for example to remote locations, this must be arranged through a courier service and comply with relevant provisions of the Code of Practice for the Storage and Transport of Drugs of Dependence. Schedule 8 drugs must maintain a drug of dependence register and record all transactions. Regulation All records must be kept a minimum of two years from date of last entry on the record. For applications to include a new electronic drug register to the approved list — please refer to Application for Electronic Drug Registers. Prescriptions are valid for a period of 12 months from the date of prescribing and 6 months in the case Schedule 8 drugs. A prescriber may, where there is a good reason, give a prescription by telephone, facsimile, or other electronic means. The same information as required for a written prescription must be provided. Unless the prescription was faxed and endorsed with the name of the single pharmacy to dispense the prescription, the prescriber must forward a written prescription as confirmation as soon as practical or if a drug of dependence, within 24 hours. These drugs of dependence may be used in opioid pharmacotherapy Medication Assisted Treatment for Opioid Dependence Program with supervised administration of doses and, when appropriate, limited take-away doses. All requirements covering drugs of dependence, including prescription records, labelling of dispensed doses for patient self-administration, storage, drug register and monthly prescription returns apply as for other drugs of dependence. A drug of dependence may be supplied on receipt of an order where the pharmacist is satisfied the person ordering is lawfully authorised to possess the drug, this includes patients, medical practitioners, dentists, veterinary surgeons and licence holders. If the person is not known to the pharmacist he or she must provide satisfactory identification before the drug is supplied, and provide the pharmacist with a signed and dated receipt for the drug. Schedule 8 drugs pharmacists must maintain a drug of dependence register and record all drug transactions. All records must be retained, protected and available for inspection for a period of two years from date of last entry on the record regulation Cancelled orders unless supplying to a health service must be forwarded to Drugs of Dependence Unit each month with the prescription returns. A drug of dependence must not be supplied without prior receipt of a lawful order or prescription written, verbal, fax or by other permitted electronic transmission. A Schedule 4 drug may be supplied to a person by a pharmacist without an order or prescription provided. Destruction and disposal must be witnessed by another appropriate person ie. A record including the full names and signatures of the person and the witness to the destruction, name, strength and amount of drug; and the date and time of destruction must be made immediately after the drug is destroyed. Drugs must be rendered unusable damage that is so severe that the drug is unrecoverable , disposed of in an environmentally responsible way and so there is no risk to the public of them being reused or diverted. Destruction and disposal of drugs of dependence must not pose a risk to public health or safety Regulation It is an offence for a person to obtain or attempt to obtain a prescription drug by fraud or have in his or her possession or utter a forged document to obtain a prescription drug. Section Pharmacists should take all reasonable actions to ensure they are treating a genuine medical condition and treatment does not contribute to the induction of drug dependence, maintenance of drug dependence without a proper treatment plan or add to the pool of drugs available for illicit drug trafficking. Supply without due diligence may be considered to be 'irresponsible' and result in the serving of an Order which effectively removes privileges granted to a pharmacist to handle prescription drugs. Pharmacists may contact the Drugs of Dependence Unit if suspicious of a person seeking prescription drugs. Unit officers, acting for the Minister for Mental Health and Substance Abuse, are empowered to provide information regarding medical history to a Medical Practitioner where an opinion is formed the person is drug dependent and acting illegally. The Minister also publishes a ' Privileged Circular ' periodically listing those major drug seekers at the time with the aim to restrict or stop further supplies of drugs to those persons. For more information, see the Forged prescription notifications page. Clomiphene, cyclofenil, follitropin-alpha, follitropin-beta, luteinisinghormone, or urofollitrophinmay only be supplied if prescribed or ordered by a specialist in endocrinology, obstetrics and gynaecology or a medical practitioner providing services to a fertility unit, an endocrinology unit, or an obstetric and gynaecological unit in a teaching hospital. Acitretin, bexarotene and etretinate for human use and isotretinoin for human internal use and may