Pharmacists Regulations (Dispensing of Veterinary Preparations), 1988

)PHARMACISTS REGULATIONS (DISPENSING OF VETERINARY PREPARATIONS 5749-1988 By virtue of the power vested in me by S62(6) of the Pharmacists Ordinance Ordinance) , [New and Version] S10 of 5741-1981 (hereinafter Pharmacists the Business Licensing Law 5728-1968 (hereinafter - Licensing Law), I enact these Regulations: CHAPTER A: INTERPRETATION Definitions 1. In these regulations: (Amended 5749) "Poisons licence" as defined in S48 of the Pharmacists Ordinance; "The Director: - any of the following civil servants jointly authorised for the purposes of these Regulations by the Director General of the Ministry of Health and the Director General of the Ministry of Agriculture: (1) A veterinarian; (2) A licensed pharmacist; "The Register" as defined in Regulation 2 of the Pharmacists Regulations (Medical Preparations) 5746-1986; "Authorised dispensary" - a place approved under these Regulations for the sale of veterinary preparations; "Dispenser of a special veterinary preparation" - any person, authorised to dispense a special veterinary preparation under the conditions stipulated in Regulation 2(a) of these Regulations, even if he is not a licensed Conditions for Dis pensing Veterinary pharmacist; "Veterinary veterinarian; "Dispensing" trans:fer; prescription'' a prescription by a transfering to a consumer by any means of "Consumer" - a person who obtains a special veterinary prep~ration for animals in his ownership, possession, control or care; "Veterinarian" - in accordance with its meaning in the Veterinarians Ordinance, 1929; "Licensed pharmacist" Ordinance. as defined in Pharmacists "Licence" - a licence in accordance with Licensing Law for an authorised dispensary in accordance with its meaning in item 178A of Licensing of Businesses Order (Business Requiring Licensing), 5733-1973 or any other item in lieu of the same; "Veterinary registered preparation" in the Register a in veterinary preparation the section relating to medical preparations for veterinary use as provided in the Pharmacists Regulations (Medical Preparations) 5746-1986; "Special veterinary preparation" a veterinary preparation for one of the animals specified in Part A of the First Schedule, provided that it is not an animal specified in Part B of the First Schedule. (a) The Director may authorise any person, who is not a licensed pharmacist, to dispense a special veterinary preparation in a place which is no is not a pharmacy, if that person shall satisfy the following conditions: sation Preparation in a place which is not a Pharmacy (l) He holds a poisons licence (2) He is, in the opinion of the Director, capable of dispensing a special veterinary preparation in the manner mentioned in Regulation 16. Submission (b) Such authorisation shall be granted for the dispensing of special veterinary preparation, instead of licensed dispensing, in.respect of which the provisions set out in these Regulations have been complied with. (c) The Director may revoke the authori granted to a person in accordance with Subregulation (a) if he is satisfied that either of the conditions specified in that Subregulation have ceased to apply to him, or that that person has committed a breach of any of the provisions of these Regulations, or has dispensed a medicative drug which is not a special veterinary preparation, or has dispensed a medicative drug in a place which is not an authorised dispensary, or that the place in which he was permitted to dispense special veterinary preparations has ceased, or is not fit, to be an authorised dispensary. 3. An applicant for a licence for an authorised of Drawings dispensary under the Licensing Law shall attach to his application engineering drawings of elevations and sections of the structure of the place approved by the Director. Area of the Place 4. (a) The area of an authorised dispensary shall not be less than 30 square metres. (b) The areas of the toilet facilities, the entrance area and the office shall be added to the area mentioned Walls ceiling and Floor Exception in Sub~egulation {a). 