FINAL TOUCH BY MLACHA JO.pdf

BY PHARM. MLACHA JO jp214479@gmail.com +255673694833
@LAW AND ETHICS IN PHARMACY PRACTICE
BASIC CERTIFICATE IN PHARMACEUTICAL SCIENCES
(NTA LEVEL 4)
FINAL TOUCH
1.Define the following terms
A) Business of a pharmacy is the type of business that includes professional
pharmacy practice and any activity carried on by a person in relation to
medicines, medical device or herbal medicines.
B) BRELA means Business Registrations and Licensing Agency mandated to
register companies, business names and intellectual property rights such as
patents of inventions, industrial designs, trade and service marks and issue
industrial licenses.
C) Council means the Council established under section 3 of the Pharmacy Act
2011
D) Dispense means supply of medicines or medicinal products in
accordance with a prescription lawfully given by a medical practitioner
E) Inspector means an Inspector appointed, authorized or recognized as such
under the Act
F) Pharmacy means any approved premises wherein or from which any
service pertaining to practice of a pharmacist is provided, and shall
include a community pharmacy, consultant pharmacy, institutional
pharmacy, or wholesale pharmacy.
G) Pharmacy practice: means any acts pertaining to the scope of practice of a
pharmacist, pharmaceutical technician or pharmaceutical assistant as
approved by the Council.
H) Premises Means a land, building, structure, basements and a vessel and in
relation to any building whether open or closed or place of storage used in
connection with any service pertaining to practice of a pharmacist.
I) Registrar means the Registrar of the Council appointed under section 12 of
the Act.
J) Retail pharmacy business is the type of business that includes the retail sale
of medicines products but does not include a professional practice carried
by a medical practitioner or veterinarian.
K) Sell means sell by wholesale or retail and include import, offer, advertise,
keep, expose display, transmit, consign, convey or deliver for sale or
authorize, direct or allow a sale or prepare or posses for the purpose of
sale and barter or exchange supply or dispose of to any person whether
for a consideration or otherwise.
L) Superintendent means a Pharmacist In-Charge who supervises a
pharmacy and is registered as such by the Council under this Act
(Pharmacy Act,2011);
M) Wholesale Pharmacy means a pharmacy that buys medicines, medical
devices or cosmetics from importers and sell in bulk to retail pharmacy;
N) Warehouse/ godown means a building for storage of pharmaceutical
products;

O) Wholesaler means a person who buys medicine, medical devices or
cosmetics from importers or local manufacturers and sells in bulk to the
retailer
2.Mention Sections in the Acts relating to Registration and Licensing of
Premises for Pharmacy Business
a)Section 34 , Pharmacy Act, 2011
b) Section 36 , Pharmacy Act, 2011
c)Section 18, Pharmacy Practice Regulations 2012
d) Section 20 of the Pharmacy (Pharmacy Practice) regulations, 2012
e)Section 21 of the pharmacy practice regulations 2012
f) Section 27 of the pharmacy practice regulations 2012
3.State the Sections in the Acts relating to Registration and Licensing of
Premises for Pharmacy Business
a)Section 34, Pharmacy Act, 2011 states the registration of premises
b) Section 36, Pharmacy Act, 2011 states the application of permits
c)Section 18, Pharmacy Practice Regulations 2012 states conditions for
establishment and operation of a pharmacy
d)Section 20 of the Pharmacy (Pharmacy Practice) regulations, 2012 state the
prescribes terms and conditions that must be adhered during the application for
the registration and permits.
e)Section 21 of the pharmacy practice regulations 2012 states registration of a
pharmacy
f) Section 27 of the pharmacy practice regulations 2012 states the categories of
registers
4. Give out the provision/subsection of Section 34
(1) A person shall not sell, dispense or supply medicinal products except in
premises registered under this Act.
(2) An application for registration or renewal of registration of premises shall be
made to the Council in the prescribed form, and shall be accompanied by such
fee as the Council may prescribe.
(3) The Registrar or any person in his behalf shall-
(a)keep a register of all premises registered under this section;

(b)register premises if he is satisfied that the requirements to be complied with
by the applicant as prescribed by the Council from time to time have been
complied with; or
(c)have powers to approve the location and name of the proposed premises.