only be supplied if prescribed or ordered by a specialist in dermatology, oncology or haematology or a medical registrar working under such a specialist , or such other specialist individually authorised by the Minister. Tretinoin for human internal use may only be supplied if prescribed or ordered by a specialist in oncology or haematology or a medical registrar working under such a specialist or such other specialist individually authorised by the Minister. Thalidomide or lenalidomide for human use may only be supplied if prescribed or ordered by a specialist in oncology or haematology or a medical registrar working under such a specialist , or a medical practitioner individually authorised by the Minister. Ambrisentan, bosentan, and sitaxentan may only be prescribed or ordered by a relevant specialist or a medical registrar working under such a specialist or a medical practitioner individually authorised by the Minister. Authority to prescribe will not be granted by the South Australian Minister for Mental Health and Substance Abuse unless the applying prescriber can demonstrate he or she is in possession of a Commonwealth authority. Convictions against the Act, or where the Minister forms an opinion a prescription drug Schedule 4 or Schedule 8 has been prescribed, supplied, or administered in an 'irresponsible manner', may result in a Prohibition Order that effectively removes the ability of a pharmacist to handle these drugs. Other courses of action may include prosecution and or reporting the alleged conduct to the Australian Health Practitioner Regulation Agency. Pharmacists are encouraged to telephone the Drugs of Dependence Unit to discuss cases where guidance or advice is required. An overview of the legal controls over medicines in force in South Australia and how this relates to different health practitioners. Overview of the types of substances that are regulated under the South Australian Controlled Substances legislation. Medicines, poisons and pest control licences are issued by the Controlled Substances Licensing Section of the Department for Health and Ageing. Use of the information and data contained within this site or these pages is at your sole risk. If you rely on the information on this site you are responsible for ensuring by independent verification its accuracy, currency or completeness. This site includes links to other websites operated by community, business and government. These linked websites will have their own terms and conditions of use and you should familiarise yourself with these. All linked websites are linked 'as is' and the Government of South Australia: does not sponsor, endorse or necessarily approve of any material on websites linked from or to this Site; does not make any warranties or representations regarding the quality, accuracy, merchantability or fitness for purpose of any material on websites linked from or to this Site; does not make any warranties or representations that material on other websites to which this site is linked does not infringe the intellectual property rights of any person anywhere in the world; and does not authorise the infringement of any intellectual property rights contained in material in other websites by linking this site to those other websites. If you use automatic language translation services in connection with this site you do so at your own risk. The information and data on this site is subject to change without notice. The Government of South Australia may revise this disclaimer at any time by updating this posting. Users are advised to confirm the application or payment by other means. Do you have an emergency? Home Clinical resources Clinical Programs and Practice Guidelines Medicines and drugs Legal control over medicines Legal requirements for the prescription and supply of drugs of dependence Pharmacist legal obligations when handling, dispensing and supplying drugs of dependence Back to Legal requirements for the prescription and supply of drugs of dependence. Close overlay Button to close overlay. Pharmacist legal obligations when handling, dispensing and supplying drugs of dependence On this page The Controlled Substances Act and the Controlled Substances Poisons Regulations regulate the prescription, supply, and administration of drugs and poisons in South Australia. Prescription drug controls Possession, prescribing, supply and administration of Schedule 4 and Schedule 8 drugs are prohibited. Section 18, 31 and 32 Pharmacists and other health workers are exempted only while acting in the ordinary course of their profession or in accordance with the Regulations. Patients are exempted where the drug has been lawfully prescribed or supplied. Manufacture of drugs Section 13,14,15,18, and 31 Pharmacists may manufacture, produce, pack, sell or supply scheduled poisons where such activity is part of ordinary pharmacy practice. Drugs must be purchased in the name of the authorised person and he or she takes responsibility for them. If purchasing as a licensed