ETHIOPIAN ES 7084:2024

STANDARD

First edition
xx-xx-2024

Pharmacy – Requirements

ICS: 11.120.01
Published by Institute of Ethiopian Standards
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Foreword

This Ethiopian standard has been prepared under the direction of the Technical Committee for essential
medicines (TC 88) and published by the Institute of Ethiopian Standards (IES).

Draft of the standard has been presented by Ethiopian Food and Drug Authority.

Acknowledgement is made for the organization for its concern to contribute to the efforts of national
standardization.

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Pharmacy – Requirements
1. Scope
The standard specifies requirements with respect to practices, premises, professionals and products
(equipment and materials) put into use for pharmacy. It is applicable for new and existing pharmacies
irrespective of ownership throughout the country. This requirement is not applicable to pharmacy services
included as a part of health facilities service.
2. Normative reference
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
No normative reference is used for this document.
3. Terms and definitions
For the purpose of this requirement the following terms and definitions shall apply.
3.1.
pharmacy
private, government or non-government owned community pharmacy which is led by a registered and licensed
pharmacist to provide pharmaceutical care and dispense medicines to consumers.

3.2.
regional health Regulatory body
a state government organ authorized to implement food, medicine and healthcare administration and control
activities at a state level;

3.3.
authority
the Ethiopian Food and Drug Authority

3.4.
proclamation
the Food and Medicine Administration Proclamation No. 1112/2019

3.5.
appropriate law
a law issued by a state to implement regulatory activities regarding food, medicine and healthcare services.

3.6.
person
any physical or juridical person
3.7.
authorized person
any pharmacy staff who is responsible for providing services

3.8.
Certificate of competence
a permit issued for a person to carry out pharmacy services at community pharmacy level as stated under the
proclamation No 1112/2019 and this standard.

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3.9.
compounding
a process of preparation of extemporaneous medicines intended for individual patients in accordance with a
written prescription.

3.10.
good pharmacy practice
the practice of pharmacy that responds to the needs of the people who use the pharmacy professionals’
services to provide optimal, evidence-based care.

3.11.
owner
person who owns the pharmacy

3.12.
technical manager
shall mean a licensed pharmacist who is either an owner or designated by the owner of a pharmacy to have
authority over and be responsible for the operation of the pharmacy and who is named in the certificate of
competence issued by appropriate regulatory body for the pharmacy as the manager;

3.13.
pharmacy professional
a pharmacist, druggist or pharmacy technician licensed by an appropriate health professional regulatory organ.

3.14.
hazardous substance
a waste that poses substantial or potential threats to public health or the environment ignitability, reactivity,
corrosiveness and toxicity;

3.15.
medicines waste
waste which encompass the following:
a)All properly unsealed bulk products or loose tablets and capsules. If unexpired these shall only be used when
the container is still sealed, properly labeled or still within the original unbroken blister packs,
b)All cold chain damaged, unexpired medicines that should have been stored in a cold chain but were not,
c) Counterfeit, substandard and adulterated,
d)Discarded items used in the handling of medicines,
e)Expired, unused, spilt, and contaminated,
f) Improperly sealed or labeled or stored,
g)Expired, damaged, and improperly sealed or labeled or stored laboratory reagents,
h)Expired, damaged, and improperly sealed or stored medical supplies;
i) Prohibited or unauthorized medicines,
j) Expired, damaged, and improperly sealed or labeled or stored raw materials, and
k) . Discarded packing materials.

3.16.
package
the immediate container or wrapping in which any preparation is contained for use or storage;

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3.17.
label
any material which is printed or affixed to a packing material which provides the necessary information about
medicine, and includes an insert;

3.18.
prescription
a paper or electronic order for medicine that meets requirements set by the authority, and written and signed by
a duly licensed medical professional and issued to patients to collect medications.

3.19.
active ingredient
any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure,
mitigation, treatment or prevention of disease.

3.20.
drug Information
written and/or verbal information on pharmaceuticals and therapeutic use of medicines.

3.21.
drug Information Service
the provision of up-to-date, unbiased, well referenced, and critically evaluated therapeutic, and pharmaceutical
information. It also includes provision of education, training, and conducting research.

3.22.
drug information center
shall mean a unit designated for providing medicine information services

4. General requirements
4.1. Any person who wants to operate as a pharmacy shall first obtain a certificate of competence from the
appropriate regulatory body as per scheme xxx.
4.2. The pharmacy shall procure medicines from licensed manufacturers, importers or wholesalers.
4.3. The pharmacy and pharmacy professionals working therein shall be responsible to prevent and report
suspected substandard and falsified (SF) medicines.
4.4. The pharmacy shall not run without a registered and licensed pharmacist
4.5. The pharmacy practice, at all times, shall strive towards higher standards of practice, for the benefit of the
patients and community being served.
4.6. The pharmacy professionals shall update their ability with current and relevant evidence-based
information.
4.7. The pharmacy shall not practice any activity other than its scope permitted by law and also the pharmacy
professionals shall implement good pharmacy practices.
4.8. Health promotion and prevention programs permitted in pharmacy shall deliver its intended benefits for
the community in promoting wellbeing, reducing preventable illness and lowering overall health care
expenditures
4.9. A pharmacy shall not engage in wholesale trade of any medicines.

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5. Specific Requirements
5.1. practices
5.1.1. Prescription
5.1.1.1. A prescription shall be required for all medicines for dispensing except over the counter medicines
as stated by the authority.
5.1.1.2. Patients shall have the right to get print out of electronic prescription with the seal of the health
institution.
5.1.1.3. The prescription paper shall contain the following information (Annex 1: standard prescription
paper):
a) Serial number
b) Name and address of health institution
c) Patient information: name of patient, gender, age, body weight, height, card number, contact
telephone number
d) Area of clinical service: Inpatient, Outpatient, Emergency
e) Diagnosis or International Classification of Disease (ICD) number
f) Rx (Treatment)
g) Prescribed medicine, dosage form, strength, route of administration, dose, frequency and duration of
use
h) If the medicine is compounded, name of the active ingredients, dosage type, posology
i) Prescriber and dispenser: name, and qualification, registration number, signature, stamp and date of
prescription and dispensing respectively
5.1.1.4. The pharmacy shall prepare and use its own transcription paper for transcription. The content of the
transcription is indicated in annex 2.
5.1.1.5. The pharmacy professionals in the pharmacy shall issue transcription papers to patients for those
medicines available in the original prescription but not available in the pharmacy.
5.1.1.6. A special prescription paper shall be required to dispense narcotic drugs or psychotropic
substances (Annex 3).
5.1.1.7. The red prescription paper for narcotic drug or blue prescription paper for psychotropic substance
shall be used to dispense narcotic drugs or psychotropic substances respectively.
5.1.1.8. It is prohibited to prescribe more than one narcotic drug or psychotropic substance on one
prescription paper.
5.1.1.9. Prescription paper shall not be valid after thirty days. However, fifteen days for narcotic drugs or
psychotropic substances from the day it is prescribed
5.1.2. Dispensing
5.1.2.1. The pharmacy shall not dispense any medicine without prescription. This shall not include over the
counter medicines.