(4) The Council may, for good cause, refuse to register or cause to be removed
from the register, any premises which is or has become unsuitable for purposes
for which they were registered.
(5) A person who contravenes the provisions of subsection (1) commits an
offence and upon conviction shall be liable to a fine not exceeding ten
million shillings or imprisonment for a term not exceeding two years or to both.
5. Give out the provision/subsection of Section 36
(1) A person shall not sell, dispense or supply medicinal products unless he has
obtained a permit issued under this Act.
(2) An application for a permit shall be made to the Council in the prescribed
form, and shall be accompanied by such fee as the Minister may prescribe.
(3) The Council shall not issue a permit to sell medicines and related medical
supplies under this section unless the Council is satisfied
(a)that the premises in respect of which the application relates shall be stored,
meets the prescribed standards;
(b)that the equipment are available for storing the medicines and
related medical supplies;
(c)with the suitability of the equipment and facilities which are used for
distributing the medicines and related medical supplies; and
(d)with the arrangements made or to be made for securing the safe
keeping, and the maintenance of adequate records in respect of medicines
and related medical supplies stored in or distributed from those premises.
(4) A separate permit under this section shall be required in respect of
each set of premises in which the business is carried on.
6. Give out the provision/subsection of Section 18, Pharmacy Practice
Regulations 2012,
1) A person shall not establish and operate a business of a pharmacist unless
the premise is registered in accordance with the Act.
2) A premise registered under these regulations shall be required to comply
with the good pharmacy practice and registration guidelines of a business
of a pharmacist
3) There shall be a separate application and registration of each premises
intended for use as pharmacy as shall be prescribed by the council in the
registration guidelines.
4)Each registered premises for establishment of a pharmacy shall be
issued with a registration certificate which is non transferable.

7. Give out the provision/subsection of Section 20 of the Pharmacy
(Pharmacy Practice) regulations, 2012
1. Any person requiring to operate a business of a pharmacist under these
regulations shall be required to submit a duly completed application form to
the Registrar accompanied:
a)A copy of any lease agreement, sub-lease agreement or other agreement
in terms of which the applicant has the right to occupy the proposed
pharmacy premises;
b)If the owner of the premises, submit a certified copy of the title deed or
similar document evidencing his right to ownership of such premises;
c)A copy of site plan of the roof and floor plan of the building, if applicable,
indicating the location or surrounding businesses and a copy of the plan layout
of the actual pharmacy premises;
1) In case of a partnership, a copy of the partnership agreement, stating the
name of the pharmacist designated to accept responsibility for the duties
as superintendent
2) An application fee prescribed by the Council; and
3) Any other information as may be requested by the Council.
4) Every application made under these regulations shall be required to comply
with all the requirements prescribed by the Council in the registration guidelines
and good pharmacy practice of a business of a pharmacist.
5) The Council shall inspect or cause an inspection of the proposed pharmacy
premises, if found to satisfy with the requirements, the application shall be
accepted, if found unsuitable, the application shall be deferred or rejected
with reasons in writing
8. Mention five (5) categories of pharmacies under Section 27 of the pharmacy
practice regulations 2012
• Community pharmacy
• Wholesale pharmacy
• Institutional pharmacy
• Consultant pharmacy
• Manufacturing pharmacy

9. Outline six (6) types of premises/pharmacies registered under section 34 of the
Pharmacy Act and 27 of the pharmacy practice regulations
• Retail pharmacy
• Wholesale (distribution) pharmacy
• Institutional pharmacy
• Medical devices shops
• Vessel/ motor vehicles carrying medicines
• Consultant pharmacy
10.Enumarate Requirements for Registration of Premises for Pharmacy Business
1. Location
- premises for retail pharmacy shall be given if it is at least 300 meters away
from the existing retail pharmacy
- away from sites or activities that emit fuel fumes/fumes and
contaminants, /open sewerage,
- no direct link to building with bar, garage, restaurant, medical laboratories,
dispensary, clinics or in direct link to residential houses,
- Premises located within shopping centers such as malls, supermarkets shall be
confined and restricted from other activities conducted therein.
-should have a postal address and physical address,
-should have a signboard conspicuously displayed and the pharmacy
identification logo displayed at the main entrance.
2. Premise design
-premises shall be durable, safe and made of permanent building materials
-roofed with corrugated iron sheets, concrete slabs or tiles and floor minimally
made up of terrazzo, tiles or any other hard washable surfaces.
-premise shall provide protection against rodents, birds, vermin, insects or
animals -rooms shall be painted with white/creamy washable paint
-surrounding should be maintained so as to minimise dust, soil and other
contamination -Sufficient lighting and ventilation
-Premises should be sufficiently secured to prevent theft and
unauthorised entry -“NO SMOKING” sign should be conspicuously
displayed at the entrance.
-suitable equipment and facilities for proper storage, safety keeping and
handling of pharmaceuticals.
-In retail outlets with compounding there shall be availability of simple
dispensing equipment like balances, mortar and pestle, measuring
cylinder and a sink in the dispensing area.
-In Premises providing human and veterinary Medicines, separate displaying
shelves and storage cabinets shall be provided for each category.
-separate secured cabinets with lock and key for keeping controlled Medicines

