7.6 Handling, Storing, Packaging, Transporting & Disposing of Finished CSPs
Key Takeaways
USP <797> Section 19 requires SOPs for handling, storing, packaging and transporting CSPs, and documented training for everyone who does those tasks inside the facility.
CSP storage areas are temperature-controlled and monitored every day, manually or continuously. Monitoring devices are verified at least every 12 months (or per the manufacturer), and a designated person decides whether a CSP exposed outside its limits can still be used; if that cannot be determined, it is discarded.
Packaging and transport are chosen from the product's specifications, vendor information and the mode of transport. Light-sensitive CSPs get light-resistant packaging, temperature-sensitive ones get insulated containers, and special handling instructions go on the outside of the container.
BUDs are not additive across storage conditions: a thawed CSP cannot be refrozen, cannot be thawed in a microwave, and its total storage time cannot exceed the original BUD for its labeled storage condition.
Liquid hazardous drugs and all antineoplastic HDs must never be sent through pneumatic tubes (USP <800>), and CSPs returned with a complaint are quarantined until destroyed after the investigation.
7.6 Handling, Storing, Packaging, Transporting & Disposing of Finished CSPs
A CSP can be compounded perfectly and still fail the patient. It can be left warm in a delivery bin, shaken apart in a pneumatic tube, frozen twice, or given after its BUD. The BCSCP outline (task 1B6) covers the handling of finished CSPs through receipt, transfer, storage, transport and disposal. USP <797> Section 19 is the core standard.
Training and SOPs (Section 19)
The facility's SOPs must describe how CSPs are handled, stored, packaged and transported. Everyone who does these tasks inside the facility must be trained on the relevant SOPs, and that training must be documented. USP's FAQ adds that people who only receive, deliver or store CSPs still need documented competence, defined by the organization.
Storage and temperature control (19.1)
| Requirement | Detail |
|---|---|
| Controlled temperature area | Established and monitored so each CSP stays within its range (USP <659> definitions: controlled room temperature 20-25 °C; refrigerator 2-8 °C; freezer -25 to -10 °C) |
| Monitoring frequency | Each day, manually or with a continuous recorder. USP's FAQ accepts recording on Monday for a site closed at the weekend |
| Records | A temperature log, or retrievable data in the continuous device |
| Device accuracy | Verified at least every 12 months, or as the manufacturer requires |
| Excursions | Detected and minimized. When a CSP is known to have been exposed outside its limits, a designated person decides from literature or testing whether it keeps its integrity. If that cannot be determined, it is discarded |
Thawing and changing storage conditions (14.2.4)
- Containers for frozen CSPs must withstand freezing without cracking.
- Thaw under appropriate conditions, for example in a refrigerator. Never use a microwave.
- Never refreeze a thawed CSP.
- A CSP may move between conditions (frozen, then refrigerated, then room temperature), but its storage time must not exceed the original BUD for its labeled storage condition, and BUDs are not additive. USP's FAQ gives two examples. A room-temperature CSP cannot be refrigerated or frozen to extend its BUD. A frozen CSP's BUD cannot be extended by storage at room temperature after thawing.
Packaging (19.2)
The facility chooses shipping containers and packaging materials based on the product specifications, vendor information and the mode of transport:
- Tamper-evident closures where needed
- Light-resistant packaging for light-sensitive CSPs
- Insulated containers (coolers, gel packs, temperature indicators) for CSPs sensitive to temperature changes
- Protection against breakage and leaks, especially for glass and for hazardous drugs
Shipping and transport (19.3)
- Choose transport that will deliver properly packed CSPs undamaged, sterile and stable.
- When a CSP needs special handling, for example because of stability concerns, put specific handling instructions on the outside of the container.
- Pneumatic tubes: USP <800> forbids sending any liquid HD, or any antineoplastic HD, by pneumatic tube. For other CSPs, the facility decides what may go by tube. Many exclude proteins and monoclonal antibodies that can be damaged by agitation, glass containers, and high-alert drugs.
- Home infusion: Validated shipping containers keep the temperature for the whole route. Patients are told how to store the CSP (for example in the refrigerator, away from food), how to bring it to room temperature before infusion, and what to do if it arrives warm or damaged (see 9.3).
Receiving CSPs from outside suppliers
CSPs bought from a 503B outsourcing facility, or from another pharmacy, are inspected on receipt. Check the shipping container and temperature indicators, the labels (including "This is a compounded drug" for 503B products), lot numbers, expiration dates or BUDs, and the physical condition of the product. Store them under the labeled conditions. Anything exposed to temperatures outside its range is quarantined and evaluated, or returned under the supplier's instructions.
Returns, recalls and disposal
| Situation | Handling |
|---|---|
| CSP returned with a complaint | Quarantined until destroyed, after the investigation is complete (USP <797> 18.2) |
| CSP recalled | Quarantined; remaining stock recovered; disposal and reconciliation documented (USP <797> 18.1; see 12.2) |
| CSP past its BUD | Removed from stock and discarded; never relabeled with a new BUD |
| Unused CSP returned from a patient care area | Re-dispensed only if SOPs allow and storage and integrity can be confirmed; otherwise discarded |
| Hazardous drug CSPs and trace waste | Handled under RCRA and EPA Subpart P rules; bulk HD waste goes to hazardous waste containers; never sewered (see 12.3) |
| Controlled substance CSPs (for example PCA opioids) | Wastage witnessed and documented under DEA and state rules; inventory destruction documented as required |
Exam traps
- "It was only warm for a few hours, so extend nothing and use it." That is wrong. A designated person must evaluate the excursion, and if integrity cannot be determined, the CSP is discarded.
- Refreezing a thawed PN bag, or adding refrigerated time on top of a frozen BUD, is not allowed.
- Sending a methotrexate syringe by pneumatic tube is not allowed.
A Category 2 CSP made from sterile components was frozen with a 45-day frozen BUD. On day 44 it is thawed in the refrigerator. May the pharmacy relabel it with a new 10-day refrigerated BUD?
Yes, because the refrigerated BUD starts when thawing begins
Yes, if the bag is inspected and found clear
No; BUDs are not additive, total storage time cannot exceed the original BUD for the labeled condition, and a thawed CSP must never be refrozen
No, because frozen CSPs must be used within 24 hours of compounding
A home infusion pharmacy is shipping a refrigerated, light-sensitive antibiotic CSP to a patient's home. Which approach follows USP <797> Section 19?
A plain envelope sent by standard mail
Packaging and shipping method chosen from the product specifications and transport mode: light-resistant packaging, an insulated container with temperature control, and specific handling instructions on the outside of the container
Freeze the CSP before shipping to extend its BUD, then let the patient thaw it
Put the handling instructions only inside the package so outsiders cannot see them
A nurse asks the IV room to send an infusion of cyclophosphamide, an antineoplastic HD, to an oncology unit through the pneumatic tube system to save time. What is the correct response?
Send it in a sealed plastic bag inside the tube carrier
Send it by tube only if a CSTD is attached
Do not send it by pneumatic tube; USP <800> prohibits sending any liquid HD or any antineoplastic HD through pneumatic tubes
Send it by tube after 5 p.m., when traffic is lower
Sections you finish are checked off in the contents.