S.I. No. 69/1993 - Medical Preparations (Prescription and Control of Supply) Regulations, 1993.


S.I. No. 69 of 1993.

MEDICAL PREPARATIONS (PRESCRIPTION AND CONTROL OF SUPPLY) REGULATIONS, 1993.

ARRANGEMENT OF ARTICLES

Article

1. Citation.

2. Commencement.

3. Revocations.

4. Interpretation.

5. Medical preparations on prescription only.

6. Restrictions on medical preparation exempted from prescription control.

7. Restrictions on dispensing of prescriptions

8. Exemptions for emergency supply.

9. Labelling of dispensed medical preparations.

10. Pharmacy records.

11. Keeping of records in the case of certain medical preparations.

12. Prohibition of supply after expiry date.

13. Exemptions for supply in certain circumstances.

14. Enforcement.

15. Evidence of result of test, examination or analysis.

16. Transitional provisions.

FIRST SCHEDULE

Substances which when contained in medical preparations are subjected to prescription control and the circumstances excluding certain preparations from such control.

SECOND SCHEDULE

Substances which, when contained in certain non prescription medical preparations may be supplied in non pharmacy outlets.

THIRD SCHEDULE

Substances which, when contained in certain medical preparations, may be dispensed in the manner prescribed for a preparation which is or which contains a substance specified in Part B of the First Schedule.

FOURTH SCHEDULE

Substances not to be contained in a medical preparation supplied under the exemption conferred by Article 8 (2).

FIFTH SCHEDULE

Cautionary and warning notices for dispensed medical preparations.

SIXTH SCHEDULE

Certificate stating results of test, examination or analysis.

S.I. No. 69 of 1993.

MEDICAL PREPARATIONS (PRESCRIPTION AND CONTROL OF SUPPLY) REGULATIONS, 1993.

The Minister for Health in exercise of the powers conferred on him by sections 5 and 65 of the Health Act, 1947 (No. 28 of 1947) as amended by section 39 of the Health Act, 1953 (No. 26 of 1953) section 36 of the Misuse of Drugs Act, 1977 (No. 12 of 1977) and by section 7 of the Health (Family Planning) (Amendment) Act, 1992 (No. 20 of 1992) hereby makes the following Regulations:—

1 Citation.

1. These Regulations may be cited as the Medical Preparations (Prescription and Control of Supply) Regulations, 1993.

2 Commencement.

2. These Regulations shall come into operation on the 22nd day of March, 1993.

3 Revocations.

3. The Medical Preparations (Control of Sale) Regulations, 1987 ( S.I. No. 18 of 1987 ), are hereby revoked.

4 Interpretation.

4. (1) In these Regulations:—

"the Act" means the Health Act, 1947 ;

"aerosol" means a product which is dispersed from its container by a propellant gas or liquid;

"authorised person" has the meaning assigned to it by of section 2 of the Pharmacy Act, 1962 (No. 14 of 1962) as amended by section 34 of the Misuse of Drugs Act, 1977 and by article 4 of the European Communities (Recognition of Qualifications in Pharmacy) Regulations, 1991 ( S.I. No. 330 of 1991 );

"controlled drug" has the meaning assigned to it by Section 2 of the Misuse of Drugs Act, 1977 ;

"dosage unit" means—

( a ) where a medical preparation is in the form of a tablet or capsule or is an article in some other similar pharmaceutical form, that tablet, capsule or other article, or

( b ) where a medical preparation is not in any such form, that quantity of the preparation which is used as the unit by reference to which the dose is measured;

"external use" means application to the skin, hair, teeth, mucusa of the mouth, throat, nose, ear, eye, vagina or anal canal when a local action only is intended and extensive systematic absorption is unlikely to occur and references to medical preparations for external use shall be read accordingly except that such references shall not include transdermal delivery systems, throat sprays, throat pastilles, throat lozenges, throat tablets, nasal drops, nasal sprays, nasal inhalations or teething preparations;

"health prescription" means a prescription issued in connection with arrangements made under section 59 of the Health Act, 1970 (No. 1 of 1970), on a form supplied by or on behalf of a health board;

"hospital" includes a clinic, nursing home or similar institution;

"inhaler" does not include an aerosol;

"maximum daily dose" or "MDD" means the maximum quantity of a substance contained in the amount of a medical preparation for internal use which it is recommended should be taken or administered in any period of 24 hours;

"maximum dose" or "MD" means the maximum quantity of a substance contained in the amount of a medical preparation for internal use which it is recommended should be taken or administered at any one time;

"maximum pack size" or "MPS" means the maximum quantity of a medical preparation by weight, volume or number of dosage units contained in the pack presentation for supply;

"maximum strength" or "MS" means such of the following as may be specified—

( a ) the maximum quantity of a substance by mass or volume contained in a dosage unit of a medical preparation, and

( b ) the maximum percentage of a substance contained in a medical preparation calculated in terms of mass in mass (m/m), mass in volume (m/v), volume in mass (v/m) or volume in volume (v/v), as appropriate;

"the Minister" means the Minister for Health;

"new chemical molecule" means a substance, not being a substance specified in any of the Schedules to these Regulations, which was not contained in a medical preparation, as one of its active ingredients, which was lawfully on the market in the State on, or immediately before, the 19th day of January 1987;

"parental administration" means administration by breach of the skin or mucous membrane;

"prescription", except in the expression "medical prescriptions", means a prescription issued by a registered medical practitioner or a registered dentist;

"registered dentist" means a person registered in the register established under the Dentists Act, 1985 (No. 9 of 1985) and includes any person entitled to be so registered by virtue of section 27 (2) (c) of the said Act;

"registered medical practitioner" means a person registered in the register established under the Medical Practitioners Act, 1978 (No. 4 of 1978) and includes any person entitled to be so registered by virtue of section 27 (2) (c) of the said Act;

"repeatable prescription" means a prescription which may be dispensed more than once;

"supply" includes sell, distribute or offer or keep for sale or distribution notwithstanding that the person supplied may be in another Member State of the European Community and cognate words shall be construed accordingly;

"supply by way of wholesale dealing" means the supply of a medical preparation to a person who obtains the preparation for one or more of the following purposes—

( a ) supply in the course of a pharmaceutical business,or

( b ) administration in the course of a professional practice, or

( c ) for or in connection with a service provided by a hospital;

"sampling officer" means a person authorised by a health board to take samples for the purposes of the Sale of Food and Drugs Acts, 1875 to 1936 or in connection with any arrangements made for testing the quality or amount of the drugs, medicines and appliances supplied for the purpose of section 59 of the Health Act, 1970 ;

(2) In these Regulations, unless the context otherwise indicates, any reference to an article or Schedule shall be construed as a reference to an article contained in these Regulations or, as the case may be, to a Schedule thereto; any reference in an article to a sub-article shall be construed as a reference to a sub-article of that article, and any reference in a sub-article to a paragraph shall be construed as a reference to a paragraph of that sub-article.

5 Medical preparations on prescription only.

5. (1) Subject to the provisions of these Regulations a person shall not supply a medical preparation of any of the following classes except in accordance with a prescription, namely—

( a ) any medical preparation which is or which contains a substance specified in column 1 of the First Schedule;

( b ) any medical preparation which is intended for parental administration;

( c ) any medical preparation which is or which contains a new chemical molecule.

(2) Sub-article (1) (a) shall not apply as respects a medical preparation where there is an entry in relation to a substance in the medical preparation in one or more of columns 3, 4 and 5 of the First Schedule; and

( a ) where the maximum strength of the substance does not exceed that, if any, specified in column 3 of the said Schedule opposite the mention of that substance in column 1 thereof: and

( b ) where a maximum pack size of the medical preparation does not exceed that, if any, specified in column 3 of the said Schedule opposite the mention in column 1 thereof of a substance contained in the said preparation; and

( c ) where a pharmaceutical form is specified in column 4 of the said Schedule opposite the mention of the substance, contained in a medical preparation, in column 1 thereof, the medical preparation is supplied in such form and

( d )where a manner of administration is specified in column 4 of the said Schedule opposite the mention of the substance, contained in a medical preparation, in column 1 thereof, the medical preparation is supplied only for such manner of administration; and

( e ) where the container or package of a medical preparation is labelled to show a use specified in column 4 of the said Schedule opposite the mention of a substance, contained in such medical preparation, in column 1 thereof, the medical preparation is supplied in such a container or package so labelled and which does not show any use not so specified; and

( f ) where the preparation is one for which a maximum dose is specified in column 5 of the said Schedule opposite the mention of a substance, contained in a medical preparation, in column 1 thereof, it is in a container or package labelled to show a maximum daily dose not exceeding that so specified; and

( g ) where the preparation is one for which a maximum daily dose is specified in column 5 of the said Schedule opposite the mention of a substance, contained in a medical preparation, in column 1 thereof, it is in a container or package labelled to show a maximum daily dose not exceeding that so specified.

(3) Sub-article (1) shall not apply as respects a medical preparation which is intended exclusively for veterinary use and is supplied in a container or package which is labelled with the words "For Animal Treatment Only".

(4) Sub-article (1) (b) shall not apply as respects a medical preparation which contains insulin.

(5) Sub-article (1) (c) shall cease to apply in respect of a new chemical molecule after the period of three years beginning with the date on which the relevant product authorisation was granted in pursuance of the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 ( S.I. No. 210 of 1984 ).

(6) Sub-article (2) shall not apply in the case of a medical preparation containing a substance specified in Part 1 of the Second Schedule unless the preparation—

( a ) is the subject of a product authorisation granted in pursuance of the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984,

( b ) is supplied in the original container and outer package (if any) supplied by the manufacturer or person responsible for placing the product on the market, and

( c ) is labelled to show that the said preparation is of a classification which may be supplied without a prescription

(7) The container and outer package of a medical preparation, which by reason of paragraphs (f) or (g) of sub-article (2) is supplied without a prescription, shall be labelled to show the words "Warning. Do not exceed the stated dose."

6 Restrictions on medical preparations exempted from prescription control

6. (1) Subject to sub-article (2), a person shall not supply a medical preparation which by reason of sub-article (2) of article 5 may be supplied without a prescription unless he is a person keeping open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons in accordance with the Pharmacy Acts, 1875 to 1977 and such supply is effected by or under the personal supervision of an authorised person.

(2) Sub-article (1) shall not apply to the supply of a medical preparation which contains a substance specified in Part 2 of the Second Schedule provided that the supply of the preparation concerned is not otherwise prohibited by virtue of these Regulations.

7 Restriction on dispensing of prescriptions.

7. (1) For the purposes of these Regulations a prescription shall comply with the following requirements, that is to say, it shall—

(i) be in ink and be signed by the person issuing it with his usual signature and be dated by him;

(ii) except in the case of a health prescription, specify the address of the person issuing it;

(iii) clearly indicate the name of the person issuing it and state whether he is a registered medical practitioner or a registered dentist; and

(iv) specify the name and address, and age if under 12, of the person for whose treatment it is issued.

(2) Subject to sub-articles (3) and (4) the following provisions shall be complied with in the dispensing of a prescription for the supply of a medical preparation—

( a ) where neither the number of occasions on which nor the intervals at which a medical preparation which is or which contains a substance specified in Part A of the First Schedule may be supplied are specified in a prescription, the prescription may be dispensed on one occasion only;

( b ) where neither the number of occasions on which nor the intervals at which a medical preparation which is or which contains a substance specified in Part B of the First Schedule but which does not contain a substance specified in Part A of the said Schedule, may be supplied are specified in a prescription, the prescription may be dispensed on such number of occasions within the period of six months after the date thereon as the person dispensing the prescription considers appropriate having regard to the specified rate of dosage;

( c ) where the intervals at which a medical preparation, which is or which contains a substance specified in Part A of the First Schedule may be supplied, are specified in a prescription but the number of occasions on which it may be supplied are not so specified, the prescription may be dispensed on not more than three occasions;

( d ) where the intervals at which a medical preparation which is or which contains a substance specified in Part B of the First Schedule but which does not contain a substance specified in Part A of the said Schedule, may be supplied are specified in a prescription, the prescription may be dispensed at those intervals within the period of six months after the date thereon;

( e ) where the number of occasions on which a medical preparation which is or which contains a substance specified in either Part A or Part B of the First Schedule may be supplied is specified in a prescription but the intervals at which it may be supplied are not so specified, the prescription may be dispensed at such intervals as the person dispensing the prescription considers appropriate having regard to the specified rate of dosage;

( f ) where the dispensing of a prescription has been completed the person who dispensed it shall forthwith write or print prominently on the prescription the word "dispensed" and the date on which it was dispensed;

( g ) where the prescription is dispensed in part, the person who so dispensed it shall, if it is not being preserved in accordance with article 10 (3), forthwith record on the prescription the quantity of each preparation supplied by him and the date on which he supplied each such quantity and the name and address of the person by whom such preparation was supplied.

