F 761 Label/Store Drugs & Biologicals is consistently a “Top 10” deficiency.  Compliance with F761 is complicated by the vast number of medications and related supplies that facilities must utilize each day, along with the multiple places they must be stored, including medication carts and med rooms.  Another cause of problems is the frequent interruptions that can occur as medication administration staff are completing medication passes.  With so many challenges related to this requirement, lets review key best practices to prevent being cited with this deficiency…

First, let us begin with a review of the F 761 regulatory requirements as found in the CMS State Operations Manual – Appendix PP.

      • 483.45(g) Labeling of Drugs and Biologicals states:
        • 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 goes on to state:
        •  (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

The intent of this requirement is that the facility, in coordination with the licensed pharmacist, provides for:

      • Accurate labeling to facilitate consideration of precautions and safe administration, of medications; and
      • Safe and secure storage (including proper temperature controls, appropriate humidity and light controls, limited access, and mechanisms to minimize loss or diversion) of all medication.

One of the most common deficient issues, and the easiest to prevent, is the presence of medications/biologicals that have expired, or as with multi-use products, have not been identified with the date opened so that the expiration date can be determined.  This is often detected with items such as insulin vials and pens, TST solution vials, nasal sprays and inhalers.  Consider these best practices:

      • Use a sticker that clearly identifies the date opened, and date of expiration that can be filled out as soon as the product is first used. Educating staff to fill these out as soon as they open new medications/biologicals will save time and frustration for those who use it for subsequent administrations.
      • Make sure that all medications/biologicals and all supplies stored in the medication rooms have large, easy to see expiration dates, and that they are arranged with the earliest expiration dates up front will be a huge time saver when re-stocking the medication carts.

Another common F 761 deficiency results from the medication cart being left unlocked as staff walk away to administer meds or perform other duties. Consider utilizing the “8 rights” of medication administration, instead of the standard “6 rights”:

      1. Identify the right patient;
      2. Verify the right medication;
      3. Verify the indication for use;
      4. Calculate the right dose;
      5. Make sure it’s the right time; and
      6. Check the right route;
      7. Make sure to protect the resident’s privacy (close/cover the MAR or computer screen;
      8. Make sure to protect the resident’s medications by locking the cart.

By implementing these simple interventions and practices, you can reduce the risk that F 761 Label/Store Drugs & Biologicals will continue to be in the “Top 10”.

Join us on April 5th for the fourth session in the Survey Success! Top Citations Webinar Series when we will share more tips, techniques and strategies to avoid F 761 deficiencies.


Janine Lehman, RN, RAC-CT, CLNC
Director of Legal Nurse Consulting

Learn more about the rest of the Proactive team.