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JABATAN KESIHATAN NEGERI SABAH

Guidance on Expiry Dates and


Storage of Medicines
2021

Guidance on Expiry Dates and Storage of Medicines 2021


Drug Information Services Committee, Pharmaceutical Services Division, Sabah State Health Department
GUIDANCE ON EXPIRY DATES AND STORAGE OF
MEDICINES

FIRST EDITION 2021

This is a publication of the Pharmaceutical Services Division, Sabah State Health Department,
Ministry of Health, Malaysia. This Guidance on Expiry Dates and Storage of Medicines has been
compiled by the Drug Information Services Committee, Pharmaceutical Services Division, Sabah
State Health Department.

Electronic publication by:

Pharmaceutical Services Division,


Sabah State Health Department
Ministry of Health, Malaysia
Tingkat 6, Rumah Persekutuan,
Jalan Mat Salleh,
88590 Kota Kinabalu,
Sabah.

Tel: 088-210963

Disclaimer

The guidance serves as a good practice guidance for pharmacists relating to the expiry
dates and storage of medicines after date of opening. Due to lack of available robust
evidence or stability studies on expiry dates of medicines once opened, the following expiry
dates are suggested unless the manufacturer states otherwise and provided the product is
still within its unopened expiry date. These guidance are subject to correct storage at
ambient temperatures recommended by manufacturers and are based on general
consensus and not evidence-based. However, the editors and publishers are not
responsible for any errors or omissions, and/or consequences arising from the use of this
guidance. Users should always consult the literature, package insert or manufacturer and
take account of new developments or change of brands because these may affect this
guidance.

Guidance on Expiry Dates and Storage of Medicines 2021


Drug Information Services Committee, Pharmaceutical Services Division, Sabah State Health Department
ADVISORS

Tuan Haji Mohd Zamri bin Baharudin


Deputy Director
Sabah State Health Department (Pharmacy)
Ministry of Health Malaysia

Dr. Liau Siow Yen


Head of Pharmacy Practice and Development
Pharmaceutical Services Division
Sabah State Health Department
Ministry of Health Malaysia

EDITORIAL BOARD

Melinda Kwan See Kee


Hospital Queen Elizabeth II

Khamisah binti Item


Klinik Kesihatan Luyang

Jackie Ho Chit Khong


Hospital Keningau

WORKING COMMITTEES
(Drug Information Service Committee, Sabah)

Connie Vun Sie Yee Mohd Ridzuan bin Zakaria


Hospital Tawau Hospital Duchess of Kent

Goh Sor Leng Noor Ilyani binti Ismail


Hospital Wanita & Kanak-Kanak Sabah Hospital Mesra Bukit Padang

James Voo Yau Hon Wong Woei Kheen


Hospital Duchess of Kent Hospital Queen Elizabeth

CONTRIBUTORS

Eva Joseph Donsia


Noratikah binti Sidek
Tang Mei Kuan
Mohamad Zulhelmy bin Che Salbini
Muhammad Syahmi bin Mohd Ameer
Muhammad Taufik bin Suaidi

Guidance on Expiry Dates and Storage of Medicines 2021


Drug Information Services Committee, Pharmaceutical Services Division, Sabah State Health Department
Guidance on Expiry Dates and Storage of Medicines

Introduction
The expiry date of a medicine is the point in time when a pharmaceutical product is no
longer within an acceptable specifications for potency and stability. The expiry date is the
date when a given batch reaches the end of its shelf-life.1 The expiry date depends on
specified storage conditions.

The shelf-life of products is determined by either how quickly the breakdown of the active
drug occurs or due to the risk of contamination from bacteria or other microbes. 2 Shelf-life
is predicted from stability studies. Temperature, humidity, lighting, temperature
fluctuations, type of container, effects of opening and closing containers and microbial
content form the core of stability study design.3 Not all drugs deteriorate at the same rate
and so expiry date can vary from product to product.1 Correct storage is crucial for
maintaining the useable shelf life of a medicine.2

Depending on the medicine, expiry dates may be set for a fixed time, after manufacture
(unopened), after dispensing or even after opening of the manufacturer’s original
container.2 Different packaging provides different protection, such as the inclusion of
desiccants in containers to trap moisture and enhance stability. Healthcare professionals are
advised to refer to the package insert or Consumer Medication Information Leaflet,
available on the National Pharmaceutical Regulatory Agency (NPRA) website
(https://npra.gov.my/index.php/en/consumers/information/products-search) for the
storage conditions and expiry dates supported by stability data.

Key points for basic storage guidelines2:


• Keep all medication in the original container in which they were dispensed.4
• Keep medicines in their original outer packaging, to protect from sunlight, especially
light-sensitive medicines.
• All medicines should be stored in a cool dry place (below 25°C or unless stated
otherwise) unless refrigeration is required (between 2°C and 8°C)
• The expiry date of products can change once opened
• Record the date opened and the calculated expiry on the medicine package/label.
• Be vigilant with product expiry dates.
• Store as recommended by manufacturer.
• Any product whose appearance suggests it may be unfit for use or quality cannot be
ascertained, for example, colour changes, visible precipitation or caking, should be
discarded irrespective of the expiry date.