(3) ( a ) The prescription in the case of a medical preparation to which this sub-article applies may be dispensed in accordance with this article as it relates to a preparation which is or which contains a substance specified in Part B of the First Schedule.

( b ) The medical preparations to which this sub-article applies are—

(i) any preparation intended for external use which is or which contains a substance specified in Part I of the Third Schedule, and

(ii) any preparation intended for use as an oral contraceptive which is or which contains a substance specified in Part II of the Third Schedule.

(4) The prescription in the case of a medical preparation to which article 5 (1) (b) or (c) applies shall be dispensed in accordance with this article as it relates to a preparation which is or which contains a substance specified in Part A of the First Schedule.

(5) The prescription in the case of a medical preparation, which by virtue of these Regulations may not be supplied except in accordance with a prescription, shall—

( a ) not be dispensed after the end of the period of six months from the date specified on the prescription; and

( b ) except in the case of Sodium Fluoride Tablets, be dispensed on one occasion only where it is issued by a registered dentist.

(6) The prescription in the case of a medical preparation which consists of or contains a substance specified in Part C of the First Schedule shall not be dispensed except in a hospital.

(7) Notwithstanding the provisions of these Regulations an authorised person may dispense a medical preparation to which this article applies, where a prescription is not in accordance with sub-article (1) by reason only that one of the conditions specified in sub-article (1) is not fulfilled, where the authorised person exercises due diligence and care, and is satisfied that it is safe to do so.

(8) The provisions of sub-articles (2), (3), (4), (5) and (7) shall not apply to a preparation which is a controlled drug specified in Schedule 1, 2 or 3 to the Misuse of Drugs Regulations, 1988 ( S.I. No. 328 of 1988 ).

8 Exemptions for emergency supply.

8. (1) It shall not be a contravention of article 5 (1) or article 7 for a person keeping open shop for the dispensing or compounding of medical prescriptions in accordance with the Pharmacy Acts, 1875 to 1977 to supply a medical preparation otherwise than in accordance with a prescription where—

( a ) the authorised person by whom or under whose supervision the preparation is to be supplied has been requested to supply the preparation for a particular patient by a registered medical practitioner or registered dentist who by reason of an emergency is unable to furnish a prescription immediately,

( b ) the practitioner concerned has undertaken to furnish a prescription within 72 hours,

( c ) the preparation is supplied in accordance with the directions of the practitioner requesting it, and

( d ) subject to sub-article (3), the preparation is not a controlled drug specified in Schedule 1, 2, 3 or 4 to the Misuse of Drugs Regulations, 1988;

(2) It shall not be a contravention of article 5 (1) or article 7 for a person keeping open shop for the dispensing or compounding of medical prescriptions in accordance with the Pharmacy Acts, 1875 to 1977 to supply a medical preparation otherwise than in accordance with a prescription where—

( a ) the authorised person by whom or under whose supervision the preparation is to be supplied has at such shop interviewed the person requesting the preparation and has satisfied himself—

(i) that there is an immediate need for the preparation to be supplied and that it is impracticable in the circumstances to obtain a prescription without undue delay,

(ii) that treatment with the preparation has on a previous occasion been prescribed by a registered medical practitioner for the person, and

(iii) that he can in the circumstances safely specify the appropriate dose of the preparation for the person;

( b ) no greater quantity of the preparation than will provide 5 days' treatment is sold or supplied, except where the preparation—

(i) is an aerosol for the relief of asthma, an ointment or a cream, and has been made up in a container elsewhere than at the place of supply, and the smallest container that the authorised person has available is supplied,

(ii) is an antibiotic for oral administration in liquid form, and the smallest quantity that will provide a full course of treatment is supplied,

(iii) is an oral contraceptive, and a quantity sufficient for a full cycle is supplied;

( c ) subject to sub-article (3), the preparation does not consist of or contain a substance specified in the Fourth Schedule and is not a controlled drug specified in Schedule 1, 2, 3 or 4 to the Misuse of Drugs Regulations, 1988; and

( d ) the container or package of the preparation is labelled so as to show—

(i) the date on which the preparation is supplied,

(ii) the name of the preparation, being either the proprietary name, or the non-proprietary name with the name of the manufacturer or of the person responsible for placing the preparation on the market,

(iii) the quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the preparation,

(iv) the name of the person requesting the preparation,

(v) the name and address of the shop from which the preparation was sold or supplied, and

(vi) the words "Emergency Supply".

(3) The conditions specified in paragraph (d) of sub-article (1) and in paragraph (c) of sub-article (2) shall not apply where the preparation consists of or contains Methylphenobarbitone, Phenobarbitone or Phenobarbitone Sodium (but no other substance specified in the Fourth Schedule or in Schedule 1, 2, 3 or 4 to the Misuse of Drugs Regulations, 1988) and is supplied for the treatment of epilepsy.

9 Labelling of Dispensed Medical Preparations.

9. (1) In this article "dispensed medical preparation" means a medical preparation—

( a ) supplied by a registered medical practitioner or registered dentist for or to a patient under his care, or

( b ) supplied by or under the supervision of an authorised person—

(i) in accordance with a prescription or specification furnished by the person to whom the preparation is to be supplied, or

(ii) in circumstances where the person under whose supervision the preparation is supplied exercises his own judgement as to the treatment required.

(2) Subject to sub-article (3), the container or outer package of a dispensed medical preparation shall be labelled to show the following particulars—

( a ) the name of the person to whom the preparation is to be administered;

( b ) the name and address of the person by whom the preparation was supplied;

( c ) the date on which the preparation was dispensed;

( d ) unless the prescriber otherwise directs, the name of the preparation, being either the proprietary name or the non-proprietary name with the name of the manufacturer or of the person responsible for placing the preparation on the market;

( e ) where the preparation is being supplied on foot of a prescription, such of the following particulars as the prescriber may specify,—

(i) directions for use of the preparation, and

(ii) precautions relating to the use of the preparation,

or, where an authorised person, in the exercise of his professional skill and judgement, is of the opinion that any of such particulars are inappropriate and has taken such steps as in all the circumstances are reasonably practicable to consult with the prescriber but has been unable to do so, particulars of the same kind as those requested by the prescriber as appear to the authorised person to be appropriate;

( f ) where the preparation is not being supplied on foot of a prescription, the directions for use of the preparation;

( g ) the words "keep out of the reach of children";

( h ) where the preparation is for external use only, the words "For external use only";

( i ) such of the cautionary and warning notices specified in the Fifth Schedule as are, in the opinion of the authorised person, deemed to be appropriate.

(3) It shall be sufficient compliance with paragraphs (d), (g), (h), and (i) of sub-article (2) if the dispensed medical preparation is supplied in the original container and outer package (if any) supplied by the manufacturer or person responsible for placing the product on the market and any of the information originally contained thereon has not been removed or obscured.

10 Pharmacy Records.

10. (1) Subject to sub-articles (2), (3) and (5), a person keeping open shop for the dispensing or compounding of medical prescriptions in accordance with the Pharmacy Acts, 1875 to 1977 shall, in respect of every supply of a medical preparation which by virtue of these Regulations may not be supplied except in accordance with a prescription, enter or cause to be entered in a register kept for that purpose, the following particulars, that is to say—

( a ) where the preparation is supplied in accordance with a prescription or in compliance with article 8 (1)—

(i) the date on which the preparation is sold or supplied;

(ii) the name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the preparation;

(iii) the name of the prescriber and where he is not known to the authorised person, his address;

(iv) the name and address of the person for whom the preparation is prescribed;

(v) the date of the prescription; and

(vi) in relation to the supply of a preparation in compliance with article 8 (1), the date on which the prescription is received;

( b ) where the preparation is supplied in the dispensing of a repeatable prescription on a second or subsequent occasion—

(i) the date on which the preparation is supplied, and a reference to an entry in the aforementioned register which was made on the first occasion on which the preparation was supplied in the dispensing of that prescription; or

(ii) the particulars specified in sub-article (1) (a); and

(iii) where the supply on the last previous occasion was at another shop, the name and address of such shop and the reference to the entry in the aforementioned register for such shop in respect of such supply.

( c ) where the preparation is sold or supplied in accordance with article 8 (2)—

(i) the date on which the preparation is supplied;

(ii) the name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the preparation;

(iii) the name and address of the person requiring the preparation; and

(iv) the nature of the emergency which rendered it necessary to supply the preparation otherwise than in accordance with a prescription;

(v) the name of the prescriber who on the previous occasion prescribed the preparation and where he is not known to the authorised person, his address;

(vi) where the supply on the previous occasion was at another shop, the name and address of such shop and the reference to the entry in the aforementioned register for such shop in respect of such supply.

( d ) where the supply is by way of wholesale dealing or is a supply referred to in article 13 (a), and no order or invoice, or copy thereof, relating to such supply has been retained by the supplier—

(i) the date on which the preparation is supplied;

(ii) the name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the preparation;

(iii) the name and address and trade, business or profession of the person to whom the preparation is supplied; and

(iv) the purpose for which the preparation is supplied.

(2) The provisions of sub-article (1) shall not apply where—

( a ) the preparation is supplied in accordance with a health prescription, or

( b ) a separate record of the supply is made in accordance with article 16 of the Misuse of Drugs Regulations, 1988, or

( c ) the supply is by way of wholesale dealing and the order or invoice relating to the supply or a copy thereof is retained by the supplier, or

( d ) the supply is to a sampling officer.

(3) A person keeping open shop for the dispensing or compounding of medical prescriptions in accordance with the Pharmacy Acts, 1875 to 1977 shall preserve for a period of two years from the relevant date—

( a ) the register kept under sub-article (1);

( b ) in the case of a health prescription, the duplicate copy thereof and in the case of any other prescription, the prescription; and

( c ) every order or invoice referred to in sub-article (2) (c).

(4) In sub-article (3) "the relevant date" means—

( a ) in relation to paragraph (a) the date on which the last entry is made in the register; and

( b ) in relation to paragraphs (b) and (c)—

(i) where the preparation is supplied in accordance with a repeatable prescription, the date on which the prescription is dispensed for the last time, and

(ii) in every other case, the date on which the preparation is supplied.

(5) The requirements of sub-article (1) shall be satisfied in the case of computerised records provided that the information required to be kept by virtue of the said sub-article is also retained in the form of a print-out for each day on which the shop is open. Such print-out shall be dated and certified, on the day to which the print-out relates or within the period of twenty four hours thereafter, by the authorised person by whom the shop is managed.

(6) References in this article to a register shall include the computerised records and daily prin-tout referred to in sub-article (5).

11 Keeping of Records in the case of certain medical preparations.

11. A person who supplies or adminsters a medical preparation which consists of or contains mifepristone shall keep a register of such supply or administration showing—

( a ) the date of such supply or administration,

( b ) the name and address of the recipient,

( c ) the dosage form, strength and quantity of the preparations supplied or administered,

( d ) the purpose or circumstances of the supply or administration, and

( e ) the signature of the person who made the supply or administration.

12 Prohibition of supply after Expiry Date.

12. A person shall not supply any medical preparation for use as such after the date specified thereon by the manufacturer thereof as its expiry date.

13 Exemptions.

13. The provisions of articles 5 and 6 of these Regulations shall not apply as respects—

( a ) the supply of a medical preparation to—

(i) a University or other institution concerned with higher education or scientific research for the purposes of such education or research,

(ii) a sampling officer, an officer of the National Drugs Advisory Board or a Public Analyst in connection with the performance of his duties,

(iii) a person who requires the preparation for the purpose of enabling him to comply with any requirements made by or in pursuance of any enactment relating to the medical treatment of persons employed or carried by that person in any trade or business carried on by him,

(iv) a person employed or engaged in connection with any arrangements made for testing the quality or amount of the drugs, medicines and appliances supplied for the purpose of section 59 of the Health Act, 1970 .

(b) the supply of a medical preparation by way of wholesale dealing.

