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Ftag of the Week – F761 Label/Store Drugs & Biologicals

This week’s Ftag of the Week is F761 Label/Store Drugs & Biologicals. F761 is currently the 7th most frequently cited deficiency on standard surveys under the new LTCSP for the entire country, so it’s one to pay extra attention to. The regulation states:

  • 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.
  • Storage of Drugs and Biologicals – (1) In accordance with State and Federal laws, 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 listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976 and other drugs subject to abuse, except when the facility uses single unit package drug distribution systems in which the quantity stored is minimal and a missing dose can be readily detected.

This regulation provides an easy opportunity to be cited, since it covers many things, such as:

  • Properly labeling of drugs and biologicals
  • Labeling/dating/discarding multi-use vials
  • Ensuring insulin pens are used for single residents only
  • Discarding expired meds timely
  • Maintaining security of narcotics in separate locked and permanently affixed cabinets
  • Cleanliness of med rooms and med carts
  • Controlled substance logs maintained and reconciled
  • Controlled medication destruction
  • Medication refrigerator temperatures

Surveyors have multiple opportunities to identify issues under the new LTCSP. The Medication Administration Observation Facility Task and the Medication Storage and Labeling Critical Element Pathway are the tools that will be used during survey, along with the Interpretive Guidance, so they are good audit tools to use in your own facility to see where you have issues.

View CMS Compliance Group’s “Ftag of the Week” series here.

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