F – 761: Labeling and Storage of Drugs and Biologicals
By Luwana Walton, RN Gayco Consultant Nurse
F761 is currently the 7th most frequently cited deficiency on standard surveys 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 dose 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. Surveyors have multiple opportunities to identify issues under this tag:
- Properly labeling of drugs and biologicals
- Labeling/dating/discarding multi-use vials
- Ensuring insulin pens are used for single resident use
- Discarding expired and discontinued medications timely
- Maintaining security of narcotics in separate locked and permanently affixed compartments
- Cleanliness of medication rooms and medication carts
- Controlled substance logs maintained and reconciled
- Controlled drug destruction
- Medication refrigerator temperatures
One area of concern when auditing a facility are the discontinued, expired and medications left in the facility after a resident discharge.
All discontinued, expired and medications left in the facility after a resident discharge should be immediately removed from medications with active orders and processed for destruction. An inventory and destruction form is completed and the medications are placed in a designated container stored in a secure area away from medications with active orders according to the facilities destruction method. Never should these medications be stored piled up on the medication room counter awaiting process for destruction, which can result in a F761 tag. The facility shall retain the original drug destruction form for a minimum of 2 years.
Ensure your facility has a system to account for the receipt, usage, disposition, and reconciliation of all controlled medications. Disposal methods for controlled medications involve a secure and safe method to prevent diversion and/or accidental exposure.
Policy and Procedures for Disposal of Medications and Medication-Related Supplies are located in Gayco’s P&P Manuel.
Medication Cart Audit
Nurse Initials: _____ Date______ Med. cart audited_____
___ Insulin exp. dates per Gayco labeled expiration date
___ Insulin from stat safe or backup follow P&P Special Situations pg.40a
___ Latanoprost (Xalatan) eye drops exp. dates per Gayco label exp.
___ Advair, Symbicort & other inhalers follow manufacture exp date after opening foil pouch. Keep vials in foil pouch.
___ Over the counter medications, exp. date on product
___ ASOP medications, meds with a stop date (“X 7 days”etc.)
___ Accu-chek sol and test strips have an open date
___ Liquid Protein requires an open date
___ Check PRN expiration dates
___ Ear drops are NOT stored with eye drops
___ Check dispense dates: eye drops, nasal sprays (have limited doses)
___ TX creams etc. stored to prevent contamination of other meds.
___ Narcotics: signed when punched for administration
___ Narcotics: NOT taped back into blister cards
___ Narcotics: narcotic count audit sheet signed at shift change
___ Narcotics: not expired
___ Narcotics removed following the 14 day rule
___ Med carts are clean, neat and free from sticky spills
___ No personal items on top or inside med cart (coffee, purse)
___ Pudding, applesauce, supplements for med pass have open dates