(c) the supply of a medical preparation in the course of a service provided by a hospital where the medical preparation is supplied in accordance with the written directions of a registered medical practitioner or registered dentist notwithstanding that those directions do not fulfil the conditions specified in article 7 (1).

(d) the supply of a medical preparation to a patient of his by a registered medical practitioner or registered dentist in the course of his professional practice.

14 Enforcement.

14. (1) The enforcement and execution of the provisions of these Regulations and the prosecution of offences under section 65 of the Act in relation to these Regulations may be carried out—

( a ) by officers of the Minister,

( b ) by the Pharmaceutical Society of Ireland and its officers,

( c ) by health boards and their officers.

(2) Subject to sub-articles (3) and (4) any such officer as aforesaid (with in the case of an officer of the Minister, a written authorisation of the Minister and in the case of an officer of the Pharmaceutical Society of Ireland, a written authorisation of that Society and in the case of an officer of a health board a written authorisation of the board), may, at all reasonable times, for the purpose of ascertaining whether or not there is or has been a contravention of these Regulations—

( a ) enter premises of any class or description,

( b ) inspect any substance or preparation which is stored, or offered or kept for supply at such premises,

( c ) require the production of and if he thinks fit, take copies of any prescription, order, invoice or other document or of any entry in any register at such premises, and

( d ) take (without payment) samples of any substance or preparation stored, or offered or kept for supply at such premises for test, examination or analysis.

(3) Sub-article (2) shall not apply as respects any of the following premises—

( a ) such part of any premises as is used by a registered medical practitioner or registered dentist for carrying on his professional practice, or

( b ) a premises used only as a private dwelling.

(4) So much of sub-article (2) as enables enables officers of the Pharmaceutical Society of Ireland to enter premises of any class or description shall not apply as respects any of the following premises—

( a ) a hospital;

( b ) the premises of a manufacturer or wholesaler of a medical preparation.

15 Evidence of Result of Test, Examination or Analysis.

15. (1) In any proceedings for an offence under section 65 of the Act in relation to these Regulations a certificate signed by—

( a ) the State Chemist, or

( b ) a public analyst appointed under section 10 of the Sale of Food and Drugs Act, 1875, or

( c ) a chemist or analyst appointed by the Pharmaceutical Society of Ireland for that purpose,

stating the result of any test, examination of analysis of a sample shall, with regard to that sample, be evidence for all purposes of such result.

(2) The certificate referred to in sub-article (1) shall be in the form set out in the Sixth Schedule.

16 Transitional provisions.

16. Any register, prescription, order or invoice required to be retained under Article 9 (3) of the Medical Preparations (Control of Sale) Regulations, 1987 shall, for the purposes of article 14, be regarded as being retained under Article 10 (3).

FIRST SCHEDULE

(Articles 5,6 and 7)

Substances which when contained in medical preparations are subjected to prescription control and the circumstances excluding certain preparations from such control.

In this Schedule:—

( a ) the designation of the Part of the Schedule in which a particular substance listed in column 1 is indicated by the letter A or B or C as the case may be in column 2;

( b ) entries specified in columns 2, 3, 4 and 5 relate to the substances listed in column 1 against which they appear and where, in relation to a particular substance listed in column 1, an entryin column 3, 4 or 5 bears a number or letter it relates only to such entries in the other of those columns as bears the same number or letter;

( c ) the entries in column 5 shall be read subject to the note at the end of the Schedule; and

( d ) the following abbreviations are used:

"g"

for gram,

"mcg"

for microgram,

"mg"

for milligram,

"ml"

for millilitre.

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Acarbose

B

Acebutolol Hydrochloride

B

Acecarbromal

B

Acepromazine Maleate

B

Acetanilide

B

Acetarsol

A

Acetazolamide

B

Acetazolamide Sodium

B

Acetohexamide

B

Acetophenazine Maleate

B

Acetrizoate Sodium

C

Acetrizoic Acid

C

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Acetylcholine Chloride

B

0.2 per cent (MS)

External

Acetylcysteine

A

Any use (except local ophthalmic use)

Acipimox

B

Acitretin

A

Aconite

B

1.3 per cent (MS)

External

Acrosoxacin

A

Actaplanin

A

Actinomycin C

A

Actinomycin D

A

Acyclovir

A

5.0 per cent (MS) 2.0g (MPS)

External (except local ophthalmic use):

Cold sores

Ardrenaline

B

(1) 0.6 per cent (MS)

(1) By inhaler

(2) External

Adrenaline Acid Tartrate

B

(1) 1.0 per cent (MS)

(1) By inhaler

(2) External

Adrenaline Hydrochloride

B

(1) 0.6 per cent (MS)

(1) By inhaler

(2) External

Adrenocortical Extract

A

Alclofenac

B

Alclomethasone Dipropionate

A

Alcuronium Chloride

A

Aldosterone

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Alfacalcidol

B

Alfentanil Hydrochloride

A

Alfuzosin

B

Alfuzosin Hydrochloride

B

Allergen Extracts

B

Allopurinol

B

Allyloestrenol

A

Almitrine

B

Aloxiprim

B

800mg (MD) 3.6g (MDD)

Alphadolone Acetate

A

Alphaxalone

A

Alprazolam

A

Alprenolol

B

Alprenolol Hydrochloride

B

Alprostadil

A

Alseroxylon

B

Amantadine Hydrochloride

B

Ambenonium Chloride

A

Ambutonium Bromide

A

5mg (MD) 20 mg (MDD)

Amcinonide

B

Ametazole Hydrochloride

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Amethocaine

A

Any use except local ophthalmic use

Amethocaine Gentisate

A

Any use except local ophthalmic use

Amethocaine Hydrochloride

A

Any use except local ophthalmic use

Amikacin Sulphate

A

Amiloride Hydrochloride

B

Aminocaproic Acid

B

Aminoglutethimide

B

Aminophylline

B

Aminopterin Sodium

A

Amiodarone Hydrochloride

B

Amiphenazole Hydrochloride

B

Amitriptyline

A

Amitriptyline Embonate

A

Amitriptyline Hydrochloride

A

Amlodipine Besylate

B

Amlodipine Maleate

B

Ammonium Bromide

B

Amodiaquine Hydrochloride

B

Prophylaxis of malaria

Amoxapine

A

Amoxycillin

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Amoxycillin Trihydrate

A

Amphetamine Sulphate

A

Amphomycin Calcium

A

Amphotericin

A

Ampicillin Sodium

A

Ampicillin Trihydrate

A

Amrinone

B

Amsacrine

A

Amygdalin

A

Amyl Nitrite

A

Amylobarbitone

A

Amylobarbitone Sodium

A

Amylocaine Hydrochloride

A

Any use except local ophthalmic use

Ancrod

A

Androsterone

A

Angiotensin Amide

B

Anistreplase

A

Anterior Pituitary Extract

A

Antimony Barium Tartrate

B

Antimony Dimercaptosuccinate

B

Antimony Lithium Thiomalate

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Antimony Pentasulphide

B

Antimony Potassium Tartrate

B

Antimony Sodium Tartrate

B

Antimony Sodium Thioglycollate

B

Antimony Sulphate

B

Antimony Trichloride

B

Antimony Trioxide

B

Antimony Trisulphide

B

Apiol

A

Apomorphine

B

Apomorphine Hydrochloride

B

Aprotinin

A

Arbaprostil

A

Arecoline Hydrobromide

B

Argipressin

A

Arsenic

A

Arsenic Triiodide

A

Arsenic Trioxide

A

Arsphenamine

A

Aspirin

B

(1) Internal: any use (except for children under 12 years of age)

(2) External

650mg (MD)

4.0g (MDD)

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Astemizole

B

10mg

(MS)

10 (MPS)

(10mg (MDD)

Atenolol

B

Atracurium Besylate

A

Atropine

B

(1) Internal:

(a) by inhaler

(b) otherwise than by inhaler

(b) 300mcg (MD) 1mg (MDD)

(2) External (except local ophthalmic use)

Atropine

Methobromide

B

(1) Internal:

(a) by inhaler

(b) otherwise than by inhaler

(b) 400mcg

(MD)

1.3mg (MDD)

(2) External (except local ophthalmic use)

Atropine

Methonitrate

B

Internal:

(a) by inhaler

(b) otherwise than by inhaler

(b) 400mcg

(MD)

1.3mg (MDD)

Atropine Oxide Hydrochloride

B

(1) Internal:

(a) by inhaler

(b) otherwise than by inhaler

(b) 360mcg

(MD)

1.2 mg (MDD)

(2) External (except local ophthalmic use)

Atropine Sulphate

B

(1) Internal:

(a) by inhaler

(b) otherwise than by inhaler

(b) 360mcg

(MD)

1.2mg (MDD)

(2) External (except local ophthalmic use)

Auranofin

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Azapropazone

B

Azathioprine

A

Azathioprine Sodium

A

Azidocillin Potassium

A

Azitromycin

A

Azlocillin Sodium

A

Aztreonam

A

Bacampicillin Hydrochloride

A

Bacitracin

A

Bacitracin Methylene Disalicylate

A

Bacitracin Zinc

A

Baclofen

B

Barbexaclone

A

Barbitone

A

Barbitone Sodium

A

Barium Carbonate

B

Barium Chloride

B

Barium Sulphate

C

Barium Sulphide

B

Beclamide

B

Beclomethasone

A

Beclomethasone Dipropionate

A

Belladonna Herb

B

(1) Internal

(1) 1mg of the alkaloids (MDD)

(2) External

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Belladonna Root

B

(1) Internal

(1) lmg of the alkaloids (MDD)

(2) External

Bemegride

B

Bemegride Sodium

B

Benapryzine Hydrochloride

B

Bendrofluazide

B

Benethamine Penicillin

A

Benorylate

B

1.2g (MD)

7.0g (MDD)

Benoxaprofen

B

Benperidol

A

Benserazide Hydrochloride

B

Bentiromide

A

Benzathine Penicillin

A

Benzbromarone

B

Benzhexol Hydrochloride

B

Benzilonium Bromide

B

Benzocaine

A

Any use except local ophthalmic use

Benzoctamine Hydrochloride

B

Benzquinamide

B

Benzquinamide Hydrochloride

B

Benzthiazide

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Benztropine Mesylate

B

Benzydamine Hydrochloride

B

3.0 per cent

(MS)

External

Benzylpenicillin Calcium

A

Benzylpenicillin Potassium

A

Benzylpenicillin Sodium

A

Bepridil Hydrochloride

B

Betahistine Hydrochloride

B

Betamethasone

A

Betamethasone Adamantoate

A

Betamethasone Benzoate

A

Betamethasone Dipropionate

A

Betamethasone Sodium Phosphate

A

Betamethasone Valerate

A

Betaxolol Hydrochloride

B

Bethanechol Chloride

B

Bethanidine Sulphate

B

Bezafibrate

B

Bifonazole

B

Biperiden Hydrochloride

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Biperiden Lactate

B

Bismuth Glycollylarsanilate

A

Bisprolol Fumarate

B

Bleomycin

A

Bleomycin Sulphate

A

Boldenone

A

Boldenone Undecanoate

A

Bornaprine Hydrochloride

B

Bretylium Tosylate

B

Bromazepam

A

Bromhexine Hydrochloride

B

Internal

Bromocriptine Mesylate

B

Bromvaletone

B

Broom (Cytisus Scoparium Species)

A

Brotizolam

A

Budesonide

A

Bufexamac

B

5.0 per cent (MS)

External

Buflomedil Hydrochloride

B

Bufuralol Hydrochloride

B

Bumetanide

B

Bunolol Hydrochloride

B

Buphenine Hydrochloride

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Bupivacaine

A

Any use except local ophthalmic use

Bupivacaine Hydrochloride

A

Any use except local ophthalmic use

Buprenorphine

A

Buprenorphine Hydrochloride

A

Buserelin

A

Buserelin Acetate

A

Buspirone Hydrochloride

A

Busulphan

A

Butacaine Sulphate

A

Any use except local ophthalmic use

Butobarbitone

A

Butobarbitone Sodium

A

Butorphanol Tartrate

A

Butriptyline Hydrochloride

A

Butyl Nitrite

A

Calcifediol

B

Calcipotriol

A

Calcitonin

B

Calcitriol

B

Calcium Benzamidosalicylate

B

Calcium Bromide

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Calcium Bromidolactobionate

B

Calcium Carbimide

B

Camazepam

A

Candicidin

A

Canrenoate Potassium

A

Canrenoic Acid

A

Cantharidin

B

0.01 per cent (MS)