Guidance on Expiry Dates and Storage of Medicines 2021


Drug Information Services Committee, Pharmaceutical Services Division, Sabah State Health Department
Expiry date after opening2
The manufacturer’s expiry on a container is the unopened expiry date. Certain oral
preparations have a shorter shelf life once they have been opened or reconstituted.2 The
stability of products is variable. A product which is stable in its container may become
unstable once the container is opened. Patients should be advised to store their medicines
as recommended and to discard them after the expiry date. The hoarding of medicines
should also be discouraged. If the manufacturer specifies an in-use shelf life for their
product, use the manufacturers’ shelf life information instead of the guidance below. 2

Table of General Suggested Expiry of Products from Date of Opening2,5

Formulation type Suggested expiry after opening Rationale


and packaging unless otherwise stated by
manufacturer and still within
manufacturer’s expiry date

Creams packed in 1 month The contents are exposed


pots, tubs or jars and can become
contaminated

Ointments packed 3 months The contents are exposed


in pots, tubs or jars and can become
contaminated

Creams/ointments 3 months from date of opening Closed container, contents are


in tubes with a lid or manufacturer’s not openly exposed to
recommendation if shorter environment

Part pack of tablets/ Manufacturer’s expiry on Closed container, contents not


capsules remaining blister. openly exposed to the
in the environment.
manufacturer’s If no visible expiry there is a
blister pack If no expiry is visible, discard it. risk that the product may
have expired.

Oral liquids (in 6 months from date of opening Exposure of liquid to


original unless otherwise specified by environment when dose is
manufacturer’s manufacturer – mark date of measured can introduce
packaging or opening on container contamination
amber bottles)

Refer to Appendix 1

Guidance on Expiry Dates and Storage of Medicines 2021


Drug Information Services Committee, Pharmaceutical Services Division, Sabah State Health Department
Formulation type Suggested expiry after opening Rationale
and packaging unless otherwise stated by
manufacturer and still within
manufacturer’s expiry date

External liquids (in 6 months from date of opening Exposure of liquid to


original unless otherwise specified by environment when dose is
manufacturer’s manufacturer – mark date of measured can introduce
packaging) opening on container contamination

Eye/Ear drops 28 days or 1 month after date of


and ointments opening unless manufacturer
advises otherwise

Refer to Appendix 2

Nasal spray Manufacturer’s recommendation

Inhalers Manufacturer’s expiry Closed container, contents are


date/refer to dose counter if not openly exposed to
available environment

Refer to Appendix 3

Insulin Unopened: Manufacturer’s The sterile seal has been


expiry date when stored in the broken and may be stored
fridge at a temperature outside the fridge
between 2°C and 8°C.
Once opened: Manufacturer’s
in use expiry date (refer to
product insert) at room
temperature.

Refer to Appendix 4

Suppositories/ Manufacturer’s expiry date


Pessaries/Rectal
Tubes/Patches

Guidance on Expiry Dates and Storage of Medicines 2021


Drug Information Services Committee, Pharmaceutical Services Division, Sabah State Health Department
Appendix 1

List of products with expiry dates as per manufacturer’s recommendation


Below are recommended expiry date for medication. Always check the expiry date for each product as
some specific products will vary from these dates.

Syrup/Oral Suspension/Tablet
Generic name Brand Expiry date after Storage condition
opening the bottle
(recommended by
manufacturer)

Abacavir 20 mg/ml Ziagen6 2 months6 Do not store above 30°C6


Oral Solution

Amoxicillin Oral Synamox7 To be used within 7 Reconstituted suspension


Suspension days of mixing7,8,9 should be stored in
Dyna refrigerator at 2°C - 8°C7,8,9
Amoxicillin8

Betamox9

Amoxicillin & Fleming®10 Reconstituted Reconstituted suspension


Clavulanate suspension should be should be stored in the
228 mg/5 ml Pharmaniaga11 used within 7 days10,11,12 refrigerator at 2°C -
Suspension 8°C10,11,12
Clamovid
BID12

Ampicillin Trihydrate Ampicilla11 Reconstituted Reconstituted suspension


125 mg/5 ml suspension should be should be stored in the
Suspension used within 7 days13 refrigerator at 2°C - 8°C13

Ampicillin Sodium & Unasyn12 Reconstituted Reconstituted suspension


Sulbactam Sodium suspension must be should be stored in the
250 mg/5 ml used within 14 days14 refrigerator at 2°C - 8°C14
Suspension

Azithromycin Powder Zynomax15 Discard any oral Reconstituted suspension


for Oral Suspension suspension left over should be stored below
200 mg/5 ml Zithromax16 after 5 days15,16 30°C15, 16

Cefuroxime Axcel17 Reconstituted suspension


125 mg/5 ml Use within 10 days17,18 should be stored in the
Suspension Zinnat18 refrigerator at 2°C - 8°C17,18

Cloxacilla24

Guidance on Expiry Dates and Storage of Medicines 2021


Drug Information Services Committee, Pharmaceutical Services Division, Sabah State Health Department
Generic name Brand Expiry date after Storage condition
opening the bottle
(recommended by
manufacturer)

Cephalexin Cephalexin19 Use within 5 days19 Reconstituted suspension


Monohydrate should be stored in the
125 mg/5 ml Oral refrigerator at 2 - 8°C19,20
Uphalexin20 Use within 7 days after
Suspension
reconstitution20

Ciclosporin 100 mg/ml Sandimmun Use within 2 months Store between 20 - 30°C21
Oral Solution Neoral21 after opening21

Clarithromycin Klacid22 After reconstitution, Do not refrigerate the


125 mg/5 ml use within 14 days22 reconstituted suspension,
Granules store at room temperature
below 30°C22

Cloxacillin Sodium Oxacil Discard 7 days after Reconstituted suspension


125 mg/5 ml Granules23 reconstitution23,24 should be stored in the
Suspension refrigerator at 2°C - 8°C23,24
Cloxacilla24

Digoxin 50 mcg/ml Lanoxin25 Discard any unused Store below 25°C25


Elixir portion 12 days after
opening25

Erythromycin Ericin26 Used reconstituted Reconstituted suspension


Ethylsuccinate solution within 7 days26 should be stored in the
Suspension refrigerator at 2°C - 8°C26

