PBS Doctor's Bag: Which Drugs Need Refrigeration? Complete Cold Chain Guide for Australian Prescribers

This information is intended for AHPRA-registered healthcare professionals only. It does not constitute medical, pharmaceutical, or therapeutic advice. All storage claims below are sourced from Australian Consumer Medicines Information (CMI) and Product Information (PI) as published on the TGA medicines register, the National Health (Prescriber Bag Supplies) Determination 2024 (F2024L00414), and the TGA National Vaccine Storage Guidelines (Strive for 5, 4th edition). Always verify current storage requirements against the manufacturer's CMI or PI before ordering, storing, or administering any medicine.

Which PBS Doctor's Bag drugs need refrigeration?

Only two items on the current PBS Prescriber Bag (Doctor's Bag) schedule require refrigeration at 2 to 8 degrees Celsius: the diphtheria and tetanus vaccine, adsorbed, adult formulation (item code 3463G) and the benzathine benzylpenicillin prefilled syringe (11755Q). Neither may be frozen. A smaller subset of items are stored below 30 degrees Celsius at room temperature (salbutamol metered dose inhaler, methoxyflurane inhalation, haloperidol injection). The remainder are stored below 25 degrees Celsius at room temperature. Critically, several injectable items must not be refrigerated. The glucagon injection kit (3467L) is the most commonly misstored item in the bag, because prescribers assume it belongs in the fridge when the Australian CMI specifies room temperature and warns that freezing may damage the glass diluent syringe. This guide sets out the full cold chain rules, item by item, with source references and practical excursion response.

PBS Doctor's Bag refrigeration: three tier quick reference

The table below is the fastest way to separate fridge items from room temperature items. Use it as your monthly audit reference. All data below is aligned with the DocPouch PBS Doctor's Bag checklist and cross-verified against Australian CMI, PI and F2024L00414.

All other PBS Doctor's Bag items are stored below 25 degrees Celsius at room temperature. For the complete item list with group codes and eligibility, see the full DocPouch PBS Doctor's Bag checklist.

Items that must be refrigerated: detail

Diphtheria and tetanus vaccine, adsorbed, adult formulation (3463G)

• PBS group: Group 25 per F2024L00414
• Storage: Refrigerate 2 to 8 degrees Celsius
• Freezing: Do not freeze. Freezing destroys the adsorbed vaccine antigen and the product must be discarded.
• Excursion tolerance: Follow the TGA National Vaccine Storage Guidelines (Strive for 5, 4th edition). Any excursion outside 2 to 8 degrees Celsius must be logged, the vaccine quarantined, and guidance sought from the state or territory immunisation program or the Strive for 5 decision tree before any further use.
• After a breach: Do not administer. Contact the state or territory immunisation program for advice on whether the vaccine may be used or must be discarded.

Benzathine benzylpenicillin, prefilled syringe (11755Q)

• PBS group: Group 58 per F2024L00414
• Primary storage: Refrigerate 2 to 8 degrees Celsius
• Freezing: Do not freeze.
• Excursion rule per Australian CMI: May be stored below 30 degrees Celsius for a single period of up to 2 months prior to expiry. Once removed from refrigerated storage, the syringe cannot be returned to the refrigerator. Write the date of removal from the fridge directly on the carton so the 2 month window can be tracked.
• After a breach outside the allowed excursion window: Do not administer. Quarantine the stock and contact your approved supplier for disposal guidance.

The benzathine benzylpenicillin trap

Two benzathine benzylpenicillin products sit in Group 58 on the PBS schedule and practitioners routinely confuse them. The storage rule is different for each.

• 11755Q, prefilled syringe: Refrigerate 2 to 8 degrees Celsius. Do not freeze.
• 15053G, powder for injection with diluent: Store below 25 degrees Celsius. Do not freeze. No refrigeration required.

The prefilled syringe needs the fridge because the drug is already in aqueous suspension. The powder formulation is stable at room temperature until reconstituted. If your practice stocks one of these items, check the item code on the carton before deciding where to store it.

Storing prescriber bag medicines: items that must not be refrigerated

The following items are routinely misstored. Each entry cites the Australian CMI storage directive and flags the specific risk of incorrect refrigeration or freezing.