External

Canthaxanthin

B

Capreomycin Sulphate

A

Captopril

B

Carbachol

B

Carbamazepine

B

Carbasalate Calcium

B

(1) Internal: Any use (except for children under 12 years of age)

Equivalent of 650 mg of Aspirin (MD) Equivalent of 4.0g of Aspirin

(MDD)

Carbenicillin Sodium

A

Carbenoxolone Sodium

B

(1) Pellet

(1) 5mg (MD)

25mg (MDD)

(2) 2.0 per cent (MS)

(2) Gel

Carbidopa

B

Carbimazole

B

Carbocisteine

B

Internal

Carbon Tetrachloride

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Carboplatin

A

Carboprost Tromethamol

A

Carbromal

B

Carbuterol Hydrochloride

B

Carfecillin Sodium

A

Carindacillin Sodium

A

Carisoprodol

B

Carmustine

A

Carperidine

A

Carteolol

B

Carteolol Hydrochloride

B

Cefaclor

A

Cefadroxil

A

Cefapirin Sodium

A

Cefazedone Sodium

A

Cefixime

A

Cefodizime

A

Cefonicid Sodium

A

Cefoperazone Sodium

A

Cefotaxime Sodium

A

Cefotiam Hydrochloride

A

Cefoxitin Sodium

A

Cefpodoxime

A

Cefpodoxime Proxetil

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Cefsulodin Sodium

A

Ceftazidime

A

Ceftizoxime Sodium

A

Ceftriaxone Sodium

A

Cefuroxime Axetil

A

Cefuroxime Pivoxetil

A

Cefuroxime Sodium

A

Celiprolol Hydrochloride

B

Cephalexin

A

Cephalexin Sodium

A

Cephaloridine

A

Cephalothin Sodium

A

Cephamandole Nafate

A

Cephazolin Sodium

A

Cephradine

A

Cerium Oxalate

B

Ceruletide

A

Ceruletide Diethylamine

A

Cetirizine

B

10 mg (MS)

10 (MPS)

10 mg (MDD)

Chenodeoxycholic Acid

B

Chloral Hydrate

B

External

Chlorambucil

A

Chloramphenicol

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Chloramphenicol Cinnamate

A

Chloramphenicol Palmitate

A

Chloramphenicol Sodium Succinate

A

Chlordiazepoxide

A

Chlordiazepoxide Hydrochloride

A

Chlorhexadol

B

Chlormadinone Acetate

A

Chlormerodrin

B

Chlormethiazole

A

Chlormethiazole Edisylate

A

Chlormezanone

B

Chloroform

B

(1) 5.0 per cent

(MS)

(1) Internal

(2) External

Chloroquine Phosphate

B

Prophylaxis of malaria

Chloroquine Sulphate

B

Prophylaxis of malaria

Chlorothiazide

B

Chlorotrianisene

A

Chlorphenoxamine Hydrochloride

B

External

Chlorpromazine

B

Chlorpromazine Embonate

B

Chlorpromazine Hydrochloride

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Chlorpropamide

B

Chlorprothixene

B

Chlorprothixene Hydrochloride

B

Chlortetracycline

A

Chlortetracycline Calcium

A

Chlortetracycline Hydrochloride

A

Chlorthalidone

B

Chlorzoxazone

B

Cholecalciferol

B

(1) Internal

(1) 0.075mg (equivalent to 3,000 iu Vitamin D) (MDD)

(2) External

Cholestyramine

B

Choline Magnesium Trisalicylate

B

Ciclacillin

A

Ciclobendazole

B

Ciclopirox

B

External (except vaginal use)

Cilazapril

B

Cimetidine

B

Cimetidine Hydrochloride

B

Cinchocaine

B

3.0 per cent (MS)

Any use except local ophthalmic use

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Cinchocaine Hydrochloride

B

Equivalent of 3.0 per cent of Cinchocaine (MS)

Any use except local ophthalmic use

Cinchophen

B

Cinnarizine

B

15 (MPS)

30mg (MD)

60mg (MDD)

Cinoxacin

A

Ciprofibrate

B

Ciprofloxacin

A

Ciprofloxacin Hydrochloride

A

Ciprofloxacin Lactate

A

Cisapride

B

Cisplatin

A

Clarithromycin

A

Clavulanate Potassium

A

Clavulanic Acid

A

Clenbuterol Hydrochloride

B

Clidinium Bromide

B

Clindamycin

A

Clindamycin Hydrochloride

A

Clindamycin Palmitate Hydrochloride

A

Clindamycin Phosphate

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Clioquinol

B

(1) 35mg

(1) Treatment of mouth ulcers

(2) External (other than treatment of mouth ulcers)

(1) 280mg

(MDD)

Clobazam

A

Clobetasol Propionate

A

Clobetasone Butyrate

A

Clodronate Sodium

B

Clofazimine

B

Clofibrate

B

Clomacran Phosphate

B

Clomiphene Citrate

A

Clomipramine

A

Clomipramine Hydrochloride

A

Clomocycline

A

Clomocycline Sodium

A

Clonazepam

A

Clonidine

B

Clonidine Hydrochloride

B

Clopamide

B

Clopenthixol Decanoate

B

Clopenthixol Hydrochloride

B

Clorazpate Potassium

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Clorexolone

B

Clostebol Acetate

A

Clotiazepam

A

Clotrimazole

B

External:

(1) Cream

(2) Powder

(3) Solution

Clovoxamine

A

Cloxacillin Benzathine

A

Cloxacillin Sodium

A

Cloxazolam

A

Clozapine

A

Co-dergocrine Mesylate

B

Co-tetroxazine

A

Co-trimoxazole

A

Cocaine

A

Cocaine Hydrochloride

A

Cocculus Indicus

A

Codeine Phosphate

A

Equivalent of 1.5 per cent of Codeine (MS)

Equivalent of 20mg of Codeine (MD)

Colaspase

A

Colchicine

A

Colestipol Hydrochloride

B

Colfosceril Palmitate

A

Colistin Sulphate

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose, and Maximum daily dose

Colistin Sulphomethate

A

Colistin Sulphomethate Sodium

A

Comfrey (Symphytum Species)

A

External

Coniine

B

Conium Leaf

B

7.0 per cent (MS)

External

Corticotrophin

A

Cortisone

A

Cortisone Acetate

A

Cromoglycate Sodium

B

(1) Administration through the nose

(2) Eye Drops

Cropropamide

B

Crotethamide

B

Croton Oil

A

Croton Seed

A

Curare

A

α-Cyanobenzylp-ß-D-glucopyranosiduronic Acid

B

0.1 per cent (MS)

α-Cyanobenzyl-6—O-P

ß-D-glucopyranosyl

-ß-D-glucopyranoside

B

0.1 per cent (MS)

Cyanocobalamin

B

25mcg (MS)

25mcg (MDD)

Cyanocolbalamin

B

25mcg (MS)

25mcg (MDD)

Cyclandelate

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Cyclobarbitone

A

Cyclobarbitone Calcium

A

Cyclofenil

A

Cyclopenthiazide

B

Cyclopentolate Hydrochloride

B

Cyclophosphamide

A

Cycloserine

A

Cyclosporin

B

Cyclothiazide

B

Cyproterone Acetate

A

Cytarabine

A

Cytarabine Hydrochloride

A

Dacarbazine

A

Danazol

B

Danthron

B

Dantrolene Sodium

B

Dapsone

A

Dapsone Ethane Ortho Sulphonate

A

Daunorubicin Hydrochloride

A

Deanol Bitartrate

B

26mg (MDD)

Debrisoquine Sulphate

B

Deflazacort

A

Delorazepam

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Demecarium Bromide

B

Demeclocycline

A

Demeclocycline Calcium

A

Demeclocycline Hydrochloride

A

Deoxycortone Acetate

A

Deoxycortone Pivalate

A

Deptropine Citrate

B

Dequalinium Chloride

B

(1)

0.25mg (MS)

(1) Internal: throat lozenges or throat pastilles

(2) 1.0 per cent

(MS)

(2) External: paint

Deserpidine

B

Desferrioxamine Mesylate

B

Desfluorotriamcinolone

A

Desipramine Hydrochloride

A

Deslanoside

B

Desmopressin

B

Desogestrel

A

Desonide

A

Desoxymethasone

A

Dexamethasone

A

Dexamethasone Acetate

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Dexamethasone Isonicotinate

A

Dexamethasone Phenylpropionate

A

Dexamethasone Pivalate

A

Dexamethasone

Sodium m-

Sulphobenzoate

A

Dexamethasone Sodium Phosphate

A

Dexamethasone Troxundate

A

Dexamphetamine Sulphate

A

Dexfenfluramine Hydrochloride

A

Dextromethorphan Hydrobromide

B

Internal

(a) In the case of controlled release preparations: Equivalent of 30 mg of Dextromethorphan (MD),

Equivalent of 75mg of Dextromethorphan (MDD)

(b) In any other case: Equivalent of 15mg of Dextromethorphan (MD)

Equivalent of 75mg of Dextromethorphan (MDD)

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Dextromethorphan Resinate

B

Internal

Equivalent of 30mg of Dextromethorphan (MD)

Equivalent of 75mg of Dextromethorphan (MDD)

Dextromoramide Hydrochloride

A

Dextromoramide Tartrate

A

Dextropropoxyphene Hydrochloride

B

Dextropropoxyphene Napsylate

B

Dextrothyroxine Sodium

B

Diatrizoate Meglumine

C

Diatrizoate Sodium

C

Diatrizoic Acid

C

Diazepam

A

Diazoxide

A

Dibenzepin Hydrochloride

A

Dichloralphenazone

B

Dichlorphenamide

B

Diclofenac Diethylammonium

B

Equivalent of 1.0 per cent of diclofenac (MS)

30.0g (MPS)

External: Rheumatic and muscular pain

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Diclofenac Sodium

B

Dicylomine Hydrochloride

B

Internal (other than liquid preparations intended for infants)

10mg (MD)

60mg (MDD)

Dienoestrol

A

Diethanolamine Fusidate

A

Diethylcarbamazine

B

Diethylcarbamazine Citrate

B

Diethylpropion Hydrochloride

A

Difenoxin Hydrochloride

A

Diflucortolone Valerate

A

Diflunisal

B

Digitalin

B

Digitalis Leaf

B

Digitalis Prepared

B

Digitoxin

B

Digoxin

B

Dihydralazine Sulphate

B

Dihydrocodeine Tartrate

A

Equivalent of 1.5 per cent of Dihydrocodeine (MS)

Equivalent of 10mg of Dihydrocodeine (MD)

Dihydroergotamine Mesylate

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Dihydrostreptomycin

A

Dihydrostreptomycin Sulphate

A

Dihydrotachysterol

B

0.075mg (MDD)

Diiodohydroxy quinoline

B

Diloxanide Furoate

B

Diltiazem Hydrochloride

A

Diltiazem Hydrochloride

B

Dimercaprol

B

Dimethisoquin Hydrochloride

B

Any use except local ophthalmic use

Dimethisterone

A

Dimethothiazine Mesylate

B

Dimethyl Sulphoxide

A

Dimethyltubocurarine Bromide

A

Dimethyltubocurarine Chloride

A

Dimethyltubocurarine Iodide

A

Dinoprost

C

Dinoprost Trometamol

C

Dinoprostone

C

Diodone

C

Diphenoxylate Hydrochloride

B

Circumstances excluding medical preparation from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Dipipanone Hydrochloride

A

Dipivefrine

A

Dipivefrine Hydrochloride

A

Dipyridamole

B

Disopyramide

B

Disopyramide Phosphate

B

Distigmine Bromide

B

Disulfiram

B

Dithranol

B

0.1 per cent (MS)

Dithranol Triacetate

B

0.1 per cent (MS)

Dobutamine Hydrochloride

B

Domperidone

B

Oral solid unit dosage forms

Dopamine Hydrochloride

A

Dopexamine Hydrochloride

B

Dothiepin

A

Dothiepin Hydrochloride

A

Doxapram Hydrochloride

A

Doxazosin Mesylate

A

Doxepin Hydrochloride

A

Doxorubicin

A

Doxycycline

A

Circumstances excluding medical preparation from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Docycycline Calcium Chelate