• - storeroom located within the pharmacy or warehouse at mezzanine or
underground shall be subject to adherence to other premises requirements
including sufficient light, air conditioning facilities
3. Premises layout
-Retail Pharmacy must have a minimum of three rooms for displaying,
dispensing and storerooms. one main secured entrance and where
applicable an emergency rear door.
▪ room size/ area at least measures 25 m2 and internal heights not
less than 2.5m
▪ with adequate shelves or pallets
- Distribution (Wholesale) Premises shall have not less than three for display,
receiving and dispatch, record keeping and storage. The premises must have one
main secured entrance.
▪ Room size/ area of at least 40m2 and have not less than 2.5m
internal heights.
▪ with adequate shelves and pallets
- Retail and Distribution (Wholesale) are professionally not encouraged and
shall be given permit depending on circumstances shall have at least three
rooms namely; display, receiving and dispatch room; sales, record keeping and
dispensing room and the storage room.
▪ Room total size/ area at least measure 60m2 and not less
than 2.5 m internal height with clear demarcation/partition
for retail and wholesale business.
▪ adequate shelves and pallets
▪ A clear demarcation of wholesale receiving/dispatch area
▪ a separate entrance door for retail and wholesale business.
-Warehouse Premises
▪ sufficient lighting and ventilation.
▪ sufficient capacity to allow storage of various
categories of pharmaceutical products.
▪ The floor shall be durable to withstand heavy traffic and
loads, easy to clean; the premises shall be provided with
well-fitted shelves or pallets.
▪ The premises shall be equipped with temperature and
humidity control facilities/monitors and fire extinguishers.
The required temperature storage condition shall be
below 25 centigrade and daily records should be kept
▪ A wall thermometer should be available
▪ A residential home shall not be used as a warehouse.
▪ Warehouse shall only be used for storage purposes and
no sells shall be allowed
- vehicle for carriage
▪ shall be approved by the Council
▪ Application for permit shall be made in prescribed forms
▪ shall be of light colour and easily cleaned. It shall be dust proof,
ventilated, water tight, covered to prevent direct sunlight and
provided

with special facilities to maintain cold chain (in a case of
cold chain products)
4. storage facilities
▪ shall protect products from deterioration or infestation by
vermin and pests.
▪ Controlled storage environment e.g. air conditioning, refrigeration
for cold chain products shall be monitored using suitable
temperature recording devices and records reviewed and filed.
▪ There should be provision for lockable shelves for keeping
schedule IA medicines and substances.
▪ A confined adequate space shall be provided within the
premises for storage of returned, recalled, expired,
quarantined and substandard or counterfeit pharmaceuticals.
▪ All pharmaceuticals shall be stored off the floor in well – fitted
shelves or pallets.
11. In what conditions does the Premises registration certificate remain valid (no
need of renewal)
▪ Premises start to operate within six (6) months following the
approval or registration
▪ Three (3) years from date of issuing have not elapsed
▪ Business permit is renewed yearly.
▪ The premises have been maintained and remained in conditions which
led to its initial registration
▪ There is no change of business name, ownership or location.
12. Every premise registration certificate shall expire on?
30th June after every three year from the date of registration.so dealers of
pharmaceutical business shall be required to fill and furnish to the Registrar their
applications for registration of premise and business permits three (3) months
before 30th June after elapsing of such period.
13. Every permit issued by the Council shall expire on?
30th Day of June every year. So all dealers of pharmaceutical business shall be
required to fill and furnish to the Registrar their applications for renewal of permits
three (3) months before 30th June.
30th Day of June every year
14. How the renewal of permit shall be done?
renewal of permit shall be done by filling application form for permit form
completely and accurately with all the required information only filling in the
application form for
permit and pay the respective annual permit fee prescribed under
Pharmacy Fees and Charges Regulations, 2012.
On submission the forms must be accompanied
• With a payment receipt of fees as prescribed under The Pharmacy (Fees and
Charges) Regulations, 2012.
• Original copy of the expired business permit