5. Th~ walls, the floor and the ceiling of an authorised dispensary shall be as follows: (1) built of concrete, bricks, concrete blocks or any ot~er building material, excluding metal, which is fire resistant and which has been approved by the Director; (2) sealed against the intrusion of water and dust; (3) the walls shall not be less than 2.75 metres in height; (4) the walls shall be smooth and painted with oil paint up to a height of at least 2 metres; the ceiling and the unpainted area of the walls shall be smooth and whitewashed; (5) there shall be no visible pipes on the walls; (6) the floor shall be level and tiled with whole and clean tiles; (7) the floor level shall not be more than 2 metres below the level of the adjacent road; (8) the height of the ceiling shall not be less than 1.50 metres above the level of the adjacent road. 6. The Director may, should it be reasonable because of the necessity of the regular supply of special veterinary preparations, permit the existence of an authorised dispensary, even if its area is less than that prescribed in Regulation 4 {a}, or its height is less than that prescribed in Regulation 5(3). Doors, Win- 7. (a) The doors, windows and lintels in an authorised dows and openings dispensary shall be whole and in proper condition, and, if they are made of wood, they shall be painted with oil paint. (b) Mesh shall be fixed in the window openings to prevent the intrusion of flying creatures, insects and rodents. Ventilation 8. (a) An authorised dispensary shall be ventilated by Toilets etc. means of external opening windows or an artificial ventilation system. (b) The area of the window openings shall not be less than one eighth of the area of the place being ventilated by means of them. (c) If the area of the window openings is less than as prescribed in Subregu.lation (b), the ventilation shall be supplemented by an artificial ventilation system. 9. (a) An authorised dispensary shall have its own toilet facilities which shall have the following installations which shall be in good working order, whole and clean: (l) a toilet cubicle containing a toilet pan with its cover and toilet paper holder; (2) an installation for washing hands, adjacent to the toilet cubicle, containing a sink, a water tap and a soap container or dispenser (hereinafter sink); (3) means disposable for drying hands, and if they are paper towels, a receptacle into which they can be thrown after use. (b) The room containing the toilet facilities shall not be connected with the authorised dispensary except by means of a connecting room. (c) The sink and hand dryer can be in the connecting room. Cupboards 10. In an authorised dispensary there shall be installed and shelves cupboards and shelves for the orderly storing of the veterinary preparations, to the satisfaction of the Director, at a height not less than 30 centimetres above the level of the floor. Maintenance ll. An authorised dispensary shall be maintained and kept Preventing Health Hazard Fixing of Signs and Display of Licences in a clean and proper condition such as will not endanger human life or health, all to the satisfaction of the Director. 12. (a) On the front of the authorised dispensary, and in a place clearly visible, there shall be fixed a sign, showing in Hebrew the name and address of the licence holder and the name of the business. (b} The business licence and poisons licence shall be displayed in a clearly visible place. Presence of 13. Whenever the dispensary is open to the public the Poisons dispenser of a special veterinary preparation under Licence- Regulation 12(a) shall be present and the dispensary shall holder only be opened and closed when he is present. Preserving Quality o.f 14 ( a) All authorised Preparations conditions special dispensary which will veterinary preparations in the shall be kept in proper storage ensure that their quality will be Keeping Toxica and Separanda Dispensing only on Prescrip tion preserved, to the satisfaction of the Director. (b) No person shall dispense special veterinary preparations after the expiry of the period of their efficacy. 15. The keeping of special veterinary preparations classified as toxica or separanda shall be in accordance with the Ordinance. The cupboards containing toxica and separanda shall be locked at all times and the key to them shall be held by the dispenser of special veterinary preparations. 