Pharmacy Regulations 1985
[GN 10 of 1985 – 19 January 1985] [Section 47]
1. These regulations may be cited as the Pharmacy Regulations 1985.
2. In these regulations –
"Act" means the Pharmacy Act;
"employee" means a member of the staff of a pharmacy and includes a student;
"examination" means an examination conducted for the purposes of Part III of the Act;
"Part I poison" means a poison specified in Part I of the First Schedule to the Act;
"Part II poison" means a poison specified in Part II of the First Schedule to the Act;
"person in charge", in relation to a pharmacy, means –
(a) the pharmacist in charge; or
(b) in his temporary absence or, in the case provided for in section 19(a)(i) of the Act, the assistant pharmacist in charge;
"service room" means a room in a pharmacy used for serving customers.
3. (1) Every person wishing to be registered as a student shall forward to the Registrar –
(a) an extract of his birth certificate;
(b) the originals of his educational certificates; and
(c) 2 character references.
(2) Subject to paragraph (3), the Registrar may register as a student a person who –
(a) possesses a Cambridge Higher School Certificate with passes at Principal level in chemistry, mathematics and any one of the following subjects –
(ii) biology; or
(b) pays the fee specified in the First Schedule.
(3) The Registrar may register as a student pharmacy technician a person who –
(a) possesses –
(i) a Cambridge School Certificate with credit in chemistry and mathematics; or
(ii) any other equivalent qualification acceptable to the Board;
(b) pays the fee specified in the First Schedule.
(4) The Registrar may register as pharmacy technician a person who –
(a) produces satisfactory evidence of having been employed as a dispenser for not less than 10 years in a pharmacy;
(b) satisfies the Board through an oral examination that he has acquired sufficient experience and skill in the dispensing of pharmaceutical products; and
(c) pays the fee specified in the First Schedule.
4. (1) The syllabus for the intermediate examination in pharmacy shall be that specified in the Second Schedule.
(2) The syllabus for the assistant pharmacist's examination shall be that specified in the Third Schedule.
(3) The syllabus for the pharmacist's examination shall be that specified in the Fourth Schedule.
(4) The syllabus for the pharmacy technician's examination shall be that specified in the Fifth Schedule.
5. (1) Examinations under regulation 4 shall be held in March and September of each year on dates that shall be notified by the Board in 2 daily newspapers not later than –
(a) 20 January, in the case of an examination held in March; and
(b) 20 July, in the case of an examination held in September.
(2) No candidate shall be admitted to any examination held in –
(a) March, unless he has applied for admission before 1 February of the same year;
(b) September, unless he has applied for admission before 1 August of the same year,
and paid the fees specified in the First Schedule.
(3) The Registrar shall send a copy of the examination timetable to every candidate not later than 10 days before the date fixed for the commencement of the examination to which he has been admitted.
6. (1) A written and a practical examination shall be held in every subject for which the syllabus so provides.
(2) The examiners may require any candidate to undergo an oral examination in any subject.
(3) The time allowed for the completion of any written, practical or oral examination shall be determined by the examiners.
7. (1) The written, practical and oral examinations shall be conducted by examiners appointed by the Board.
(2) Each candidate shall, unless the examiners otherwise direct, be examined individually.
8. A candidate at a practical examination may be required to produce for inspection to the examiners his laboratory notebook duly certified by the person in charge of the course of instruction which he has followed.
9. (1) Subject to paragraph (2), the examiners may disqualify any candidate who, in the course of an examination –
(a) makes use of any note or document;
(b) copies from any book or from the paper of another candidate;
(c) without lawful authority or reasonable excuse, communicates with any other person; or
(d) uses any unfair means.
(2) The examiners may, where notice to that effect has been given in the examination timetable, allow candidates to use notes or materials relating to any practical or analytical work.
10. (1) Subject to paragraph (3), no candidate shall obtain a pass in an examination unless at one and the same sitting he satisfies the examiners in all the subjects taken by him at that sitting.