• A copy of premise registration certificate
• A certified copy of the contract agreement between two parties
(Proprietor and Superintendent)
• A copy of registration certificate of the superintendent issued by Council
• A letter of commitment from the superintendent to supervise the said pharmacy
• Copies of certificate of other pharmaceutical personnel working in the
pharmacy and their certified contract agreements.
• Dealers who shall delay to renew their permits beyond 31stJulyof the following
financial year shall be required to pay to the Council the prescribed annual
permit fee together with 25% penalty as stipulated in regulations 38 (1-5) The
Pharmacy (Pharmacy Practice) regulations,2012.
15. Mention down the Procedures for Application for Approval of Location.
▪ applicants Shall apply for the approval of location to the Registrar, through
zonal coordinators, respective Regional Pharmacist (RP) and District
Pharmacist (DP).
▪ Application for the approval of location of the premises shall be
made in a prescribed approval of location form.
▪ The Application form shall be obtained from Pharmacy Council
office, zonal coordinators or through RP and DP offices of the
respective Regions and Districts or through the Pharmacy Council
Website www.pctz.or.tz
▪ Applicant shall be required to fill in completely and accurately all the
required information in the approval of location form.
• On submission the form must be accompanied
• With a payment receipt of fees as prescribed under The
Pharmacy (Fees and Charges) Regulations, 2012.
• Copy of the site plan of the building indicating the location of the
pharmacy premises in relation to adjoining or surrounding
businesses and access to and from the premises’
• Copy of the professionally drawn floor plan indicating the actual
layout of the pharmacy premises drawn to scale with exact
measurements.
16. Mention down the Procedures for Application for the registration of the premise
and business permits under (Sections 36 of the Pharmacy Act and 19 and 20 of
the Pharmacy (Pharmacy Practice) regulations, 2012).
▪ Upon successful final inspection and inspectors approve the
premise that is suitable to provide pharmaceutical services
▪ applicant shall Apply for the registration of premise and permits to the
Registrar, through zonal coordinators, respective Regional Pharmacist
(RP) and District Pharmacist (DP).
▪ Forms must be filled in completely and accurately with all the
required information
-Application form for Registration of Premises
-Application form for Permit to operate business of a pharmacist
• The Application form shall be obtained from Pharmacy Council office, zonal
coordinators or through RP and DP offices of the respective Regions and
Districts or through the Pharmacy Council Website www.pctz.or.tz

On submission the forms must be accompanied
• With a payment receipt of fees as prescribed under The
Pharmacy (Fees and Charges) Regulations, 2012.
• A certified copy of the contract agreement between two parties
(Proprietor and Superintendent)
• A copy of registration certificate of the superintendent issued by
Council
• A letter of commitment from the superintendent to supervise
the said premise
• Copies of certificate of other pharmaceutical personnel planned
to work in the pharmacy and their certified contract agreements.
• A copy of registration certificate of names/business/
corporate from relevant authorities (BRELA).
• A copy of lease or sub-lease agreement or any document
evidencing his right to ownership of the premise.
• Final approved plan of the layout of the pharmacy premise (roof
and floor plan if necessary).
17. Outline the sequence of events occurs during Inspection of new premise
▪ Upon receipt of the duly filled approval of location form, inspectors will
visit the said area/premise for first inspection
▪ The inspector or any other public officer authorized by the Council
shall make sure that the premises applied for registration is inspected
to verify if all the requirements have been met
▪ The inspectors shall use the inspection checklist when conducting the
inspection of new pharmacy premises and give their observations and
recommendation on the suitability of the premises.
▪ If the premise/area failed to comply with the required standards,
applicant will be informed immediately during inspection in writings,
either to address short falls or to look for another location/premise.
▪ The applicant after first inspection report, if allowed may continue with
process of construction/renovation of the premises. Shall do so in six (6)
months and upon completion shall inform the registrar/regional/district
pharmacist for final inspection within prescribed.
▪ In case an applicant fails to inform the Council within 6 months for
final inspection, the Council will cancel/refute the report and
declares for any interested person(s) to use the said area for the
same business
▪ The applicant after a successful final inspection report shall apply for
registration of premise and for the permit to operate business of a
pharmacist.
18. Outline the sequence of events occurs during Registration of new premise
▪ Upon receipt of duly filled of all forms necessary for application,
premises inspection report and all other necessary documents from the
inspectors, the officer authorized by the Registrar shall scrutinise all the
documents and if satisfied that all the requirements have been met,
shall compile and give its recommendations to the Committee
responsible for registration of premises for consideration.