Furosemide 10 mg/ml Vusimide27 Discard opened bottle Store below 30°C27


Oral Solution after 90 days27

Discard 8 weeks after Protect from light and


Glyceryl Trinitrate GTN
first opening28 store in a dry place below
500 mcg Tablets Actavis28
30°C28

Lamivudine 10 mg/ml 3TC29 Discard one month Store at or below 30°C29,30


Oral Solution after first opening29,30
Lamivox30

Linezolid 20 mg/ml Zyvox31 Use within 21 days31 Reconstituted suspension


Suspension should be stored at room
temperature31

Guidance on Expiry Dates and Storage of Medicines 2021


Drug Information Services Committee, Pharmaceutical Services Division, Sabah State Health Department
Generic name Brand Expiry date after Storage condition
opening the bottle
(recommended by
manufacturer)

Lopinavir 80 mg/ Kaletra32 Refrigeration of Kaletra Store at 2°C - 8°C until


Ritonavir 20 mg oral solution by the dispensed. Avoid exposure
(per ml) Oral Solution patients is not required to excessive heat32
if used within 2 months
and stored below
25°C32

Medium Triglyceride Ezical MCT 14 days33 Store in dry place below


Chain Oil Oil33 25°C. Protect from heat.
Store in its original glass
container33

Multivitamin Drops Appeton34 Do not use after 3 Store below 25°C34


30 ml month of opening34

Nevirapine 50 mg/ Nevirex35 Use within 2 months Store below 30°C35


5 ml Oral Suspension of opening35

Phenoxymethyl Beapen VK36 Discard 7 days after Store below 30°C36


Penicillin 125 mg/5 ml reconstitution36
Syrup

Risperidone 1 mg/ml Risperdal37 3 months37 Store below 30°C and


Oral Solution should be protected from
freezing37

Zidovudine 10 mg/ml Retrovir38 Discard 1 month after Store below 30°C38


Oral Solution opening38

Zuclopenthixol Clopixol39 6 weeks after first Before opening: store in a


20 mg/ml Drops opening39 refrigerator at 2°C - 8°C.39
After opening (in-use):
Store below 25°C.39

Guidance on Expiry Dates and Storage of Medicines 2021


Drug Information Services Committee, Pharmaceutical Services Division, Sabah State Health Department
Appendix 2

Eye/Ear drops/ointment

Generic name Brand Expiry date after Storage condition


opening
(recommended by
manufacturer)

Acyclovir 3% Eye Ointment Acivir40 Use within one month Store in a cool place at
after opening40 room temperature40

Artificial Tears/Eye Eye Glo Discard 4 weeks after Store in a dry place
Lubricant Ophthalmic (Moist)41 opening41 below 25°C41
Solution

Artificial Tears/Eye Lubricant Tears Discard container 12 Store at room


Ophthalmic Solution – Naturale hours after opening42 temperature42
Preservative Free Free42

Artificial Tears/Eye GenTeal43 Discard one month Store at 8°C - 25°C43


Lubricant Ophthalmic Gel after opening43

Atropine Sulphate 1% Eye Isopto Discard one month Store below 30°C44
Drops Atropine44 after opening44

Betamethasone/ Betagen45 Discard 4 weeks after Store below 25°C45


Gentamicin sulphate (0.1% opening45
w/v/0.3% w/v) Eye Drops

Betamethasone Phosphate/ Betacin46 Discard 4 weeks after Store below 25°C46


Neomycin Sulphate opening46
(0.1% w/v/0.5% w/v)
Eye/Ear Drops

Bimatoprost 0.01% Lumigan47 Discard 28 days after Store below 30°C47


Ophthalmic Solution opening47

Brinzolamide 1% and Simbrinza48 Discard one month Store below 30°C48


Brimonidine Tartrate 0.2% after first opening48
Ophthalmic Suspension

Chloramphenicol 5% w/v Enclor49 Discard after 30 days Store at 2°C - 8°C49


Ear Drops from date of
opening49
Chloramphenicol 1% Eye Chlorop50 Discard contents 4 Store below 30°C
Ointment weeks after opening50 away from direct light
and heat50

Guidance on Expiry Dates and Storage of Medicines 2021


Drug Information Services Committee, Pharmaceutical Services Division, Sabah State Health Department
Generic name Brand Expiry date after Storage condition
opening
(recommended by
manufacturer)

Ciclosporin Ophthalmic Restasis51 Discard vial Store below 25°C51


Emulsion 0.05% immediately after
use51

Ciprofloxacin HCl 0.3% Cipmax52 Discard one month Store below 30°C52
Ophthalmic Solution after opening52

Cyclopentolate 1% Eye Cyclogyl53 Discard one month Store below 30°C53


Drops after opening53

Dexamethasone Sodium Maxidex54 Discard 4 weeks after Store below 30°C54


Phosphate 0.1% Eye Drops opening54

Dexamethasone and Maxitrol55 Discard one month Store at room


Neomycin Sulphate and after opening55 temperature at 8°C -
Polymyxin B Sulphate 30°C.55
Ophthalmic Suspension

Dexamethasone and Maxitrol55 Discard one month Store below 25°C55


Neomycin Sulphate and after opening55
Polymyxin B Eye Ointment

Dorzolamide HCl 2% Ocudor56 Discard 28 days after Store below 30°C56


Ophthalmic Solution opening56

Ear Wax Softener Cerumol57 Discard 6 months Store below 30°C. Do


after opening57 not freeze.57

Fluorometholone 0.1% FML Discard 4 weeks after Store below 30°C.