person, the licence should be viewed before the sale. If drugs are to be purchased in the name of the practice, the practice must obtain a license to possess such drugs. The cancelled Order for a drug of dependence must be forwarded to the Drugs of Dependence Unit by the 7 th day of the following month. Sale or supply of drugs Section 14,15,18, and 31 Pharmacists are authorised to sell or supply all classes of drugs and poisons but must be satisfied the supply is lawful. Sale or supply of Schedule 3 medicines pharmacist only Regulation 13 A Pharmacist must personally not through an assistant give oral directions, supplemented where practicable with written directions, for the safe and proper use of a schedule 3 medicine to the person who is being supplied the medicine. These medicines are: Dihydrocodeine in cough preparations Doxylamine in preparations also containing codeine Promethazine in preparations also containing codeine Pseudoephedrine. Sale or supply of pseudoephedrine Regulation 14 Pharmacists must not sell or supply pseudoephedrine either as Schedule 3 or Schedule 4 unless the person presenting for the supply provides a specified form of photo-identification or his or her birth certificate. Sale or supply of Schedule 7 poisons Section 16 Regulation 12 and 21 Schedule 7 poisons must not be sold to a person under 18 years of age, a person not known to the pharmacist unless evidence of identity is produced or for domestic or garden use. Supply of needles and syringes Regulation 8A The Controlled Substances Controlled Drugs, Precursors and Plants Regulations permits a pharmacist to supply needles, syringes and advice regarding their safe use to drug users. Labelling of drugs Section 24 Regulation 26 All poisons must be labelled with the original manufacturers label or labelled with the name trade and approved , form and strength of the medicine, directions for safe use including route of administration, name of patient, date dispensed, reference number linking to the prescription record if dispensed, name and address of pharmacy. No poison can be stored: in a container that is normally used for food or beverages or is similar to a container that is normally used for food or beverages, if Schedule 3, where the public has access, or if Schedule 2, 5 or 6, where public has access unless it is a Schedule 6 hair colouring preparation, or it is above 1. Larger quantities, or where there is less monitoring, require greater security. For further information refer to the Code of Practice for the Storage and Transport of Drugs of Dependence Transportation of drugs Section 25 Regulation 28 and Schedule 8 drugs must be transported in a manner consistent with the Code of Practice for the Storage and Transport of Drugs of Dependence. Record keeping Schedule 8 drugs must maintain a drug of dependence register and record all transactions. Regulation 41 All records must be kept a minimum of two years from date of last entry on the record. Regulation 49 For applications to include a new electronic drug register to the approved list — please refer to Application for Electronic Drug Registers. Sale or supply of drugs to authorised health professionals Section 18 Regulation 35 and 37 Persons authorised to possess or persons licensed to possess such as medical practitioners, nurse practitioners, dentists, veterinarians may purchase S4 and S8 drugs by written and signed order not prescription from a pharmacy. A medical practitioner must not unless an emergency exists prescribe or supply a drug of dependence for self- treatment or for the treatment of his or her spouse or other family member unless authorised by the Minister. If purchasing as a licensed person, the licence should be viewed by the pharmacist before the sale. The cancelled order for a drug of dependence must be forwarded to the Drugs of Dependence Unit by the 7 th day of the following month. Supply of Schedule 4 drugs on receipt of a written order Regulation 21 Pharmacists are permitted to supply Schedule 4 drugs on receipt of a written order to: a council or health service for use in an immunisation program, a health professional authorised to supply or administer the drug such as a medical practitioner, nurse practitioner or dentist, the owner of animals for mass treatment of those animals, where the owner has an order from a veterinary surgeon for the drug or the drug is an antibiotic ordered from an inspector under the Livestock Act SA and the order is countersigned by the Chief Inspector, a Master or Medical Officer of a ship where the drugs are required to be carried by law. For drugs of dependence Regulation 40 A drug of dependence may be supplied on receipt of an order. The pharmacist must not supply unless: satisfied the person ordering is lawfully authorised to possess the drug, this includes medical practitioners, dentists, veterinary surgeons and licence holders if not known to the pharmacist, provides satisfactory identification unless a receipt is provided. Other prescribers Section 18 