A

Doxycycline Hydrochloride

A

Doxylamine Succinate

B

10mg (MD)

40mg (MDD)

Droperidol

A

Drostanolone

A

Drostanolone Propionate

A

Dydrogesterone

A

Dyflos

B

Econazole

B

External (except vaginal use)

Econazole Nitrate

B

External (except vaginal use)

Ecothiopate Iodide

A

Edrophonium Chloride

A

Embutramide

A

Emepronium Bromide

B

Emetine

B

1.0 per cent (MS)

Emetine Bismuth Iodide

B

Emetine Hydrochloride

B

Equivalent of 1.0 per cent of Emetine (MS)

Enalpril

B

Encainide

B

Circumstances excluding medical preparation from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Endralazine

B

Enoxacin

A

Enoximone

A

Enprostil

A

Ephedrine

B

External (except local ophthalmic use)

Ephedrine Hydrochloride

B

External (except local ophthalmic use)

Ephedrine Sulphate

B

External (except local ophthalmic use)

Epicillin

A

Epithiazide

B

Epoetin Alfa

A

Epoetin Beta

A

Epoprostenol Sodium

A

Ergocalciferol

B

0.075mg

(equivalent to 3,000 iu Vitamin D) (MDD)

Ergometrine Maleate

B

Ergometrine Tartrate

B

Ergot, Prepared

B

Ergotamine Tartrate

B

Erythromycin

A

Erythromycin Estolate

A

Circumstances excluding medical preparation from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Erythromycin Ethyl Carbonate

A

Erythromycin Ethyl Succinate

A

Erythromycin Lactobionate

A

Erythromycin Phosphate

A

Erythromycin Stearate

A

Erythromycin Thiocyanate

A

Esmolol Hydrochloride

B

Estazolam

A

Estramustine Phosphate

A

Etafedrine Hydrochloride

B

Ethacrynate Sodium

B

Ethacrynic Acid

B

Ethambutol Hydrochloride

B

Ethamivan

B

Ethamsylate

B

Ethchlorvynol

B

Ethebenecid

B

Ethiazide

B

Ethinyl Androstenediol

A

Ethinyloestradiol

A

Ethionamide

B

Ethisterone

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Ethoglucid

A

Ethoheptazine Citrate

A

Ethopropazine Hydrochloride

A

Ethosuximide

B

Ethotoin

B

Ethyl Biscoumacetate

B

Ethyl Loflazepate

A

Ethyl Moniodostearate

C

Ethylmorphine Hydrochloride

A

Equivalent of 0.2 per cent of Ethylmorphine(MS)

Equivalent of 7. 5 mg of Ethylmorphine (MD)

Ethyloestrenol

A

Ethynodiol Diacetate

A

Etidronate Disodium

B

Etifoxine

A

Etodolac

B

Etofenamate

B

Etomidate

A

Etoposide

A

Etorphine Hydrochloride

A

Etretinate

A

Famotidine

B

Fazadinium Bromide

A

Circumstances excluding medical preparation from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Felbinac

B

3.17 per cent (MS) 30.0g (MPS)

External: Rheumatic and muscular pain

Felodipine

A

Felypressin

A

Fenbufen

B

Fencamfamin Hydrochloride

A

Fenclofenac

B

Fenfluramine Hydrochloride

A

Fenofibrate

B

Fenoprofen

B

Fenoprofen Calcium

B

Fenoterol Hydrobromide

B

Fentanyl Citrate

A

Feprazone

B

Ferrous Arsenate

B

Filgrastim

A

Finasteride

A

Flavoxate Hydrochloride

B

Flecainide Acetate

B

Floctafenine

B

Fluanisone

A

Flubendazole

B

Fluclorolone Acetonide

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Flucloxacillin Sodium

A

Fluconazole

B

Flucytosine

A

Fludiazepam

A

Fludrocortisone Acetate

A

Flufenamic Acid

B

Flumazenil

A

Flumethasone

A

Flumethasone Pivalate

A

Flunarizine Hydrochloride

B

Flunisolide

A

Flunitrazepam

A

Fluocinolone Acetonide

A

Fluocinonide

A

Fluocortin Butyl

A

Fluocortolone

A

Fluocortolone Hexanoate

A

Fluocortolone Pivalate

A

Fluorescein Dilaurate

A

Fluorescein Sodium

A

Fluorometholone

A

Fluorometholone Acetate

A

Fluorouracil

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Fluorouracil Trometamol

A

Fluoxetine

A

Fluoxetine Hydrochloride

A

Fluoxymesterone

A

Flupenthixol Decanoate

B

Flupenthixol Hydrochloride

B

Fluperolone Acetate

A

Fluphenazine Decanoate

B

Fluphenazine Enanthate

B

Fluphenazine Hydrochloride

B

Fluprednidene Acetate

A

Fluprednisolone

A

Fluprostenol Sodium

A

Flurandrenolone

A

Flurazepam Hydrochloride

A

Flurazepam Monohydrochloride

A

Flurbiprofen

B

Fluspirilene

A

Flutamide

A

Fluticasone Propionate

A

Circumstances excluding medical preparation from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Fluvoxamine Maleate

A

Folic Acid

B

500mcg

(MDD)

Folinate Calcium

B

Formocortal

A

Foscarnet Sodium

A

Fosfestrol Sodium

A

Fosinopril

B

Fosinopril Sodium

B

Framycetin Sulphate

A

Frusemide

B

Furazolidone

B

Fusafungine

A

Fusidic Acid

A

Gadopentetate Meglumine

C

Gadopentetic Acid

C

Gallamine Triethiodide

A

Ganciclovir

A

Ganciclovir Sodium

A

Gelsemine

B

0.1 per cent (MS)

Gelsemium

B

25mg (MD)

75mg (MDD)

Gemeprost

C

Gemfibrozil

B

Gentamicin

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Gentamicin Sulphate

A

Gestodene

A

Gestrinone

A

Gestronol

A

Gestronol Hexanoate

A

Ginkgo biloba

B

Glibenclamide

B

Glibornuride

B

Gliclazide

B

Glipizide

B

Gliquidone

B

Glisoxepide

B

Glucagon

B

Glutethimide

A

Glyceryl Trinitrate

B

Glycopyrronium Bromide

B

1mg (MD)

2mg (MDD)

Glymidine

B

Gonadorelin

A

Gonadotrophin

A

Gonadotrophin Chortonic

A

Gonadotrophin Serum

A

Goserelin Acetate

A

Gramicidin

A

0.2 per cent (MS)

External

Granisetron

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Granisetron Hydrochloride

A

Griseofulvin

A

Growth Hormone

A

Guanacline Sulphate

B

Guanethidine Monosulphate

B

Guanfacine Hydrochloride

B

Guanoclor Sulphate

B

Guanoxan Sulphate

B

Halazepam

A

Halcinonide

A

Haloperidol

A

Haloperidol Decanoate

A

Haloxazolam

A

Harmine

A

Heparin

A

External

Heparin Calcium

A

External

Heparin Sodium

A

External

Heptabarbitone

A

Hexachlorophane

B

(a) 2.0 per cent (MS)

External:

(a) soaps

(b) 0.1 per cent (MS)

(b) aerosols

(c) 0.75 per cent (MS)

(c) preparations other than soaps and aerosols

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Hexamethonium Bromide

A

Hexamethonium Iodide

A

Hexamethonium Tartrate

A

Hexamine Phenylcinchoninate

B

Hexobarbitone

A

Hexobarbitone Sodium

A

Hexoestrol

A

Hexoestrol Dipropionate

A

L-Histidine Hydrochloride

B

Homatropine

B

(1) Internal

(1) 0.15mg

(MD)

0.45mg

(MDD)

(2) External (except local ophthalmic use)

Homatropine Hydrobromide

B

0.2mg (MD)

0.6mg (MDD)

Homatropine Methylbromide

B

2mg (MD)

6mg (MDD)

Hydralazine Hydrochloride

B

Hydrargaphen

B

Local application to skin

Hydrobromic Acid

B

Hydrochlorothiazide

B

Hydrocodone Resinate

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Hydrocodone Tartrate

A

Hydrocortisone

A

1.0 per cent (MS) 15.0g (MPS)

External: Contact dermatitis, irritant dermatitis and insect bite reactions.

Hydrocortisone Acetate

A

1.0 per cent (MS) 15.0g (MPS)

External: Contact dermatitis, irritant dermatitis and insect bite reactions.

Hydrocortisone Butyrate

A

Hydrocortisone Caprylate

A

Hydrocortisone Hydrogen Succinate

A

Hydrocortisone Sodium Phosphate

A

Hydrocortisone Sodium Succinate

A

Hydroflumethiazide

B

Hydromorphone Hydrochloride

A

Hydroxocobalamin

B

25mcg (MS)

25mcg (MDD)

Hydroxychloroquine Sulphate

B

Prophylaxis of malaria

Hydroxyprogesterone

A

Hydroxyprogesterone Enanthate

A

Hydroxyprogesterone Hexanoate

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Hydroxyurea

A

Hydroxyzine Embonate

B

Hydroxyzine Hydrochloride

B

Hyoscine

B

(1) 0.15 per cent (MS)

(1) Internal

(2) External (except local ophthalmic use)

Hyoscine Butylbromide

B

(1) Internal:

(a) By inhaler

(b) Otherwise than by inhaler

(b) 3mg (MD) 9mg (MDD)

(2) External

Hyoscine Hydrobromide

B

(1) Internal:

(a) By inhaler

(b) Otherwise than by inhaler

(b) 300mcg (MD) 900mcg (MDD)

(2) External (except local ophthalmic use)

Hyoscine Methobromide

B

(1) Internal:

(a) By inhaler

(b) Otherwise than by inhaler

(b) 2.5mg (MD) 7.5mg (MDD)

(2) External

Hyoscine Methonitrate

B

(1) Internal:

(a) By inhaler

(b) Otherwise than by inhaler

(b) 2.5mg (MD) 7.5mg (MDD)

(2) External

Hyoscyamine

B

(1) Internal:

(a) By inhaler

(b) Otherwise than by inhaler

(b) 300mcg (MD) lmg (MDD)

(2) External

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

(3) Preparations for the relief of asthma in the form of cigarettes, smoking mixtures or fumigants which contain Hyoscyamine as an alkaloid of Stramonium

Hyoscyamine

B

(1) Internal:

Hydrobromide

(a) By inhaler

(b) Otherwise than by inhaler

(b) Equivalent of 300mcg of Hyoscyamine (MD) Equivalent of lmg of Hyoscyamine (MDD)

(2)External

Hyoscyamine Sulphate

B

(1) Internal:

(a) By inhaler

(b) Otherwise than by inhaler

(b) Equivalent of 300mcg of Hyoscyamine (MD) Equivalent of lmg of Hyoscyamine (MDD)

(2) External

(1) Internal:

(1)

400mg (MD) l,200mg

(MDD)

Ibuprofen

B

Rheumatic and muscular pain, backache,

neuralgia,

migraine,

headache,

dental pain,

dysmenorrhoea,

feverishness,

symptoms of colds and influenza

(2)5.0 per cent (MS) 30.0g (MPS)

(2) External: Rheumatic and muscular pain

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substances

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Idarubicin Hydrochloride

A

Idoxuridine

A

0.1 per cent (MS)

External (except local ophthalmic use): Cold sores

Ifosfamide

A

Ignatius Bean

B

Imipramine

A

Imipramine Hydrochloride

A

Imipramine Resinate

A

Impromidine Hydrochloride

A

Indapamide Hemihydrate

B

Indomethacin

B

Indoprofen

B

Indoramin Hydrochloride

B

Inosine Pranobex

A

Interferon Alfa

A

Interferon Beta

A

Interferon Gamma

A

Iobenamic Acid

C

Iocarmate Meglumine

C

Iocarmic Acid

C

Iodamide

C

Iodamide Meglumine

C

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Iodamide Sodium

C

Iodipamide

C

Iodipamide Meglumine

C

Iodised Oil

C

Iodohippurate Sodium

C

Iodoxamate Meglumine

C

Iodoxamic Acid

C

Ioglicate Meglumine

C

Ioglicic Acid

C

Ioglycamate Meglumine

C

Ioglycamate Sodium

C

Ioglycamic Acid

C

Iohexol

C

Iopamidol

C

Iopanoic Acid

C

Iophendylate

C

Iopromide

C

Iotasul

C

Iothalamate Meglumine

C

Iothalamate Sodium

C

Iothalaimic Acid

C

Iotrolan

C

Iotroxate Meglumine

C

Iotroxic Acid

C

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Ioxaglate Meglumine

C

Ioxaglate Sodium

C

Ioxaglic Acid

C

Ioxitalamate Meglumine

C

Ioxitalamate Sodium

C

Ioxitalamic Acid

C

Ipodate Calcium

C

Ipodate Sodium

C

Ipratropium Bromide

B

Iprindole Hydrochloride

A

Iproniazid Phosphate

A

Isoaminile

B

Isoaminile Citrate

B

Isocarboxazid

A

Isoconazole Nitrate

B

External (except vaginal use)

