Pharmacies will now be required to have running water, toilets, waste disposal systems and space for storage of cleaning equipment.
Health Chief Administrative Secretary Rashid Aman yesterday announced the new guidelines at the Pharmacy and Poisons Board offices in Nairobi. For any premises to be licensed as a retail pharmacy, it has to be fixed.
A fixed premises does not include a vehicle, trailer, caravan or any other thing which may be transported on, in or attached to a vehicle, the guidelines state. It does not include unroofed and or temporary structures.
The premise should meet all the relevant local by-laws and planning regulations, the rules state. The pharmacy premises will also be required to be protected against adverse weather conditions, ground water seepage, vermin and pest infestation.
“There should be some basic equipment such as a tablet counter, a refrigerator, appropriate litter bins, drinking water dispenser, weighing balance, measuring cylinders with a capacity to accurately measure volumes between zero and 100 ml and pestle and mortar.
Prescription-only medicines will be required to be separated from over the counter drugs and narcotic and psychotropic drugs shall be kept in a secure fixed and lockable storage place.
The pharmacists will be expected to keep records of these products, reflecting true stock balances.
No prescription-only medicine will be dispensed except in compliance with a valid prescription written by a registered medical practitioner, dental surgeon or veterinary surgeon.
Under the regulations, records of all stocks received their source, batch number, expiry date and quantity received shall be maintained.
“Procedures and job descriptions for employees and other persons having access to the products must be designed and administered to minimise the possibility of drugs coming into unauthorized possession.”
During operating hours, the business will be required to be conducted under the continuous personal supervision of a pharmacist or pharmaceutical technologists at all times.
According to the rules and regulations, stock which has been damaged or withheld from sale and which is not immediately destroyed should be placed in quarantine until disposal so that it cannot be sold in error or, in the case of liquid leakage, cause contamination to other goods.
“Stocks of products with broken seals, damaged packaging or suspected of possible contamination must not be sold or supplied.”
Products which are suspected to be substandard, falsified or falsely labeled will be required to be kept in a designated area apart from other medicinal products to avoid confusion.
They should be clearly labelled as “NOT FOR SALE” and the The Pharmacy and Poisons Board and the holder of the products registration immediately informed.
Should a retailer come across or detect such products, it is advisable that such product encountered/ detected should be quarantined and PPB be notified for necessary regulatory action.