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5.1.2.2. Standard operating procedure for dispensing practice shall be established and implemented to
ensure patient safety and rational medicines use. This shall include:
a) Receiving a prescription
b) Evaluation and interpretation of a prescription
c) Selecting and preparing the medicines
d) Labeling and packaging the medicines
e) Provision of information and instruction
f) Recording transactions
g) Issuing medicines to the patient
5.1.2.3. The pharmacy shall have standard operating procedure to control the dispensing of narcotic drugs
and psychotropic substances in accordance with relevant laws.
5.1.2.4. The pharmacy professional shall not dispense expired, damaged, substandard, diverted or illegal
medicine.
5.1.2.5. The pharmacy professional shall make sure that prescriptions are legal, legible, complete, and
signed by an authorized prescriber.
5.1.2.6. The pharmacy professional shall check correctness of prescriptions in terms of appropriateness for
patient, dosage, frequency, duration, route of administration, drug interactions, contraindication,
polypharmacy, and inappropriate therapy based on approved standard treatment guidelines and/or
accepted national or international guidelines before dispensing.
5.1.2.7. The pharmacy professional shall consult the prescriber in any means if he/she is in doubt regarding
the prescription or suspicion of error without arousing doubts or fears in the patient.
5.1.2.8. A pharmacy professional is legally entitled to substitute generic medicine for brand name products
while dispensing of medicines by informing the patient unless there is indicated special
circumstances.
5.1.2.9. After dispensing medicine as per article 5.2.8, the information provided under the prescription shall
be logged into a paper or electronic logbook prepared for this purpose, and the prescription shall be
filed after being stamped, named, signed and dated by the dispenser.
5.1.2.10. The containers or packing materials used for dispensing shall be appropriate for the product
dispensed and all containers intended for medicine shall be protected and kept free from
contamination, moisture and light.
5.1.2.11. Medicines to be dispensed shall be labeled and the labels shall be unambiguous, clear, legible
and indelible. The following minimum information shall be indicated on the label/sticker:
a) The generic name of the medicine;
b) The name of each active ingredient for compounded preparations;
c) The strength, dose, frequency, duration of administration and total quantity;
d) The name of the person for whom the medicines are dispensed;
e) Route of administration tailored to patient or caregiver literacy and language;
f) The name and address of the pharmacy;

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g) Date of dispensing;
h) Expiry date/beyond use date, and
i) Special precautions as applicable
5.1.2.12. The labels should be printed. If handwritten, labels shall be neat and legible with clear instruction
of use.
5.1.2.13. Dispensed prescriptions shall be signed during time of dispensing and accountability shall be
accepted by the dispensing pharmacy professional.
5.1.2.14. Narcotic drugs and psychotropic substances shall be handled by the technical manager in the
pharmacy.
5.1.2.15. Narcotic drugs and psychotropic substances shall be dispensed by the technical manager or
his/her delegate.
5.1.2.16. The pharmacy professional shall retain records of the following information when dispensing
narcotic drugs and psychotropic substances.
a) Name and signature of dispensing pharmacist
b) The date and time of dispensing.
c) The name, strength, and quantity dispensed.
d) The serial number assigned to the particular prescription corresponds to the same number recorded in
the pharmacy's dispensing record.
5.1.2.17. The pharmacy professionals shall not dispense narcotic drugs or psychotropic substances to
patients below the age of 18 years directly, but to their caregivers.
5.1.2.18. The pharmacy professionals shall ensure that dispensing is conducted accurately, reflects the
prescriber’s intention, and is consistent with the needs and safety of the patient. The requisites
here are:
a) The right patient gets the right medicine
b) Possible interactions are avoided.
c) The quality and integrity of the medicine are maintained throughout the indicated shelf life.
d) Correct and clear instructions are given to the patient to ensure correct and safe use of the medicine,
for the optimal benefit of the patient in line with the objective of the treatment.
e) The patient is given, at the least, basic information regarding special instructions for use, warnings if
applicable, possible adverse or side effects and action to be taken in the event of certain events
occurring.
5.1.2.19. The pharmacy professionals shall obtain personal details and complete medication history from
the patient and/or where appropriate from document reviews.
5.1.2.20. The pharmacy professional shall have a right to refuse dispensing of medicines considering the
following conditions:
a) When there is doubt on the prescription and prescribed medication
b) When the patient is not willing to disclose his/her medical history
c) When there is illegible prescription handwriting

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d) When there is a safety concern on the prescribed medicine

e) When the prescribed medication is not effective for the indicated diagnosis
f) When there is no clear indication for the indicated diagnosis
5.1.2.21. The pharmacy professionals shall contact the prescriber about a prescription or a patient’s therapy
when necessary.
5.1.2.22. The pharmacy professional shall update the patient’s medication history during the dispensing
process for patients with chronic disease.
5.1.2.23. Medicine shall be dispensed in the original primary packaging (i.e. blister or foil packs), except in
particular cases where repacking is required to assist patients.
5.1.2.24. Open or split packs shall be clearly marked, and mixing of stock of the same product shall be
avoided.
5.1.2.25. To minimize the incidence of dispensing errors, similarly packaged medicine shall not be stored
adjacent to each other on the dispensary shelf.
5.1.2.26. The pharmacy professional shall not promote and advertise in the pharmacy using media, banners
and posters except in legally permitted situations.
5.1.3. Medicine Use Counseling and Drug Information Service
5.1.3.1. Standard operating procedure for medication use counseling shall be prepared and implemented to
ensure patient safety and rational use of medicine
5.1.3.2. The pharmacy professionals shall maintain confidentiality of patient information.
5.1.3.3. The pharmacy professionals shall provide verbal and/or written information to the patient to ensure
safe and effective use of the medicines.
5.1.3.4. Medicine use counseling shall ensure that the patient knows how and when to take the medicines;
a) Care shall be taken with counseling where understanding is likely to be a problem.
b) Cautionary instructions and ancillary information about medications shall be communicated.
c) The pharmacy professionals shall provide counseling that is supported by current, evidence-based
information from relevant resources.
d) The Pharmacy professionals shall provide counseling according to the needs of the patient or
consumer.
e) The pharmacy professionals shall adequately explain and/or demonstrate the use of medicines to the
patient.
5.1.3.5. The drug information service shall include the following:
a) production and dissemination of recent medicine information considering scientific and valid
references
b) Provide medicine use education to clients.
c) managing to prescribed and OTC medicines information queries
d) Assess available medicine information and gather data needed to characterize questions/issues
e) Use systematic approach to find needed information
f) Poison management and provision of poison information