(2) No candidate shall obtain a pass in a subject unless in each written, oral and practical examination he has obtained not less than 40 per cent of the maximum marks obtainable.
(3) The Board may, where a student fails in not more than one subject in an examination, allow him to take that subject alone at any subsequent examination.
11. The fees payable for the purpose of registration as pharmacist, assistant pharmacist or pharmacy technician under section 12 of the Act shall be those specified in the First Schedule.
12. (1) An application shall, for the purpose of section 18(2) or 23(2) of the Act, be made to the Board in the form set out in Part I or Part II of the Sixth Schedule.
(2) Where an application under paragraph (1) is granted, the fee payable under section 18(5) or 23(3) of the Act shall be that specified in the First Schedule.
13. (1) Every pharmacy shall consist of at least 2 adjoining rooms, each having –
(a) a minimum floor space of 12.5 square metres; and
(b) a minimum height of 2.75 metres.
(2) One room of a pharmacy shall be used as a service room and either 2 other rooms or one other room divided into 2 sections by a partition of not less than 2 metres in height shall be used for dispensing and storage respectively.
(3) No room used for storage shall have direct access to the service room.
[Reg. 13 amended by reg. 3 of GN 3 of 1993 w.e.f. 16 January 1993.]
14. Every licensee of a pharmacy shall cause the pharmacy to be fitted with –
(a) suitable cupboards and shelves;
(b) complete sets of wide and narrow mouthed bottles for solids and liquids;
(c) porcelain jars for ointments;
(d) all necessary measures, weights, mortars, infusion pots, bottles, suppository moulds, spirit lamps, stoves and other usual pharmacy apparatuses and utensils;
(e) suitable storage accommodation for dispensing needs;
(f) suitable means of disposal for litter; and
(g) at least one of each of the following types of scales –
(i) counterbalance scales to weigh 5 kilogrammes and fractions of a kilogramme;
(ii) scale to weigh one kilogramme;
(iii) scales sensitive to 0.0005 gramme, each with an accurate and complete set of weights.
15. (1) Every person in charge of a pharmacy shall –
(a) keep a register in which shall be entered particulars of persons having been employed in the pharmacy during the preceding 3 years;
(b) on demand, produce to an inspector the register;
(c) keep in the pharmacy the latest editions of the British Pharmacopoeia, British Pharmaceutical Codex and of the French Codex;
(d) keep all pharmaceutical products in proper containers properly stoppered, labelled and arranged on shelves in single file, with adequate space among them;
(e) keep packed goods, such as proprietary preparations, food and drink separate from the products specified in subparagraph (d);
(f) cause Part I poisons which are in frequent use, other than poisons contained in ampoules, proprietary medicines and similar preparations, to be kept in a special cupboard;
(g) keep poisons in proprietary or packed medicines in a separate cupboard from, or in a separate part of the safe cupboard as, Part I poisons;
(h) cause Part II poisons to be kept in a special cupboard;
(i) place containers of solids, liquids and extracts on separate shelves;
(j) store any reserve stock of Part I poisons in the room or section used for dispensing or storage in suitable containers which shall be –
(i) labelled with the word "POISON"; and
(ii) placed in a special cupboard on the doors of which shall be painted or otherwise affixed the words "PART I POISONS" printed in red against a white background;
(k) keep chemicals affected by air in glass stoppered or adequately sealed bottles;
(l) use actinic or blue bottles for storing chemicals affected by light;
(m) keep all equipment in the dispensing room clean and ready for immediate use in a special cupboard or on a shelf protected from contamination;
(n) keep an adequate supply of clean dispensing bottles, of various sizes, which shall be arranged according to size on the shelves in the dispensing room;
(o) keep sera, vaccines and other pharmaceutical preparations required to be kept in the cold in a refrigerator;
(p) keep all antibiotics in a locked cupboard and separate from other drugs sold in the pharmacy;
(q) keep all fixtures and furniture in the pharmacy in a clean condition.