Ophthalmic Suspension LIQUIFILM58 opening58 Protect from freezing.
Store upright.58

Fusidic Acid 1% Eye Drops Fucithalmic59 Discard after 28 days Store below 30°C59
of opening59

Gentamicin 0.3% Eye Drops Beagenta60 Discard one month Store below 30°C.
after opening60 Protect from heat and
direct sunlight.60

Homatropine 2% Eye Drops Homide61 Use the solution within Store below 30°C61
one month after
opening61

Guidance on Expiry Dates and Storage of Medicines 2021


Drug Information Services Committee, Pharmaceutical Services Division, Sabah State Health Department
Generic name Brand Expiry date after Storage condition
opening
(recommended by
manufacturer)

Latanoprost 0.005% Eye Xalatan62 Discard 4 weeks after Before use: store in a
Drops opening62,63 refrigerator (2°C -
8°C).62,63
Opened bottle: Store
Latandrops63 below 25°C. Protect
from light by keeping
in the outer carton.62,63

Latanoprost 0.005% and Xalacom64 Use within 4 weeks64 Before use: store in a
Timolol Maleate 0.5% Eye refrigerator at 2°C -
Drops 8°C.64
Opened bottle: Store
below 25°C. Protect
from light by keeping
in the outer carton.64

Moxifloxacin 0.5% Vigamox65 Discard after 28 days Store below 30°C65


Ophthalmic Solution of opening65

Nepafenac 0.1% Nevanac66 Discard after 28 days Store below 30°C66


Ophthalmic Solution of opening66

Ofloxacin 0.3% Otic Tarivid67 This product exhibits Store at room


Solution good stability for 4 temperature of 25°C
months at room after opening67
temperature after
opening67

Olopatadine Hydrochloride Pataday68 Discard after 28 days Store below 30°C68


0.2% Ophthalmic Solution of opening68

Phenylephrine HCI 2.5% Mydfrin69 Discard one month Store below 30°C69
Eye Drops after opening69

Pilocarpine 2% Eye Drops Isopto Discard one month Store below 30°C70
Carpine70 after opening70

Prednisolone Acetate 1% Pred Forte71 Discard 4 weeks after Store below 30°C.
Ophthalmic Suspension opening71 Protect from freezing
Store upright.71

Guidance on Expiry Dates and Storage of Medicines 2021


Drug Information Services Committee, Pharmaceutical Services Division, Sabah State Health Department
Generic name Brand Expiry date after Storage condition
opening
(recommended by
manufacturer)

Proparacaine HCI 0.5% Alcaine72 Discard one month Store refrigerated


Ophthalmic Drops after opening72 between 2°C - 8°C.
Do not use if
discolored.72

Sodium Cromoglycate 2% Allercrom73 Discard one month Store below 30°C73


Eye Drops after opening73

Timolol 0.5% Eye Drops Iotim74 Discard one month Store below 30°C74
after opening74

Timolol 0.5% Eye Drops Timo- To be used within 12 Store below 25°C75
(without preservatives) Comod75 weeks after opening75

Travoprost 0.004% & DuoTrav76 Discard 4 weeks after Store below 30°C76
Timolol 0.5% Eye Drops opening76

Tropicamide 1% Eye Drops Mydriacyl77 Discard one month Store below 30°C77
after opening77

Guidance on Expiry Dates and Storage of Medicines 2021


Drug Information Services Committee, Pharmaceutical Services Division, Sabah State Health Department
Appendix 3

Inhalers

Generic name Brand Expiry date after Storage condition


opening
(recommended by
manufacturer)

Tiotropium 2.5 mcg/puff Spiriva 3 months after Store below 30°C78


Solution for Inhalation Respimat78 cartridge is inserted
into Respimat
reusable inhaler78

Tiotropium 2.5 mcg and Spiolto Discard open Store below 30°C79
Olodaterol 2.5 mcg per Respimat79 cartridges within 3
Actuation, Inhalation months of opening79

80 To be used within 6 Store below 30°C80


Umeclidinium 62.5 mcg and Anoro Ellipta
weeks of first
Vilanterol 25 mcg
opening of the
Inhalation
tray80

Guidance on Expiry Dates and Storage of Medicines 2021


Drug Information Services Committee, Pharmaceutical Services Division, Sabah State Health Department
Appendix 4

Injectables

Generic name Brand Expiry date after Storage condition


opening
(recommended
by manufacturer)

Insulin Aspart 30%/ NovoMix 30 After first use: Storage when not in used: Store in
Protaminated FlexPen81 4 weeks81 the refrigerator between 2°C - 8°C.81
Insulin Aspart 70% Storage during use: Store at room
Injection temperature below 30°C.81

Insulin Aspart NovoRapid After first use: Storage when not in used: Store in
100 IU/ml Injection Flexpen82 4 weeks 82 the refrigerator between 2°C - 8°C.82
Storage during use: Store at room
temperature below 30°C.82

Insulin Degludec/ Ryzodeg83 After first use: 4 Storage when not in used: Store in
Insulin Aspart 70/30 weeks83 the refrigerator between 2°C - 8°C.83
Solution for Storage during use: Store at room
Injection in Pre- temperature below 30°C.83
Filled Pen 100
units/mL

Insulin Detemir Levemir84 After first use: Storage when not in used: Store in
100 IU/ml Injection 6 weeks84 the refrigerator between 2°C - 8°C.84
Storage during use: Store at room
temperature below 30°C.84

Basalog After first use: Storage when not in used: Store in


Insulin Glargine 85 28 days85 the refrigerator between 2°C -8°C.85
300 IU/3 ml Injection ONE
Storage during use: Store at room
(Prefilled Pen)
temperature below 30°C.85

Insulin Glargine Toujeo86 After first use: Before first use: Store in the
300 IU/ml Injection 6 weeks86 refrigerator between 2°C - 8°C.86
(Prefilled Pen) After first use: store below 30°C.86

