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Guidance On Expiry Dates and Storage of Medicines JKN Sabah 2021 Dec 2021
Guidance On Expiry Dates and Storage of Medicines JKN Sabah 2021 Dec 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.
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.
EDITORIAL BOARD
WORKING COMMITTEES
(Drug Information Service Committee, Sabah)
CONTRIBUTORS
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.
Refer to Appendix 1
Refer to Appendix 2
Refer to Appendix 3
Refer to Appendix 4
Syrup/Oral Suspension/Tablet
Generic name Brand Expiry date after Storage condition
opening the bottle
(recommended by
manufacturer)
Betamox9
Cloxacilla24
Ciclosporin 100 mg/ml Sandimmun Use within 2 months Store between 20 - 30°C21
Oral Solution Neoral21 after opening21
Eye/Ear drops/ointment
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
Atropine Sulphate 1% Eye Isopto Discard one month Store below 30°C44
Drops Atropine44 after opening44
Ciprofloxacin HCl 0.3% Cipmax52 Discard one month Store below 30°C52
Ophthalmic Solution after opening52
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
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
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
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
Inhalers
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
Injectables
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
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
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
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.
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Pharmaceutical journal 276; 75-81.
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