16. No person in an authorised dispensary shall dispense a special veterinary preparation, whether the same is marked "On Doctor's Prescription only" or is not so marked, except on a veterinarian's prescription cq,ntaining the following partiulars: {l) Its date; (2) Name of the veterinarian, his address, or address of the institute in which he is employed, and his licence number; (3) Description of animal for whom the prescription is intended, .as set out in Part A of the First schedule; (4) Name of the preparation, written in separate and legible Latin capitals, or typed; (5) The dose. (6) The overall amount for a single animal or for a group of animal all held in the same place; (7) Instruction for use of the preparation; (8) Signature of the veterianrian; (9) Name and address of the consumer. Prohibition 17. {a) No person shall keep or dispense in an authorised on opening Original Package dispensary a special veterinary preparation except in its original package, which remains whole and unopened, or in wrapping, marked as required by law, by the manufacturer. (b) Notwithstanding the provisions of Subregulation (a) the Director may permit in writing, and on conditions which he shall prescribe, the dispensing of a special veterinary preparation even if it has been removed from its original package. Prohibition 18. Nothing in these Regulations shall be deemed to permit on making- anyone, who is not a licensed pharmacist, to make up or up prepare a medicative drug or poison for medical use, as defined in the Pharmacists Ordinance. Prohibition 19. No person shall keep or dispense in an authorised on keeping dispensary a special veyterinary preparation which is, or Dangerous contains, a dangerous drug, as defined in Dangerous Drugs Drugs Ordinance (New Version], 5733-1973; nothing in these regulations shall derogate from the provisions of the Dangerous Drugs Regulations, 5740-1979. Keeping and 20. (a) No person Preserving preparation in an Records recorded the same shall keep a special veterinary authorised dispensary unless he has in a card index of special veterinary preparations kept by him; the form card index shall be according to Form l in the Second Schedule and it shall be kept in accordance with the instructions of the Director. (b) No person shall dispense a special veterinary preparation in an authorised dispensary unless he has recorded the veterinary preparation being dispensed in a register of veterinary preparations dispensed; the form of the register of veterinary preparations dispensed shall be according to Form 2 in the Second Schedule. (c) The cards and the register relating to the dispensing of special veterinary preparations shall be preserved for three years from the date of the last entry in them and shall be available for inspection by the Director. Commencement 21. (a) The commencement of these Regulations is six and Repeal months after the date of their publication. (b) The Pharmacists Regulations (Dispensing of Veterinary Preparations), 5747-1987, are repealed as from the date of the commencement of these Regulations. FIRST SCHEDULE {Regulation 2) Part A Animals constituting agro-economic produce: A. Cattle 1. Cows, bulls and oxen 2. Flocks: sheep, goats and ibex 3. Buffaloes 4. Camels 5. Horses 6. Mules 7. Donkeys a. pigs 9. Rabbits B. Furry Animals C. Poultry Domesticated animals whose hide manufacture of furs, including 1. Minks 2. Chinchillas 3. Nutrias 4. Foxes 5. Ocelots 6. Sables l. Cockerels and hens 2. Geese 3. Ducks is used for the 4. Turkeys 5. Pigeons 6. Swans 7. Wild ducks 8. Mallards 9. Peafowls 10. Guinea fowls 11. Ostriches 12. Quails 13. Pheasants D. Other animals Part B l. Fish bred for Food .2. Bees Animals which are pets or are wild, whether they are kept in captivity or roam freely, including: 1. Dogs 2. Cats 3. Monkeys 4. Hamsters 5. Mice 6. Rats 7. Wild mammals 8. Wild reptiles 9. Birds 10. Aquarium Fish Form 1 SECOND SCHEDULE (regulation 20) Veterinary Preparation Card Card No. Preparation: Name of Preparation Form of Dose No. of Units or Concentration Packing No. Manufacturer's Name Importer' name (if imported) Date Received Quantity Despatch No. Weight or Volume Dispensed on lrought forward from previous Card Serial No. of Prescr iption Name of Owner of Animal for which intended Quantity Balance Weight or of Volume stock Weight or Volume. ame of Holder of Poisons Licence Business Stamp. Address Signature of Holder of Poisons Licence. Form 2 Register of Veterinary Preparations Dispensed (Pages bound into a hard cover containing the following particulars) serial No. Date Name of Quantity Preparation Dispensed Name of Pre- Name and Address scribing of Purchaser of Veterinarian Preparation 7 Heshvan 5749 (18 October 1988) Shoshana Arbeli-Almozlino Minister of Health