▪ If the premises registration or licensing requirements have not been
met, the applicant will be informed accordingly to address the
shortfalls before reconsideration.
▪ The Council may register, withhold, reject or register with
conditions any application by providing reason(s) for his/her
decisions.
▪ All applicants, whose applications have been approved, approved with
condition, withhold or rejected as the case may be, shall be informed in
writing’s on the status of their application.
▪ Before starting the business, approved applicants will be required to
purchase all necessary material necessary for the operation of the
pharmacy i.e. Logo, reference materials, dispensing coats etc.
▪ The Registrar shall then issue the Premises Registration Certificate and the
respective permits, which allow the applicant to start carrying out the
business of a pharmacy.
19. Define Health care system
is a system which consists of all organizations, people and actions whose
primary intent is to promote, restore or maintain health OR
is the organization of people, institutions, and resources that deliver health care
services to meet the health needs of target populations.
20. Mention goals Health care
system -To promote universal
health care
-To ensure that all people obtain health services they need without suffering
financial hardship when they paying for them
-To ensure good health for the citizen
21.Explain five (5) Levels of Health Care Delivery System
✓ National Level
The central level, is the Ministry of Health and social Welfare. Its mission is to
facilitate the provision of basic health services that are good, quality,
equitable, accessible, affordable, sustainable and gender sensitive.
✓ Regional Level
This level sometimes referred to as an extension of the MOH. It has the
regional secretariat and one hospital in the region.
✓ District hospital level
The district is the focal point for the implementation of the national
health policy managed by the local authorities.
✓ Divisional Level
This consist of a health centre which provides both curative and preventive
✓ Ward Level
This is the lowest level (dispensary) of the formal health care delivery system.
22.Define Referral System
is an organizational structure for coordinating, linking and transferring responsibility of
care.

OR
is a system of transferring case that is beyond the technical competence of one
infrastructure to a higher level infrastructure /institutional having technical competency
and all other resources to provide desired health services.
23.How the referral system May be done?
May be done by
-a generalist to a specialist
-a specialist to a specialist
- one hospital to another
24. Government’s referral system is a pyramidal pattern explain referral system from
low level to the highest level.
-Dispensary Services
The dispensary caters for 6,000 to 10,000 people and supervises all the village health
posts in its ward. This is the first level where patients are attended to. If the patient cannot
be attended to at this level because of the complexity of the condition is then referred
to the next level which is a health centre
-Health Centre Services
A health Centre is expected to cater for 50,000 people which is approximately the
population of one administrative division. This is the second level where patients are
attended to. If the patient cannot be attended to at this level because of the
complexity of the condition is then referred to the next level which is a district level
-District Hospitals
The district is a very important level in the provision of health services in the country
each district is supposed to have a district hospital. For those districts which donate
have Government normally negotiates with religious organizations to designate
voluntary hospitals get subventions from the Government to contract terms. Patients
are referred to here from Health centres and dispensaries present within the District
-Regional Hospitals
• Every region is supposed to have a hospital. Regional Hospital offer similar
services like
those agreed at district level, however regional hospitals have specialists in
various fields and offer additional services which are not provided at district
hospitals. Patients from districts are referred to these hospitals for further
management
-Referral/Consultant Hospitals

• This is the highest level of hospital services in the country presently there are four
referral hospitals namely, the Muhimbili National Hospital which cater the
eastern zone; Kilimanjaro Christian Medical Centre (KCMC) which cater for the
northern zone, Bugando Hospital which cater for the western zone; and Mbeya
Hospital which serves the southern Highlands.
25.In Tanzania there are four zones mention four hospitals that serves in
geographical zones as referral/consultant hospitals
✓ Muhimbili National Hospital which cater the eastern zone
✓ Kilimanjaro Christian Medical Centre (KCMC) which cater for the northern zone
✓ Bugando Hospital which cater for the western zone
✓ Mbeya Hospital which serves the southern Highlands.
26.Identify 5 medicines provided at level A (dispensaries level)
• Lignocaine injection 1%
• Acetylsalicylic acid 300mg tablet (aspirin)
• Diclofenac 25mg,50mg tablet /injection /gel
• Adrenaline injection 1mg
• Paracetamol 500mg
• Charcoal, activated tablet/powder 50g,Mrtronidazole
200mg,albendazole 400mg,mebendazole 100mg,Folic acid 5mg.
27.Identify 5 medicines provided at level B (health centres level)
• Calamine lotion 15mg/100mls
• Ivermection 3mg/6mg tablet
• Thialbendazole 500mg tablet
• Ciprofloxacin 250/500mg tablet
• Fluconazole 150mg
• Efavirenz 200mg/600mg and Lamivudine 150mg
28.Identify 5 medicines provided at level C ( council hospital level)
• (Vitamin B 12)inj 1mg/ml
• Nifedipine 10mg tablet
• Propranolol 40mg
• Praziquantel Tablets 600mg
• Metronidazole inj 5mg/ml
29.Identify 5 medicines provided at level D (referral hospital at regional levels)
• Amikacin 250MG inj
• Dopamine 40mg/ml Injection in 5ml ampoule
• Flucloxacillin 250mg inj
• Kanamycin 1g inj powder
• Vancomycin 500mg
30.Identify 5 medicines provided at level S ( zonal referral, national and special
hospitals)
• Itraconazole 100MG tablet