Insulin Glulisine Apidra After first use: Before first use: Store in the
100 IU/ml Solution SoloStar87 4 weeks87 refrigerator between 2°C - 8°C.87
for Injection in After first use: store below 25°C.87
Prefilled Pen

Guidance on Expiry Dates and Storage of Medicines 2021


Drug Information Services Committee, Pharmaceutical Services Division, Sabah State Health Department
Generic name Brand Expiry date after Storage condition
opening
(recommended
by manufacturer)

Insulin Lispro 50%/ Humalog After first use: Before first use: Store in the
Insulin Lispro Mix 50 28 days88 refrigerator between 2°C - 8°C.88
Protamine 50% Kwikpen88 After first use: Store below 30°C.88
100 IU/ml Injection

Insulin Recombinant Actrapid89 After first use: Before first use: Store in the
Neutral Human 6 weeks89 refrigerator between 2°C - 8°C.89,90
Short-Acting After first use: Store below
100 IU/ml Insugen-R90 After first use: 30°C.89,90
42 days90

Insulin Recombinant Insulatard91 After first use: Before first use: Store in the
Synthetic Human, 6 weeks91 refrigerator between 2°C - 8°C.92
Intermediate-Acting After first use: Store below 30°C.92
100 IU/ml Insugen-N92 After first use:
42 days92

Insulin Recombinant Mixtard93 After first use: Before first use: Store in the
Synthetic Human 6 weeks93 refrigerator between 2°C - 8°C.93,94
Premixed 100 IU/ml After first use: Store below
Insugen- After first use:
30°C.93,94
30/7094 42 days94

Guidance on Expiry Dates and Storage of Medicines 2021


Drug Information Services Committee, Pharmaceutical Services Division, Sabah State Health Department
References:

1. Dawson M. Expiry dates. Aust Prescr 1994;17:46-8. https://www.nps.org.au/australian-


prescriber/articles/expiry-dates

2. Rotherham Clinical Commissioning Group. Good Practice Guidance on Expiry Dates of Medicines.
Available from:
http://www.rotherhamccg.nhs.uk/Rotherham%20CCG%20good%20practice%20guidance%20on%2
0expiry%20dates%20of%20medicines%20Approved.pdf.

3. Carstensen JT. Drug Stability: principles and practices. In: Drugs and the pharmaceutical sciences,
vol 43. New York: Dekker, 1990.

4. Church C, Smith J. How stable are medicines moved from original packs into compliance aids? The
Pharmaceutical journal 276; 75-81.

5. Sheffield Clinical Commissioning Group; Good Practice Guidance for Care Homes – Expiry dates.
Available from: http://psnc.org.uk/sheffield-lpc/wp-content/uploads/sites/79/2013/06/Expiry-
Dates-Guidance-Oct-2013.pdf.

6. Ziagen 20 mg/ml oral solution [package insert]. Ontario: Bora Pharmaceutical Services Inc; 3
December 2020. Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/724/pharma/210629/V_51631_20210225_165654_D3.pdf.

7. Synamox [package insert]. Bandar Seri Iskandar, Perak: Idaman Pharma Manufacturing Sdn. Bhd.;
2020. Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/14559/pharma/218492/V_39641_20201210_181437_D4.pdf.

8. Dyna Amoxicillin Suspension [package insert]. Seberang Perai: Dynapharm (M) Sdn. Bhd.; 18 Jun
2019. Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/770/pharma/222819/V_16265_20191220_113751_D4.pdf.

9. Betamox Granules [package insert]. Selangor Darul Ehsan: Duopharma (M) Sdn. Bhd.; 13 August
2019. Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/17051/pharma/218376/V_31479_20190814_173632_D4.pdf.

10. Fleming Oral Suspension [package insert]. Virgonagar, Bangalore: Medreich Limited.; 2020.
Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/537/pharma/240262/V_45427_20201202_095116_D4.pdf.

11. Pharmaniaga Co-Amoxiclav suspension 228 mg [package insert]. Perak Darul Ridzuan: Idaman
Pharma Manufacturing Sdn. Bhd.

12. Clamovid BID Forte Granules [package insert]. Istanbul: Bilim Pharmaceuticals.

13. Ampicilla Powder for Oral Suspension [package insert]. Bandar Seri Iskandar, Perak: Idaman
Pharma Manufacturing Sdn. Bhd.; 2020. Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/14559/pharma/217270/V_30797_20190604_111323_D4.pdf.

14. Unasyn Oral [package insert]. New York, USA: Pfizer Inc.,; 2019. Available from:
https://quest3plus.bpfk.gov.my/front-
end/attachment/286/pharma/210317/V_39629_20200205_101659_D3.pdf.

Guidance on Expiry Dates and Storage of Medicines 2021


Drug Information Services Committee, Pharmaceutical Services Division, Sabah State Health Department
15. Zynomax Powder for Oral Suspension [package insert]. Bandar Baru Bangi, Selangor; Duopharma
Marketing Sdn. Bhd.; 2020. Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/489/pharma/66053/V_35714_20200615_162126_D4.pdf.

16. Zithromax Oral Suspension [package insert]. New York: Pzifer Inc.;28 Nov 2019. Available from:
https://quest3plus.bpfk.gov.my/front-
end/attachment/286/pharma/210456/V_40318_20200224_134728_D3.pdf.

17. Axcel Cefuroxime-125 for Oral Suspension [package insert]. Melaka: Kotra Pharma (M) Sdn. Bhd.;
30 September 2019. Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/650/pharma/62288/V_6000_20191003_200329_D4.pdf.

18. Zinnat Suspension [package insert]. Barnard Castle: Glaxo Wellcome Operations; 1 July 2019.
Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/724/pharma/210329/V_35237_20190926_172116_D3.pdf.