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5.1.3.6. The drug information service shall not involve in facility and medicine promotion and advertisement
activities.
5.1.4. Good storage practice
5.1.4.1. The pharmacy shall follow standard operating procedures for good storage practices.
5.1.4.2. Medicine storage room shall be dry, well ventilated and protected from direct sunlight and heat.
5.1.4.3. The storage room shall possess an adequate number and type of shelves to allow orderly storage
and adequate segregation of different types of medicines to avoid mix ups.
5.1.4.4. Shelves in the storage room shall be smooth, easily cleanable and impermeable to maintain
hygienic condition.
5.1.4.5. Every medicine shall be stored in accordance with the manufacturer's storage instructions.
5.1.4.6. Light conditions, temperature and humidity within the storage room shall comply with requirements
for storage of medicine, raw materials and packaging materials, and shall be monitored regularly.
5.1.4.7. The technical manager or authorized pharmacy professional shall ensure that every key, key card
or other device, or the combination of any device, which allows access to a storage area when it is
locked, is kept only on his/her person.
5.1.4.8. Narcotic drugs and psychotropic substances shall be maintained in a securely locked cabinet and
access restricted places. After dispensing of narcotic drugs and psychotropic substances, the
remaining shall be returned to the cabinet immediately.
5.1.4.9. Chemotherapy agents, biological products, radiopharmaceuticals, narcotics drugs and psychotropic
substances. Other hazardous, sensitive and/or dangerous pharmaceutical products, as well as
other products presenting special risks of abuse, fire or explosion (e.g. combustible liquids, solids
and pressurized gases) shall be stored in a dedicated area that is subject to appropriate additional
safety and security measures.
5.1.4.10. Medicines that require a cold chain shall be kept in a refrigerator.
5.1.4.11. The temperature of the refrigerator shall be maintained between 2-8 oC
5.1.4.12. The refrigerator shall only be used for storing medicine.
5.1.4.13. The temperature of the refrigerator shall be regularly monitored and recorded twice daily (morning
and afternoon) and maintained records.
5.1.4.14. The size of the refrigerator shall enable the pharmacy professional to keep the necessary stock in
an organized manner.
5.1.4.15. Medicines shall be arranged on strong and robust shelves made of steel or treated wood or glass.
5.1.4.16. Medicines shall be arranged in shelves according to pharmacological category, alphabetical order
by generic name or dosage forms.
5.1.4.17. Medicines shall not be stored directly on the floor without a pallet or shelves.
5.1.4.18. The pharmacy shall segregate expired, damaged and recalled products.
5.1.4.19. The pharmacy shall monitor regularly the temperature and humidity of the storage room.

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5.1.4.20. The pharmacy professional shall conduct periodic self-assessment audits against the national
standards.
5.1.4.21. Liquids shall be stored on a pallet or on the lowest level of shelf
5.1.4.22. Flammable substances shall be kept separately
5.1.4.23. Medical devices, cosmetics, baby food (infant formula, follow-up formula, & growing-up formula),
food supplements, disinfectants, sanitary and hygiene materials shall be kept separately
5.1.4.24. Any return of narcotic drugs or psychotropic substances to the pharmacy shall be documented by
the technical manager in the pharmacy by notifying to the authority or regional health regulatory
body.
5.1.5. Good Compounding practice (if compounding is performed in the pharmacy)
5.1.5.1. Standard operating procedures (SOP) for compounding of pharmaceutical preparations shall be
established and implemented.
5.1.5.2. The standard operating procedure shall address each process for preparations including raw
material receiving, cleaning, raw materials and dispensing of compounded products, method of
preparation, and water purification process.
5.1.5.3. The SOP shall contain an approved Master Formula for each type of preparation that shows the
list of ingredients and their quantities required for the formulation of a specified amount of the
preparation.
5.1.5.4. All compounding processes must be in accordance with SOPs authorized by the technical
manager, pharmacist.
5.1.5.5. Compounding of medicines shall be in accordance with prescription issued by authorized
prescriber.
5.1.5.6. Extemporaneous preparations shall only be prepared if there is no equivalent medicine available
commercially or the medicine has to be compounded based on the patient’s needs.
5.1.5.7. Ingredients for compounding shall be sourced from recognized pharmaceutical suppliers
5.1.5.8. Compounding shall be done by the pharmacist in charge of the pharmacy or pharmacists under
his/her direct supervision
5.1.5.9. The pharmacist shall review the ingredients, preparation process, and the intended use of the
product, and conduct a risk assessment.
5.1.5.10. The pharmacist shall use pharmaceutical grade ingredients that are stored in accordance with the
manufacturer’s recommendations.
5.1.5.11. The pharmacist shall ensure that compounding is being carried out in a dedicated room that is
clean and suitable for compounding.
5.1.5.12. The pharmacist shall ensure that equipment used in compounding are in good working order.
5.1.5.13. The pharmacist shall ensure that all equipment and work surfaces are cleaned before and after
compounding.
5.1.5.14. The pharmacist shall ensure that equipment are maintained and calibrated regularly according to a
documented procedure.

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5.1.5.15. The pharmacist shall document the details of the compounding procedure, compounded products
and patient information.
5.1.5.16. The pharmacist shall use suitable containers and packaging to maintain the quality and stability of
prepared products. The containers and container closures shall be made of clean materials that
are neither reactive, additive nor absorptive and the packaging shall be appropriate for the stability
of the product and proper patient use.
5.1.5.17. The pharmacist shall use purified water when water is required as ingredients in non-sterile
preparations.
5.1.5.18. Labeling of the compounded products shall provide adequate information including:
a) Preparation Name and strength
b) Total weight or volume of the preparation
c) Name and quantity of each active ingredients
d) Directions for administration and use
e) Storage conditions and special warning/precaution
f) Lot number
g) dosage form
h) name and address of pharmacy
i) Name of compounding pharmacist
j) patient name
k) preparation date
l) beyond use date
5.1.5.19. Standard operating procedures and records shall exist for investigating and correcting failures or
problems in compounding, testing, or in the preparation itself.
5.1.5.20. Medicine preparations compounded in the pharmacy shall be packaged in standard containers
procured from licensed suppliers.
5.1.6. Clinical pharmacy service
5.1.6.1. The pharmacy professionals should when necessary access physician notes, patient diagnoses,
or results of medical procedures or laboratory tests upon request.
5.1.6.2. The pharmacy professionals should access patient specific medication therapy information.
5.1.6.3. The pharmacy professionals should provide injectable and non-injectable vaccines specific to adult
vaccination when permitted by law.
5.1.6.4. Patient-specific medication therapy information should be evaluated and a medicine therapy plan
should be developed by the pharmacist mutually with the patient, and prescriber.
5.1.6.5. Through prescription and medication history monitoring, the pharmacist shall identify problems or
opportunities for optimizing treatment and ensure optimal use of medicines.
5.1.6.6. The pharmacy professional should provide Medication Therapy Management (MTM) service for
chronic illness using the following five core components:
a) Medication Therapy Review (MTR)
b) Personal Medication Record (PMR)

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c) Medication-related Action Plan (MAP)

d) Intervention and/or referral
e) Documentation and follow-up
5.1.6.7. The pharmacy professional shall provide responding to symptoms service in the pharmacy. The
pharmacists will consider 1 of 3 recommendations during each encounter involving symptom
presentations:
a) Provide assurance that drug therapy is unnecessary.
b) Suggest treatment with non-drug measures, OTCs, or both.
c) Refer the patient to the appropriate health facility.
5.1.6.8. The pharmacy professional shall be aware of the following high risk of a serious conditions and
consider referring the patient to the health facility:
a) Long duration of symptoms.
b) Recurring or worsening problems.
c) Severe symptoms.
d) Failed medication.
e) Suspected adverse drug reactions (prescription or OTC medicine).
f) Danger symptoms such as blood in the sputum, vomit, urine or faces
5.1.6.9. The pharmacy professional shall involve in signposting and referral to other services and support
including:
a) Advise clients visiting the pharmacy of other health and social care providers and support
organizations, such as patient groups, when appropriate.
b) Refer the patient when this is felt appropriate by the pharmacy professional.
c) Record the advice or referral may be made on the patient’s pharmacy record, when the pharmacist
deems it to be of clinical significance.
5.1.6.10. The pharmacy professional should work with Primary Care Organizations (PCOs), social care
providers and other health facilities in their area with details of health so that patients can be
referred.
5.1.6.11. The pharmacy professional should take appropriate measurements such as weight, height, fasting
blood sugar/random blood sugar and vital signs (blood pressure, body temperature, pulse rate,
oxygen saturation measurement) for patients with chronic illness which are hypertensive, diabetics
and chronic cardiac failure (CHF) patients. Logbook for documentation of such service shall be
maintained.
5.1.6.12. The pharmacy professional shall take appropriate training to provide clinical pharmacy service and
carry out patient measurements.
5.1.6.13. The pharmacy professional shall prevent, detect and respond to drug therapy problems.
5.1.7. Procurement and stock management
5.1.7.1. The pharmacy shall have standard operating procedure for procurement, stock management,
storage, return and recall of medicines.
5.1.7.2. The pharmacy shall be obliged to avail essential medicines for the local community.

