THE PHARMACY ACT 1983

THE PHARMACY ACT 1983

Act No. 60 of 1933

I assent.

S. RAMGOOLAM

29 December 1983 Governor-General

ARRANGEMENT OF SECTIONS

Section

PART 1 — PRELIMINARY

PART II — BOARD AND COMMITTEES

PART III — REGISTRATION AND EXAMINATIONS

PART IV — PHARMACEUTICAL TRADE

PART V — POISONS

PART VI — THERAPEUTIC SUBSTANCES

PART VII — MANUFACTURE OF PHARMACEUTICAL PRODUCTS

PART VIII — MISCELLANEOUS

First Schedule (Part 1 Part 2)     Second Schedule    Third Schedule     Fourth Schedule     Fifth schedule     Sixth schedule   

An Act

To amend and consolidate the law relating to the manufacture and sale of pharmaceutical products

ENACTED by the Parliament of Mauritius, as follows—

PART I — PRELIMINARY     Back to top

1. Short title     Back to top

This Act may be cited as the Pharmacy Act 1983.

2. Interpretation.     Back to top

In this Act—

" assistant pharmacist"

means any person registered as such under section 12;

"authorised person"

means

(a) a medical practitioner;

(b ) a dental surgeon; or

(c) a veterinary surgeon

in the exercise of his profession;

" Board"

means the Pharmacy Board established under section 3;

"Committee"

means the Education Committee, the Trade and Therapeutics Committee, the Poisons Committee or the Planning Committee;

" Comptroller"

means the Comptroller of Customs;

"dangerous drug"

has the same meaning as in the Dangerous Drugs Act;

"drug"

means a substance or ingredient intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in a human being or an animal;

Education Committee"

means the Education Committee specified in section 6;

" inspector"

means any public officer designated as such by the Minister:

"manufacture"

, in relation to a pharmaceutical product, includes compound, formulate, fill, package and label or perform any other operation;

"manufacturer"

means a person licensed under section 36;

"medicine"

means a chemical product, preparation, biological product or other substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of any ailment, infirmity or injury affecting a human being or an animal or for dental treatment;

" Permanent Secretary"

means the Permanent Secretary of the Ministry of Health;

"Pesticides Control Board"

means the Pesticides Control Board established under section 3 of the Pesticides Control Act;

" pharmaceutical product"

means a drug, medicine, preparation, poison or therapeutic substance;

"pharmacist"

means any person registered as such under section 12;

" pharmacy"

means any premises where, subject to this Act, any pharmaceutical product may be dispensed, sold, exposed or offered for sale;

" pharmacy technician"

means a person registered as such under section 12 who is a dispenser of pharmaceutical products or assists a pharmacist or an assistant pharmacist in the dispensing of pharmaceutical products;

"Planning Committee"

means the Planning Committee established under section 9;

" poison"—

(a) means a substance specified in the First, Third, Fourth and Fifth Schedules;

(b) subject to paragraph (c), includes any poisonous substance or liquid;

(c) does not include —

(i) a substance which is an ingredient in adhesives, antifouling compositions, builders' materials, ceramics, distempers, electrical valves, enamels, explosives, fillers, fire works; fluorescent lamps, glazes, glue, inks, lacquer solvents, loading materials, machine spread plasters, matches, motor fuels and lubricants, paints other than pharmaceutical paints, photographic paper, pigments, plastics propellants, rubber, surgical dressings, varnishes or vascular plants and their seeds;

(ii) a substance specified in the first column of the Second Schedule and constituted or used in the manner specified in the second column of that Schedule;

(iii) any article containing barium carbonate or zinc phosphide which has been prepared for the destruction of rats or mice;

(iv) cannabis or a cannabis derivative when used as an ingredient in a corn paint.

"Poisons Committee"

means the Poisons Committee established under section 8:

" preparation"

means—

(a) a solution or mixture, in any physical state, containing amedicine or a therapeutic substance; or

(b) a medicine or a therapeutic substance in dosage form;

" prescription"

means a written order for a pharmaceutical product issued by an authorised person:

psychotropic substance"

has the same meaning as in the Psychotropic Substances Act:

" purity"

, in relation to a substance, means the degree to which other chemical or biological entities are present in the substance;

" quality control"

means measures designed to ensure the conformity of raw materials, finished products and stocks with established specifications of identity strength, purity and other characteristics;

" register"

means the register specified in section 11(b):

Registrar"

means the registrar of the Board:

"shelf life"

, in relation to drug, means the period under which the potency of the drug has been maintained under such conditions of storage as may be specified on the label of the drug:

"specified standards"

means such standards as are specified in the British, French, United States or European Pharmacopoeia;

" student"

means a person registered as such under section 14;

" temporary absence"

means any period of absence not exceeding two hours in a day;

" therapeutic substances"—

(a) means a substance whose purity and potency cannot be adequately tested by chemical means: and

(b) includes a preparation;

" Trade and Therapeutics Committee"

means the Trade and Therapeutics Committee established under section 7;

" wholesale pharmacy"

means any premises used or intended to be used for the sale of pharmaceutical products by wholesale.

PART II ---BOARD AND COMMITTEES     Back to top

3. Pharmacy Board.     Back to top

(1) There is established for the purposes of this Act a Pharmacy Board which shall consist of —

(a) the Chief Medical Officer, Chairman;

(b) the Chief Government Pharmacist;

(c) 5 pharmacists appointed by the Minister

(d) a law officer designated by the Attorney-General.

(2) A Government Pharmacist designated by the Minister shall act as Registrar of the Board.

4. Functions of the Board.     Back to top

The Board may, subject to the approval of the Minister—

(a) consider and, if satisfied, approve the qualifications of any person wishing to be registered as a pharmacist, assistant pharmacist, pharmacy technician or student;

(b) exercise control over the manufacture, importation, distribution, sale, and possession of any drug, poison, dangerous drug and psychotropic substance;

(c) on what appears to it to be good cause, take disciplinary action against any pharmacist, assistant pharmacist, pharmacy technician or student;

(d) remove from, or restore to, the register the name of any pharmacist, assistant pharmacist, pharmacy technician or student;

(e) exercise supervision and control over any inspector in the exercise of his functions under this Act;

(f) conduct and appoint examiners for any examination in pharmacy and award diplomas to candidates who succeed at that examination:

(g) grant a licence to any person who wishes to operate any pharmacy;

(h) seek the advice of any committee in respect of any matter relating to this Act;

(i) take such measures as it thinks fit to ensure the implementation of this Act.

5. Meetings of the Board.     Back to top

(1) The quorum of the Board shall be 5.

(2)

(a) The Chairman or, in his absence, the Chief Government Pharmacist shall preside at all meetings of the Board.

(b) In the absence of both the Chairman and the Chief Government Pharmacist from a meeting of the Board, the members present shall elect from among themselves a member to preside at that meeting and the member so elected shall, in relation to that meeting, exercise the functions and have all the powers of the Chairman.

(3) Everything required or authorised to be done by the Board shall be decided by a simple majority of the members present and voting.

(4) At any meeting of the Board, each member shall have one vote on the matter in issue and, in the event of an equality of votes, the Chairman shall have a casting vote.

(5) Subject to the other provisions of this section, the Board shall regulate its meetings in such manner as it thinks fit.

6. Education Committee.     Back to top

(1) There is established for the purposes of this Act an Education Committee which shall advise the Board on —

(a) the qualifications required in respect of persons applying for registration as students;

(b) the organisation of courses of instruction for students and assistant pharmacists;

(c) the preparation of syllabus for any examination in pharmacy;

(d) the appointment of examiners for, and the conduct of, examinations in pharmacy.

(2) The Committee shall consist of—

(a) the Chief Government Pharmacist, Chairman;

(b) a representative of the Ministry of Education and Cultural Affairs;

(c) a representative of the University of Mauritius;

(d) 2 pharmacists appointed by the Minister.

7. Trade and Therapeutics Committee.     Back to top

(1) There is established for the purposes of this Act a Trade and Therapeutics Committee which shall advise the Board on —

(a) any matter relating to the manufacture and importation of pharmaceutical products;

(b) the compilation and maintenance of a National Drugs Formulary;

(c) any reported adverse effect caused by any drug and any measure required to be taken to protect public health;

(d) any area which is in need of a pharmacy.

(e) any matter referred to it by the Board.

(2) The Committee shall consist of —

(a) the Principal Medical Officer, Chairman;

(b) the Chief Government Pharmacist;

(c) a representative of the Ministry of Trade and Shipping;

(d) 3 medical practitioners appointed by the Minister;

(e) 2 pharmacists appointed by the Minister.

8. Poisons Committee.     Back to top

(1) There is established for the purposes of this Act, a Poisons Committee which shall advise the Board on any matter relating to poisons, dangerous drugs and psychotropic substances.

(2) The Committee shall consist of —

(a) the Chief Government Pharmacist, Chairman;

(b) a representative of the Ministry of Agriculture, Fisheries and Natural Resources;

(c) a Government analyst or a Forensic Science Officer with experience in toxicology;

(d) 3 pharmacists appointed by the Minister;

(e) a specialist in general medicine appointed by the Minister.