19. Cephalexin Granules for Oral Suspension [package insert]. Bayan Lepas, Penang: Malaysian
Pharmaceutical Industries Sdn. Bhd.; 21 October 2020. Available from:
https://quest3plus.bpfk.gov.my/front-
end/attachment/527/pharma/218057/V_36100_20201031_202531_D4.pdf.

20. Uphalexin Granules [package insert]. Selangor, Malaysia: Upha Pharmaceutical Manufacturing (M)
Sdn Bhd.. Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/489/pharma/517854/V_44403_20200712_114932_D4.pdf.

21. Sandimmun Neoral Oral Solution 100 mg/ml. Petaling Jaya: Novartis Corporation (Malaysia) Sdn.
Bhd.; October 2020. Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/17050/pharma/240191/V_40909_20201008_154401_D3.pdf.

22. Klacid Granules for Oral Suspension [package insert]. Jakarta: P.T. Abbott Indonesia; May 2021.
Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/511/pharma/210385/V_54688_20210528_153938_D3.pdf.

23. Oxacil Granules [package insert]. Selangor Darul Ehsan: Duopharma (M) Sdn. Bhd; 6 April 2020.
Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/17051/pharma/211736/V_27639_20200407_203526_D4.pdf.

24. Cloxacilla Powder for Syrup [package insert]. Selangor Darul Ehsan: Idaman Pharma Manufacturing;
2 April 2020. Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/14559/pharma/226464/V_42019_20200630_110227_D4.pdf.

25. Lanoxin PG Elixir [package insert]. Bad Oldesloe, Germany: Aspen Bad Oldesloe GmbH; 15 June
2020. Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/54379/pharma/210152/V_44007_20200703_090908_D3.pdf.

26. Ericin for Oral Suspension 200 mg/5ml [package insert]. Sungai Petani, Kedah: Idaman Pharma
Manufacturing.

27. Vusimide oral solution [package insert]. Penang: Winwa Medical Sdn. Bhd; March 2017. Available
from: https://quest3plus.bpfk.gov.my/front-
end/attachment/4391/pharma/77956/V_1648_20170303_063140_D4.pdf.

28. GTN Actavis Tablet [package insert]. Selangor Darul Ehsan: Actavis Sdn. Bhd; 1 March 2019.

Guidance on Expiry Dates and Storage of Medicines 2021


Drug Information Services Committee, Pharmaceutical Services Division, Sabah State Health Department
Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/17138/pharma/214865/V_27983_20190507_160346_D4.pdf.

29. 3TC Oral Solution [package insert]. Ontario, Canada: Bora Pharmaceutical Services Inc; 2020.
Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/724/pharma/210480/V_51772_20210301_193205_D3.pdf.

30. Lamivox 10 mg/ml oral solution [package insert]. Telangana state: Aurobindo Pharma Ltd.; 30 May
2017. Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/624/pharma/23169/V_4735_20170602_072533_D4.pdf.

31. Zyvox Oral Suspension [package insert]. Puerto Rico: Pzifer Pharmaceutical LLC.; 6 Nov 2020.
Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/286/pharma/210750/V_51112_20210218_132837_D3.pdf.

32. Kaletra [package insert]. North Chicago, Illnois: Abbvie Inc; March 2020. Available from:
https://quest3plus.bpfk.gov.my/front-
end/attachment/35964/pharma/210800/V_41904_20200416_112619_D3.pdf.

33. Ezical [package insert]. Germany: Sternchemie GmbH & Co.KG.

34. Appeton Baby Drops Full Prescribing Information, Dosage & Side Effects | MIMS Malaysia.
Accessed September 23, 2021.
https://www.mims.com/malaysia/drug/info/appeton%20baby%20drops?type=full

35. Nevirex [package insert]. India: Aurobindo Pharma Limited Unit III; July 2018.

36. Beapen VK Granules [package insert]. Selangor: Duopharma Manufacturing Sdn. Bhd.;16 April
2019. Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/487/pharma/211626/V_30327_20190507_111753_D4.pdf.

37. Risperdal Oral Solution. Belgium: Janssen Pharmaceutica N.V.; 10 July 2020. Available from:
https://quest3plus.bpfk.gov.my/front-
end/attachment/44/pharma/210628/V_41018_20200716_113321_D3.pdf.

38. Retrovir Oral Solution [package insert]. Ontario: GlaxoSmithKline Inc.; 8 Dec 2020. Available from:
https://quest3plus.bpfk.gov.my/front-
end/attachment/724/pharma/210359/V_51203_20210224_181131_D3.pdf.

39. Clopixol Drops 20 mg/ml [package insert]. Denmark: H. Lundbeck A/S; February 2018. Available
from: https://quest3plus.bpfk.gov.my/front-
end/attachment/45476/pharma/210268/V_15437_20180313_142207_D3.pdf.

40. Acivir Eye Ointment 3% w/w [package insert]. Boisar: Cipla Ltd.

41. Eye Glo [package insert]. Selangor Darul Ehsan: Duopharma (M) Sdn. Bhd.

42. Tears Naturale Free [package insert]. Kaysersberg: Kaysersberg Pharmaceuticals.

43. GenTeal Gel [package insert]. Texas: Alcon Laboratories, Inc.

44. Isopto Atropine 1% sterile ophthalmic solution [package insert]. Belgium: Alcon Laboratories; 20
Aug 2020. Available from: https://quest3plus.bpfk.gov.my/front-

Guidance on Expiry Dates and Storage of Medicines 2021


Drug Information Services Committee, Pharmaceutical Services Division, Sabah State Health Department
end/attachment/598/pharma/210201/V_37932_20200820_153734_D3.pdf.

45. Betagen Eye/Ear Drops [package insert]. Selangor Darul Ehsan: Duopharma (M) Sdn. Bhd.; March
2020. Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/17051/pharma/228422/V_38369_20200311_165804_D4.pdf.