Regulation 18 Other professions are permitted to administer and thus purchase and possess , prescribe or supply a limited range of Schedule 4 medicines. Podiatrists, dental therapists, dental hygienists, oral health therapists and optometrists are able to administer the Schedule 4 medicines listed in regulation Optometrists and podiatrists whose registration is endorsed with a scheduled medicines endorsement are authorised to prescribe, supply or administer scheduled medicines in accordance with that endorsement. Eligible midwives acting in the ordinary course of their profession whose registration is endorsed with a scheduled medicines endorsement are authorised to prescribe Schedule 4 and Schedule 8 drugs, in accordance with that endorsement Section 18 and 18A. For drugs of dependence Schedule 8 drugs , prescriptions must also include: date of birth of the patient quantity in words and numerals. Dispensing requirements Regulation 35 Only valid prescriptions may be dispensed. The pharmacist must: Dispense from an original or a copy attached to an original repeat authorisation do not dispense from a repeat authorisation as this may contain an error. Endorse the prescription or copy if dispensing from a copy with his or her name, business name and address, date dispensed and a unique prescription number. Enter details of the prescription into a prescription record on the same day as it is dispensed. Cancel the prescription when it is dispensed for the last time. Retain the original unless not cancelled. If for a drug of dependence, forward the original, or a true copy if the original is to be forwarded to Medicare Australia, or in the case of a repeat still to be dispensed to the Drugs of Dependence Unit by the 7 th day of the following month. If no drugs of dependence sales or dispensing occurred, a nil return must be forwarded. Repeats cannot be dispensed earlier than stipulated unless the pharmacist is satisfied the patient will be out of the state, has lost the previous supply and the pharmacist notifies the prescriber. If intervals are not stipulated, dispensing must not occur earlier than needed based on the prescribed dose. Where there is reasonable cause to believe the prescription has been altered, forged or obtained by false pretences, the prescription must not be dispensed and in the case of forgery, forwarded to the Police and a copy to the Drugs of Dependence Unit. A pharmacist must not hand over drugs until the prescription or copy is signed and dated by the person collecting the drugs and if the person is not known, produced satisfactory evidence of his or her identity. Dispensing a medicine supplied under the Medication Charts Program Regulation 35 12 The requirements under regulation 35 in relation to dispensing prescriptions do NOT apply if a pharmacist or medical practitioner dispenses a medicine supplied under the Medication Charts Program on a medication chart prescription, and the supply is in accordance with the National Health Residential Medication Chart Determination. Sale or supply of a schedule 4 drug under the Continued Dispensing Program Regulation 21 A pharmacist may sell or supply a Schedule 4 drug without dispensing a prescription if the drug is a pharmaceutical benefit that may be supplied under the Continued Dispensing Program. The sale or supply of the drug must comply with the National Health Continued Dispensing Determination. Where supply is made under this program, the maximum quantity permitted under the Pharmaceutical Benefits Scheme for that medicine may be supplied. Under the Continued Dispensing Program, the medicine may only be supplied to the person once in a 12 month period. Dispensing from a verbal instruction Regulation 33 A prescriber may, where there is a good reason, give a prescription by telephone, facsimile, or other electronic means. Methadone and buprenorphine dispensing These drugs of dependence may be used in opioid pharmacotherapy Medication Assisted Treatment for Opioid Dependence Program with supervised administration of doses and, when appropriate, limited take-away doses. Recording the supply of drugs of dependence Regulation 40 A drug of dependence may be supplied on receipt of an order where the pharmacist is satisfied the person ordering is lawfully authorised to possess the drug, this includes patients, medical practitioners, dentists, veterinary surgeons and licence holders. The supply must be recorded with the following details and the pharmacist must sign the record: his or her name and business address the name and address of the person to whom the drug was supplied the date on which the drug was supplied the name or ingredients of the drug the amount, and if applicable the strength of the drug if the drug was sold or supplied on order, the invoice number if any for the sale or supply of the drug the total amount of the drug now in stock on the premises Cancelled orders unless supplying to a health service must be forwarded to Drugs of Dependence Unit each month with the prescription