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5.1.7.3. The pharmacy shall hold medicines as per the lists of medicines for pharmacy.
5.1.7.4. The technical manager or his/her delegate shall procure medicines for the pharmacy.
5.1.7.5. Medicine procurement for chain pharmacies shall be made at the head quarter of the pharmacy.
But each branch pharmacies shall submit procurement need and keep copy of procurement
documents.
5.1.7.6. Medicines shall be obtained from licensed manufacturers, importers and wholesalers.
5.1.7.7. The pharmacy shall procure medicines that are registered or authorized by the authority.
5.1.7.8. When receiving medicines, the pharmacy shall
a) Inspect the medicine for any damages. Check that all original containers are unopened and are in
good condition
b) Inspect the medicines for any expired medicines
c) Separate and quarantine any defective stock from the usable stock.
d) Dispose of these unfit for use medicines without delay, using established disposal procedures
5.1.7.9. The pharmacy shall have manual or electronic stock management systems for available stock,
dispensed and unfit for use medicines.
5.1.7.10. Stock rotation should be done on the "FIRST EXPIRY- FIRST OUT" (FEFO) or "FIRST IN - FIRST
OUT" (FIFO) basis. It shall include:
a) Removing regularly all expired items from the store and checking for near-to expiry medicines which
cannot be used completely.
b) Mark all containers and boxes with the expiration date of the medicines.
c) Arrange stock according to FEFO or FIFO to allow stock rotation.
d) Put medicines with the earliest expiration date in front/on top and medicines with the latest expiration
date in the back/below.
e) Do not divide medicine stocks for the same products over different locations.
f) Record the expiration date for every medicine during physical inventories.
g) Use a stock card and bin card or electronic recording system for stock management
h) Conduct periodic stock reconciliation by comparing the actual and recorded stocks
5.1.7.11. The record of stock on hand and dispensed prescription only medicines shall be maintained so
that the disposition of any particular item may be readily traced.
5.1.7.12. The pharmacy shall implement procedures whereby a registered pharmacist shall reconcile
quantities of narcotic drugs and psychotropic substances dispensed in the pharmacy against the
narcotic drugs and psychotropic substances recorded. Any discrepancies shall be reported to the
appropriate regulatory body.
5.1.7.13. The pharmacy shall receive medicines using standard receiving vouchers. Receiving vouchers
shall have the following information.
a) Generic and brand name of medicines received;
b) Unit of measurement and quantity
c) Name and address of manufacturer of medicines;
d) Dosage form and strength

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e) Batch number
f) Manufacturing and Expiry dates;
g) Unit and total price;
h) Date received;
i) Name and signature of receiver; and
j) Address of the pharmacy.
5.1.7.14. The pharmacy shall use a standard stamp and seal for approving legal transactions.
5.1.8. Recording, reporting and documentations
5.1.8.1. The pharmacy shall have standard operating procedure for recording of procurement, stock
management, recall, expired and damaged products, and disposal.
5.1.8.2. The pharmacy shall record product procured, stock status, recall, expired and damaged, and
disposed of products immediately on the stock controlling cards (bin card, stock card or electronic
system).
5.1.8.3. The pharmacy shall properly fill the receiving, requesting, and dispensing documents by the
pharmacist.
5.1.8.4. The pharmacy shall keep information for each patients with chronic illnesses medication program
using standardized information tracking formats and update patient medication profile during each
refill visit (annex 5: Logbook for chronic patients)
5.1.8.5. The pharmacy shall document the following information labeled for easy retrieval
a) Invoices, receipts, daily sales records, stock control cards related with the stored, compounded and
dispensed medicines
b) Dispensed prescriptions ordering by date, month and year
c) Narcotic drugs and psychotropic substances prescription ordering by date, month and year, and
registration logbooks.
d) Valid copy of certificate of competency of the seller
e) Laws and guidelines
f) Medicine lists for pharmacy prepared by the authority
5.1.8.6. The pharmacy shall maintain narcotic drugs and psychotropic substances prescription paper and
their registration book for at least five years and two years for other medicines.
5.1.8.7. The pharmacy shall report any stored, dispensed and stock discrepancies of narcotic drugs and
psychotropic substances to the appropriate regulatory body.
5.1.8.8. The consumer shall have the right to know the exact price of a prescription before it is filled.
5.1.8.9. The pharmacy shall ensure that each consumer has the right to get a receipt having the following
information about medicines dispensed.
a) Name of patient
b) Name and dose of medicine dispensed
c) Unit of measurement and quantity
d) Unit and total price
e) Date

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f) Signature of dispenser
g) Address of the pharmacy
5.1.9. Safety and quality defect monitoring
5.1.9.1. The pharmacy shall establish and implement standard operating procedure for reporting of any
adverse drug events of medicines in accordance with the national reporting systems designed by
authority.
5.1.9.2. The pharmacy professionals shall identify any suspected adverse drug reactions, medication
errors, quality defects, precaution and contraindication during dispensing.
5.1.9.3. The pharmacy professionals shall coordinate activities related to detection and reporting of any
adverse events.
5.1.9.4. The pharmacy professionals shall report to the authority or regional health regulatory bodies when
he/she encounters defects associated with quality, safety, and efficacy of medicines.
5.1.9.5. All reports sent to the authority shall be recorded and treated in strict confidence.
5.1.9.6. The pharmacy professional shall conduct physical inspection when receiving, stocking and
dispensing of medicines to identify defective products.
5.1.9.7. The pharmacy professional shall support the national medicine recall program.
5.1.10. Antimicrobial resistance prevention and containment
5.1.10.1. The pharmacist shall understand the emergence and spread of antimicrobial resistance and be
involved in the prevention and containment of it.
5.1.10.2. The pharmacy professional shall bring about a change in behavior of prescribers, dispensers and
community to ensure the rational use of antimicrobial medicines.
5.1.10.3. The pharmacist shall rationalize the use of antimicrobial medicines in line with the laws, guidelines
and National Strategic Frameworks for prevention and containment of antimicrobial resistance.
5.1.10.4. The pharmacy professional shall promote and practice Access, Watch and Reserve (AWaRE)
classification of antibiotics to ensure rational use of medicines.
5.1.10.5. It is unlawful to dispense antimicrobial medicines without prescription
5.1.11. Public health promotion
5.1.11.1. The pharmacists shall ensure that any information or services related to health promotion offered
to patients are safe, up-to-date and in accordance with the relevant local and international
guidelines.
5.1.11.2. The nature of health promotion activities in community pharmacy shall align with national medicine
policy and scope of practices.
5.1.11.3. The pharmacy professionals should provide services in screening and referral of health conditions
for:
a) Hypertension e) Pregnancy testing
b) Diabetes Mellitus f) Malaria rapid test
c) Asthma g) STD rapid testing
d) Dyslipidemia

