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Pharmacy Services42 CFR §483.45(g)-(h)
F0761 — Label/Store Drugs and Biologicals
F0761 requires drugs and biologicals to be labeled in accordance with accepted professional standards, and stored in secure, properly organized locations with appropriate temperature control, separate from non-medication items.
Common Deficiency Examples
- Medication cart or storage area left unsecured or unlocked
- Expired medications found in active storage
- Medication labeling missing required information
- Refrigerated medications not maintained within required temperature range
What Your Plan of Correction Needs
F0761 PoCs are typically straightforward operational fixes but should include a verification layer:
Condition observedspecific storage/labeling issue and location
Immediate actioncorrection completed (securing, removing expired stock, relabeling)
Systemic fixstorage security process and expiration-check routine
Monitoring planmedication storage audits at a defined frequency
Frequently Asked Questions
How is F0761 different from F0759 or F0760?+
F0761 covers drug labeling and storage — how medications are kept and organized. F0759 and F0760 cover medication administration errors. A locked-cart or expired-stock finding falls under F0761; a wrong-dose finding falls under F0759/F0760.
Cited on F0761? PoC360 generates your Plan of Correction instantly.
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