returns. Emergency supply Regulation 35 and 40 A drug of dependence must not be supplied without prior receipt of a lawful order or prescription written, verbal, fax or by other permitted electronic transmission A Schedule 4 drug may be supplied to a person by a pharmacist without an order or prescription provided the person is currently under treatment with the drug the continued supply is essential for health reasons there is good reason why the person cannot supply a prescription the drug is not one listed in the table in regulation 19 1 and the supply does not exceed three 3 days or the smallest standard pack if a mixture, cream or ointment. Destruction of drugs of dependence Destruction and disposal must be witnessed by another appropriate person ie. Drug seeking behaviours It is an offence for a person to obtain or attempt to obtain a prescription drug by fraud or have in his or her possession or utter a forged document to obtain a prescription drug. Section 30 Pharmacists should take all reasonable actions to ensure they are treating a genuine medical condition and treatment does not contribute to the induction of drug dependence, maintenance of drug dependence without a proper treatment plan or add to the pool of drugs available for illicit drug trafficking. Section 57 Pharmacists may contact the Drugs of Dependence Unit if suspicious of a person seeking prescription drugs. Section 58 Forged or fraudulently altered prescriptions It is an offence to obtain or attempt to obtain a prescription drug by fraud or false pretences or present or have possession of a forged document for this purpose. Pharmacists must : not dispense a prescription they have reasonable cause to believe has been forged or obtained fraudulently and if forged, retain the prescription and forward it together with the Notification Form for Forged or Fraudulently Altered Prescriptions to the police a copy of the prescription and form is to be forwarded to the Drugs of Dependence Unit also. See the Forged prescription notifications page to download the relevant forms. Pharmacists are a prescribed profession and able to access publications by the Minister to warn of persons known or suspected of consuming medicines in a manner that places their health at risk, obtain drugs unlawfully or for an unlawful purpose for example drug seekers, pseudoephedrine seekers, persons presenting forged prescriptions. Section 58 For more information, see the Forged prescription notifications page. Special provision relating to certain drugs Regulation 19 Schedule 4 drugs Ovulatory stimulants Clomiphene, cyclofenil, follitropin-alpha, follitropin-beta, luteinisinghormone, or urofollitrophinmay only be supplied if prescribed or ordered by a specialist in endocrinology, obstetrics and gynaecology or a medical practitioner providing services to a fertility unit, an endocrinology unit, or an obstetric and gynaecological unit in a teaching hospital. Retinoids Acitretin, bexarotene and etretinate for human use and isotretinoin for human internal use and may only be supplied if prescribed or ordered by a specialist in dermatology, oncology or haematology or a medical registrar working under such a specialist , or such other specialist individually authorised by the Minister. Thalidomide and lenalidomide Thalidomide or lenalidomide for human use may only be supplied if prescribed or ordered by a specialist in oncology or haematology or a medical registrar working under such a specialist , or a medical practitioner individually authorised by the Minister. Endothelin Receptor Antagonists Ambrisentan, bosentan, and sitaxentan may only be prescribed or ordered by a relevant specialist or a medical registrar working under such a specialist or a medical practitioner individually authorised by the Minister. Schedule 8 drugs Dronabinol deltatetrahydrocannabinol Prescribers must be authorised by the Secretary of the Commonwealth Department of Health and Ageing to prescribe or order dronabinol contact the TGA. Administrative and other powers of the Drugs of Dependence Unit Convictions against the Act, or where the Minister forms an opinion a prescription drug Schedule 4 or Schedule 8 has been prescribed, supplied, or administered in an 'irresponsible manner', may result in a Prohibition Order that effectively removes the ability of a pharmacist to handle these drugs. Related information You can search through to find related information. Services Documents Links. Legal control over medicines An overview of the legal controls over medicines in force in South Australia and how this relates to different health practitioners. Controlled substances legislation Overview of the types of substances that are regulated under the South Australian Controlled Substances legislation. Controlled substances governance and licensing Medicines, poisons and pest control licences are issued by the Controlled Substances Licensing Section of the Department for Health and Ageing.
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