Pharmacy and Poisons Act (Standards for Pharmacies) Regulations 1979

Title 11 Laws of Bermuda Item 5(c) 1989 Revision 1 BERMUDA STATUTORY INSTRUMENT BR 47/1979 PHARMACY AND POISONS (STANDARDS FOR PHARMACIES) REGULATIONS 1979 [made under section 22 of the Pharmacy and Poisons Act 1979 [title 11 item 5] and brought into operation on 1 January 1980] ARRANGEMENT OF REGULATIONS 1 Citation 2 Interpretation 3 Equipment and facilities 4 Where drugs to be kept 5 Presence of pharmacist 6 Display of certificate 7 Record keeping 8 Maintenance 9 Overcrowding 10 Minimum working space 11 Ventilation 12 Illumination 13 Workbench 14 Sanitary conveniences 15 Potable water 16 Storage of clothing 17 Offences Citation 1 These Regulations may be cited as the Pharmacy and Poisons (Standards for Pharmacies) Regulations 1979. PHARMACY AND POISONS (STANDARDS FOR PHARMACIES) REGULATIONS 1979 2 1989 Revision Interpretation 2 In these Regulations— "dispensary" means in relation to the pharmacy the designated area in which medicines are compounded and sold upon presentation of a valid prescription and such area from which the public are excluded; "sanitary convenience" means water closets, urinals and lavatory basins. Equipment and facilities 3 No person shall be permitted to operate a registered pharmacy unless the dispensary located therein is, for the proper dispensing and compounding of medicines equipped with— (a) a balance which shall be accurate within l milligram; (b) a scale having the capacity to weigh with reasonable accuracy up to l kilogram large quantities of medicines; (c) adequate facilities for measuring medicines in varying quantities; (d) a refrigerator maintained in proper working condition; (e) a pestle and mortar, a table counter, and a typewriter; (f) an adequate supply of assorted advice and warning labels; (g) a Martindale; (h) an adequate supply of childproof containers for the dispensing of tablets; and (i) an adequate supply of bottles in which liquids are to be dispensed. Where drugs to be kept 4 (1) All drugs listed in Schedule 3 to the Pharmacy and Poisons Act 1979 [title 11 item 5] shall be kept in the dispensary or in any other area from which the public are excluded. (2) All drugs listed in Schedule 4 to the Pharmacy and Poisons Act 1979 [title 11 item 5] shall be kept in an area immediately adjacent to the dispensary so as to be visible to any Pharmacist on duty in the dispensary. Presence of pharmacist 5 In any pharmacy that is open for sale to the public of a drug listed in Schedule 3 or 4 to the Pharmacy and Poisons Act 1979 [title 11 Title 11 Laws of Bermuda Item 5(c) 1989 Revision 3 item 5], a registered pharmacist shall, so far as is practicable, be present at all times in the dispensary thereof. Display of certificate 6 Every pharmacist or owner of a pharmacy who has received a Bermuda certificate of registration from the Council shall prominently display that certificate in his place of business. Record keeping 7 (1) Any invoice relating to the receipt of a drug listed in Schedule 3 and 4 to the Pharmacy and Poisons Act 1979 [title 11 item 5] and any prescription relating to the sale of such drug shall be kept for a period of not less than two years. (2) For purposes of inspection the owner of a registered pharmacy shall on demand made by the Minister or by any person authorized in writing by the Minister in that behalf— (a) furnish such particulars as may be requested in respect of receiving and selling of any drug listed in Schedule 3 or 4 to the Pharmacy and Poisons Act 1979 [title 11 item 5], or in respect of any stock of such drugs in his possession; (b) for the purpose of confirming any such particulars, produce any stock or such drugs in his possession; (c) produce books or documents in his possession relating to any dealings in drugs listed in Schedule 3 or 4 to the Pharmacy and Poisons Act 1979 [title 11 item 5] as may be requested, Maintenance 8 Every person who operates a registered pharmacy shall keep and maintain in clean condition— (a) the interior and exterior of that pharmacy; and (b) the furniture, furnishings, fixtures and fittings placed and installed therein. Overcrowding 9 (1) For the protection from injury to health or risk thereof of all employees, every person who operates a registered pharmacy shall provide adequate space in the dispensary and in any other working area of the pharmacy. (2) Every person shall in compliance with paragraph (1), avoid any overcrowding by employees in any working area of the pharmacy, and shall have regard— PHARMACY AND POISONS (STANDARDS FOR PHARMACIES) REGULATIONS 1979 4 1989 Revision (a) to the total number of persons on duty at any time in the dispensary and in any other working area of the pharmacy; and (b) to the quantity of furniture, furnishings, fixtures and fittings and the placement and installation thereof. Minimum working space 10 (1) There shall be allocated to each person working in a dispensary or in any other working area of the pharmacy an area of floor space of not less than forty square feet; and where the ceiling height is less than ten feet four hundred cubic feet shall be allowed for each person. Ventilation 11 Every person who operates a pharmacy shall provide throughout that pharmacy adequate and proper circulation of fresh or artificially purified air. Illumination 12 The interior of a pharmacy shall be illuminated suitably and adequately by means of natural or artificial lighting and particular regard in respect of such lighting shall be directed to those areas in which employees work or pass. Workbench 13 Every dispensary shall be equipped with adequate and suitable work benches, sinks, cupboards and other furnishings, fixtures and fittings for the proper operation and functioning of the dispensary. Sanitary conveniences 14 (1) There shall be provided on the premises of every pharmacy suitable sanitary conveniences. (2) No person shall install sanitary conveniences in a dispensary or in any working area of the pharmacy. (3) Sanitary conveniences shall be installed in an area which is not in proximity to the dispensary or other work place. (4) For purposes of privacy all sanitary conveniences shall be enclosed and provided with suitable doors and fastenings. (5) in any pharmacy where the employees of which exceed five in number and are persons of both sexes, being regularly employed in such pharmacy, there shall be provided for each sex, separate sanitary conveniences and washing facilities. Title 11 Laws of Bermuda Item 5(c) 1989 Revision 5 Potable water 15 All sinks and other outlets supplying potable water in the dispensary shall be equipped so as to supply hot and cold water. Storage of clothing 16 There shall be provided in a pharmacy suitable and adequate space in which may be stored clothing which is not worn by employees during the hours of work or clothing worn by employees during the hours of work but which is left on the premises. Offences 17 Any person who contravenes any of these Regulations commits an offence: Punishment on summary conviction: imprisonment for 12 months or a fine of $2,000 or both such imprisonment and fine.