9. Planning Committee.     Back to top

(1) There is established for the purposes of this Act, a Planning committee which shall advise the Board on any matter relating to the building of any factory which is intended to manufacture pharmaceutical products.

(2) The Committee shall consist of—

(a) a Principal Medical Officer, Chairman;

(b) the Chief Government Pharmacist;

(c) the Chief Government Analyst; and

(d) a Principal Engineer designated by the Minister of Works.

10. Appointed member of Committee.     Back to top

(1) Every appointed member of a committee shall hold office on such terms and conditions as the Minister may determine.

(2) No appointed member of a Committee shall be deemed to hold a public office solely by virtue of his appointment.

(3) Every Committee shall regulate its meetings in such manner as it thinks fit.

PART III—REGISTRATION AND EXAMINATIONS     Back to top

11. Registrar.     Back to top

The Registrar shall—

(a ) act as Secretary to the Board;

(b) keep a register in which he shall record separately the particulars relating to pharmacists, assistant pharmacists, pharmacy technicians and students;

(c) correct any entry in the register which, in the opinion of the Board, is incorrect; and

(d ) keep a record of every licence granted by the Board for operating a pharmacy or wholesale pharmacy.

12. Registration.     Back to top

(1) No person shall practise as a pharmacist, assistant pharmacist or pharmacy technician unless he is registered.

(2) Any person who —

(a) wishes to be registered under this section; and

(b) holds the prescribed qualifications.

shall make a written application to the Registrar for registration.

(3) On receipt of an application under subsection (2), the Registrar shall—

(a) on being satisfied that the applicant holds the prescribed qualifications; and

(b) on payment of the prescribed fee by the applicant,

register, with the approval of the Board, the applicant and issue to him a certificate of registration.

(4) No person shall be registered as a pharmacist unless he has obtained —

(a) a diploma of pharmacist awarded by the Board; or

(b) a diploma or degree in pharmacy acceptable to the Board and satisfies the Board that he reckons a full year's postgraduate practical experience in Mauritius or elsewhere.

(5)

(a) A pharmacist, assistant pharmacist or pharmacy technician shall on or before 15 January in each year pay the prescribed fee to the Registrar for the retention of his name on the register.

(b) The Registrar shall remove from the register the name of any pharmacist, assistant pharmacist or pharmacy technician who fails to pay the prescribed fee.

(c) A name removed from the register under paragraph (b) may be restored on payment of the prescribed fee together with a surcharge of 15 per cent of the prescribed fee.

13. Students.     Back to top

(1) No person shall serve as a student in a pharmacy unless he is registered.

(2) Any person who —

(a) wishes to be registered as a student; and

(b) holds the prescribed qualifications,

shall make a written application to the Registrar for registration.

(3) On receipt of an application under subsection (2), the Registrar shall —

(a) on being satisfied that the applicant holds the prescribed qualifications; and

(b) on payment of the prescribed fee by the applicant,

register the student and issue to him a certificate of registration.

14. Admission to examination.      Back to top

(1) Any student who has —

(a) served a period of 2 years on a full-time basis in a pharmacy; and

(b) followed a course of instruction arranged by the Board,

may apply to the Registrar for admission to the prescribed examination for an assistant pharmacist's diploma or a pharmacy technician's diploma.

(2) The applicant shall, on succeeding at the prescribed examination, be awarded an assistant pharmacist's diploma or a pharmacy technician's diploma.

(3) Every pharmacist under whose supervision a student has served on a full-time basis in a pharmacy shall, on request, submit to the Board a written statement certifying the period of training served by the student under his supervision.

15. Pharmacist's diploma.     Back to top

Any person who has—

(a) been awarded the assistant pharmacist's diploma;

(b) practised as an assistant pharmacist in a pharmacy for a period of 2 years; and

(c) followed a course of instruction arranged by the Board,

may apply to the Registrar for admission to the prescribed examination for the pharmacist's diploma.

16. Examinations.     Back to top

No person shall be admitted to any prescribed examination unless his application is accompanied by a certificate from the supervisor in charge of the course of instruction specified in section 14 or 15 to the effect that the applicant has attended the course regularly.

PART IV — PHARMACEUTICAL TRADE     Back to top

17. Sale of pharmaceutical products.     Back to top

(1) No person shall sell in a pharmacy any article other than —

(a) a pharmaceutical product:

(b) a surgical, medical, scientific or hygienic appliance;

(c) a toilet preparation; or

(d) such other product as may be prescribed which is used, prepared or sold for a medical, scientific, hygienic or industrial purpose.

(2) Subject to subsection (3), no person shall, except with the written permission of the Minister, sell by retail any prescribed medicine or drug in any place other than a pharmacy.

(3) A medical practitioner may sell any medicine or drug if he does not keep open shop and there is no pharmacy within a distance of 3 miles from the place where he attends a patient.

18. Operation of pharmacy.     Back to top

(1) No person shall operate a pharmacy unless—

(a) he holds a licence; and

(b) there is a pharmacist in charge of the pharmacy.

(2) Any person who wishes to obtain a licence under this section shall make an application to the Board on the prescribed form.

(3) The Board shall, on receipt of an application under subsection (2), require the Trade and Therapeutics Committee to inspect the premises of the applicant which are intended for use as a pharmacy and submit its recommendation.

(4) In considering an application under subsection (2), the Board shall take into account —

(a) the number of pharmacies in the area in which the applicant intends to operate;

(b) the needs of the area for an additional pharmacy; and

(c) the recommendations of the Trade and Therapeutics Committee.

(5) The Board may grant the application on payment of the prescribed fee and on such conditions as it thinks fit or reject the application.

(6) Where the Board rejects an application under subsection (5), it shall notify the applicant of the reasons for its decision.

(7) A licence which is granted under this section shall be valid for a period of one year as from the date specified in the licence and may be renewed annually on payment of the prescribed fee.

(8) Except with the written permission of the Board, no pharmacist shall be in charge of more than one pharmacy.

(9)

(a) Subject to paragraph (b) and to section 19, no person in a pharmacy, other than a pharmacist, shall dispense a prescription, compound a medicine or sell a drug specified in the First and Sixth Schedules.

(b) A person in a pharmacy may perform any of the acts specified in paragraph (a)—

(a) in the presence of the pharmacist in charge of the pharmacy; or

(b) where the pharmacist in charge is temporarily absent, in the presence of an assistant pharmacist.

(10) Every licensee shall —

(a) affix a conspicuous sign board outside his pharmacy, bearing his name and that of the pharmacist in charge;

(b) display his licence in a conspicuous position in his pharmacy.

(11) Where the Board is satisfied that a licensee has contravened this Act or any condition attached to his licence, it may, by notice in writing require the licensee within 15 days from the date of service of the notice to show cause why his licence ought not to be revoked and if the Board is satisfied that, having regard to all the circumstances of the case, it is expedient to do so, it may revoke his licence.

19. Death of pharmacist.     Back to top

On the death of any pharmacist who is in charge of a pharmacy —

(a) the licensee or, where the pharmacist was himself the licensee, the spouse or heirs of the deceased pharmacist may, with the approval of the Board —

(i) operate the pharmacy under the direct management of an assistant pharmacist for a period not exceeding 8 days; and

(ii) cause the pharmacy to be supervised by a pharmacist already in charge of another pharmacy for a further period not exceeding 3 months;

(b) where there is no pharmacist or assistant pharmacist to take charge of the pharmacy —

(i) the licensee or, where the pharmacist was the sole licensee, the spouse or heirs of the deceased pharmacist shall, subject to sub-paragraph (ii), sell the stock of the pharmacy to another pharmacy within such time as the Board may determine;

(ii) the stock of dangerous drugs shall be placed under seal by the Board and may be sold through the Board to another pharmacy.

20. Prescription Book.     Back to top

(1) Every pharmacist or, in his temporary absence or in the case provided for in section 19(a)(i), an assistant pharmacist shall keep a Prescription Book in which shall be entered all prescriptions which are dispensed.

(2) The book shall be kept in the pharmacy for a period of 2 years from the date on which the last prescription is entered.

21. Prescriptions.     Back to top

(1) Subject to subsection 2, no pharmacist or assistant pharmacist shall refuse to dispense a prescription at a pharmacy to any person who offers to pay in cash for any pharmaceutical product prescribed.

(2) Where the pharmacist considers that the authorised person has made an evident error or overlooked something which may endanger the life or health of the patient, he shall delay the execution of the prescription and refer the matter immediately to such person for confirmation.