Isoetharine

B

Isoetharine Hydrochloride

B

Isoetharine Mesylate

B

Isoniazid

B

Isoprenaline Hydrochloride

B

Isoprenaline Sulphate

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Isopropamide Iodide

B

Equivalent of 2.5mg of Isopropamide (MD) Equivalent of 5.0mg of Isopropamide (MDD)

Isosorbide Dinitrate

B

Isosorbide Mononitrate

B

Isotretinoin

A

Isoxicam

B

Isoxsuprine Hydrochloride

B

Isradipine

B

Itraconazole

B

Jaborandi

B

External

Kanamycin Sulphate

A

Ketamine Hydrochloride

A

Ketazolam

A

Ketoconazole

B

External (except vaginal use)

Ketoprofen

B

2.5 per cent (MS) 30.0g (MPS)

External: Rheumatic and muscular pain

Ketorolac

B

Ketorolac Trometamol

B

Ketotifen Fumarate

B

Labetolol Hydrochloride

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Lamotrigine

B

Lanatoside C

B

Lanatoside Complex A, B and C

B

Latamoxef Disodium

A

Leuprorelin Acetate

A

Levallorphan Tartrate

B

Levamisole

A

Levamisole Hydrochloride

B

Anthelmintic

Levobunolol Hydrochloride

B

Levodopa

B

Levorphanol Tartrate

A

Lidoflazine

A

Lignocaine

A

Any use except local ophthalmic use

Lignocaine Hydrochloride

A

Any use except local ophthalmic use

Lincomycin

A

Lincomycin Hydrochloride

A

Liothyronine Sodium

B

Lisinopril

B

Lisuride Maleate

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Lithium Carbonate

A

Equivalent of 5mg of Lithium (MD) Equivalent of 15mg of Lithium (MDD)

Lithium Succinate

B

Lithium Sulphate

A

Equivalent of 5mg of Lithium (MD) Equivalent of 15mg of Lithium (MDD)

Lobeline

B

(1) Internal

(1) 3mg (MD) 9mg (MDD)

(2) External

Lobeline Hydrochloride

B

(1) Internal

(1) Equivalent of 3mg of Lobeline (MD) Equivalent of 9mg of Lobeline (MDD)

(2) External

Lobeline Sulphate

B

(1) Internal

(1) Equivalent of 3mg of Lobeline (MD) Equivalent of 9mg of Lobeline (MDD)

(2) External

Lodoxamide

B

Lodoxamide Ethyl

B

Lodoxamide Tromethamine

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Lodoxamide Tromethamol

B

Lofepramine

A

Lofexidine Hydrochloride

B

Lomustine

A

Loperamide Hydrochloride

B

Treatment of acute diarrhoea

Loprazolam Mesylate

A

Loratadine

B

10mg (MS) 10 (MPS)

10mg (MDD)

Lorazepam

A

Lormetazepam

A

Loxapine

B

Loxapine Succinate

B

Luteinising Hormone

A

Lymecycline

A

Lynoestrenol

A

Lypressin

A

Lysuride Maleate

B

Mafenide

A

Mafenide Acetate

A

Mafenide Hydrochloride

A

Mafenide Propionate

A

5.0 per cent (MS)

Eye drops

Magnesium Fluoride

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Magnesium Metrizoate

B

Mandragora Autumnalis

B

Mannomustine Hydrochloride

A

Maprotiline Hydrochloride

B

Mazindol

A

Mebanazine

A

Mebendazole

B

Internal

Mebeverine Hydrochloride

B

Internal

Mebhydrolin

B

Mebhydrolin Napadisylate

B

Mecamylamine Hydrochloride

B

Mecillinam

A

Meclofenoxate Hydrochloride

B

Medazepam

A

Medicinal Opium

A

(1) Equivalent of 0.02 per cent of an-hydrous morphine (MS)

(1) Liquids

(1) Equivalent of 3mg of anhydrous morphine (MD)

(2) Equivalent of 0.04 per cent of an-hydrous morphine (MS)

(2) Solids

(2) Equivalent of 3mg of anhydrous morphine (MD)

Medigoxin

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Medrogestone

A

Medroxyprogesterone Acetate

A

Medrysone

A

Mefenamic Acid

B

Mefloquin Hydrochloride

B

Prophylaxis of malaria

Mefruside

B

Megestrol

A

Megestrol Acetate

A

Meglumine Antimonate

A

Melperone

A

Melperone Hydrochloride

A

Melphalan

A

Melphalan Hydrochloride

A

Menotrophin

A

Mepenzolate Bromide

B

25mg (MD)

75mg (MDD)

Mephenesin

B

Mephenesin Carbamate

B

Mepindolol

B

Mepivacaine Hydrochloride

A

Any use except local ophthalmic use

Meprobamate

A

Meptazinol Hydrochloride

A

Mequitazine

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Mercaptopurine

A

Mercuric Chloride

B

Mercuric Iodide

B

Mersalyl

B

Mersalyl Acid

B

Mesalazine

B

Mesna

A

Mesterolone

A

Mestranol

A

Metaraminol Tartrate

B

Meteneprost

C

Metergoline

A

Metformin Hydrochloride

B

Methacycline

A

Methacycline Calcium

A

Methacycline Hydrochloride

A

Methadone Hydrochloride

A

Methallenoestril

A

Methandienone

A

Methapyrilene Fumarate

A

Methapyrilene Hydrochloride

A

Methaqualone

A

Methenolone Acetate

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Methenolone Enanthate

A

Methicillin Sodium

A

Methiodal Sodium

C

Methixene

B

Methixene Hydrochloride

B

Methocarbamol

B

Methocidin

A

Throat lozenges and throat pastilles

Methohexitone Sodium

A

Methoin

B

Methoserpidine

B

Methotrexate

A

Methotrexate Sodium

A

Methotrimeprazine

B

Methotrimeprazine Hydrochloride

B

Methotrimeprazine Maleate

B

Methoxamine Hydrochloride

B

0.25 per cent (MS)

Nasal sprays or nasal drops not containing liquid paraffin as a vehicle

Methsuximide

B

Methyclothiazide

B

Methylcysteine Hydrochloride

B

Internal

Methylamphetamine Hydrochloride

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Methyldopa

B

Methyldopate Hydrochloride

B

Methylephedrine Hydrochloride

B

Methylphenidate Hydrochloride

A

Methylphenobarbitone

A

Methylprednisolone

A

Methylprednisolone Acetate

A

Methylprednisolone Sodium Succinate

A

Methyltestosterone

A

Methylthiouracil

B

Methyprylone

A

Methysergide Maleate

B

Metipranolol

B

Metirosine

A

Metoclopramide Hydrochloride

B

Metolazone

B

Metoprolol Fumarate

B

Metoprolol Succinate

B

Metoprolol Tartrate

B

Metrizoate Calcium

C

Metrizoate Sodium

C

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Metrizoic Acid

C

Metrizamide

C

Metronidazole

B

Metyrapone

B

Mexiletine Hydrochloride

B

Mezlocillin Sodium

A

Mianserin Hydrochloride

B

Miconazole

B

External (except vaginal use)

Miconazole Nitrate

B

External (except vaginal use)

Midazolam

A

Midodrine Hydrochloride

B

Mifepristone

C

Milrinone

B

Milrinone Lactate

B

Minocycline

A

Minocycline Hydrochloride

A

Minoxidil

B

Misoprostol

A

Mistletoe (Viscum album L)

A

Mithramycin

A

Mitobronitol

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Mitomycin C

A

Mitozantrone Hydrochloride

A

Mitrizoate

C

Meglumine

Moclobemide

A

Molindone Hydrochloride

B

Molsidocane

B

Molsidomine

B

Mopidamol

A

Morazone Hydrochloride

B

Morphine Hydrochloride

A

(1) Equivalent of 0.02 per cent of anhydrous morphine (MS)

(1) Liquids

(1) Equivalent of 3mg of anhydrous morphine (MD)

(2) Equivalent of 0.04 per cent of anhydrous morphine; equivalent of 300 mcg of anhydrous morphine (MS)

(2) Solids

(2) Equivalent of 3 mg of anhydrous morphine (MD)

Morphine Sulphate

A

(1) Equivalent of 0.02 per cent of anhydrous morphine (MS)

(1) Liquids

(1) Equivalent of 3mg of anhydrous morphine (MD)

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

(2) Equivalent of 0.04 per cent of anhydrous morphine; equivalent of 300mcg of anhydrous morphine (MS)

(2) Solids

(2) Equivalent of 3mg of anhydrous morphine (MD)

Mupirocin

A

Mustine Hydrochloride

A

Nabilone

A

Nabumetone

B

Nadolol

B

Nafarelin Acetate

A

Naftidrofuryl Oxalate

B

Nalbuphine Hydrochloride

A

Nalidixic Acid

A

Nalorphine Hydrobromide

A

Nalorphine Hydrochloride

A

Naloxone Hydrochloride

A

Naltrexone Hydrochloride

A

Nandrolone Decanoate

A

Nandrolone Laureate

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Nandrolone Phenylpropionate

A

Naphazoline Hydrochloride

B

(1) 0.05 per cent (MS)

(1) Nasal sprays or nasal drops not containing liquid paraffin as a vehicle

(2) 0.015 per cent (MS)

(2) Eye drops

Naphazoline Nitrate

B

(1) 0.05 per cent (MS)

(1) Nasal sprays or nasal drops not containing liquid paraffin as a vehicle

(2) 0.015 per cent (MS)

(2) Eye drops

Naproxen

B

5.0 per

cent (MS) 30.0g (MPS)

External:

Rheumatic and muscular pain

Naproxen Sodium

B

Natamycin

A

Nedocromil Sodium

B

Nefopam Hydrochloride

B

Neomycin

A

Neomycin Oleate

A

Neomycin Palmitate

A

Neomycin Sulphate

A

Neomycin Undecanoate

A

Neostigmine Bromide

B

Neostigmine Methylsulphate

B

Netilmicin Sulphate

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Nialamide

A

Nicardipine Hydrochloride

B

Niclosamide

B

Nicotine

B

Internal: Oral dosage forms

4 mg (MD)

60 mg (MDD)

Nicotine Resinate

B

Internal:

Oral

dosage forms

Equivalent of 4 mg of Nicotine

(MD) Equivalent of 60 mg of

Nicotine

(MDD)

Nicoumalone

B

Nifedipine

B

Nifenazone

B

Nikethamide

B

Nimetazepam

A

Nimodipine

B

Nimorazole

B

Niridazole

B

Nitrazepam

A

Nitrofurantoin

B

Nitrofurazone

B

Nizatidine

B

Nomifensine Maleate

A

Noradrenaline

B

Noradrenaline Acid Tartrate

B

Nordiazepam

A

Norethandrolone

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Norethisterone

A

Norethisterone Acetate

A

Norethisterone Heptanoate

A

Norethynodrel

A

Norfloxacin

A

Norgestimate

A

Norgestrel

A

Nortriptyline Hydrochloride

A

Noscapine

B

Noscapine Hydrochloride

B

Novobiocin Calcium

A

Novobiocin Sodium

A

Nux Vomica Seed

B

Nystatin

B

External (except vaginal use)