46. Betacin Eye/Ear Drops [package insert]. Klang: Duopharma (M) Sdn. Bhd.; 4 Jun 2019. Available
from: https://quest3plus.bpfk.gov.my/front-
end/attachment/17051/pharma/228400/V_31587_20190604_155352_D4.pdf.

47. Lumigan [package insert]. County Mayo: Allergan Pharmaceuticals Ireland; July 2018. Available
from: https://quest3plus.bpfk.gov.my/front-
end/attachment/18593/pharma/74133/V_13648_20180926_090555_D3.pdf.

48. Simbrinza Eye Drops, Suspension [package insert]. Basel: Novastis Pharma AG; September 2019.
Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/17050/pharma/77800/V_35912_20191015_164923_D3.pdf.

49. Enclor ear drops [package insert]. Kedah Darul Aman: Idaman Pharma Manufacturing Sdn. Bhd.; 23
July 2019. Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/6099/pharma/211371/V_45446_20201106_105057_D4.pdf.

50. Chlorop eye ointment [package insert]. Kedah: SM Pharmaceuticals Sdn. Bhd; 7 November 2016.

51. Restasis 0.05% Ophthalmic Emulsion [package insert]. Texas: Allergan Sales, LLC. 2017. Available
from: https://quest3plus.bpfk.gov.my/front-
end/attachment/18593/pharma/211004/V_8145_20170725_071139_D3.pdf.

52. Cipmax eye drops [package insert]. Samchundang Pharma Co.

53. Cyclogyl 1% Sterile Ophthalmic Solution [package insert]. Belgium: Alcon-Couvreur.

54. Maxidex [package insert]. Belgium: S.A. Alcon-Couvreur N.V.; March 2018. Available from:
https://quest3plus.bpfk.gov.my/front-
end/attachment/17050/pharma/210202/V_21683_20180829_031313_D3.pdf.

55. Maxitrol [package insert]. Belgium: S.A. Alcon-Couvreur N.V.; March 2018. Available from:
https://quest3plus.bpfk.gov.my/front-
end/attachment/17050/pharma/210200/V_20240_20180713_073020_D3.pdf.

56. Ocudor Dorzolamide Hydrochloride eye drops 2% w/v [package insert]. Maharashtra State: FDC
Limited; 21 January 2020. Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/624/pharma/62393/V_37972_20200121_093614_D4.pdf.

57. Cerumol [package insert]. Huddersfield: Thornton & Ross Ltd.

58. FML Liquifilm [package insert]. Westport: Allergan Pharmaceuticals Ireland; September 2020.
Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/18593/pharma/210247/V_44321_20200908_143024_D3.pdf.

59. Fucithalmic Viscous Eye Drops [package insert]. Dublin: LEO Laboratories Ltd.; November 2018.
Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/66/pharma/210308/V_13660_20181206_080330_D3.pdf.

Guidance on Expiry Dates and Storage of Medicines 2021


Drug Information Services Committee, Pharmaceutical Services Division, Sabah State Health Department
60. Beagenta Eye/Ear Drops [package insert]. Selangor Darul Ehsan: Duopharma (M) Sdn Bhd.; 2 March
2020. Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/17051/pharma/240313/V_32659_20200302_171733_D4.pdf.

61. Homide [package insert]. Gurajat: Sion Healthcare.

62. Xalatan [package insert]. Belgium: Pzifer Manufacturing Belgium NV; 29 Jan 2020. Available from:
https://quest3plus.bpfk.gov.my/front-
end/attachment/115837/pharma/210716/V_43237_20200605_144158_D3.pdf.

63. Latandrops 0.005% w/v eye drops [package insert]. Attiki: Vianex S.A.-Plant A; 20 March 2020.
Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/12179/pharma/228591/V_28444_20200320_140901_D4.pdf.

64. Xalacom [package insert]. Belgium: Pzifer Manufacturing Belgium NV; 2 Sep 2020. Available from:
https://quest3plus.bpfk.gov.my/front-
end/attachment/115837/pharma/210768/V_49022_20210301_155238_D3.pdf.

65. Vigamox [package insert]. Singapore: Alcon Singapore Manufacturing Pte. Ltd.; June 2018. Available
from: https://quest3plus.bpfk.gov.my/front-
end/attachment/17050/pharma/211022/V_19507_20180626_020429_D3.pdf.

66. Nevanac [package insert]. Texas: Alcon Laboratories, Inc; 4 February 2021. Available from:
https://quest3plus.bpfk.gov.my/front-
end/attachment/17050/pharma/211073/V_50903_20210211_104629_D3.pdf.

67. Tarivid Otic Solution [package insert]. Ishikawa: Santen Pharmaceutical Co., Ltd.; June 2016.

68. Pataday [package insert]. Texas: Alcon Laboratories, Inc.; March 2018. Available from:
https://quest3plus.bpfk.gov.my/front-
end/attachment/17050/pharma/211175/V_28034_20190304_141650_D3.pdf.

69. Mydfrin [package insert]. Texas: Alcon Laboratories, Inc.; 2018.

70. Isopto Carpine [package insert]. Belgium: Alcon-Couvreur; 11 November 2017. Available from:
https://quest3plus.bpfk.gov.my/front-
end/attachment/17050/pharma/210321/V_56135_20210920_161049_D3.pdf.

71. Pred Forte [package insert]. Westport: Allergan Pharmaceuticals Ireland; Feb 2019. Available from:
https://quest3plus.bpfk.gov.my/front-
end/attachment/18593/pharma/210248/V_27269_20190508_134227_D3.pdf.