(2) Subject to paragraph (5), no person shall sell a pharmaceutical product otherwise than in a sealed container which bears a label indicating –
(a) the name and address of the manufacturer;
(b) the name of the product;
(c) the date of manufacture;
(d) the number of any licence issued by the Permanent Secretary in respect of the product;
(e) the composition of its ingredients;
(f) the date after which it cannot be safely used;
(g) any dosage restrictions;
(h) the conditions of storage necessary to ensure stability and maintenance of potency;
(i) the directions for use;
(j) the words "for external use" or "not to be taken" in red lettering, where it is intended for external use;
(k) where applicable, the words "to be administered under medical supervision only" or the words "to be dispensed only by or on prescription of a medical practitioner";
(l) in printed form, a batch number which shall identify the batch of the preparation and permit the production history of the batch and all stages of manufacture and control to be traced;
(m) the name and address of the pharmacy selling the product.
(3) Subject to paragraph (5), no person shall sell a pharmaceutical product otherwise than in a container which is accompanied by a notice of information for the benefit of authorised persons, pharmacists and consumers.
(4) The notice of information under paragraph (3) –
(a) shall convey information relating to the pharmacology, composition, chemistry, method of administration, dosage, contraindication, side effects and toxic effects of the pharmaceutical product and any precaution which may be required to be taken;
(b) shall not purport –
(i) to draw any comparison between the pharmaceutical product and a different brand of that pharmaceutical product; or
(ii) to make any exaggerated claim as to the efficiency of the pharmaceutical product.
(5) Paragraphs (2) and (3) shall not be applicable where, at the request of the purchaser, the pharmacist sells the product in a quantity which is less than that in which the pharmaceutical product was intended to be sold.
[Reg. 15 amended by reg. 3 of GN 42 of 1993 w.e.f. 13 March 1993.]
16. (1) Subject to regulation 38, no person shall sell a therapeutic substance otherwise than in a container which is labelled with –
(a) the name of the substance as specified in the Sixth Schedule to the Act;
(b) the number of the licence under which the substance was imported or manufactured;
(c) the name and address of the manufacturer;
(d) where a test for potency in units is required by the quality control standards, a statement of the potency in units;
(e) where a test for potency or maximum toxicity is required by a quality control standards, the date up to which the substance, if kept under suitable conditions, may be expected to retain a potency not less than the stated potency or not to acquire a toxicity greater than that permitted by the test;
(f) the date on which the manufacture of the particular batch was completed;
(g) the precautions necessary for preserving the properties of the contents to the date indicated in subparagraph (f);
(h) where a bacteriostatic has been added, the nature and the proportion of the bacteriostatic in the material as prepared for use.
17. The general arrangement and manner of storage of drugs in the service room shall, as far as practicable, be followed in the storage and dispensing rooms.
18. (1) Where there is a change in the management of a pharmacy –
(a) the outgoing pharmacist shall, before handing over the control and management of the pharmacy to the incoming pharmacist âˆ’
(i) balance the accounts in respect of drugs kept at the pharmacy;
(ii) check the existing stock;
(iii) close the books;
(iv) jointly with the incoming pharmacist, sign a handing over certificate in duplicate in the form set out in Part I of the Seventh Schedule showing any excess or shortage in the stock of pharmaceutical products and endorsed with his explanations regarding any discrepancy in the stock;
(v) forward to the Registrar, both the original and duplicate of the certificate under subparagraph (iv);
(b) the incoming pharmacist shall –
(i) jointly with the outgoing pharmacist, ascertain the existing stock of pharmaceutical products in the pharmacy at the time of the handing over; and
(ii) take charge of the stock, books and documents entrusted to him.
(2) Where the original and duplicate of a certificate under paragraph (1) have been forwarded to the Registrar, the Registrar shall return the duplicate to the incoming pharmacist who shall keep it for inspection.