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 ES 7084:2024

5.1.11.4. The pharmacy professionals shall involve in behavioral and lifestyle modification services and shall
include:
a) Sexual and reproductive health counseling (family planning, STI, etc.)
b) Oral health counseling
c) Counseling on smoking cessation
d) Nutritional and physical-activity promotion
e) Counseling on healthy eating
f) Weight management
g) Alcohol consumption
h) Explaining physiological harms of chat chewing
i) Immunization counseling
j) Traditional medicine use counseling
k) Women’s health (e.g., preconception care)
l) Contraception and sexual health
m) Baby and child health
n) Drug misuse and abuse counseling and harm reduction program
5.1.11.5. The pharmacy professional shall prevent the promotion of unregistered and off-label medicines
information.
5.1.11.6. The pharmacy professional shall be trained on priority public health promotion initiatives before
engaging on such services
5.1.11.7. Laws and guidelines shall be issued to provide public health promotion activities.
5.1.12. Drug information center activities (if drug information center is established in the pharmacy)
5.1.12.1. The drug information center shall:
a) Meet the needs of health-care practitioners by providing an organized database source of information
on specialized medicines
b) Provide evidence-based and updated drug information to all health-care professionals, patients and
the general community.
c) Monitor and evaluate the quality of drug information
d) Guide and act as a learning center about drug information to pharmacy, medical and health sciences
students.
e) Support in the promotion of clinical services and roles of pharmacy in various health-related fields.
f) Coordinate, customize and support various programs on population-based medication practices (e.g.,
development of guidelines, protocol, evaluation criteria for therapeutic usage and optimization of drug
therapy)
g) Engage in various efforts to prevent adverse drug effects.
h) Conduct and monitor medication safety alerts communicated by regulatory authorities, drug
manufacturers, and other sources

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ES 7084:2024

i) Identify and manage alternative treatments for various diseases on formulary based and develop
protocols on restrictive usage of medications
5.1.13. Medicines waste management and disposal
5.1.13.1. The pharmacy shall have a procedure for disposal of unfit for use medicines.
5.1.13.2. The pharmacy shall not store unfit for use medicines for more than six months.
5.1.13.3. Medicine wastes shall be disposed of in designated areas for disposal.
5.1.13.4. Medicine wastes shall be managed and disposed according to Medicine Waste Management and
Disposal Directive and the procedures developed by the pharmacy.
5.1.13.5. Unfit for use medicines shall be clearly segregated, identified, recorded and stored separately
before disposal or return to the supplier.
5.1.13.6. The pharmacy professionals shall take responsibility that disposal of medicines shall be
undertaken in a manner that protects and preserves the environment and ensures that medicines
due for disposal do not return into the population for use.
5.1.13.7. Every attempt shall be made to minimize the amount of medicine waste generated in the
pharmacy.
5.1.13.8. The pharmacy professionals and other staff shall be trained and well informed about the potential
risks of medicine wastes and their management.
5.1.13.9. Disposal of medicines wastes shall be supported by proper documentation in accordance with the
national laws or these requirements.
5.1.13.10. The pharmacy professionals and other staff shall use personal protective equipment during
handling medicine wastes.
5.2. Premises
5.2.1. Design, Layout, and Location
5.2.1.1. The pharmacy shall be self-contained and secured with single point of entry and exit
5.2.1.2. The pharmacy shall be a minimum of 100 meter radius far away from hospitals, health centers,
specialty centers, and clinics.
5.2.1.3. The minimum distance between the proposed site for a pharmacy and other existing drug retail
outlets shall be a minimum of 100 meter radius.
5.2.1.4. The premise from which services are provided shall be safe and fit for purpose and make sure
they are well maintained.
5.2.1.5. Construction of the premises shall ensure that direct sunlight, dust, moisture, entry of insects,
animals (especially rodents) or birds, and floods is prevented.
5.2.1.6. The walls of the pharmacy shall be constructed and maintained from concrete, bricks and paint
washable walls. If partition is required inside the pharmacy, aluminum board or bricks shall be
used.
5.2.1.7. The design and layout of the pharmacy shall permit a logical flow of work, effective
communication and supervision, and ensure effective cleaning and maintenance.

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 ES 7084:2024

5.2.1.8. The design and layout of the pharmacy shall minimize the risk of errors, cross-contamination or
mix up.
5.2.1.9. A well-written signboard bearing the pharmacy’s name shall be displayed near the pharmacy. The
pharmacy shall indicate its working hours in the signboard.
5.2.1.10. The pharmacy shall have the following rooms
a) Store room
b) Dispensing room
c) Compounding room (optional)
d) Counseling room
e) Drug information service shared with counseling room
f) Drug information center (optional)
g) Administrative office and changing room or area
h) Toilet with water
i) Waiting area
5.2.1.11. Floors, ceilings and walls shall be free of cracks and holes, discoloration, leakage, water stains
and other signs of disrepair.
5.2.1.12. The pharmacy entrance, dispensing counter and doorways shall be accessible to people with
disability.
5.2.1.13. The pharmacy shall have adequate lighting and ventilation.
5.2.1.14. The dedicated rooms and areas shall be labeled.
5.2.2. Security and safety
5.2.2.1. The pharmacy shall have a procedure for safety and security
5.2.2.2. The pharmacy shall be lockable and exclude any unauthorized entry.
5.2.2.3. The safety and security procedure shall be implemented for safety of both staff and medicines
5.2.2.4. A health and safety procedure shall be available, read and signed by all staff.
5.2.2.5. Working conditions shall be appropriate to protect the safety of staff working in the premises and
comply with relevant legislation relating to safety in the workplace.
5.2.2.6. There shall be a fire extinguisher in the pharmacy which shall be checked regularly. Staff shall be
familiar with the use of fire extinguishers
5.2.2.7. Electrical equipment shall be safe and maintained regularly. Care shall be taken to avoid trailing
wires across floors, work surfaces or sinks.
5.2.2.8. All containers of chemicals shall be fully labeled and include prominent warnings (e.g. “Poison”,
“Flammable”, “Radiation”, etc.) whenever appropriate.
5.2.2.9. Combustibles/flammables shall be stored in a special or separate shelf.
5.2.2.10. First-aid materials shall be provided and staff shall be instructed in first-aid techniques,
emergency care and the use of antidotes.
5.2.3. Environment in pharmacy premises
5.2.3.1. Storage of thermolabile medicines shall be in accordance with the storage instructions of the
manufacturer.