(3) Every prescription shall —

(a) be handwritten, dated and signed by an authorised person;

(b) state the address of the authorised person who signed it;

(c) specify the name and address of —

(i) the patient for whose use it is given; or

(ii) where it is given by a veterinary surgeon, the person to whom the medicine prescribed is to be delivered;

(d) where it is given by —

(i) a dental surgeon, contain the words "For Dental Treatment Only";

(ii) a veterinary surgeon, contain the words "For Animal Treatment Only";

(e) specify—

(i) the total amount of the pharmaceutical product to be supplied: or

(ii) where the pharmaceutical product is packed in ampoules, the total amount intended to be administered or injected;

(f) indicate —

(i) the dose to be taken; or

(ii) the amount intended to be administered or injected in each dose where the pharmaceutical product is packed in ampoules.

22. Dispensing prescriptions.     Back to top

(1) No person shall dispense a prescription unless —

(a) the prescription complies with section 21(2);

(b) he recognises the signature of the authorised person by whom the prescription purports to have been issued and is satisfied that the signature is genuine.

(2) Subject to subsection (3), no person shall supply a pharmaceutical product more than once.

(3) Where a prescription so directs, it may be dispensed on any number of occasions at the interval specified in the prescription.

(4) Every person dispensing a prescription shall —

(a) at the time of dispensing, record on the prescription —

(i) the date on which it is dispensed; and

(ii) where it is a prescription which may be dispensed on more than one occasion, the dates on which it is dispensed;

(b) deliver to the person for whose use the pharmaceutical product is supplied or to his agent a true copy of the prescription bearing —

(i) the serial number of the prescription;

(ii) the date on which the prescription is dispensed; and

(iii) the stamp of the pharmacy; and

(c) place on the container of each drug dispensed a proper label indicating all instructions for the proper use of the drugs:

23. Wholesale pharmacy.     Back to top

(1) No person shall operate a wholesale pharmacy unless —

(a) he holds a licence;

(b) there is a pharmacist who is in charge of the wholesale pharmacy on a full-time basis;

(c) the premises used for the wholesale pharmacy are distinctly separate from those of any other pharmacy.

(2) Any person who wishes to obtain a licence under this section shall make an application to the Board on the prescribed form.

(3) The Board may, on receipt of an application under subsection (2), grant the application on payment of the prescribed fee and on such conditions as it thinks fit or reject the application.

(4) A licence which is granted under this section shall be valid for a period of one year as from the date specified on the licence and may be renewed annually on payment of the prescribed fee.

(5) Where the Board rejects an application under subsection (3), it shall notify the applicant of the reasons for its decision.

(6) Where the Board is satisfied that a licensee has contravened this Act or any condition attached to his licence, it may, by notice in writing require the licensee within 15 days from the date of service of the notice to show cause why his licence ought not to be revoked and if the Board is satisfied that, having regard to all the circumstances of the case, it is expedient to do so, it may revoke his licence.

24. Quality of pharmaceutical products.     Back to top

No person shall sell-

(a) any pharmaceutical product which-

(i) is adulterated or impure;

(ii) does not conform to a prescription or to specified standards;

(b) any drug —

(i) which is not of good quality and in perfect state of preservation for medicinal use; or

(ii) whose shelf life has expired;

(c) any medicine with any ingredients which injuriously affect its quality.

25. Import of drugs.     Back to top

(1) No person shall, unless he holds a permit, import a drug other than a poison.

(2) Any person who wishes to obtain a permit shall make a written application to the Board.

(3) On receipt of an application under subsection (2), the Board may refer the application to the Trade and Therapeutics Committee and in the light of the recommendations of the Committee, shall decide whether or not to approve the application.

(4) Where the application is approved by the Board under subsection (3), the Permanent Secretary shall issue the permit on such conditions as he thinks fit.

(5) No pharmacist in charge of a pharmacy shall, for himself or on behalf of another person, import any drug for sale by wholesale.

PART V — POISONS      Back to top

26. Import of poisons.     Back to top

(1) No person other than-

(a) a manufacturer;

(b) a licensee of a wholesale pharmacy:

(c) an authorised person;

(d) a pharmacist;

(e) a person who holds a licence under section 27(1)(b), shall import any poison.

(2) No person shall, unless he holds a permit, import a poison specified in Part II of the First Schedule.

(3) No person shall, unless he holds a permit issued by the Pesticides Control Board, import a poison specified in the Third Schedule.

(4) Any person who wishes to import a poison specified in Part II of the First Schedule shall —

(a) make a written application to the Permanent Secretary;

(b) furnish, in support of his application, such information as the Permanent Secretary may require.

(5) The Permanent Secretary may, on receipt of an application under subsection (4), reject the application or accept it on such conditions as he thinks fit.

27. Sale of poisons.      Back to top

(1) Subject to section 28, no person, other than a pharmacist, shall sell—

(a) a poison specified in Part I of the First Schedule;

(b) a poison specified in Part II of the First Schedule or in the Third or Fourth Schedule unless he holds a licence.

(2) No person shall sell---

(a) a poison specified in the Third Schedule except to a person who is engaged in the business of agriculture or horticulture and for the purpose of that business;

(b) a poison specified in the first column of the Fourth Schedule, otherwise than in the form specified in the second column of that Schedule, after obtaining a written declaration from the buyer regarding the use to which the poison will be put.

(3) No person who holds a licence under this section shall sell a poison specified in Part II of the First Schedule or in the Third or Fourth Schedule to any person other than a person who holds a permit to purchase the poison, issued by the Permanent Secretary.

(4) No person shall purchase a poison specified in Part II of the First Schedule or in the Third or Fourth Schedule unless he holds a permit issued by the Permanent Secretary.

(5) No person shall sell a poison specified in the Fifth Schedule unless the purchaser is—

(a) certified by an authorised person in the prescribed form to be a person to whom the poison may properly be sold; or

(b) known by the seller or by a pharmacist in the employment of the seller at the premises where the sale is effected to be a person to whom the poison may properly be sold.

(6) No person shall, except on a prescription, sell by retail any poison specified under this section.

(7) Any person who wishes to obtain a licence under this section shall make a written application to the Board.

(8) The Board shall, on receipt of an application under subsection (7), require the Poisons Committee to examine the application and submit its recommendations.

(9) Where the Board is satisfied, in the light of the recommendations of the Poisons Committee, that the sale of poisons will be effected--

(i) under the supervision of a pharmacist; and

(ii) on premises registered with the Permanent Secretary

it may, on payment of the prescribed fee, grant the licence on such conditions as it thinks fit.

(10) A licence which is granted under this section shall be valid for a period of one year as from the date specified on the licence and may be renewed annually on payment of the prescribed fee.

(11) Where the Board is satisfied that a licensee has contravened this Act or any condition attached to his licence, he may, by notice in writing require the licensee within 15 days from the date of service of the notice to show cause why his licence ought not to be revoked and if the Board is satisfied that, having regard to all the circumstances of the case, it is expedient to do so, it may revoke his licence.

28. Exemption.     Back to top

Section 27(1) shall not apply to the sale of a poison—

(a) by wholesale;

(b) to an authorised person;

(c) for use in—

(i) a hospital, infirmary or dispensary maintained by any public authority; or

(ii) in a private clinic;

(d) to any person who proves to the satisfaction of the Board that he is engaged in scientific education or research and requires the poison for the purpose of scientific education or research.

29. Poisons Book.      Back to top

(1) Subject to subsection (2), every person who sells a poison specified in the First or Fifth Schedule shall--

(a) keep a Poisons Book;

(b) in the case of a poison--

(i) specified in the First Schedule, make an entry in the book before the delivery of the poison to the purchaser;

(ii) specified in the Fifth Schedule, cause the purchaser to sign an entry in the book before delivering the poison to him;

(c) keep the book on his premises for a period of 2 years from the date on which the last entry is made.

(2) Any person who sells a poison specified in the Fifth Schedule may accept a signed order from the purchaser in lieu of a signature in the Poisons Book where

(a) the poison is sold to a person for the purpose of his trade, business or profession;

(b) the seller has obtained a signed order before the completion of the sale;

(c) the signed order contains--

(i) the signature, name, address and trade, business or profession of the purchaser;

(ii) the total quantity of the poison to be purchased or, in the case of a poison packed in ampoules, the total quantity intended to be administered or injected; and

(iii) the purpose for which the poison is required;

(d) the seller is satisfied that.-

(i) the signature on the signed order is genuine;

(ii) the person signing the order carries on the business, trade or profession stated; and

(iii) the poison will be used in that business, trade or profession; and

(e) the seller inserts in the entry in the Poisons Book the words "signed order" and a reference number by which the order can be identified.

(3) Any person who makes a false statement for the purpose of obtaining delivery of any poison shall commit an offence.

PART VI-THERAPEUTIC SUBSTANCES     Back to top

30. Import of therapeutic substances.     Back to top

(1) No person shall import any therapeutic substance other than that specified in the Sixth Schedule.

(2) No person shall, unless he holds a permit, import a therapeutic substance specified in the Sixth Schedule.

(3) No permit for the importation of a therapeutic substance shall be issued to any person other than—

(a) a pharmacist;

(b) an authorised person; or

(c) a person who proves to the satisfaction of the Permanent Secretary that he requires the therapeutic substance for purposes of scientific education or research.

