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Table 2 Rules governing the retail pharmaceutical sector in Kenya

From: The policy-practice gap: describing discordances between regulation on paper and real-life practices among specialized drug shops in Kenya

Area regulated

Specific rules

Structure-related regulations

▪ → Premises must be registered

▪ → Annual premise license must be in place

▪ → Licenses must be displayed on the wall

▪ → Premises must comply with structural requirements for pharmacy practice:

- → Premises must have construction of permanent nature

- → Premises must be well lit and ventilated

- → Premises must have a separate dispensing area of minimum size 8 by 10 feet

- → Premises must have water, toilet facilities and lighting; proper storage area for medicines

Personnel and practice related regulations

▪ → Personnel must have proper qualification and registration

▪ → Annual practice license must be in place

▪ → Dispensing prescription medicines only with a valid prescription

▪ → Medicines sold must be properly labeled

▪ → Advertising of medicines and services not allowed without due permission

▪ → SDSs must not stock other household commodities alongside medicines

▪ → Records must be kept for the sale of prescription medicines

Equipment and materials related regulations

▪ → The premises should have basic equipment, including a refrigerator and a narcotics cupboard

▪ → The premises should have reference materials such as Martindale, reference showing drugs available in the Kenyan market, and the Pharmacy and Poisons Act