Glucagon injection kit (3467L)

This is the single most commonly misstored item in the PBS Doctor's Bag. The kit contains a vial of lyophilised glucagon powder and a prefilled glass syringe of sterile water diluent.

• Storage per Australian CMI: "Should be stored at room temperature (i.e. less than 25 degrees Celsius). Avoid freezing to prevent damage to the glass syringe." The powder vial should be stored in the original package to protect from light.
• Refrigeration: The Australian CMI directs storage at room temperature. The manufacturer has separately indicated that refrigeration does not damage the product, but the label direction remains room temperature. Defaulting to room temperature reduces the risk of accidental freezing.
• Why freezing matters: Freezing can fracture the prefilled glass diluent syringe, rendering the kit unusable at the point of clinical need.
• Practical rule: Keep the kit at room temperature below 25 degrees Celsius, in the bag with the rest of the emergency stock. Do not store it in the vaccine fridge, where it may be accidentally pushed against the back wall and freeze.

Glyceryl trinitrate sublingual spray (3475X)

• Storage per Australian CMI: Store below 25 degrees Celsius. Do not refrigerate.
• Why: The product is a pressurised metered dose spray. Refrigeration can cause condensation in the valve and unreliable dose delivery, and is explicitly not recommended by the manufacturer.

Midazolam injection (10178Q)

• Storage per Australian CMI: Store below 25 degrees Celsius. Protect from light.
• Schedule 8 obligation: Midazolam is a Schedule 8 controlled substance. Locked storage is required under state and territory drugs and poisons legislation. Do not conflate S8 locked storage with refrigeration: locked and refrigerated are two separate requirements and midazolam only needs locked.

Which doctors bag drugs need fridge? The short answer

Two, and only two. The adsorbed diphtheria and tetanus vaccine (3463G) and the benzathine benzylpenicillin prefilled syringe (11755Q). Everything else on the PBS Prescriber Bag schedule is stored at room temperature. A small subset (salbutamol metered dose inhaler, methoxyflurane inhalation, haloperidol injection) is stored below 30 degrees Celsius rather than below 25 degrees Celsius, which gives a slightly wider tolerance but still does not mean the fridge.

Doctors bag cold chain logistics: home visits, rural practice, and locum work

Cold chain for home visits and house calls

If you are carrying a refrigerated item to a home visit, it must remain at 2 to 8 degrees Celsius from the moment it leaves the fridge to the moment it is administered or returned to the fridge. Practical measures:

• Use a validated insulated medical transport bag with conditioned gel packs. Household cooler bags with freezer ice packs are not appropriate, because direct contact with a freezer pack can freeze the product.
• Include a minimum and maximum thermometer or a single use temperature data logger in the bag for any trip longer than a short round trip. Log the reading on return.
• Do not leave the bag in a parked car. Vehicle cabin temperatures exceed 50 degrees Celsius in Australian summer conditions and will breach both cold chain and room temperature limits.
• On return, record the duration the item was out of the fridge and whether any excursion occurred. For the benzathine benzylpenicillin prefilled syringe (11755Q) this counts against the 2 month below 30 degrees Celsius window.

Rural and remote cold chain challenges

Rural and remote practice adds distance, ambient heat, and power reliability to every cold chain decision. For a full treatment of these issues, see our dedicated guide for rural and remote GPs. Key points:

• Carry a battery backed temperature monitor on long drives. A single excursion above 8 degrees Celsius can compromise vaccine immunogenicity even if the product looks visually unchanged.
• If you operate across multiple clinic sites, do not rotate refrigerated stock between fridges without a continuous cold chain. Treat each relocation as a transport event and document it.
• Plan reorders around delivery lead times. Same day dispatch from a metropolitan pharmacy still takes 2 to 5 business days to reach many MMM 5 to 7 locations. Order earlier than you think you need to. See our step by step guide to completing the PB052 order form.

Locum work

Locums should not transport refrigerated PBS Prescriber Bag items between placements unless the host practice explicitly requests it and a validated cold chain can be maintained end to end. It is almost always safer to rely on the host practice's existing refrigerated stock and order replacements locally.