(4) Any person who wishes to obtain a permit under this section shall-

(a) make a written application to the Permanent Secretary; and

(b) furnish, in support of his application, such information as the Permanent Secretary may require.

(5) The Permanent Secretary may, on receipt of an application under subsection (4), reject the application or grant it on such conditions as he thinks fit.

31. Standards of therapeutic substances.      Back to top

(1) Subject to section 32, no person shall manufacture or sell a therapeutic substance specified in the Sixth Schedule unless it conforms to the specified standards.

(2) The Permanent Secretary may order the forfeiture of any therapeutic substance which does not comply with subsection (1).

32. Sale of therapeutic substances.      Back to top

(1) Subject to subsection (2), no person shall, except on a prescription, sell by retail any therapeutic substance.

(2) Subsection (1) shall not apply-

(a) to the supply of a therapeutic substance which is an antibiotic where it is made on production of a written requisition from one pharmacist to another; or

(b ) to a therapeutic substance sold-

(i) by wholesale;

(ii) for export;

(iii) to an authorised person;

(iv) to the owner or master of a ship or aircraft for medical use on board;

(v) to any institution or business which proves to the satisfaction of the Board that it carries on scientific education or research;

(vi) to Government; or

(vii) to a person in charge of a hospital, clinic or nursing home, or of any other institution which is approved by the Board and provides medical, dental, surgical or veterinary treatment.

33. Sale of antibiotics.     Back to top

(1) Every person who sells or supplies a therapeutic substance which is an antibiotic shall-

(a) keep an Antibiotic Book; and

(b) make a record of every sale or supply in the book.

(2) The book and every requisition produced under subsection 32(2)(a) shall be kept by the seller on his premises for a period of 2 years from the date on which the last entry is made.

34. Treatment.     Back to top

(1) No person shall administer a therapeutic substance by way of treatment unless-

(a) he is, or is acting under the directions of, an authorised person; or

(b) he is the master, or a person authorised by the master, of a ship or aircraft which does not include among its crew a medical practitioner.

PART VII-MANUFACTURE OF PHARMACEUTICAL PRODUCTS     Back to top

35. Building of factory.     Back to top

(1) No person shall, unless he holds a licence, build a factory to manufacture pharmaceutical products.

(2) Any person who wishes to obtain a licence under this section shall-

(a) make a written application to the Board;

(b) furnish, in support of his application-

(i) plans of all installations to be made;

(ii) details of the type of machinery to be used and the sources of energy;

(iii) details of the type of pharmaceutical products to be manufactured; and

(iv) such other information or documents as the Board may require.

(3) The Board shall, on receipt of an application under subsection (2), require the Planning Committee to examine the application and submit its recommendations.

(4) The Board may, in the light of the recommendations of the Planning Committee, grant the application on payment of the prescribed fee and subject to such conditions as it thinks fit or reject the application.

(5) Where the Board rejects an application under subsection (3), it shall notify the applicant of the reason for its decision.

(6) Where the Board is satisfied that a licensee has contravened this Act or any condition attached to his licence, it may, by notice in writing, require the licensee within 15 days from the date of service of the notice to show cause why his licence ought not to be revoked and if the Board is satisfied that, having regard to all the circumstances of the case, it is expedient to do so, it may revoke his licence.

36. Licence for manufacture.     Back to top

(l) No person shall, unless he holds a licence, manufacture any pharmaceutical product.

(2) Any person who wishes to obtain a licence under this section shall-

(a) make a written application to the Board;

(b) furnish, in support of his application-

(i) the formula of each pharmaceutical product to be manufactured;

(ii) the technical description of the production process;

(iii) details of all quality control;

(iv) such other information or documents as the Board may require.

(3) The Board may, on receipt of an application under subsection (2), grant the application on payment of the prescribed fee and on such conditions as it thinks fit or reject the application.

(4) Where the Board rejects an application under subsection (3), it shall notify the applicant of the reasons for its decision.

(5) No application for a licence to manufacture therapeutic substances shall be granted unless-

(a) there are adequate facilities for manufacture of sterile preparations;

(b) there is appropriate quality control of any therapeutic substance used and of the finished product; and

(c) the manufacture takes place under the supervision of a pharmacist, a pharmacologist or a chemist who proves to the satisfaction of the Board that he has adequate experience in the manufacture of the therapeutic substances.

(6) Every licence issued under this section shall be valid for a period of one year as from the date specified in the licence and may be renewed annually on payment of the prescribed fee.

(7) Where the Board is satisfied that a licensee has contravened this Act or any condition attached to his licence, it may, by notice in writing. require the licensee within 15 days from the date of service of the notice to show cause why his licence ought not to be revoked and if the Board is satisfied that, having regard to all the circumstances of the case, it is expedient to do so, it may revoke his licence.

37. Supervision of factory.     Back to top

No manufacturer shall operate a factory except under the supervision and control of a manager who-

(a) has such degree in pharmacy or pharmacology as is approved by the Board; and

(b) satisfies the Board that he has adequate qualifications and at least ten years' experience in the manufacture of pharmaceutical products.

38. Quality control.      Back to top

Every manufacturer shall-

(a) provide on his premises adequate facilities for quality control of raw materials, finished products and stocks;

(b) ensure that raw materials used in the manufacture of a pharmaceutical product are of the required degree of purity and fit for pharmaceutical use;

(c) ensure that in pharmaceutical products requiring aseptic technique-

(i) the factors influencing their contamination are under control;

(ii) the aseptic precautions are fulfilled; and

(iii) the finished products comply with tests for pyrogens or for freedom from undue toxicity or for sterility.

39. Storage, records and samples.     Back to top

Every manufacturer shall-

(a) provide facilities for storing his raw materials and products at the required temperature and relative degree of humidity to ensure that loss of potency and deterioration are reduced to a strict minimum;

(b) keep at the factory, for a period of 3 years after the date of manufacture, a record of-

(i) all products manufactured;

(ii) the date of manufacture and the expiry date of products manufactured;

(iii) the batch or lot number of raw materials and finished products;

(iv) the raw materials used in the manufacture of a product; and

(v) all analytical results in respect of each raw material and each finished product;

(c) keep at the factory, for a period of 5 years after the date of manufacture, representative samples of all raw materials and finished products .

PART VIII-MISCELLANEOUS      Back to top

40. Illegal arrangements.      Back to top

(1) No manufacturer, licensee of a wholesale pharmacy or pharmacist shall enter into any arrangement with an authorised person under which the authorised person is to receive any gain or benefit in return for the custom he brings to the manufacturer, licensee of a wholesale pharmacy or pharmacist.

(2) No authorised person shall have any share, participation or other financial interest in the manufacture or sale, whether by wholesale or retail, of pharmaceutical products.

41. Advertising.      Back to top

No person shall advertise any pharmaceutical product intended for human or veterinary use except in such technical or professional publications, as may be approved by the Board.

42. Inspectors.      Back to top

An inspector may, for the purpose of ensuring that this Act or any subsidiary enactment made under this Act, is being complied with-

(a) visit and inspect any premises registered or licensed under this Act;

(b ) examine any document required to be kept under this Act;

(c) seize and, with the authority of the Board, destroy any pharmaceutical product which is, in his opinion, unwholesome or unfit for use;

(d) institute proceedings in respect of any offence under this Act or any subsidiary enactment made under this Act.

43. Samples.      Back to top

Where an inspector takes a sample for analysis, he shall-

(a) divide the sample into 3 parts, each part to be marked, sealed and signed by him and by the person from whom it is taken;

(b) deliver one part to the person from whom the sample has been taken;

(c) retain one part for future comparison; and

(d) forward one part to the appropriate laboratory for analysis.

44. Comptroller's powers.      Back to top

(1) The Comptroller shall not allow the removal of any imported pharmaceutical product from the place where it is stored unless the relevant invoice has been endorsed by the Registrar to show that the importation of the article is authorised under this Act.

(2) Where any pharmaceutical product is imported in contravention of this Act, the Comptroller shall seize and remit it to the Permanent Secretary to be disposed of in such manner as the Permanent Secretary thinks fit.

45. Offences.      Back to top

(1) Any person who-

(a) contravenes-

(i) this Act or any subsidiary enactment made under this Act; or

(ii) any condition of a certificate of registration, licence or permit granted under this Act;

(b) manufactures a pharmaceutical product which does not comply with the specified standards of purity, potency or quality, shall commit an offence.

(2) Any person who commits an offence under subsection (1) shall, on conviction, be liable to a fine not exceeding 2,000 rupees and to imprisonment for a term not exceeding 2 years.

(3) The court before which a person is convicted of an offence under subsection (1), may, in addition to any penalty imposed, order the cancellation or suspension of any certificate of registration, licence or permit in respect of which the offence was committed and the forfeiture of any pharmaceutical product which is the subject matter of the offence.