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ES 7084:2024

5.2.3.2. Refrigerators used for the storage of thermolabile medicine shall be calibrated regularly.
5.2.3.3. Medicines shall be protected from the adverse effects of light, heat, freezing or other temperature
extremes and dampness.
5.2.3.4. All parts of the premises shall have suitable and effective means of heating or cooling, lighting and
ventilation.
5.2.3.5. Background music or other broadcasts in the pharmacy shall not be played at such a volume so as
to cause distraction as per environmental standards.
5.2.3.6. The pharmacy premises shall be 100 meters radius far away from the premises of any other
facilities that adversely affect the quality of medicines including public toilets, high dust, heat or
smoke generating small & large scale industry, Garage, grinding mills, chemical industries, gas
depot and waste disposal sites.
5.2.4. Sanitation and hygiene
5.2.4.1. The pharmacy shall have a cleaning procedure and schedule, and retain cleaning records.
5.2.4.2. All parts of the pharmacy premises and environments shall be kept clean particularly for the floors,
work surfaces and shelves.
5.2.4.3. Spillages shall be wiped away immediately.
5.2.4.4. Food and drink shall be kept out of the dispensing area and the refrigerator shall be used strictly
for storage of medicines.
5.2.4.5. There shall be a regular checking, cleaning and defrosting of the refrigerator
5.2.4.6. Direct contact between dispensing staff’s bare hands and the dispensed medicines shall be
avoided.
5.2.4.7. The pharmacy professionals shall wear a white gown when she/he is on duty at all times and keep
it neat, wrinkle free and in good repair.
5.2.4.8. The gown of pharmacy professionals and supportive staff shall be different in color.
5.2.5. Storage room
5.2.5.1. The storage room shall be dry, well ventilated and protected from direct sunlight and heat.
5.2.5.2. Storage room shall be self-contained and secure with a lockable door.
5.2.5.3. There shall be a designated area or room in the store room for expired, damaged or returned
medicines.
5.2.5.4. The minimum size of the store room shall be 16 square meter with a minimum side of 3 meter
5.2.5.5. The ceiling height shall not be less than 2.6 m. In areas with consistently elevated temperature
which is greater than 25 degree centigrade, the minimum ceiling height shall be 3m.
5.2.5.6. Storage room shall have sufficient shelving constructed from a smooth, washable and
impermeable material
5.2.5.7. The floor shall be smooth and easily washable, and constructed from cement, ceramic, epoxy or
other related materials.
5.2.5.8. The wall shall be smooth, and washable. It shall not be constructed from wood, corrugated sheet,
mud or grass materials.
5.2.5.9. The ceiling shall be smooth, washable and heat resistant.

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 ES 7084:2024

5.2.5.10. Medicines in the storage room shall be shelved a minimum of 20 cm above the floor, one meter
wide between shelves and 25 cm away from the wall and 50 cm ceiling. If pallets are used, there
shall be 20 cm above the floor, one meter between pallets and 25 cm away from the wall.
5.2.6. Dispensing room
5.2.6.1. The size of the dispensary shall reflect the volume of prescriptions dispensed and allow a safe and
efficient flow of work and effective communication and supervision for the number of persons
working in the dispensary.
5.2.6.2. The minimum area for the dispensing room shall be 25 square meters with a minimum side of 4
meters.
5.2.6.3. The minimum ceiling height shall not be less than 2.6m. . In areas with consistently elevated
temperature which is greater than 25 degree centigrade, the minimum ceiling height shall be 3m.
5.2.6.4. Dispensing counter shall not be less than 1.5meter far away from back shelf and 2.5 meter far
away from the patient gate.
5.2.6.5. The dispenser counter shall have at least a width of 0.60 meter, height of 1.10 meter and length of
1m per dispenser with a total length of not less than 3.5 meters.
5.2.6.6. A waiting area with seating option shall be situated inside the dispensing room. The number of
seating available in the waiting area shall depend on the number of patients expected to arrive at a
time.
5.2.6.7. Narcotic drugs and psychotropic substances shall be kept separately in a fixed and lockable metal
cabinet or shelf.
5.2.6.8. Access to the actual dispensing area shall be restricted to authorized personnel
5.2.6.9. Medicines in the dispensing room shall be shelved a minimum of 20 cm above the floor, one meter
wide between shelves and 25 cm away from the wall and 50cm ceiling. If pallets are used, there
shall be 20 cm above the floor, one meter between pallets and 25 cm away from the wall.
5.2.7. Compounding room (optional)
5.2.7.1. The pharmacy shall have a designated compounding room that avoids contamination and cross
contamination.
5.2.7.2. The compounding room shall be neat, ventilated and appropriate for compounding activities.
5.2.7.3. The walls of the compounding room shall be finished from a smooth, washable and impermeable
material, which is easy to clean and maintain in a hygienic condition.
5.2.7.4. There shall be a suitable and clean wash basin made of a smooth, washable and impermeable
material for the compounding room and has a source of tap water and a closed drainage system.
5.2.7.5. The minimum area of the compounding room shall be 9 square meters with minimum side not less
than 2.5 meters.
5.2.7.6. The compounding bench top shall be made of stainless steel, marble or similar acceptable
material which is washable, impermeable, chemical resistant and waterproof material.
5.2.7.7. The compounding bench top shall not be made of wood, cement, corrugated sheet or plastic
materials.

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ES 7084:2024

5.2.7.8. The compounding bench shall have at least a width of 0.75 meter, a total length of not less than 2
meters, and not be less than 1.5 meters far away from the gate.
5.2.7.9. There shall be a designated storage cabinet or shelf for labeling and raw materials.
5.2.8. Counseling room
5.2.8.1. The minimum area of the counseling room shall be 4 square meters with a minimum side of 1.5
meters that enables to demonstrate the correct and safe use of specific medicines as required.
5.2.8.2. Facilities for confidential conversation between a pharmacists and client about their medication
and general health matters over heard by others.
5.2.8.3. The counseling room shall be easily accessible and, where possible, be close to the dispensary.
5.2.8.4. Clear directions shall be provided if the counseling room is not close to the dispensing room.
5.2.8.5. The counseling room shall be designated in such a manner as to ensure reasonable privacy to the
patient at all times and eliminate background noise as far as possible.
5.2.8.6. The counseling room shall be equipped with reference material, patient information leaflets and
demonstration charts, kits and other demonstration material, registration book, chair and table.
5.2.9. Drug information service shared with counseling room
Drug information service shall be provided within the pharmacy shared with the counseling room.
5.2.10. Drug information center ((if drug information center is established)
5.2.10.1. The pharmacy shall establish a well-equipped drug information center.
5.2.10.2. The minimum area for a drug information center shall be 12 square meters with minimum side not
less than 3 meters.
5.2.10.3. The center shall have additional office room for drug information center staff
5.2.11. Administrative office and changing room or area
The pharmacy shall have a dedicated area or room to perform office activities and changing of working
clothes.
5.2.12. Toilet with water
5.2.12.1. There shall be toilet room for the pharmacy. If the pharmacy is in a multipurpose building, the toilet
may be shared with other facilities.
5.2.12.2. The toilet room shall have readily available potable water with hand wash basin, and soap and a
closed drainage system.
5.2.12.3. Toilet facilities shall be kept clean and in good order.
5.2.12.4. The toilet room shall not be used for storage, and as a source of water for dispensing and
compounding.
5.2.12.5. The toilet shall not have direct access to the store and dispensing rooms.
5.2.12.6. The toilet shall be designated and labeled with arrows or images.
5.3. Professionals
5.3.1. The pharmacy shall be directed by registered and licensed pharmacist with a minimum:
5.3.1.1. Total of three years work experience as pharmacist with bachelor or advanced degree in
pharmaceutical sciences, or