Cold chain failure response workflow

The conservative principle for every scenario below is the same: if in doubt, quarantine and do not administer. Reference the TGA National Vaccine Storage Guidelines (Strive for 5, 4th edition) for vaccine specific excursion decision making and contact your state or territory immunisation program or approved supplier for item specific advice.

Scenario 1. Fridge power failure overnight

1. Do not open the fridge door. An unopened fridge holds temperature for longer than most people assume.
2. As soon as power returns, read the minimum and maximum thermometer and the data logger if installed. Record the lowest and highest temperatures reached and the estimated duration outside 2 to 8 degrees Celsius.
3. Quarantine any 3463G diphtheria-tetanus vaccine and 11755Q benzathine benzylpenicillin prefilled syringe stock with a clear DO NOT USE label.
4. For vaccine stock, follow the Strive for 5 cold chain breach process: notify the state or territory immunisation program with the temperature log and await advice before returning stock to use or disposal.
5. For the benzathine benzylpenicillin prefilled syringe, assess whether the excursion falls within the below 30 degrees Celsius for up to 2 months allowance permitted by the CMI. If the temperature exceeded 30 degrees Celsius at any point, treat the stock as compromised and do not administer.

Scenario 2. Item left out of fridge during a home visit

1. Record the time the item left the fridge and the time it returned (or the time it was administered).
2. For 3463G, any unplanned excursion should be logged and advice sought before further use. The product was not designed for ambient transport.
3. For 11755Q, brief excursions below 30 degrees Celsius are within CMI tolerance. Excursions above 30 degrees Celsius are not. Write the date of the first removal from the fridge on the carton and do not return the syringe to the fridge once used or part used.

Scenario 3. Temperature log shows excursion outside 2 to 8 degrees Celsius

1. Quarantine all cold chain stock immediately.
2. Document the excursion: date, duration, minimum temperature, maximum temperature.
3. Contact the state or territory immunisation program for vaccine stock (3463G) and your approved supplier for the benzathine benzylpenicillin prefilled syringe (11755Q).
4. Do not administer compromised stock based on visual inspection alone. Adsorbed vaccines can lose potency without any visible change.

Scenario 4. Freezing of an item that must not be frozen

1. Frozen 3463G diphtheria-tetanus vaccine must be discarded. Freezing denatures the adsorbed antigen and the product cannot be recovered by thawing.
2. Frozen 11755Q benzathine benzylpenicillin prefilled syringe must be discarded. The CMI explicitly prohibits freezing.
3. Frozen 3467L glucagon injection kit must be discarded. The prefilled glass diluent syringe may have fractured even if the damage is not visible.
4. Frozen 11265X benzatropine injection must be discarded. The PI directs storage below 25 degrees Celsius and freezing is not permitted.
5. Contact your approved supplier for disposal guidance and order replacement stock under the one order per calendar month rule.

Returning expired or compromised cold chain stock to pharmacy

Do not pour compromised injectable stock down a sink, bin intact ampoules, or send medicines via standard post. Contact the approved supplier that provided the stock (for DocPouch orders, this is Priceline Pharmacy Sunshine Marketplace) and follow their returns process. The pharmacy will advise on whether to return the stock in person, by courier with cold chain packaging, or through a designated medicine waste service. Schedule 8 items (morphine, midazolam) require destruction with two witnesses under state and territory drugs and poisons legislation and cannot be returned to general pharmacy disposal.

Compliance references

• TGA National Vaccine Storage Guidelines, Strive for 5 (4th edition, October 2025). The national authority on vaccine cold chain management. Every practice that stores 3463G should have a copy available and a documented cold chain breach process aligned to it.
• State and territory drugs and poisons legislation. Temperature excursion record keeping, S8 locked storage, and destruction of compromised controlled substances are all governed by state and territory law. Requirements vary. Confirm with your jurisdiction's health department.
• RACGP Standards for General Practices (5th edition). Criterion GP5.3 covers clinical equipment and medicine storage, including cold chain management for practices that hold vaccines. Applies alongside Strive for 5.
• Schedule 8 storage note. Morphine (10862Q, 3479D, 10868B, 3480E) and midazolam (10178Q) require locked storage under S8 legislation but do not require refrigeration. Do not conflate locked with refrigerated.
• National Health (Prescriber Bag Supplies) Determination 2024 (F2024L00414). The legislative instrument setting out PBS Doctor's Bag items, groups, forms, and maximum quantities. Available on legislation.gov.au.