46. Application of Act.      Back to top

This Act shall not apply to-

(a) any pharmaceutical product found in possession of a person in transit in Mauritius from a ship or aircraft who satisfies the Comptroller or the Permanent Secretary that the pharmaceutical product is solely intended for his own use:

(b) any pharmaceutical product based on the principles of ayurvedic or Chinese or homeopathic medicine and certified as such by the Board:

47. Regulations.     Back to top

(1) The Minister may make such regulations as he thinks fit for the purpose of this Act.

(2) Any regulations made under subsection (1) may-

(a) provide for the taking of fees and the issue of licences;

(b) amend the Schedule.

48. Repeal.      Back to top

The following enactments arc repealed-

(a) Pharmacy and Poisons Act;

(b) Antibiotics (Control of Importation, Sale and Distribution) Regulations 1962;

(c) Pharmacy and Poisons Regulations 1957.

49. Consequential amendment.     Back to top

The Licences Act is amended in Schedule 1—

(a) in item F, by deleting sub-item 12;

(b) in item H, by deleting sub-items 7 and 9;

(c) by deleting item L;

(d) in item M, by deleting sub-item 7;

(e) in item O, by deleting sub-item 9.

50. Transitional provision.     Back to top

(1) Subject to subsections (2), (3) and (4), any pharmacist, assistant pharmacist or student who, at the commencement of this Act, is registered under the pharmacy and Poisons Act shall be deemed to have been registered under this Act.

(2) Every student registered under the Pharmacy and Poisons Act shall be allowed to take the Intermediate examination to be held under the Pharmacy and Poisons Act within a period not exceeding 15 months after the date of commencement of this Act.

(3) Every student registered under the Pharmacy and Poisons Act who has passed the Intermediate examination held under the Pharmacy and Poisons Act shall be allowed to take the Assistant Pharmacist's examination to be held under the Pharmacy and Poisons Act, within a period not exceeding 4 years after the commencement of this Act.

(4) Every assistant pharmacist commissioned under the Pharmacy and Poisons Act shall be allowed to take the Pharmacists examination to be held under the Pharmacy and Poisons Act within a period not exceeding 30 months after the commencement of this Act.

(5) Every pharmacy which at the commencement of this Act is licensed under the Pharmacy and Poisons Act shall be deemed to have been licensed under this Act.

(6) Subject to subsection (7), any registration, other than that specified in subsections (l) and (2), any licence, permit or authorisation relating to a pharmacy, a wholesale .pharmacy or a factory, shall expire within 6 months from the date of commencement of this Act.

(7) Any person who operates at the commencement of this Act, a wholesale pharmacy, shall comply with section 23 within one year from the date of commencement of this Act.

51. Commencement.     Back to top

This Act shall come into operation on a day to be fixed by Proclamation.

Passed in the Legislative Assembly on the twentieth day of December one thousand nine hundred and eighty-three.

G. MAURICE BRO

Clerk of the Legislative Assembly

FIRST SCHEDULE     Back to top 

First Schedule (Part 1 Part 2)     Second Schedule    Third Schedule     Fourth Schedule     Fifth schedule     Sixth schedule   

(Sections 2, 27 and 29)

PART I     Back to top

Acetanilide; alkyl acetanilides

Acctohcxamide

Acctorphine: its salts; its esters and others; their salts

Acetylcarbromal

Acetyldihydrocodeine; its salts

Alcuronium

Alkali fluorides other than those specified in Part II

Alkaloids, their quarternary compounds: any salt, simple or complex, of any such

substance

Aconite, alkaloids of

Atropine

Belladonna, alkaloids of

Brucine

Calabar bean, alkaloids of

Coca, alkaloids of

Coniine

Cotarnine

Curare, alkaloids of, curare bases

Ecgonine, its esters and ethers

Ephedra, alkaloids of

Ergot, alkaloids of, whether hydrogenated or not; their homologues

Gelsemium, alkaloids of

Homatropine

Hyoscyamine

Jaborandi, alkaloids of

Lobelia, alkaloids of

Morphine, its esters and others

Papaverine

Pomegranate, alkaloids of

Quebracho, alkaloids of, other than the alkaloids of red quebracho

Rauwolfia, alkaloids of, their derivatives

Sabadilla, alkaloids of

Solanaceous, alkaloids not otherwise included in this Schedule

Stavesacre, alkaloids of

Strychnine

Thebaine

Veratrum, alkaloids of

Yohimba, alkaloids of

Allylisopropylacetylurea

Allylprodine; its salts

Alphameprodine; its salts

Alphaprodine; its salts

Amino-alcohols esterified with benzoic acid, phenylacetic acid, phenylpropionic acid, cinnamic acid or the derivatives of these acids; their salts

p-Aminobenzencsulphonamide, its salts, derivatives of p-aminobcnzcne-sulphona-mide naving any of the hydrogen atoms of the p-amino group or of the sulpho-namidc group substituted by another radical; their salts

p-Aminobenzoic acid, esters of; their salts

Aminorex; its salts

Amitriptyline; its salts

Amyl nitrite

Androgenic, oestrogenic and progestational substances—Benzoestrol

Derivatives of stilbcne, dibenzyl or naphthalene with oestrogenic activity, their esters

Steroid compounds with androgenic or oestrogenic or progestational activity; their esters

Anileridine; its salts

Anti-histamine substances, their salts; their molecular compounds—

Antazoline

Bromodiphchydramine

Buclizine

Carbinoxamine

Chlorcyclizine

Chlorpheniramine

Cinnarizine

Clemizole

Cyclizine

Cyproheptadine

3-Di-n-bulylaminomethyl-4,5,6-trihydroxyphthalidc

Diphenhydramine

Diphenylpyraline

Doxylamine

lsothipendyl

Mebhydrolin

Meclozinc

Phenindamine

Pheniramine

Phenyltoloxamine

Promethazine

Pyrrobutamine

Tetra-N-substituted derivatives of ethylenediamine or propylenediamine

Thenalidine

Tolpropamine

Triprolidine

Antimony chlorides of; antinomates; antinomites; organic compounds of antimony

Apomorphine; its salts

Arsenical substances, other than those specified in Part II—

halides of arsenic; oxides of arsenic; arsenates; arsenites; organic compounds of arsenic Azacyclonol; its salts

Barbituric acid; its salts; derivatives of barbituric acid; their salts; compounds of barbituric acid; its salts, its derivatives; their salts, with any other substance

Barium, salts of, other than barium sulphate and the salts of barium specified in Part II

Benaetyzine; its salts

Benzethidine; its salts

Benzhexol; its salt

Benzoylmorphine, its salts

Benztropine and its homologues; their salts

Benzylmorphine; its salts

Betameprodine; its salts

Betaprodine; its salts

Bezitramide; its salts

Bromvaletone

Busulphan; its salts

Butychloral hydrate

Cannabis (the dried flowering of fruiting tops of Cannabis Saliva Linn.); the resin of cannabis; extracts of cannabis; tinctures of cannabis; Cannabin tannate

Cantharidin; cantharidates

Captodiame; its salts

Caramiphen; its salts

Carbachol

Carbromal

Carisoprodol

Carperidine; its salts

Chloral; its addition and its condensation products; their molecular compound

Chlordiazepoxide; its salts

Chlormethiazole; its salts

Chloroform

Chloroquine

Chlorothiazide and other derivatives of benzo-1, 2, 4-thiadiazine-7-sulphonamidel, 1-dioxide, whether hydrogenated or not

Chlorphenoxamine; its salts

Chlorphentermine; its salts

Chlorpropamide; its salts

Chlorprothizene and other derivatives of 9- methylenethixanthen; their salts

Chlorthalidone and other derivatives of co-chlorobenzene sulphonamide

Clioquinol

Clonitazene; its salts

Clorexolone

Clorprenaline; its salts

Corticitrophine, natural and synthetic

Creosotc obtained from wood

Croton, oil of

4-Cyano-2-dimethylamino-4, 4-diphenylbutane; its salts

4-Cyano-1-methyl-4-phenylpiperidine; its salts

Cyclarbamate

Cyerimine; it salts

Dehydroemetine; its salts

Demeearium bromide

Desipramine; its salts

Desomorphine; its salts; its esters and others; their salts

Dextromethorphan, its salts

Dextromoramide; its salts

Dextrorphan; its salts

Diacetylmorphine; its salts

Diacetylnalorphine; its salts

Diampromide; its salts

Diazepam and other compounds containing the chemical structure of dihydro-1

4-benzoiazephine substituted to any degree; their salts

Digitalis, glycosides of; other active principles of digitalis

Dihydrocodeine; its salts; its esters and ethers; their salts

Dihydrocodeinone O-carboxymethyloxime; its salts; its esters; their salts

Dihydromorphine; its salts; its esters and ethers; their salts

3-(3-4-Dihydroxyphenyl) alanine; its salts

Diemnoxadole; its salts

Dimepheptanol; its salts; its esters and ethers; their salts

Dinitronaphtols; dinitrophenols; dinitrothymols

Dioxaphetyl butyrate; its salts

Diperodon; its salts

Diphenoxylate; its salts;

