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CMS F-Tag · 42 CFR §483.45(g)-(h), Labeling and Storage of Drugs and Biologicals · Pharmacy Services

Labeling and Storage of Drugs and Biologicals

Cited for F761? Here's what surveyors were looking for, how serious it tends to be, and how to structure a Plan of Correction that holds up.

Paul Richards, RN, MSHI·Founder, EasyPOC·✓ Clinically reviewed·Updated Jul 6, 2026
#3
Most-cited nationally

Citation figures from the CMS Provider Data Catalog. Rank reflects the most recent CASPER data.

What the regulation says

42 CFR §483.45(g)-(h), Labeling and Storage of Drugs and Biologicals
§483.45(g) Labeling of Drugs and Biologicals. Drugs and biologicals used in the facility must be labeled in accordance with currently accepted professional principles, and include the appropriate accessory and cautionary instructions, and the expiration date when applicable. §483.45(h) Storage of Drugs and Biologicals. (1) ...the facility must store all drugs and biologicals in locked compartments under proper temperature controls, and permit only authorized personnel to have access to the keys. (2) The facility must provide separately locked, permanently affixed compartments for storage of controlled drugs...
Verbatim from the CMS State Operations Manual, Appendix PP.

What F761 actually means

F761 is a med-room and medication-cart observation tag. It's cited for what surveyors find in storage, not for a clinical outcome: an expired medication still available, a cart left unlocked and unattended, a refrigerator out of range, controlled substances not double-locked. These are among the most preventable citations in the entire manual because they're about housekeeping and security, not clinical judgment.

What surveyors check

The medication room, carts, and refrigerators. They look for expired or discontinued drugs still available for use, unlocked carts or rooms left unattended, refrigerator temperatures (especially for insulin and vaccines), controlled-substance double-lock and reconciliation, dating of opened multi-dose vials and insulin, and separation of look-alike/sound-alike or external/internal products.

What most often triggers it

  • Expired or discontinued medications still present and available
  • Medication cart or room unlocked and unattended
  • Refrigerator temperature out of range for stored biologicals
  • Opened insulin or multi-dose vials undated or used past their limit
  • Controlled substances not stored in a separately locked compartment

How serious is it? Scope & severity

F761 is most often cited at D–E, a storage or labeling gap with potential for harm but none realized. It rises only if a resident actually received an expired, mis-stored, or degraded medication, which moves it toward actual harm.

Severity ↓ / Scope →
Isolated
Pattern
Widespread
Immediate Jeopardy
J
K
L
Actual harm
G
H
I
No harm, higher potential
D
E
F
No harm, minimal potential
A
B
C

The CMS scope & severity grid runs from an isolated no-harm gap (A) up through widespread Immediate Jeopardy (L). The level a surveyor assigns drives how urgent and far-reaching your Plan of Correction must be.

Example citation

F761 · Illustrative composite
Based on observation, the facility failed to ensure drugs were stored properly and unexpired. Observation of the 300-hall medication cart revealed two insulin pens with a hand-written open date more than 28 days prior, and one bottle of oral solution with a manufacturer expiration date of the previous month, all available for resident use.
Illustrative example, not a real facility.

How to write the Plan of Correction

(1) Remove and properly dispose of the specific expired or mis-stored items. (2) Identify scope: audit all carts, med rooms, and refrigerators facility-wide. (3) Systemic change: re-educate nursing on dating, expiration checks, and cart security; verify refrigerator logs and controlled-substance procedures. (4) Monitoring: nursing leadership or pharmacy audits carts and storage on a defined schedule through QAPI.

Cited for F761? Draft your Plan of Correction now.

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Common questions

What is F761?+

The CMS tag for labeling and storage of drugs and biologicals, under 42 CFR §483.45(g)-(h).

What most commonly triggers it?+

Expired medications available for use, unlocked carts, and out-of-range refrigerators.

How serious is it?+

Usually a no-harm "D–E"; higher if a resident receives an expired or mis-stored drug.

How do you respond?+

Remove the items, audit all storage, re-educate staff, and put cart and refrigerator auditing in place.

Related tags

F758 Psychotropic DrugsF880 Infection ControlF684 Quality of Care

This page is a compliance reference and does not constitute legal or clinical advice.