• Prednisolone 5mg tablet
• Levodopa+Carbidopa Tablets 100mg + 25mg
• Carvedilol 6.25mg tablet
• Metoprolol 50mg tablet
• Amlodipine 5mg/10mg tablet
31. Define the following terms
• Storage
means putting and safe keeping of medicines and medical supplies up to the
point of use.
• Good Storage Practices (GSP)
means part of quality assurance that ensures that the quality of
pharmaceutical products is maintained by means of adequate control
throughout the storage.
• Distribution
means a business of dealing in human medicines or medical devices in bulk or
wholesale but does not include importers of human medicines, medical devices,
food, cosmetics and veterinary medicines.
• Good distribution practices (GDP)
Are practices that ensure that the quality of a pharmaceutical product is
maintained by means of adequate control of the numerous activities which occur
during the distribution process as well as providing a tool to secure the distribution
system from counterfeits, unapproved, illegally imported, stolen, substandard,
adulterated, and/or misbranded pharmaceutical products
33. What are the 3 Sections in the Pharmacy Act 2011, related to Storage and
Distribution of Medicines and Medical Supplies and state them
• Section 34 states Registration of premises
• Section 36 states Application of permits
• Section 44 states Conditions for body corporate to become authorized seller of
medicines and pharmaceutical products
34.Explain the Conditions for body corporate to become authorized seller of medicine
and pharmaceutical products under section 44.
• Anybody corporate carrying on business involving sale of drugs shall be an
authorized seller of medicines within the meaning of this Act, if-

• with regard to the keeping, selling, dispensing and compounding of
medicines the business is under the management of a superintendent
who-

-is a Pharmacist;
- has signed and submitted to the Registrar a statement in writing on behalf of
the body corporate stating his name and specifying whether or not he is a
member of that body; and
- is not at that time acting in similar capacity for any other body;
• in each set of premises for the sell of medicines, the business is carried on
either under the personal supervision of the superintendent or subject to his
directions under the personal control of another Pharmacist;
• The name and certificate of registration of the superintendent or of some
other Pharmacist having control of the business is conspicuously exhibited in
the premises.
• Where a body corporate which is an authorized seller of drugs has been
convicted of an offence under this Act; or
• any member of the body corporate or any of its officer or any officer employed
by it in carrying on the business, has been convicted of any criminal offence, or
has been guilty of misconduct which, in the opinion of the Council, renders him
or would, if he were a Pharmacist, render him unfit to be on the register, the
Council may inquire into the matter and may, subject to this Act, direct that-
- the body corporate cease to be an authorized seller of medicines, and
be disqualified for a period to be specified in the directions from being an
authorized seller of medicines; or
- any or all of the premises of medicines and the body corporate be
removed from the register of premises and be disqualified for such
period as the Council may direct.
35.At what condition do Medicines and Cosmetic products shall be considered as unfit?
when they are:
• expired
• improperly sealed
• damaged, unexpired and improperly stored
• improperly labelled
• counterfeit, substandard and adulterated
• prohibited
• unauthorized

36.Define the followings terms
• Prohibited drugs
means any drug declared to be a prohibited drug in terms of the provisions of
section 81 of this Act (TFDA Act).
• Expired product
means a product should not be sold because of an expected decline
in quality or effectiveness after a certain date.
• Substandard products
are products that do not meet their quality standards and specifications.
• Adulterated drug product
is a drug product whose composition has been affected by the addition to or
subtraction from of any substance; or which is not of the nature or quality
demanded by the purchaser
37.List five condition that a medical device or herbal drug shall be deemed
to be counterfeit.
• it is manufactured under a name which belongs to another drug
• it is an imitation of, or is a substitute for, another drug, medical device or herbal
drug resembles another drug or medical device likely to deceive or bears upon
its label or container the name of another drug, medical device or herbal drug
unless it is plainly and conspicuously marked so as to reveal its true character
and its lack of identity with such other drug, medical device or herbal drug;
• the label or container bears the name of an individual or company purporting
to be a manufacturer of the drug, medical device or herbal drug; which
individual or company is fictitious or does not exist
• it has been substituted wholly or in part by another drug substances; or
• it purports to be it is a product of manufacturer of whom it is not truly product.
38.At your facility level what are the procedures/requirements for managing properly
unfit medicines and cosmetic
• Maintain a register book (Annex I) for unfit medicines and cosmetic products
• Keep them into different categories by dosage form such as:-
-Solids, semi-solids and powders: capsules, powders for injection, tablets,
granules, creams, gels, suppositories etc.
-Liquids: Solutions, suspension, syrups, mixtures, lotions, aerosol, inhalers etc.