Disulfiram/Dipipanone its salts

Dithienylallylamines; dithienylalkylallylamines; their salts

Dothiepin; its salts

Dyllos

Ecothiopate iodine

Ectylurea

Elaterin

Embutramide

Emylcamate

Erythrityl tctranitrate

Ethacrynic acid; its salts

Ethehlorvynol

Ethinamate

Ethionamide

Ethoheptazine; its salts

Ethylmorphine; its salts, its esters and ethers; their salts

Ethylnoradrenaline; its salts

Etonitzene; its salts

Etorphine; its salts; its esters and ethers; their salts

Etoxeridine; its salts

Fenfluramine; its salts

Fentanyl; its salts

Fluanisone

Flufenamic acid; its salts, its esters; their salts

Fluoroacetamide

Fluoracetanilide

Furethidine its salts

Gallaminc; its; salts its quartcnary compounds

Glutcthimide; its salts

Gyceryl trinitrate

Glymidine

Guanidines

di-p-anisyl-p-phenetylguanidine

polymethylcne diguanidines

Haloperidol and other 4-substituted derivatives of N-(3-p-fluorobenzolylpropyl)

Piperidine

Hexapropymate

Hydrazines, benzyl, phenetyl and phenoxyethyl; their methyl derivatives; acyl derivatives of any of those substances; salts of any compounds specified in this item

Hydrocyanic acid; cyanides, other than fcrrocyanidcs and fcrrycyanides

Hydromorphinol; its salts, its esters and ethers; their salts

Hydroxycinchoninic acid; derivatcs of; their salts; their esters

Hydroxy-N, N-dimethyltryptamines; their esters or cthers; any salt of other substance falling within this item

Hydroxypcthidinc; its esters and ethers; their salts

Hydroxyurea

Hydromysine; its salts

Imipramide; its salts

Indomethacin; its salts

Insulin

Ipridole; its salts

Isoaminile; its sails

lsoetharine; its salts

Isomethadone (isoamidone); its salts

lsoprcnaline; its salts

Ketobemidone; its salts; its cstcrs and ethers; their salts

Laudcxium; its salts

Lead acetates; compounds of lcad with acids from fixed oils

Levomcthorphan; its salts

Levophenacylmorphan; its salts; its esters and ethers; their salts

Levorphanol; its salts; its esters and ethers; their salts

Lysergide; its salts, simple or complex; its quarternatry compounds

Mannytyl hexanitrate

Mannomustine; its salts

Mebezonium iodine

Mebutamate

Meclofenoxate; its salts

Mefenamic acid; its salts; its esters; their salts

Mepacrine

Mephensin; its esters

Meprobamate

Mercaptopurine; its salts: derivativcs of mercaptopurine; their salts

Mercury, oxide of; nitrates of mercury; mercuric ammonium chlorides; potassiomercuric iodides; organic compounds of mercury which contain a methyl (CH) group directly linked to the mercury atom; mercuric osycyanides; mercuric thiocyanate

Mescaline and other derivativcs, of phenthylamine formed by substitution in the aromatic ring; their salts

Metaxalone

Metazocine; its salts; its esters and ethers; their salts

Metformin; its salts

Methadone (amidone); its salts

Methadyl acetate; its salts

Methaqualone; its salts

Methixene; its salts

Methocarbamol

Methoxsalen

Methoxyphenamine; its salts

Methylaminoheptane; its salts

Methyldesorphine; its salts; its esters and ethcrs; their salts

Methydihydromorphine; its salts; its esters and ethers; their salts

2 Methyl-3 morpholino-1, 1-diphenylpropanecarboxylic acid; its salts, its esters;

Methypentynol; its esters and other derivatives

&-Methylphene thylamine, B-methylphenethylamine and &-ethylphenethylamine,any synthetic compound structurally derived from any of those substances by substitution in the aliphatic part or by ring closure therein (or by both such substitution and such closure) or by substitution in the aromatic ring (with or without substitution at the nitrogen atom), except ephedrine, its optical isomers and N-substituted derivatives, fenfluramine, hydroxyamphetamine, methoxyphenamine, phenulpropanalamine pholedrine and prenylamine; any salt of any substance falling within this item 1- Methyl-4 phenylpiridine-4- carboxylic acid; esters of; thcir salts

Methyprylone

Metoclopramide; its salts

Metopon; its salts, its esters and ethers; their salts

Mitopodozide; its salts

Monofluoroacetic acid; its salts

Morpheridine; its salts

Mustine and any other N-substituted derivatives of di-(2-chlorocthyl) amine, their salts

Myrophine, its salts

Nalorphine; its salts

Nicocodine; its salts

m-Nitrophenol; o-nitrophenol; p-nitrophenol

Noracymethadol; its salts

Norcodeine; its salts; its esters and ethers; their salts

Norlevorphanol; its salts, its esters and ethers; their salts

Normethadone; its salts

Normophine; its salts; its esters and ethers; their salts

Norpipanone

Nortryptyline; its salts

Nux Vomica

Opium

Orciprenaline; its salt

Orphenadrine; its salts

Orthocaine; its salts

Ouabain

Oxalic acid

Oxethazaine

Oxycodone; its salts; its esters and ethers, their salts

Oxymorphone, its salts, its esters and ethers; their salts

Oxypehnbutazone

Oxytocins, natural and synthetic

p-chloro-a, a-dimethy phemethyl-carbonate

Paraldehyde

Paramethadione

Pargyline; its salts

Pemoline; its salts

Pentazocine; its salts

Phenacemide

Phenadoxone; its salts

Phenaglycodol

Phenampromide; its salts

Phenazocine; its salts; its esters and ethers; their salts

Phenbutrazate

Phenbucyclidine; its salts

Phenetidylphenacetin

Phenformin; its salts

Phenmetragine

Phenols (any member of the series of phenols of which the first member is phenol and of which the molecular composition varies from member to member by one atom of carbon and two atoms of hydrogen) except in substances containing less than sixty per cent, weight, of phenols; compounds of phenol with a metal, except in substances containing less than the equivalent of sixty per cent, weight in weight, of phenols

Phenomorphan; its salts; its esters and ethers; their salts

Phenoperidine; its salts; its esters and ethers; their salts

Phenothiazine, derivatives of; their salts; except dimethoxanate; its salts and promethazine; its salts and its molecular compounds

Phenylbutazone; its salts

2-Phenylcinchoninic acid; 2-salicycinchonimic acid; their salts; their esters

5-Phenylhydantoin; its alkyl and aryl derivatives; thier salts

4-Phenylpiperidine-4-carboxylic acid ethyl ester; its salts

Pholcodine; its salts; its esters and ethers; their salts

Phosphorus, yellow

Picric acid

Picrotoxin

Piminodine; its salts

Pipradol

Piritramide; its salts

Pituitary gland, the active principles of

Podophyllum resin

Polymethylenebistrimethylammonium salts

Primaquine

Procainamide; its salts

Procarbazine; its salts

Procyclidine; its salts

Proguanil

Proheptazine; its salts

Promoxolan

Propoxphene; its salts

Propylhexedrine; its salts

Prothionamide

Prothipendyl; its salts

Pyrimethamine

Quinethazone

Quinine; its salts

Quinine; amodiaquine

Recemethorphan; its salts

Racemoramide; its saits

Racemorphan; its salts; its esters and ethers; their salts

Salbutamol; its salts

Savin, oil of

Sontonquine

Strophanthus; glycosides of strophanthus

Styramate

Sulphinpyrazone

Sulphonal; alkyl sulphonals

Suprarenal gland medulla, the active principles of; their salts

Syrosingopine

Tetrabenazine; its salts

Thalidomide; its salts

Thallium, salts of

Thebacon; its salts

Thiocarlide; its salts

Thyroid gland, the active principles of; their salts

Tolbutamide

Totramine; its salts

Triaziquouo

Tribromethyl alcohol

2,2,2-Trichloroethyl alcohol, esters of; their salts

Trimeperidine; its salts

Trimipramine; its salts

Troxidone

Tybamate

Vasopressina, natural and synthetic

Verapamil; its salts

Zoxazolamine: its salts

PART II     Back to top

First Schedule (Part 1 Part 2)     Second Schedule    Third Schedule     Fourth Schedule     Fifth schedule     Sixth schedule   

Ammonia

Arsenieal substances

Arsenic sulphides

Arsenious oxide

Calcium arsenites

Copper acetoarsenite

Copper arsenates

Copper arsenites

Lead arsenates

Potassium arsenites

Sodium arsenates

Sodium arsenites

Sodium thioarsenate,

Barium, salts of

Barium carbonate

Barium silicofluoride

Diamines, the following; their salts

phenylene diamines

tolylene diamines

other alkylated-benzene diamines

Dinitrocresols (DNOC): their compounds with a metal or a base

Dinosam; its compounds with a metal or a base

Dinoscb; its compounds with a metal or a base

Endosulfan

Endothal; its salts

Endrin

Formaldehyde

Formic acid

Hydrochloric acid

Hydrofluoric acid; alkali metal bifluorides; ammonium bifluoride; potassium fluoride; sodium fluoride; sodium silicofluoride