Octacosactrin

A

Octreoide

A

Octreotide Acetate

A

Oestradiol

A

Oestradiol Benzoate

A

Oestradiol Cypionate

A

Oestradiol Dipropionate

A

Oestradiol Diundecanoate

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Oestradiol Enanthate

A

Oestradiol Phenylpropionate

A

Oestradiol Undecanoate

A

Oestradiol Valerate

A

Oestriol

A

Oestriol Dihemisuccinate

A

Oestrogenic Substances Conjugated

A

Oestrone

A

Ofloxacin

A

Olsalazine Sodium

B

Omeprazole

B

Ondansetron Hydrochloride

A

Opipramol Hydrochloride

A

Orciprenaline Sulphate

B

Orphenadrine Citrate

B

Orphenadrine Hydrochloride

B

Ouabain

B

Ovarian Gland Dried

A

Oxamniquine

B

Oxandrolone

A

Oxantel Pamoate

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Oxatomide

B

Oxazepam

A

Oxazolam

A

Oxedrine Tartrate

B

Oxiconazole Nitrate

B

Oxidronate Sodium

A

Oxitropium Bromide

B

Oxolinic Acid

B

Oxpentifylline

B

Oxprenolol Hydrochloride

B

Oxybuprocaine Hydrochloride

B

Any use except local ophthalmic use

Oxybutynin Hydrochloride

B

Oxycodone Hydrochloride

A

Oxycodone Pectinate

A

Oxymetholone

A

Oxypertine

B

Oxypertine Hydrochloride

B

Oxyphenbutazone

B

Oxyphencyclimine Hydrochloride

B

Oxyphenonium Bromide

B

5 mg (MD)

15 mg (MDD)

Oxytetracycline

A

Oxytetracycline Calcium

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Oxytetracycline Dihydrate

A

Oxytetracycline Hydrochloride

A

Oxytocin, natural

B

Oxytocin, synthetic

B

Pamidronate Disodium

A

Pancuronium Bromide

A

Papaveretum

A

Papaverine

B

(1) By inhaler

(2) Otherwise than by inhaler

(2) 50mg (MD) l50mg (MDD)

Papaverine Hydrochloride

B

(1) By inhaler

(2) Otherwise than by inhaler

(2) Equivalent of 50mg of Papaverine (MD) Equivalent of l50mg of Papaverine (MDD)

Paracetamol

B

1g (MD)

4g (MDD)

Paraldehyde

B

Paramethadione

B

Paramethasone Acetate

A

Parathyroid Gland

A

Pargyline Hydrochloride

A

Paroxetine Hydrochloride

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Pecilocin

A

Pemoline

A

Pempidine Tartrate

B

Penamecillin

A

Penbutolol Sulphate

B

Penfluridol

A

Penicillamine

B

Penicillamine Hydrochloride

B

Pentaerythritol Tetranitrate

B

Pentagastrin

A

Pentamidine

A

Pentamidine Isethionate

A

Pentazocine Hydrochloride

A

Pentazocine Lactate

A

Penthienate Methobromide

B

5mg (MD)

15mg (MDD)

Pentobarbitone

A

Pentobarbitone Sodium

A

Pentolinium Tartrate

B

Pentyl Nitrite

A

Pergolide Mesylate

B

Perhexiline Maleate

B

Pericyazine

B

Perindopril

B

Permethrin

B

External

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Perphenazine

B

Pethidine Hydrochloride

A

Phenacetin

A

0.1 per

cent (MS)

External

Phenazone

B

External

Phenazone and Caffeine Citrate

B

Phenazone Salicylate

B

Phenbutrazate Hydrochloride

A

Phenelzine Sulphate

A

Phenethicillin Potassium

A

Phenformin Hydrochloride

B

Phenglutarimide Hydrochloride

B

Phenindione

B

Phenmetrazine Hydrochloride

A

Phenobarbitone

A

Phenobarbitone Sodium

A

Phenoperidine Hydrochloride

A

Phenothrin

B

External

Phenoxybenzamine Hydrochloride

B

Phenoxymethylpenicillin

A

Phenoxymethylpenicillin Calcium

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Phenoxymethylpenicillin Potassium

A

Phenprocoumon

B

Phensuximide

B

Phentermine Hydrochloride

A

Phentermine Resinate

A

Phentolamine Hydrochloride

B

Phentolamine Mesylate

B

Phenylbutazone

A

Phenylbutazone Sodium

A

Phenylephrine Bitartrate

B

Internal

Equivalent of 10mg of Phenylephrine Hydrochloride (MD)

Equivalent of 40mg of Phenylephrine Hydrochloride (MDD)

Phenylephrine Hydrochloride

B

(1) Internal (other than controlled release capsules and tablets, nasal sprays and nasal drops)

(1) 10mg (MD)

40mg (MDD)

(2) controlled release capsules and tablets

(2) 20mg (MD)

40mg (MDD)

(3) 0.5

per cent

(MS)

(3) nasal sprays and nasal drops

(4) External (except local ophthalmic use)

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Phenylmethyl-barbituric Acid

A

Phenylpropanolamiine Hydrochloride

B

Internal:

(1) all preparations except controlled release capsules, nasal sprays and nasal drops

(1) 25mg

(MD)

100mg (MDD)

(2) controlled release capsules

(2) 50mg (MD)

100mg (MDD)

(3) 2.0 per cent

(3) nasal sprays and nasal drops

Phenylpropanolamine resinate

B

Internal

Equivalent of 50mg of phenlypropanolamine hydrochloride (MD)

Equivalent of 100mg of phenylpronenolamine hydrochloride

(MDD)

Phenytoin

B

Phenytoin Sodium

B

Pholcodine

A

1.5 per cent

(MS)

20mg (MD)

Pholcodine Citrate

A

Equivalent of 1.5 per cent of Pholcodine (MS)

Equivalent of 20mg of Pholcodine (MD)

Pholcodine Tartrate

A

Equivalent of 1.5 per cent of Pholcodine (MS)

Equivalent of 20mg of Pholcodine (MD)

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Phthalylsulphathiazole

B

Physostigmine

B

Physostigmine Aminoxide Salicylate

B

Physostigmine Salicylate

B

Physostigmine Sulphate

B

Picrotoxin

B

Pilocarpine

B

Pilocarpine Hydrochloride

B

Pilocarpine Nitrate

B

Pimozide

B

Pinacidil

B

Pinazepam

A

Pindolol

B

Pipenzolate Bromide

B

5mg (MD)

15mg (MDD)

Piperacillin Sodium

A

Piperazine Oestrone Sulphate

A

Piperidolate Hydrochloride

B

50mg (MD)

150mg (MDD)

Pipothiazine Palmitate

B

Pipradrol Hydrochloride

A

Piracetam

B

Pirbuterol Acetate

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Pirbuterol Hydrochloride

B

Pirenzepine Hydrochloride

A

Piretanide

B

Piritramide

A

Piromidic Acid

A

Piroxicam

B

0.5 per cent (MS) 30.0g (MPS)

External: Rheumatic and muscular pain

Pirprofen

B

Pituitary Gland (Whole Dried)

B

Pituitary Powdered (Posterior Lobe)

B

Pivampicillin Hydrochloride

A

Pivmecillinam

A

Pivmecillinam Hydrochloride

A

Pizotifen

B

Pizotifen Maleate

B

Podophyllotoxin

B

Podophyllum

B

Podophyllum Indian

B

Podophyllum Resin

B

20.0 per cent (MS)

External

Poke Root (Phytolacca Species)

A

Poldine Methylsulphate

B

2mg (MD)

6mg (MDD)

Polidexide

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Polyestradiol Phosphate

A

Polymyxin B Sulphate

A

Polythiazide

B

Poppy Capsule

A

Potassium Arsenite

B

0.0127 per cent (MS)

Potassium Bromide

B

Potassium Perchlorate

B

Practolol

B

Pralidoxime Chloride

B

Pralidoxime Iodide

B

Pralidoxime Mesylate

B

Pravastatin

B

Pravastatin Sodium

B

Prazepam

A

Prazosin Hydrochloride

B

Prednisolone

A

Prednisolone 21-Steglate

A

Prednisolone Acetate

A

Prednisolone Butylacetate

A

Prednisolone Hexanoate

A

Prednisolone Sulphoebenzoate

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Prednisolone Pivalate

A

Prednisolone Sodium m-Sulphobenzoate

A

Prednisolone Sodium Phosphate

A

Prednisone

A

Prednisone Acetate

A

Prenalterol Hydrochloride

B

Prenylamine Lactate

B

Prilocaine Hydrochloride

A

Any use except local ophthalmic use

Primidone

B

Probenecid

B

Probucol

B

Procainamide Hydrochloride

B

Procaine Hydrochloride

A

Any use except local ophthalmic use

Procaine Penicillin

A

Procarbazine Hydrochloride

A

Procaterol Hyrdochloride

B

Prochlorperazine Edisylate

B

Prochlorperazine Maleate

B

Prochlorperazine Mesylate

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Procyclidine Hydrochloride

B

Progesterone

A

Proguanil Hydrochloride

B

Prophylaxis of malaria

Prolactin

A

Proligestone

A

Prolintane Hydrochloride

A

Promazine Embonate

B

Promazine Hydrochloride

B

Propafenone Hydrochloride

B

Propanidid

B

Propantheline Bromide

B

15mg (MD)

45mg (MDD)

Propizepine

A

Propofol

A

Propranolol Hydrochloride

B

Propyliodone

C

Propylthiouracil

B

Proquazone

B

Proscillaridin

B

Protamine Sulphate

B

Prothionamide

B

Protirelin

B

Protriptyline Hydrochloride

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Proxymetacaine Hydrochloride

B

Any use except local ophthalmic use

Pseudoephedrine Hydrochloride

B

Internal:

(1) All preparations except controlled release capsules and tablets

(1) 60mg

(MD)

180mg

(MDD)

(2) Controlled release capsules and tablets

(2) 180mg (MDD)

Pseudoephedrine Sulphate

B

Internal:

(1) All preparations except controlled release capsules and tablets

(1) 60mg

(MD)

180mg

(MDD)

(2) Controlled release capsules and tablets

(2) 180mg (MDD)

Pyrantel Embonate

B

Pyrantel Tartrate

B

Pyrazinamide

B

Pyridostigmine Bromide

B

Pyridoxine Hydrochloride

B

50mg (MD)

l00mg (MDD)

Pyrimethamine

B

Quazepam

A

Quinalbarbitone

A

Quinalbarbitone Sodium

A

Quinapril

B

Quinapril Hydrochloride

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Quinestradol

A

Quinestrol

A

Quinethazone

B

Quinidine

B

Quinidine Bisulphate

B

Quinidine Phenylethylbarbiturate

A

Quinidine Polygalacturonate

B

Quinidine Sulphate

B

Quinine

B

100mg (MD)

300mg (MDD)

Quinine and Urea Hydrochloride

B

Quinine Bisulphate

B

Equivalent of 100mg of Quinine (MD) Equivalent of 300mg of Quinine (MDD)

Quinine Dihydrochloride

B

Equivalent of l00mg of Quinine (MD) Equivalent of 300mg of Quinine (MDD)

Quinine Ethyl Carbonate

B

Equivalent of 100mg of Quinine (MD) Equivalent of 300mg of Quinine (MDD)

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Quinine Glycerophosphate

B

Equivalent of 100mg of Quinine (MD) Equivalent of 300mg of Quinine (MDD)

Quinine Hydrobromide

B

Equivalent of 100mg of Quinine(MD)Equivalent of 300mg of (MDD)

Quinine Hydrochloride

B

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Iodobismuthate

B

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Phenyl-cinchoninate

B

Equivalent of 100mg of Quinine (MD)

Equivalent of 300mg of Quinine (MDD)

Quinine Phosphate

B

Equivalent of 100mg of Quinine (MD)Equivalent of 300mg of Quinine (MDD)

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Quinine Salicylate

B

Equivalent of 100mg of Quinine (MD) Equivalent of 300mg of Quinine (MDD)

Quinine Sulphate

B

Equivalent of 100mg of Quinine (MD) Equivalent of 300mg of Quinine (MDD)

Quinine Tannate

B

Equivalent of 100mg of Quinine (MD) Equivalent of 300mg of Quinine (MDD)

Radionuclide compounds

C

Radionuclides

C

Ragworth (Senecio jacobaea L)