20 ©IES
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5.3.1.2. Three years work experience as druggist/level IV pharmacy technician and one year as a
pharmacist.
5.3.2. Any professional who has an advanced degree in pharmaceutical sciences that does not have a
bachelor degree in pharmacy shall not be eligible for providing community pharmacy services.
5.3.3. The pharmacy shall have at least one additional licensed pharmacist or druggist/level IV pharmacy
technician who works as technical assistant only under the supervision of the technical manager.
5.3.4. The pharmacy shall have at least one registered and licensed pharmacist when it establishes a drug
information center.
5.3.5. The pharmacy professional working in the drug information center shall have a minimum of bachelor
degree in pharmacy who has at least three years work experience in pharmacy services.
5.3.6. The pharmacy professional shall not have mental illness, disabilities, alcohol, narcotic drugs,
psychotropic substances, or other controlled substance addictions that hinder his/her ability to perform
his/her professional duties.
5.3.7. The technical manager shall perform his/her responsibilities autonomously. But in his/her absence,
she/he shall delegate a pharmacy professional in writing who fulfills the minimum requirements to
obtain a certificate of competence for not more than one month within a year. This information shall be
notified to the regulatory body. But if the delegation is due to illness or maternity, this shall be as per
labour law of the country.
5.3.8. All staff working in the pharmacy shall have a medical check-up every year from a licensed health
facility and shall keep the medical check-up reports of staff in the pharmacy.
5.3.9. The pharmacy shall maintain documentation of staff educational, valid professional license and
training certificates.
5.3.10. The pharmacy professional on duty shall wear an identification badge at all times indicating his/her
name, profession and title facing outward.
5.3.11. The pharmacy professionals shall be provided with current written job descriptions and be oriented to
their specific job responsibilities at appointment time.
5.3.12. The pharmacy professional’s job description shall include the title and grade of the position, specific
function of the job, job requirement, reporting mechanism and work environment.
5.3.13. The pharmacy shall provide and maintain evidence of an orientation program for all new staff and, as
needed, for existing staff. The orientation program should include:
a) Sector related proclamation, regulations and directives.
b) Job duties and responsibilities
c) Sanitation and hygiene
d) Patient rights
e) Good dispensing practice and or good compounding practices
f) Service provision
g) Reporting requirements for adverse drug event and narcotic drugs & psychotropic substances
h) Safety procedures

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ES 7084:2024

5.4. Products (Equipment and materials)

5.4.1. The pharmacy shall have appropriate dispensing, storage and compounding equipment and materials.
5.4.2. Adequate equipment and material that is suitable for all the operations that have to be carried out shall
be available.
5.4.3. The pharmacy shall have continuous power supply.
5.4.4. The dispensing and storage device shall be calibrated, maintained, kept clean at all times and be in
good repair.
5.4.5. Equipment used for compounding shall be calibrated on a regular basis and documentation showing
proof of calibration and servicing shall be maintained.
5.4.6. Countertops and shelves shall be finished in a smooth, washable and impermeable material which is
easy to maintain in a hygienic condition.
5.4.7. Dispensing and storage equipment and materials shall include:
a) Counting devices for tablets and capsules
b) Tablet cutter
c) Stainless steel spoon
d) A refrigerator equipped with a maximum and minimum thermometer which is capable of storing
products at temperatures between 2°C and 8°C. Pharmaceutical grade refrigerators should be
recommended.
e) A suitable range of dispensing containers with separate sets for internal and external use.
f) Separate secured fixed metal cabinet or shelf with lock and key for keeping narcotics drugs and
psychotropic substances.
g) Wall thermometer and hygrometer or thermo hygrometer for both storage and dispensing room.
h) Ventilator or air conditioner as appropriate.
i) Fire extinguisher.
j) First aid kit
k) Weighing balance with height measurement (optional)
l) Blood pressure (BP) apparatus (optional)
m) Blood glucose measuring equipment (optional)
n) Pulse oxymeter (optional)
o) Pregnancy test kit (optional)
p) Scientific calculator and scissor
q) Fixed telephone or mobile phone
r) Computer (s)
s) Shelves and pallets
t) chairs for waiting area
5.4.8. The pharmacy shall have the following reference materials (soft or hard copy version)
a) One of the last three editions of Martindale
b) Comprehensive textbook on Pharmacology

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c) Medical dictionary
d) Latest copy of medicine related proclamation
e) Latest copy of Community pharmacy medicine list
f) Latest copy of National standard treatment guideline
g) Latest copy of National medicine formulary
h) Latest copy of National good dispensing manuals
i) Demonstration charts, kits and other demonstration material
j) Reporting formats, transcription paper, bin card, stock card, registration books
5.4.9. The drug information center shall have the following products
a) Furniture (shelves, tables and chairs).
b) Telephone line
c) Internet access
d) Computer and software
e) Printers and duplication machine
f) Drug databases: Access to reliable databases and references such as Micromedex, Lexicomp, Clinical
Pharmacology, or UpToDate.
g) Drug information center standard operating procedures
h) Reference materials (primary, secondary and tertiary sources).
5.4.10. Compounding equipment and material shall include, if compounding is performed in the pharmacy:
a) Working bench with upper part made of marble or stainless steel
b) Dispensing balance (Analytical balance),
c) Mortar and pestle (glass or porcelain) not less than 250ml
d) Stainless steel hot water bath (electrical) with four or more openings
e) Hot plate (electrical)
f) Shaker or stirring rods (glass or plastic) of different length and thickness
g) Spatula (stainless steel, plastic, flexible or non-flexible)
h) Ointment tile or slab
i) Wash bottle
j) Funnel (glass or poly ethylene)
k) Beaker (different sizes)
l) Test tubes of different sizes
m) Graduated cylinders (different volumes)
n) Weighing paper (normal, grease-proof for semi solids)
o) Weighing dishes (plastic, aluminum, stainless steel)
p) Evaporating dish
q) Volumetric flask
r) PH meter
s) Alcoholometry
t) Thermometers

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u) Purified water
v) Disposable gloves and masks
w) Labeling and packing materials
x) Electrical light or lamp

24 ©IES
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Annex-A
Application form for registration of Higher Community Pharmacy
premises
Application notes (under review):
This application comprises two parts description of the proposed premises and some basic standard of
medicine retail outlet.
Incomplete applications forms may be returned to the applicant for completion.
A.1 Name and address of the applicant
Name: ----------------------------------------------------------------------------------
Address: --------------------------------------------------------------------------------
P.Box:------------------------------------------------------------------------------------
Tell phone: --------------------------------------------------------------------------------
Email: -----------------------------------------------------------------------------------------
Fax: -------------------------------------------------------------------------------------------
A.2 Address of the Higher Community Pharmacy premises to be approved:
Address:----------------------------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------------------------------------
---------------------------
A.3 State the reason for the application: You require: (Please tick (x)
a)Registration of New Higher Community Pharmacy premises (for a new Higher Community Pharmacy service).
b)Registration of New (relocated) Higher Community Pharmacy premises (relocating an existing retail service to
new premises).
c) Approval of Alterations to existing registered Higher Community Pharmacy premises.
d)Approval of Alterations and extension of existing registered Higher Community Pharmacy premises
e)If Other please specify:-------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------
A.4If relocating an existing pharmacy business into new premises, state the address of the existing pharmacy
premises which will be vacated.
----------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------
A.5 the services to be provided from the premises(only for Higher Community Pharmacy)
a)Dispense medicines to the public.
b)Dispense medicines to the public and extemporaneous preparations (pharmaceutical compounding).