Mercuric chloride; mercuric iodile; organic compounds of mercury except compounds which contain a methyl (CH?) group directly linked to the mercury atom

Metallic oxylates

Nicotine; its salts

Nitric acid

Nitrobenzene

Organo-tin compounds, the following:-

Compounds of fentin

Paraquat; salts of

Phenols as defined in Part I in substances containing less than sixty per cent, weight in weight, of phenols; compounds of phenol with a metal in substances containing less than the equivalent of sixty per cent, weight in weight, of phenols

Phosphoric acid

Phosphorus con pounds, the following—

Amiton

Azinphos-ethyl

Azinphos-methyl

Chlorfevinphos

Demeton-0

Demeton-S

Demeton-0-methyl

Demeton-S-methyl

Dichlorvos

Dicthyl-4-methyl-7-coumarinyl phosphorothionate

Diethyl p-nitrophonyl phosphate

Dimefox

Disulfoton

Ethion

Ethyl p-nitrophenyl phenylphosphonothionate

Mazidox

Mecarbam

Mevinphos

Phosphamidon

Schradau

Sulfotep

TEPP (HETP)

Thionazin

Triphosphoric pentadimethylamide

Vamidothion

Potassium hydroxide

Sodium hydroxide

Sodium nitrite

Sulphuric acid

Zinc phosphide

SECOND SCHEDULE     Back to top

First Schedule (Part 1 Part 2)     Second Schedule    Third Schedule     Fourth Schedule     Fifth schedule     Sixth schedule   

(section 2)

Special Exemptions

In this Schedule—

"granular preparation"

, in relation to a poison, means a preparation-

(a) which consists or absorbent mineral or synthetic solid particles impregnated with the poison, where the size of the particles is such that not more than 4.0 per cent, weight in weight, of the preparations is capable of passing, in sieve with a mesh of 250 microns; and not more than 1.0 per cent, of passing a sieve with mesh of 150 microns;

(b) which has an apparent density of not less than 0.4 grammes per millilitre if compacted without pressure; and

(c)of which not more than 12 per cent, weight in weight, consists of, the poison.

THIRD SCHEDULE     Back to top

First Schedule (Part 1 Part 2)     Second Schedule    Third Schedule     Fourth Schedule     Fifth schedule     Sixth schedule   

(Sections 2 and 27)

Arsenical poisons other than lead arsenates and copper acetoarsenite

Dinitrocresols (DNOC); their compounds with a metal or a base; other than winter washes containing not more than the equivalent of 5.0 per cent of dinitrocresols

Dinosam; its compounds with a metal or a base

Dinoseb; its compounds with a metal or a base

Mercuric chlorides; mercuric iodide; organic compounds of mercury; other than solutions, containing not more than 5.0 per cent, weight in volume, of phenyl

mercuric acetate, for use in swimming baths

Organo-tin compounds,—

Compounds of Fentin

Phosphorus compounds—

Amiton

Azinphos-ethyl

Azinphos-methyl

Chlorfenvinphos

Demeton-0

Demeton-S

Dichlorvos

Diethyl 4-methyl-7-coumarinyl phosphorothionate

Diethyl p-nitrophenyl phospate

Dimefox

Disulfoton

Ethion

Ethyl p-nitrophenyl phenylphosphonothionate

Mazidos

Mecarbam

Mevinphos

Mipafox, except in the form of a cap on a stick or wire

Oxydemeton-methyl

Parathion

Phenkapton

Phorate

Phosphamidon

Schradan

Sulfotop

Thionazin

Triphosphoric Pentadimethylamide

Vamidothion

FOURTH SCHEDULE     Back to top

First Schedule (Part 1 Part 2)     Second Schedule    Third Schedule     Fourth Schedule     Fifth schedule     Sixth schedule   

(Sections 2 and 27)

FIFTH SCHEDULE     Back to top

First Schedule (Part 1 Part 2)     Second Schedule    Third Schedule     Fourth Schedule     Fifth schedule     Sixth schedule   

(Sections 2 and 29)

Acetorphine, its salts, its esters and ethers; their salts

Acetyldihydrocodeine; its salts

Alcuronium chloride

Alkaloids, their quarternary compounds; any salt, simple or complex, of any substance falling within the following—

Aconite, alkaloids of; except substances containing less than 0.02 per cent of the alkaloids of aconite

Atropine; except substances containing less than 0.15 per cent of atropine or not more than 1.0 per cent of atropine methonitrate;

Belladonna, alkaloids of; except substances containing less than 0.15 per cent of the alkaloids of belladonna calculated as hyoscyamine;

Brucine, except substances containing less than 0.2 per cent of brucine Calabar bean, alkaloids of

Coca, alkaloids of; except substances containing less than 0.1 per cent of the alkaloids of coca;

Cocaine; except substances containing less than 0.1 per cent of cocaine

Codeine; its esters and ethers; except substances containing less than 1.5 per cent of codeine:

Coniine except substances containingless than 0.1 per cent of coniine

Cotarnine; except substances containing less than 0.2 per cent of cotarnine

Curare, alkaloids of curare bases

Ecgonine; its esters and ethers; except substances conraining less than the equivalent of 0.1 per cent of eogonine;

Ephedrine; its optical isomers; except when contained in liquid preparations or preparations not intended for the internal treatment of human ailments and except solid preparations containing less than 10 per cent of ephedrine or its optical isomers otherwise than in an inert diluent;

Gelsemium, alkaloids of; except substances containing less than 0.1 per cent of the alkaloids of gelsemium

Homatropine; except substances containing less than 0.15 per cent of homatropine;

Hyoscine; except substances containing less than 0.15 per cent of hyoscine;

Hyoscyamine; except substances containing less than 0.15 per cent of hyoscyamine;

Jaborandi alkaloids of; except substances containing less than 0.5 per cent of the alkaloids of jaborandi;

Lobelia, alkaloids of; except substances containing less than 0.5 per cent of the alkaloids of lobellia;

Morphine; its esters and ethers; except substances containing less than 0.2 per cent of morphine calculated as anhydrous morphine;

Nicotine

Papaverine; except substances containing less than 1.0 per cent of papaverine;

Pomegranate, alkaloids of; except substances containing less than 0.5 per cent of the alkaloids of pomegranate;

Quebracho, alkaloids of

Sabadilla, alkaloids of; except substances containing less than 1.0 per cent of the alkaloids of sabadilla;

Salanaccous alkaloids, not otherwise included in this Schedule; except substances containing less than 0.15 per cent of solanaccous alkaloids calculated as hyoscyamine;

Stavesacre, alkaloids of except substances containing less than 0.2 per cent of the alkaloids of stavesacre

Strychnine; except substances containing less than 0.2 per cent of strychnine;

Thebaine; except substances containing less than 1.0 per cent of thebaine;

Veratrum, alkaloids of; except substances containing less than 1.0 per cent of the alkaloids of veratrum;

Yohimba, alkaloids of

Allylisopropylacetylurca

Allyoprodine; its salts

Alphamelrodine; its salts

Alphaprodine; its salts

Amino-alcohols esterilied with benzoic acid, phenylacetic acid, phenylpropionic acid, cinnamic acid or the derivatives of these acids; except substances containing less than 10 per cent of esterified amino-alcohols and except procaine when in a preparation containing a therapeutic substance prohibited by regulation

Anileridine; its salts

Antimonial poisons; except substances containing less than the equivalent of 1.0 per cent of antimony trioxide

Apomorphine; its salts; except substances containing less than 0.2 per cent of apomorphine;

Arsenical poisons; except substances containing less than the equivalent of 0.01 per cent of arsenic trioxide and except dentifrices containing less than 0.5 per cent of acetarsol;

Barbituric acid; its salts; derivatives of barbituric acid; their salts; compounds of barbituric acid; its salts; its derivatives; their salts, with any other substance

Barium, salts of

Benzethidine; its salts

Benzoylmorphine; its salts

Benzylmorphine; its salts

Betameprodine; its salts

Betaprodine; its salts

Bezitramide; its salts

Busulphan; its salts

Cannabis; the resin of cannabis; extracts of cannabis; tinctures of cannabis; cannabis tannate

Cantharidin; except substances containing less than 0.01 per cent of cantharidin

Cantharidates; except substance containing less than equivalent of 0.01 per cent of cantharidin;

Carbachol

Carperidine; its salts

Chloroform; except substances containing not more than 5 per cent of chloroform or when in preparations not intended for the internal treatment of human ailments;

Clonitazene; its salts

4 Cyano-2-dimethylamino-4, 4-diphenylbutane; its salts

Dehydroemetine; itssalts

Demecarium bromide

Desomorphine; its salts; its esters and ethers; their salts

Dextromethorphan; its salts except substances containing less than 1.5 per cent of dextromethorphan

Dextromoramide; its salts

Dextrorphan; its salts

Diacetylmorphine; its salts

Diampromide; its salts

Digitalis, glucosides and other active principles of; except substances containing less than one unit of activity (as defined in the British Pharmacopoeia) in two grammes of the substances;

Dihydrocodeine; its salts, its esters and ethers; their salts

Dihydrocodeinone 0-carboxymethyloxime; its salts; its esters; their salts

Dihydromorphine; its salts, its esters and ethers; their salts

Dimenoxadole; its salts

Dimepheptanol; its salts; its esters and ethers; their salts

Dinitrocresols (DNOC); their compounds with a metal or base; except winter washes containing not more than the equivalent of 5.0 per cent of dinitrocresols

Dinitronaphthols; dinitrophenols; dinitrothymols.