72. Alcaine 0.5% sterile ophthalmic solution [package insert]. Belgium: Alcon-Couvreur; June 2019.
Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/598/pharma/210323/V_20378_20190610_120944_D3.pdf.

73. Allercrom Eye Drops [package insert]. Maharashtra State: FDC Limited.

74. Iotim 0.5% Eye Drops [package insert]. Maharashtra State: FDC Limited.

75. Timo-Comod 0.5% Eye Drops [package insert]. Saabrucken: Ursapharm Arzneimittel GmbH.
Available from: https://www.ursapharm.in/wp-content/uploads/2020/10/PB-TIMO-COMOD-0.5-
10-ML-ATRO-IN_web.pdf.

Guidance on Expiry Dates and Storage of Medicines 2021


Drug Information Services Committee, Pharmaceutical Services Division, Sabah State Health Department
76. DuoTrav eye drops solution [package insert]. Belgium: Alcon-Covreur; 23 July 2020. Available from:
https://quest3plus.bpfk.gov.my/front-
end/attachment/17050/pharma/211162/V_44900_20201117_104848_D3.pdf.

77. Mydriacyl 1% Ophthalmic Preparation [package insert]. Belgium: Alcon-Couvreur.

78. Spiriva Respimat [package insert]. Germany: Boehringer Ingelheim GmbH & Co.KG.; 31 May 2020.
Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/1159/pharma/211226/V_43264_20200607_180735_D3.pdf.

79. Spiolto Respimat Inhalation Solution 2.5 microgram/2.5 microgram per actuation [package insert].
Germany: Boehringer Ingelheim Pharma GmbH & Co. KG; 31 May 2020. Available from:
https://quest3plus.bpfk.gov.my/front-
end/attachment/1159/pharma/79415/V_43267_20200607_200746_D3.pdf.

80. Anoro Ellipta 62.5/25 micrograms inhalation powder [package insert]. North Carolina:
GlaxoSmithKline LLC; November 2019. Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/724/pharma/71733/V_29686_20191213_093841_D3.pdf.

81. NovoMix 30 FlexPen Suspension for Injection [package insert]. Denmark: Novo Nordisk A/S; 31 July
2021. Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/519/pharma/209963/V_55823_20210731_185635_D3.pdf.

82. NovoRapid FlexPen 100 U/ml Solution for Injection in Pre-filled Pen [package insert]. Denmark:
Novo Nordisk A/S; 31 March 2021. Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/519/pharma/525288/525288_20210504_075012_.pdf.

83. Ryzodeg FlexTouch [package insert]. Denmark: Novo Nordisk A/S; August 2020. Available from:
https://quest3plus.bpfk.gov.my/front-
end/attachment/519/pharma/242625/V_45829_20200828_170914_D3.pdf.

84. Levemir Flexpen 100 U/ml Solution for Injection in Pre-filled Pen [package insert]. Denmark: Novo
Nordisk Production SAS; 30 September 2021. Available from:
https://quest3plus.bpfk.gov.my/front-
end/attachment/519/pharma/525870/V_58377_20210930_102043_D3.pdf.

85. Basalog One [package insert]. Johor; Biocon Sdn. Bhd.; March 2019. Available from:
https://quest3plus.bpfk.gov.my/front-
end/attachment/38316/pharma/508956/V_34321_20190828_174442_D3.pdf.

86. Toujeo 300 units/ml solution for injection in a pre-filled pen [package insert]. Frankfurt: Sanofi-
Aventis Deutschland GmbH; Sept 2020. Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/679/pharma/79191/79191_20200930_135906_.pdf.

87. Apidra Solostar [package insert]. Frankfurt: Sanofi-Aventis Deutschland GmbH; October 2018.
Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/679/pharma/210032/210032_20190717_152139_.pdf.

88. Humalog Mix 50 KwikPen Injection [package insert]. Sesto Fiorentino: Eli Lilly Italia S.p.A.; 28
December 2020. Available from: https://quest3plus.bpfk.gov.my/front-
end/attachment/791/pharma/210062/V_47459_20210104_165443_D3.pdf.

89. Actrapid [package insert]. Brazil: Novo Nordisk; 20 November 2019. Available from:

Guidance on Expiry Dates and Storage of Medicines 2021


Drug Information Services Committee, Pharmaceutical Services Division, Sabah State Health Department
https://quest3plus.bpfk.gov.my/front-
end/attachment/519/pharma/209830/V_38421_20191222_030759_D3.pdf.

90. Insugen-R [package insert]. Johor: Biocon Sdn. Bhd.; July 2020. Available from:
https://quest3plus.bpfk.gov.my/front-
end/attachment/38316/pharma/69206/V_44092_20201211_225835_D3.pdf.

91. Insulatard [package insert]. Brazil: Novo Nordisk; 20 December 2019. Available from:
https://quest3plus.bpfk.gov.my/front-
end/attachment/519/pharma/209829/V_38380_20191220_121649_D3.pdf.

92. Insugen-N [package insert]. Johor: Biocon Sdn. Bhd.; July 2020. Available from:
https://quest3plus.bpfk.gov.my/front-
end/attachment/38316/pharma/69207/V_44110_20201216_030209_D3.pdf.

93. Mixtard 30 [package insert]. Brazil: Novo Nordisk; 20 December 2019. Available from:
https://quest3plus.bpfk.gov.my/front-
end/attachment/519/pharma/209828/V_38417_20191220_191758_D3.pdf.

94. Insugen-30/70 [package insert]. Johor: Biocon Sdn. Bhd.; July 2020. Available from:
https://quest3plus.bpfk.gov.my/front-
end/attachment/38316/pharma/69211/V_45102_20201216_030546_D3.pdf.

Guidance on Expiry Dates and Storage of Medicines 2021


Drug Information Services Committee, Pharmaceutical Services Division, Sabah State Health Department

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