A.6 Will the pharmacy premises be freely accessible to persons from other premises where a business
other than a pharmacy is conducted? (i.e. will there be a direct entry to the pharmacy from another business)
Yes no

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 ES 7084:2024

Provide details of that other business, including type and ownership

E.g. Medical Clinic,--------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------------------
A.7Enclose a floor plan of the premises, drawn to specified scale showing:
I. The total area of the Higher Community Pharmacy premises expressed in Square meters; -------------------------
------------
a)The total area of the pharmacy store expressed in square meters. -----------
b)The total area of the dispensary expressed in square meters; ----------------
c) The total area for compounding room expressed in square meters(for Higher Community Pharmacy only if
necessary)-----------------------------------
II. The height of the Higher Community Pharmacy room from the floor to the ceiling in meters. ----------------------
A.8 Will dispensing station include a dispensing bench? yes no
A.9Is the design of the dispensary such that access to medicines stored in the dispensary is restricted to
dispensary staff only? yes no
A.10 Will the dispensary include a specific bench or bench area of at least 2(two) m2 located near to the
sink for the compounding or preparation of medicines and that also provides storage for compounding
equipment? (for Higher Community Pharmacy only if necessary)
Yes no
A.11 Will the dispensary include a drug cabinet for the storage of controlled drugs that facilitates the accurate
selection of medicines?
A.12.Will the dispensary be equipped with a refrigerator dedicated to the storage of medicines?
I hereby declare that the information provided in this application for Registration of Pharmacy Premises is true
and correct
Please sign below: Please write your name legibly
--------------------------- ------------------------------------------------------------
Date------------/----------------/----------------- (date/month/year)

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 ES 7084:2024

Annex B (Informative)
Standard Prescription

PRESCRIPTION PAPER Code____________

Institution Name: __________________Tel. No… ……
Patient’s full Name: __________________________________
Sex: ___ Age:___ Weight: ______ Card No. _____________
Region: _______Town ________ Woreda______Kebele _____

Diagnosis, if not ICD ______________________________

Medicine Name, Strength, Dosage Form, Dose, Price
Frequency, Duration, Quantity, How to use & other (dispensers
information use only)

Total Price
Prescriber’s Dispenser’s
Full name ________________________ _________________________
Qualification _____________________ _________________________
Registration #_______________________ _________________________
Signature ________________________ _________________________
Date: _________________________ _________________________
See overleaf
Please Note the Following Information
Prescriptions:
⮚ May valid only if it has the seal of the health institution.
⮚ filled and blank are legal documents, treat them as fixed assets
⮚ written and verbal information to the client complement one another

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 ES 7084:2024

The prescriber:
⮚ Medicine treatment is only one of the treatment options
⮚ write the prescription correctly and legibly
⮚ diagnosis and other parts of the prescription have to be complete
⮚ abbreviations are NOT recommended
⮚ please accept prescription verification call from the dispenser
The Dispenser:
⮚ check legality of the prescription
⮚ check completeness and accuracies before dispensing
⮚ check for whom the medicine is being dispensed: actual client or care taker
⮚ if in doubt about the contents of the prescription; verify with the prescriber
⮚ containers used for packaging must be appropriate for the product
⮚ labels of drugs should be clear, legible and indelible
⮚ Medicines should be dispensed with appropriate information and counseling
⮚ keep filled prescriptions at least for 3 years
Minimum drug label information should include the following:
⮚ Patient name
⮚ Generic name, strength and dosage form of the medicine
⮚ Dose, Frequency and Duration of use of the medicines
⮚ Quantity of the medicine dispensed
⮚ How to take or administer the medicine?
⮚ Storage condition

28 ©IES
 ES 7084:2024

Bibliography

Food and Medicines Administration Proclamation No. 1112/2019

Regional regulations and directives
Good pharmacy practice, Joint FIP/WHO guidelines on GPP: standards for quality of pharmacy services
Good pharmacy practice in South Africa, 4th Ed, 2010
Medicine retail outlets licensure and control model directive, EFMHACA, 2013

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Orga
anization
n and Objectives

The Innstitute of Ethiopian

E Staandards (IES) is the national standards body of
Ethiop
pia. IES is re--named by th
he proclamatioon number 12263/2021, fro
om Ethiopian
Standaards Agency (ESA) to In nstitute of Ethiopian stand
dards, with the
t mandate
given by the regulation Number, 193/2010 an nd proclamatio
on number, 1263/2021.

IES’s
s objectiv
ves are፡
 Develop Eth dards and esttablish a systtem that enable to check
hiopian stand
whether gooods and servicce are in com mpliance with the required standards,
s
 Facilitate t
the countryy’s technolog gy transfer through the use of
standards,
 Develop nattional standards for local products and d services soo as to make
them compe etitive in the in
nternational market.
m
 Conduct staandards related research h and provide training an nd technical
support.
Ethio
opian Sta
andards

The Ethiopian
E Stanndards are developed
d byy national tecchnical comm mittees which
are co omposed of different stakkeholders consisting of educational
e a
and research
instituttes, governm mental orga anizations, certification,
c inspection, and testing
organiizations, reguulatory bodiess, consumer association
a ettc. The requirrements and/
or recommendation ns contained in Ethiopian Standards are a consensuss based that
reflectts the interestt of the TC re
epresentativess and also of comments re eceived from
the pu ublic and othe er sources. Ethiopian
E Staandards are approved
a by the National
Standa ardization Co
ouncil and are e kept under continuous
c review after publication and
update ed regularly too take accounnt of latest scientific and te
echnological changes.
c

Orderss for all Ethio

opian Standa ards, International Standard and ASTM M standards,
includiing electronicc versions, should
s be adddressed to the Docume entation and
Public
cation Team ata the Head office
o and Bra anch (Liaisonss) offices). A catalogue of
Ethiop
pian Standard ds is also avaiilable freely and can be acccessed from our website.

IES haas the copyright of all its publications. No part of th

hese publicattions may be
reprod
duced in any form without the prior perrmission in wrriting of IES. International
Involve
ement IES, representing g Ethiopia, is a memb ber of the International
Organnization for Sttandardizationn (ISO), Intern
national Electro-technical Commission
(IEC) and Codex Alimentariuss Commission (CODEX). It also maintains close
ng relations with
workin w the Ameriican Society for f Testing an nd Materials (ASTM). It is
a founnding memb ber of the African
A Regioonal Organiza ation for sta
andardization
(ARSOO).

For Moree Information?

C
Contact us at thee following addreess.
Th
he Head Office of
o IES is at Addiss Ababa.

011‐6460685,, 011‐6460565
011‐6460880
2310AddisAbbaba, Ethiopia
E-mail:info@e
E ethiostandard ds.org
Website:www.
W ethiostandardds.org S
Standard Ma
ark