19. (1) On the death of a pharmacist who is in charge of a pharmacy, the licensee, or where the pharmacist himself was the licensee, the spouse or heirs of the deceased pharmacist, shall forthwith notify the Board of the death of the pharmacist and of the arrangements proposed to be made with regard to the pharmacy.
(2) The pharmacy shall remain closed until the proposed arrangements have been approved under section 19 of the Act.
(3) Where the proposed arrangements are approved by the Board, the pharmacy shall not be re-opened except in the presence of the Chief Government Pharmacist who shall –
(a) jointly with the incoming pharmacist, an assistant pharmacist, or a pharmacist in charge of another pharmacy who has taken charge of the pharmacy –
(i) ascertain the existing stock of pharmaceutical products kept at the pharmacy;
(ii) with the authority of the Board, sign a handing over certificate in duplicate in the form set out in Part II of the Seventh Schedule;
(b) hand over the existing stock of pharmaceutical products to the incoming pharmacist, assistant pharmacist or pharmacist in charge of another pharmacy who has taken charge of the pharmacy.
(4) Where, on the death of the pharmacist in charge of the pharmacy, it is decided to close the pharmacy, the board shall be notified accordingly and the stocks of pharmaceutical products, shall be sold under the supervision of the Registrar or the Chief Government Pharmacist.
20. No employee of a pharmacy shall use a dropper other than one of standard calibration for measuring drops.
21. No person shall –
(a) allow any part of a pharmacy to be used for any purpose other than that of a pharmacy;
(b) sublet any part of a pharmacy.
22. (1) No person shall be employed or continue to be employed in a pharmacy if he suffers from a contagious or infectious disease or is a carrier of an infectious disease.
(2) No person shall enter any part of a pharmacy, other than the service room, unless he is an employee of the pharmacy.
(3) No person in charge of a pharmacy shall cause or permit any person who is not an employee of the pharmacy to enter any part of the pharmacy other than the service room.
23. Subject to regulation 26, no person shall, except with the written authorisation of the Permanent Secretary, sell any poison in dosage form not being a poison specified in the Eighth Schedule, otherwise than in a container labelled with –
(a) the name of the poison;
(b) the proportion of the poison;
(c) the word "poison" and, in the case of a poison specified in the first column of the Ninth Schedule, the words specified in the second column of that Schedule;
(d) in the case of a '˜Part I poison', a lettering in red set on a white background or in black set on a red background;
(e) in the case of a poison specified in the first column of the Tenth Schedule, the words specified in the second column of that Schedule;
(f) in the case of a liquid poison, other than a poison sold in a bottle of a capacity of not more than 3.5 litres, the words "NOT TO BE TAKEN";
(g) in the case of a poison for external application, the words "FOR EXTERNAL USE ONLY";
(h) the name of the seller; and
(i) the address of the premises on which the poison is sold.
24. No person shall sell a poison specified in the Third or Fourth Schedule to the Act otherwise than in a container labelled with a notice specifying the purpose for which the poison is intended and a warning that it is to be used only for that purpose.
25. Subject to regulation 26, no person shall sell a poison otherwise than in a container which is –
(a) impervious to the poison;
(b) of hard material;
(c) in the case of a liquid poison, a bottle of a capacity of not more than 3.5 litres with the outer surface fluted vertically with ribs or grooves.
26. Regulations 23 and 25 shall not apply to the sale of agricultural or horticultural insecticides consisting of nicotine dust and containing not more than 4 per cent of nicotine or its salts.
27. No person shall sell strychnine or its salts otherwise than –
(a) as an ingredient in a medicine;
(b) for the purpose of being compounded in a medicine prescribed or administered by an authorised person; or
(c) to a person engaged in scientific education or research for the purpose of education or research.
28. (1) No person shall sell or supply monofluoroacetic acid or its salts except –
(a) by wholesale;
(b) to a person engaged in scientific education or research for the purpose of education or research; or
(c) to a person producing a certificate in the form set out in the Eleventh Schedule and in the quantity specified in the certificate.