A

Ramipril

B

Ranitidine Hydrochloride

B

Rauwolfia Serpentina

B

Rauwolfia Vomitoria

B

Razoxane

A

Remoxipride Hydrochloride

A

Reproterol Hydrochloride

B

Rescinnamine

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Reserpine

B

Rifampicin

A

Rifamycin

A

Rimiterol Hydrobromide

B

Ritodrine Hydrochloride

B

Rolitetracycline Nitrate

A

Rosoxacin

A

Sabadilla

B

Safrole

A

Salbutamol

B

Salbutamol Sulphate

B

Salcatonin

B

Salcatonin Hydrated Polyacetate

B

Salmefamol

B

Salmeterol

B

Salmeterol Xinafoate

B

Salsalate

B

Saralasin Acetate

B

Sassafras Bark

A

Sassafras Oil

A

Sassafras Root

A

Secbutobarbitone

A

Secbutobarbitone Sodium

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Secretin

B

Selegiline Hydrochloride

B

Sera and Antisera:—

Botulin Antitoxin

A

Diphtheria Antitoxin

A

Gas-gangrene Antitoxin (Oedematiens)

A

Gas-gangrene Antitoxin (Perfringens)

A

Gas-gangrene Antitoxin (Septicum)

A

Leptospira Antiserum

A

Mixed Gas-gangrene Antitoxin

A

Rabies Antiserum

A

Scorpion Venom Antiserum

A

Serum Gonadetrophin

A

Snake Venom Antiserum

A

Tetanus Antitoxin

A

Sermorelin

A

Sermorelin Acetate

A

Sertraline Hydrochloride

A

Simvastatin

B

Sissomicin

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Sissomicin Sulphate

A

Snake Venoms

B

Sodium Aminosalicylate

B

Sodium Antimonylgluconate

B

Sodium Arsanilate

B

Sodium Arsenate

B

Sodium Arsenite

B

0.013 per cent (MS)

Sodium Bromide

B

Sodium Fluoride

B

(1) 0.33 per cent

(MS)

(1) Dentifrices

(2) Other preparations for use in the prevention of dental caries in the form of:—

(a) tablets or drops

(a) 2.2mg

(MDD)

(b) 0.2 per cent (MS)

(b) mouth rinses other than those for daily use

(c) 0.05 per cent (MS)

(c) mouth rinses for daily use

Sodium Fusidate

A

Sodium Metrizoate

B

Sodium Monofluorophosphate

B

1.14 per cent (MS)

Dentifrice

Sodium Stibogluconate

B

Somatorelin

A

Somatotrophin

A

Somatrem

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Somatropin

A

Sotalol Hydrochloride

B

Spectinomycin

A

Spectinomycin Hydrochloride

A

Spiramycin

A

Spiramycin Adipate

A

Spironolactone

A

Stannous Flouride

B

0.62 per cent (MS)

Dentifrice

Stanolonetanozoid

A

Stenbolone Acetate

A

Stilboestrol

A

Stilboestrol Dipropionate

A

Streptodornase

B

External

Streptokinase

B

External

Streptomycin

A

Streptomycin Sulphate

A

Strophanthin-K

B

Strychnine

B

Strychnine Arsenate

B

Strychnine Hydrochloride

B

Styramate

B

Succinyl-sulphathiazole

B

Sufentanil Citrate

A

Sulbactam Sodium

A

Sulbactam Tosylate

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Sulbenicillin

A

Sulbenicillin Sodium

A

Sulconazole Nitrate

B

External (except vaginal use)

Sulfacytine

A

Sulfadoxine

A

Sulfametopyrazine

A

Sulfamono-methoxine

A

Sulindac

B

Suloctidil

B

Sulphacetamide

A

Sulphacetamide Sodium

A

Sulphadiazine

A

Sulphadiazine Silver

A

Sulphadiazine Sodium

A

Sulphadimidine

A

Sulphadimidine Sodium

A

Sulphafurazole

A

Sulphafurazole Diethanolamine

A

Sulphaguanidine

B

Sulphaloxate Calcium

A

Sulphaloxic Acid

B

Sulphamerazine

A

Sulphamerazine Sodium

A

Sulphamethizole

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Sulphamethoxazole

A

Sulphamethoxydiazine

A

Sulphamethoxypyridazine

A

Sulphamethoxypyridazine Sodium

A

Sulphamoxole

A

Sulphaphenazole

A

Sulphanilamide

A

Sulphanilamide, N-Benzoyl

A

Sulphapyridine

A

Sulphapyridine Sodium

A

Sulphasalazine

B

Sulphathiazole

A

Sulphathiazole Sodium

A

Sulphaurea

A

Sulphinpyrazone

B

Sulpiride

B

Sulprostone

C

Sultamicillin

A

Sultamicillin Tosylate

A

Sulthiame

B

Sumatriptan

B

Sumatriptan Hemisuccinate

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Sumatriptan Succinate

B

Sutoprofen

B

Suxamethonium Bromide

A

Suxamethonium Chloride

A

Suxethonium Bromide

A

Tacrine Hydrochloride

A

Talampicillin

A

Talampicillin Hydrochloride

A

Talampicillin Napsylateamoxifen

A

Tamoxifen Citrate

A

Taurolidine

B

Teicoplanin

A

Temafloxacin

A

Temafloxacin Hydrochloride

A

Temazepam

A

Temocillin

A

Temocillin Sodium

A

Teniposide

A

Tenoxicam

B

Terazosin Hydrochloride

B

Terbutaline

B

Terbutaline Sulphate

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Terfenadine

B

120mg

(MS)

10 (MPS)

120mg

(MDD)

Terlipressin

A

Terodiline Hydrochloride

B

Tertatolol Hydrochloride

B

Testosterone

A

Testosterone 17ß Chloral Hemiacetal

A

Testosterone Acetate

A

Testosterone Cyclohexylpropionate

A

Testosterone Cypionate

A

Testosterone Decanoate

A

Testosterone Enanthate

A

Testosterone Isocaproate

A

Testosterone Phenylpropionate

A

Testosterone Propionate

A

Testosterone Undecanoate

A

Tetrabenazine

B

Tetracosactrin

A

Tetracosactrin Acetate

A

Tetracycline

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Tetracycline Hydrochloride

A

Tetracycline Phosphate Complex

A

Tetrazepam

A

Thallium Acetate

A

Thallous Chloride

A

Theophylline

B

Thiambutosine

B

Thiamphenicol

A

Thiamphenicol Glycinate Hydrochloride

A

Thiamphenicol Palmitate

A

Thiethylperazine

B

Thiethylperazine Malate

B

Thiethylperazine Maleate

B

Thiocarlide

B

Thioguanine

A

Thiopentone Sodium

A

Thiopropazate Hydrochloride

B

Thioproperazine Mesylate

B

Thioridazine

B

Thioridazine Hydrochloride

B

Thiosinamine

A

Thiotepa

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Thiothixene

B

Thiouracil

B

Thymoxamine Hydrochloride

B

Thyroid

B

Thyrotrophin

A

Thyroxine Sodium

B

Tiamulin Fumarate

A

Tiaprofenic Acid

B

Tibezonium Iodide

A

Tibolone

A

Ticarcillin Sodium

A

Tienilic Acid

B

Tigloidine Hydrobromide

B

Timolol Maleate

B

Tinidazole

B

Tinzaparin Sodium

A

Tioconazole

B

External (except vaginal use)

Tizanidine Hydrochloride

A

Tobramycin Sulphate

A

Tocainide Hydrochloride

B

Tofenacin Hydrochioride

B

Tofisopam

A

Tolazamide

B

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substances

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Tolazoline Hydrochloride

B

External

Tolbutamide

B

Tolbutamide Sodium

B

Tolmetin Sodium

B

Tolobuterol Hydrochloride

B

Tolrestat

B

Tramazoline Hydrochloride

B

Tranexamic Acid

B

Tranylcypromine Sulphate

A

Trazodone Hydrochloride

B

Trenbolone Acetate

A

Treosulfan

A

Tretinoin

B

Triamcinolone

A

Triamcinolone Acetonide

A

Triamcinolone Diacetate

A

Triamcinolone Hexacetonide

A

Triamterene

B

Triazolam

A

Tribavirin

A

Triclofos Sodium

B

Trientine Hydrochloride

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Trifluoperazine

B

Trifluoperazine Hydrochloride

B

Trifluperidol

A

Trifluperidol Hydrochloride

A

Trilostane

A

Trimazosin Hydrochloride

B

Trimeprazine

B

Trimeprazine Tartrate

B

Trimetaphan Camsylate

B

Trimetazidine

B

Trimetazidine Hydrochloride

B

Trimethoprim

A

Trimipramine Maleate

A

Trimipramine Mesylate

A

Triptorelin

A

Tropicamide

B

Tropicamide

A

Troxidone

B

L-Tryptophan

B

External

Tubocurarine Chloride

A

Tulobuterol Hydrochloride

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Tyropanoate Sodium

C

Tyrothricin

A

Throat lozenges and throat pastilles

Uramustine

A

Urapidil

B

Urea Stibamine

B

Urethane

A

Uridine-5-Triphosphoric Acid

B

Urofollitrophin

A

Urokinase

B

Ursodeoxycholic Acid

B

Vaccines:—

Anthrax Vaccine (Bacillus Anthracis)

A

Bacillus Calmette-Guerin Vaccine

A

Bacillus Calmette-Guerin Vaccine (Percutaneous)

A

Cholera Vaccine

A

Diphtheria and Tetanus Vaccine

A

Diphtheria and Tetanus Vaccine (Adsorbed)

A

Diphtheria, Tetanus and Pertussis Vaccine

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substances

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed)

A

Diphtheria, Tetanus and Poliomyelitis Vaccine

A

Diphtheria, Tetanus, Pertussis and Poliomyelitis Vaccine

A

Diphtheria Vaccine

A

Diphtheria Vaccine (Adsorbed)

A

Eltor Vaccine

A

Haemophilus Influenza Vaccine

A

Haemophilus Type B Polysaccharide Conjugate Vaccine

A

Hepatitis A Vaccine

A

Hepatitis B Vaccine

A

Hepatitis B Virus Vaccine (Inactivated)

A

Influenza Vaccine

A

Measles, Mumps and Rubella Virus Vaccine (Live)

A

Measles Vaccine (Live Attenuated)

A

Old Tuberculin

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Pertussis Vaccine

A

Plague Vaccine

A

Pneumococcal Vaccine (Bacterial Antigen)

A

Poliomyelitis Vaccine (Inactivated)

A

Poliomyelitis Vaccine (Oral)

A

Rabies Vaccine

A

Rubella Vaccine (Live Attenuated)

A

Schick Control

A

Schick Test Toxin

A

Smallpox Vaccine

A

Smallpox Vaccine (Dried)

A

Tetanus Vaccine

A

Tetanus Vaccine (Adsorbed)

A

Tuberculin Purified Protein Derivative

A

Typhoid and Tetanus Vaccine

A

Typhoid-paratyphoid A and B and Cholera Vaccine

A

Typhoid-paratyphoid A and B and Tetanus Vaccine

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Thphoid-paratyphoid A and B Vaccine

A

Typhoid Vaccine

A

Typhus Vaccine

A

Yellow Fever Vaccine

A

Valproate Sodium

B

Valproic Acid

B

Vancomycin Hydrochloride

A

Vasopressin

A

Vasopressin Tannate

A

Vecuronium Bromide

A

Veralipride

B

Verapamil Hydrochloride

B

Veratrine

B

Veratrum (Green and White)

B

Vidarabine

A

Vigabatrin

B

Viloxazine Hydrochloride

B

Vinblastine Sulphate

A

Vincristine Sulphate

A

Vindesine Sulphate

A

Viomycin Pantothenate

A

Circumstances excluding medical preparations from prescription control

Column 1

Column 2

Column 3

Column 4

Column 5

Substance

Part in Schedule

Maximum Strength and Maximum Pack Size

Use, pharmaceutical form or manner of administration

Maximum dose and Maximum daily dose

Viomycin Sulphate

A

Vitamin A

B

(1) Internal

(1) 7,500 iu (2,250mcg Retinol equivalent) (MDD)

(2) External

Vitamin A Acetate

B

(1) Internal

(1) Equivalent to 7,500 iu Vitamin A (2,250mcg Retinol equivalent) (MDD)

(2) External

Vitamin A Palmitate

B

(1) Internal

(1) Equivalent to 7,500 iu Vitamin A (2,250mcg Retinol equivalent) (MDD)

(2) External

Warfarin

B

Warfarin Sodium

B

Xamoterol Fumarate

B

Xipamide

B

Yohimbine Hydrochloride

B

Zeranol

A

Zidovudine

A

Zimeldine Hydrochloride

A

Zomepirac Sodium

B

Zopiclone

A

Zuclopenthixol

A

Circumstances excluding