FOR PHARMACISTS · REFERENCE EDITION 8.0261 monographs · 32 SOPs · 18 forms
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SOP-012 / SOP v2.0

Packaging, labelling and handover

Every finished preparation and its safe-use instructions.

Download individual SOP · PDF

Procedure

  1. Approve the exact container, closure and dosing device based on compatibility and use.
  2. Check cleanliness, integrity, code and packaging lot. Record fill quantity and closure.
  3. Generate a label from a controlled template showing name, strength and unit basis, route, batch, preparation date, BUD and storage.
  4. Add individual directions only from the confirmed prescription. Distinguish dose in mL from strength in mg/mL and specific warnings.
  5. A second check reconciles the container, label and batch record. Void unused labels that could cause a mix-up.
  6. At handover verify the recipient, explain storage/use with teach-back, and document required transport/cold-chain arrangements.

Edition-specific detail

Check label against order, F-002 and F-003: active/strength, form, route, quantity, patient where required, batch, actual BUD, storage and specific shaking. Demonstrate the measuring device and ask the recipient to repeat the process. Use F-018 for general supply and F-010 specifically for allergens.

Stop criterion

Label mismatch, unsuitable dosing device or critical transport failure: suspend supply.

Related forms

F-003, F-018, F-010 (allergens only)

Sources and references

  1. NAPRA — Model Standards for Pharmacy Compounding of Non-sterile PreparationsMarch 2018, clarification January 2022Sections 4–9Risk, personnel, facilities and QA; its historical BUD table is not used for current USP defaults2026-09-12
  2. NAPRA — Guidance Document for Pharmacy Compounding of Non-sterile PreparationsMarch 2018, clarification January 2022Sections 5, 6 and 7; master/batch records, delivery, qualityQuality-system implementation; historical BUD table not substituted for 2022 USP revision2026-09-12
  3. PIC/S — Guide to Good Practices for the Preparation of Medicinal Products in Healthcare EstablishmentsPE 010-4, 1 March 2014Chapters 1–9; Annex 2 (nonsterile liquids, creams, ointments)Professional quality-system framework; not automatic national legal adoption or certification2026-09-12