(2) Where monofluoroacetic acid or its salts are sold under paragraph (1)(c), the seller shall keep the certificate on the premises where the sale took place.
29. (1) No person shall sell a Part II poison otherwise than in a container as sealed by the manufacturer or other person from whom the poison was obtained.
(2) Paragraph (1) shall not apply to a sale of ammonia, hydrochloric acid, nitric acid, potassium quadroxalate or sulphuric acid.
30. No person shall sell a poison specified in the Twelfth Schedule unless it has a distinctive colour.
31. No person shall consign a poison specified in the Thirteenth Schedule for transport by any method –
(a) otherwise than in a container labelled with the name or description of the poison as specified in that Schedule; and
(b) unless the poison is kept effectively separated from any food or liquid intended for human consumption.
32. (1) The form required by a purchaser under section 27(5) of the Act shall be as set out in Part I of the Fourteenth Schedule.
(2) The fee payable under section 27(9) of the Act shall be that specified in Part II of the Fourteenth Schedule.
33. No person shall import, manufacture, keep, store, distribute, sell, export, use, possess or otherwise deal with any drug specified in the Fifteenth Schedule.
34. No person shall sell any pharmaceutical product otherwise than in a container –
(a) sealed to protect the contents; and
(b) of such size, shape, form or material as the Permanent Secretary may require.
35. (1) No wholesale pharmacist shall sell any pharmaceutical product otherwise than to –
(a) a pharmacist in charge of a pharmacy on production of a requisition signed by the pharmacist;
(b) a private health clinic on production of a requisition signed by a medical practitioner who is designated by the clinic and approved by the Board;
(c) a sugar estate dispensary on production of a requisition signed by the medical practitioner in charge of the dispensary;
(d) a livestock breeder on production of an authorisation granted under paragraph (2).
(2) The Board may, on an application by a livestock breeder, grant him an authorisation to purchase such pharmaceutical products as the Board may specify.
[Reg. 35 revoked and replaced by reg. 3 of GN 16 of 1986 w.e.f. 1 March 1986.]
36. (1) Subject to regulation 38, an importer shall, as soon as reasonably practicable after taking delivery of a consignment of antibiotics, record in an Antibiotics Register kept by him for the purpose, full particulars of the consignment.
(2) The Antibiotics Register shall be in the form set out in Part I of the Sixteenth Schedule and shall at all times be made available for inspection to the inspector.
(3) Every requisition of antibiotics from one pharmacist to another shall be kept for a period of 2 years from the date of supply.
(4) The person in charge of a pharmacy shall keep in a Purchase and Sale Antibiotics Register, which shall be in the form set out in Part II of the Sixteenth Schedule, a record containing full particulars of every purchase and sale of antibiotics made by him.
37. Every pharmacist shall, not later than 15 days after the end of each quarter, furnish to the Permanent Secretary a return, in respect of that quarter, of all antibiotics, other than antibiotics contained in an animal feed in the form set out in Part III of the Sixteenth Schedule.
38. Regulations 16 and 36 shall not apply to a preparation used as animal feed which contains an antibiotic.
39. The fees payable under sections 35(4) and 36(3) of the Act in respect of a licence to build a factory or to manufacture a pharmaceutical product shall be as specified in the First Schedule.
40. (1) The Board shall, by notice published in the Gazette, and in 2 daily newspapers on or before the twentieth day of each month, designate the pharmacies which shall remain open on every public holiday of the ensuing month.
(2) The licensee of a pharmacy designated under paragraph (1) shall be notified by the Board, by letter forwarded to him by registered post within the delay specified in paragraph (1) of the fact that his pharmacy has been so designated.
(3) A licensee to whom a letter has been forwarded under paragraph (2) shall keep his pharmacy open on the public holiday specified in the letter.
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