Dinosam; its compounds with a metal or a base

Dinoseb; its compounds with a metal or a base

Dioxaphetyl butyrate; its salts

Diphenoxylate

1. pharmaceutical preparation in solid or liquid form containing not more than 0.0025 grammes of diphenoxylate calculated as base and not less than 25 microgrammes of atropine calculated as atropine sulphate per dosage unit and containing no substance to which the Dangerous Drugs Act 1974 applies; and

2. liquid preparations containing not more than 0.5 milligrammes of diphenoxylate hydrochloride, 0.005 milligrammes atropine sulphate, 0.16 millilitres ethyl alcohol, 0.002 millilitres imitation cherry flavour, 0.45 millilitres glycerine, 0.4 millilitres sorbital solution (70 per cent) 0.01 milligrammes red dye colour index No. 14700 (F. D 4C. Red No. 4) and 0.0008 millilitres water

Dipipanone; its salts

Disulfiram

Dithienylallylamines; dithienylalkylallylamines: their salts

Dyflos

Ecothiopate iodine

Embutramide

Endosulfan

Endothal; its salts

Endrin

Ethylmorphine; its salts; its esters and ethers; their salts; except substances containing less than 0.2 per cent of ethylmorphine

Etonitazene; its salts

Etorphine; its salts; its esters and ethers; their salts;

Etoxeridine; its salts

Fentanyl; its salts

Fluanisone

Fluoroacetamide; fluoroacetanilide

Furethidine; its salts

Gallamine; its salts; its quarternary compounds

Guanidines, the following—

di-p-anisyl-p-phenetylguanidine

polymethylene diguanidines

Hydrocyanic acid; except substances containing less than 0.15 per cent weight in weight, of hydrocyanic acid (HCN): cyanides, other than ferrocyanides and ferricyanides; except substances containing less than the equivalent of 0.1 per cent, weight in weight, of hydrocyanic acid (HCN)

Hydromorphinol; its esters and ethers; their salts

Hydromorphone; its salts; its esters and ethers; their salts

Hydrozycinchoninie acids; derivatives of; their salts; their esters; except substances containing less than 3.0 per cent of hydroxycinchoninie acid or a derivative thereof.

Hydroxypethidine; its salts; its esters and ethers; their salts

Hydroxyurea

Isomethadonee (isomidone); its salts

Ketobemidone; its salts; its esters and ethers: their salts

Laudexium: its salts

Lead, compounds of, with acids from fixed oils

Levomethorphan; its salts

Levomoramide; its salts

Levophenacylmorphan; its salts; its esters and ethers; their salts

Levorphanol; its salts; its esters and ethers; their salts

Mannomustine; its salts

Mebezonium

Mercaptopurine; its salts; derivatives of mercaptopurine, their salts

Mercuric chloride; except substances containing less than 1.6 per cent of mercuric chloride; mercuric iodide; except substances containing less than 2.0 per cent of mercuric iodide; nitrates of mercury; except substances containing less than the equivalent of 3.0 per cent, weight in weight, of mercury (Hg); potassio-mercuric iodide; organic compounds of mercury; except substances, not being aerosols, containing less than the equivalent of 0.2 per cent, weight in weight, of mercury (Hg)

Mescaline, and other derivatives of phenethylamine formed by substitution in the aromatic ring; their salts

Metazocine; its salts, its esters and ethers: their salt

Methadone (amidone); its salts

Methadyl acetate; its salts

Methyldesorphine; its salts, its esters and ethers; their salts

Methyldihydromorphine; its salts, its esters and ethers, their salts

2-Methyl-3-morpholino-I. 1-diphenylpropanecarboxylic acid; its salts; its esters; their salts

Metopon; its salts; its esters and ethers, their salts

Monolluoroacetic acid; its salts

Morpheridine; its salts and any other N-substituted derivative of di- (2-chloroethyl) amine; their salts

Myrophine; its salts

Nalorphine; its salts

Nococodine; its salts

m-Nitrophenol; o-nitrophenol; p-nitrophenol

Norcodeine; its salts; its esters and ethers; their salts

Norlevorpbanol; its salts; its esters and ethers: their salts

Normethadone: its salts

Normorphine; its salts; its esters and ethers; their salts

Norpipanone

Nux Vomica; except substances containing less than 0.2 per cent of strychnine

Opium; except substances containing less than 0.2 per cent or morphine calculated as anhydrous morphine

Organo-tin compounds, Compounds of Fentin

Ouabain

Oxycodone; its salts: its esters and ethers; their salts

Oxymorphone; its salts, its esters and ethers; their salts

Phenacemide

Phenadoxone; its salts

Phenampromide; its salts

Phenazocine; its salts; its esters and ethers; their salts

Phencyclidine; its salts

Phenomorphan; its salts, its esters and ethers; their salts

Phenoperidine; its salts, its esters and ethers; their salts

2-Phenylcinchoninic acid; 2-salicylcinchoninie acid; their salts; their esters

4-Phenylpiperdine-4-carboxylic acid ethyl ester; its salts

Pholcodine; its salts; its esters and ethers; their salts; except substances containing less than 1.5 per cent of pholcodine

Phosphorous compounds—

Amiton

Azinphos-ethyl

Azinphos-methyl

Chlorfenvinphos except sheep dips containing not more than 10 per cent, weight in weight, of chlorfenvinphos

Demeton-0

Demeton-S

Demeton-S-methyl

Dichlorvos

Diethyl 4-methyl-7-coumarinyl phosphorothionate

Diethyl p-nitrophenyl phosphate

Dimefox

Disulfoton

Ethion

Ethyl-p-nitrophenyl phenylphosphorothionate

Mazidox

Mecarbam

Mevinphos

Mipafox

Oxydemeton-methyl

Parathion

Phenkapton

Phorate

Phosphamidon

Schradan

Sulfotep

TEPP (HETP)

Thionazin

Triphosphoric pentadimethylamide

Vamidothion

Picrotoxin

Piminodine; its salts

Piritramide; its salts

Polymethylenebistrimethylammonium salts

Proheptazine; its salts

Propoxyphene; its salts

Racemethorphan; its salts

Racemorphan; its salts; its esters and ethers; their salts

Savin, oil of

Strophanthus, glycosides of

Thallium, salts of

Thebacon; its salts

Tretamine; its salts

Triaziquone

Trimeperidine; its salts

Zine Phosphide

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First Schedule (Part 1 Part 2)     Second Schedule    Third Schedule     Fourth Schedule     Fifth schedule     Sixth schedule   

(Section 30)

Vaccines, sera; toxins, antitoxins and antigens

Amikaein; its salts

Amphomycin; its salts; its esters; their salts

Amphotericins; their salts

Arsphenamine and analogue substances used for the specific treatment of infective disease

Bacitracin

Campreomycin; its salts; its esters; their salts

Cephalosporins; their salts; their esters; their salts; esters or such salts

Cephamyeins

Chloramphenicol; its esters

Chlortetracycline

Clindamycin; its salts; its esters

Colistin: its salts; its esters

Corticotrophin (Adrenocorticotrophichormone. ACTH)

Cortisone; its esters Cycloserine; its salts

Dimethylchlortetracycline; its salts

Erythromycin; its esters

Framycetin; its salts

Fusidic acid; its salts; its esters; their salts

Gentamicin; its salts; its esters; their salts

Griscofulvin; its salts

Hydrocortisone; its esters

Isoniazial; its salts; its derivatives; their salts

Kanamycin; its salts

Lincomycins—

S-alkyl derivatives of 6, 8-dedeoxy-6-trans-(4-alkyl-L-2-pyrolidine-carboxamido) 1-thio-D-erythro-&-D-galacto-octo-pyranoside N-pyrollidine analogues thereof; their esters: their salts

Nalidixic acid; its salts; its esters; their salts

Neomycin; its salts

Novobiocin; its salts

Nystatin; its salts

Oleandomycin; its salts; its esters; their salts

Organic substances having the specific biological action of curare on neuro-muscular transmission; preparations of such substances

Oxytetracycline; its salts

Para-aminosalicylic acid; its salts

Paramomyclin; its salts; its esters; their salts

Penicillins; their salts; their derivatives: their esters

Polymyxins; their salts

Prednisolone; its esters

Prednisone; its esters

Preparations of the specific antidiabetic principle of the pancreas known as insulin

Preparations of the posterior lobe of the pituitary body

Preparations of human blood

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