- Keep separately medicines which fall under controlled drugs, antineoplastics,
antibiotics and any other hazardous medicines or cosmetic products.
• Keep in containers according to their dosage forms to facilitate verification
exercise, sorting and selection of disposal method
• Demarcate an area for keeping containers of unfit medicines and cosmetic
products which shall be labeled conspicuously with words “Expired medicines/
cosmetic products
– Not for Sale” or “Unfit medicines/cosmetics – Not for sale” or “Dawa/
Vipodozi hivi muda wake wa matumizi umekwisha – visiuzwe” au
“Dawa/Vipodozi hivihavifai kwa matumizi – zisiuzwe” in red ink.
• Maintain safe custody of unfit pharmaceutical products in registered premises
until they are disposed off to avoid pilferage.
• The decision of when to initiate disposal of unfit medicines and cosmetic
products shall be made by regional, district or hospital pharmacist, owners, in-
charge of facility, dispensers, and inspectors (including inspectors at ports of
entry) to avoid accumulation of such products.
• Application for disposal of unfit medicines from Government institutions shall be
accompanied by an approval from Accountant General declaring that the
product have been written off and that are subject to disposal as required by
law under Section 256 of the Public Finance Regulations,2001.
39. At your facility level decision of when to initiate disposal of unfit medicines
and cosmetic products shall be made by
• regional, district or hospital pharmacist
• owners
• in-charge of facility
• dispensers
• and inspectors (including inspectors at ports of entry)
40.Explain the Procedures for Application to Dispose off Unfit Medicines and
Cosmetic products
Any person who intends to dispose off unfit medicines or cosmetic products
shall adhere to the following procedures:
• Request in writing to the Director General of TFDA (Currently TMDA) by using
application for (Annex II) which is available at TFDA headquarter offices, TFDA
zone offices, Regional and District Medical officer’s offices and TFDA website:
www.tfda.ac.tz.
• A request shall be accompanied with a list of products to be disposed of and
should state clearly trade name, generic name and strength (where
applicable), dosage form, pack size, quantity, manufacturer, batch number
and market value of product.

• Once the request has been received by TFDA, the Authority shall acknowledge
and inform the applicant through a letter to contact Directorate of Medicines
and Cosmetics to arrange or TFDA zone offices for verification of the product. In
case of regions where there are no TFDA zone offices, applicant shall be
informed to contact the Regional or
District Medical officer’s offices for the same.
• TFDA-HQ or TFDA zone office/Regional/District Medical officer’s offices shall
send inspectors to the premises to verify and authenticate the information
submitted.
41. List down the important information in the Register book of Unfit Medicines
/Cosmetic products
• Name of the product
• trade name
• generic name
• Strength of the product(where applicable)
• Dosage form: suspension, cream, ointment, tablet ...
• Pack size
• Quantity
• Batch number, and
• Value (Tshs.)
42. Draw the Register book of Unfit Medicines /Cosmetic products
S/N Name of
a
product
Trade Generic
name name
Strength
where
applica
ble
Dosage Pack
form size
quantity Batch
numb
er
Value
(TZs)

43. List down the important information in the Application Form for Disposal
• Form number
• Postal address of TFDA
• Postal address of the applicant
• Specification of type of business of the applicant
• Type of products to be disposed
• License number
• Date of issue
• Location of business
• Name of in-charge and reg. number
• Reason for disposal
• Weight of the total products in Kg
• Value of the total products in Tshs
• Declaration by the applicant
• Name of the receiving officer, signature and official stamp.
44. Define the term Sorting of medicines and cosmetic products
means to separate the medicines and cosmetic products into separate
categories for which different disposal methods are required.
45.Provide the examples of category of products and their recommended disposal
methods
S/N Categories Disposal methods
1. Solids, semi-solids and Landfill, incineration and waste
Powders Immobilization
2. Liquids Sewer, high temperature incineration
and treated waste
3. Antineoplastics Treated waste and landfill, high
temperature incineration and return
to manufacturer
4. Controlled drugs Treated waste and landfill, high