Frequently asked questions

Does glucagon need to be refrigerated?

No. The Australian CMI for the glucagon injection kit (3467L) directs storage at room temperature below 25 degrees Celsius, and warns that freezing may damage the glass diluent syringe. The manufacturer has separately advised that refrigeration does not damage the product, but the label direction remains room temperature. This is the single most commonly misstored item in the PBS Doctor's Bag.

What temperature should the Doctor's Bag fridge be at?

2 to 8 degrees Celsius continuously, per the TGA National Vaccine Storage Guidelines (Strive for 5, 4th edition). Use a purpose built vaccine refrigerator or a pharmacy grade fridge with a minimum and maximum thermometer and twice daily temperature logging. Domestic bar fridges are not recommended for vaccine storage.

What do I do if the benzathine benzylpenicillin prefilled syringe has been out of the fridge?

Check the duration and the maximum temperature reached. The Australian CMI permits a single period of up to 2 months below 30 degrees Celsius prior to expiry. If that window applies, write the date of removal on the carton. If the temperature exceeded 30 degrees Celsius at any point, or the syringe has already been removed and returned to the fridge, treat the stock as compromised and contact your approved supplier.

Can I use a compromised vaccine if it looks fine?

No. Adsorbed vaccines including 3463G can lose immunogenicity without any visible change. Visual inspection is not a valid test of vaccine viability after a cold chain breach. Quarantine the stock and seek advice from the state or territory immunisation program before any further use.

How do I transport cold chain items for a home visit?

Use a validated insulated medical transport bag with conditioned gel packs (not direct freezer packs, which can freeze the product). Include a thermometer or single use data logger for trips longer than a short round trip. Do not leave the bag in a parked car. On return, log the duration outside the fridge and any excursion.

Do morphine and midazolam need to be refrigerated?

No. Morphine (all four PBS item codes, 10862Q, 3479D, 10868B, 3480E) and midazolam (10178Q) are stored below 25 degrees Celsius at room temperature. Both are Schedule 8 controlled substances and require locked storage under state and territory drugs and poisons legislation. Locked storage and refrigerated storage are separate requirements: S8 items need locked, not cold.

Can I store Doctor's Bag fridge items with patient vaccines in the practice vaccine fridge?

Yes, provided the fridge meets TGA Strive for 5 standards (2 to 8 degrees Celsius, continuous monitoring, documented cold chain breach process). Store 3463G and 11755Q clearly labelled and separated from patient vaccine stock so the two are not cross dispensed. Do not store the 3467L glucagon injection kit in the vaccine fridge, because it does not require refrigeration and risks freezing if pushed to the back of the unit.

Related DocPouch guides

• Doctor's Bag checklist Australia: complete PBS Prescriber Bag item list
• PBS Doctor's Bag scheme: complete guide
• PBS Doctor's Bag for rural and remote GPs
• How to order the PBS Doctor's Bag online in Australia
• PB052 Prescriber Bag order form: step by step walkthrough

Order your Prescriber Bag online

Disclaimer: This article is provided for informational and reference purposes only and is intended for AHPRA-registered healthcare professionals. It does not constitute medical, pharmaceutical, or legal advice. Storage data has been verified against the Australian CMI and PI as published on the TGA medicines register, the National Health (Prescriber Bag Supplies) Determination 2024 (F2024L00414), and the TGA National Vaccine Storage Guidelines (Strive for 5, 4th edition). The PBS schedule and CMI content are updated periodically and should be rechecked before ordering, storing, or administering any medicine. Prescribers must comply with all applicable Commonwealth and state or territory legislation including the National Health Act 1953 (Cth), the Therapeutic Goods Act 1989 (Cth), and relevant Drugs, Poisons and Controlled Substances legislation. DocPouch (docpouch.com.au) is an ordering platform and does not provide clinical, pharmaceutical, or legal advice.