temperature incineration
5. Aerosols and inhalers Landfill without waste inertization
6. Disinfectants Sewer or fast-flowing watercourse
7. PVC plastics, glass Landfill and re-cycling
(ampoules, bottles and
vials)
8. Paper, cardboard Recycle, burn, landfill
46. State eight (8) disposal methods for safe disposal of unfit medicines
Introduction. Define the unfit medicine
Main body
1. Landfill, involve 3 types; Landfill for untreated unfit medicines and cosmetic
products, Engineered landfill & Highly engineered sanitary landfill:
2. Landfill for treated unfit medicines and cosmetics; which include;
Encapsulation (applicable to solid, semi solid, powder & liquids)
3. Inertization: applicable to solids, semi-solids, powders, antineoplastics
controlled drugs of that nature and cosmetics containing heavy metals
(e.g. mercury).
4. Sewer (appl. to liquid form)
5. Medium temperature incineration (min. Temp=8500C)
6. High temperature incineration (temperature well in excess of 8500C. ) or
14500C – 20000C
7. Burning in open containers
8. Return to donor or manufacturer (wherever practical)
47.Describe the Sorting process of Unfit Medicines and Cosmetic Products
• The drug inspector shall supervise sorting exercise of unfit medicines and
cosmetics products before determination of disposal method.
• Sorting should be done in an open or in a well ventilated area/building
as close as possible to the stock pile in an orderly manner.
• Staff involved in sorting exercise shall be provided with protective gears such as
gloves, boots, overalls and dust masks and shall be briefed on the sorting
exercise, health and safety risks associated with handling the materials.
• Sorted medicines and cosmetics shall be carefully packed into steel drums or
cardboard boxes or jute bags and information to be indicated outside the
container shall include; dosage form(s) and proposed mode of destruction. The
materials should be kept in a dry secure and preferably separate room to

avoid being confused with in–date medicines or cosmetics until disposal is
carried out.

48. Describe five (5) steps of Verification process of Unfit Medicines and Cosmetic
Products
• Identification of the product.
• Separate medicines which fall under controlled drugs, antineoplastics,
antibiotics and any other hazardous medicinal or cosmetic products.
• Sort according to Destruction Method (Annex IV).
• After verification the applicant shall be informed by either TFDA-HQ or TFDA
zone office, Regional or District Authorities through a letter on the proposed
mode of destruction and shall be directed to arrange with the respective local
authority e.g. Municipal/ District Medical Officer/ Pharmacist to determine
disposal site, cost and date of destruction.
• The cost of destruction shall be borne by the owner of the product as
stipulated under Section 99 of Tanzania Food, Drugs and Cosmetics Act of
2003.
49.Mention 5 Different Participants Involved in the Destruction Process Unfit
Medicines and Cosmetic Products
• Health Officer
• Environmental Officer
• Policeman
• Drug Inspector
• the owner/witness/superintended (pharmacist in charge) of the business.
50. List 5 areas were Participants/supervisors Involved in the Destruction Process
Unfit Medicines and Cosmetic Products are chosen from?
• the drug regulatory authority
• the ministry of health
• the police authority
• institutional pharmacists
• A qualified hazardous waste experts sectors example expert in
environmental management, a registered water chemist, hydro-
geologist or sanitary engineer.

51.Explain the eight (8) Procedures for Destruction of Unfit Medicines and
Cosmetic Products
• A Drug Inspector, Health Officer, Environmental Officer and Policeman shall
supervise the transport of consignment from the owner’s premises to the
disposal site for destruction exercise.
• The destruction exercise shall be supervised by Health Officer, Environmental
Officer, Policeman and Drug Inspector.
• Unfit medicines and cosmetic products shall be transported in a closed motor
vehicle to avoid pilferage.
• Supervisors shall wear protective gears such as overalls, gloves, masks, caps
and boots during the exercise.
• Upon completion of the exercise, a Drug Disposal Form (Annex V) shall be duly
filled in and signed by the supervisors and owner/owner’s representative.
• Drug Disposal Form shall be sent to TFDA headquarter offices.
• Once TFDA has received the form, a certificate of destruction of unfit
medicines and cosmetic products (Annex VI) shall be prepared and sent to
the consignee.
• Particular care shall be taken while handling anti cancer drugs, narcotic
drugs and penicillins to avoid associated hazards.
52.List down the Important information in the Drug Disposal Form of Unfit Medicines and
Cosmetic Products
• Name and address of the owner of the products destroyed
• Location/site where destruction exercise was conducted
• Date of the destruction exercise
• Methods of destruction used
• Total weight (Kg) and value(Tshs) of the products destroyed
• Name and signature of owner/in charge/representative of the organization
• Names, title and signatures of Drug Inspector, other supervisor(s) and
witness of the disposal exercise.

53 List down the Important information in the Certificate of Destruction of Unfit
Medicines and Cosmetic Products
• Reference number of the certificate
• Date
• Name and postal address of owner
• Methods of destruction
• Place/site of destruction
• Serial number of the attached disposal form
• Weight (Kg) and value(Tshs) of products disposed
• Name and signature of Director Gene
✓ dentify medicines and medical supplies provided at council hospital level
✓ Identify medicines and medical supplies provided at referral hospital at regional
levels
✓ Identify medicines and medical supplies provided at zonal referral, national
and special hospita

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