Skip to Main Content

Regulations Update

Marci Pederson, RN, BSN, Nurse Educator/Consultant

Federal Regulation F431

Federal Regulation - F431 "Pharmacy Service Consultation (for controlled drugs); Labeling of Drugs and Biologicals; Storage of Drugs and Biologicals."

South Dakota long-term care facilities had 19 deficiencies cited F431 in 2010. It ranks number 7 in the top twenty deficiencies for long-term care facilities in South Dakota.

The regulation F431 states, "Service Consultation. The facility must employ or obtain the services of a licensed pharmacist who:

  • Establishes a system of records of receipt and disposition of all controlled drugs in sufficient detail to enable an accurate reconciliation; and

  • Determines that drug records are in order and that an account of all controlled drugs is maintained and periodically reconciled.

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.

  • 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.

  • The facility must provide separately locked, permanently affixed compartments for storage of controlled drugs listed in Schedule ll 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 easily detected.

The regulatory languages states F431 covers three main areas - controlled drugs, medication access and storage, and labeling of medications and biologicals. I would like to focus on compliance with the controlled drugs section of F431 this month. Compliance with controlled drug requirements is a priority due to the daily potential for the occurrence of drug diversions. To accomplish compliance, the facility must have a system in place to account for receipt, usage, disposition, and reconciliation of all controlled medications. This system has to include but is not limited to:

  • Records of receipt of all controlled medications with sufficient detail to allow reconciliation (e.g., the name and strength of the medication, the quantity and date received, and the resident's name). If single-unit package medication delivery system or automated dispensing systems utilizing single-unit packages of medication that are not dispensed pursuant to a specific order, the resident's name may not be applicable;

  • Note: The facility's policies and procedures must address the reconciliation and monitoring of the supply of controlled medications in an emergency medication supply if having an emergency medication supply is in accordance with state requirements.

  • Records of usage and disposition of all controlled medications with sufficient detail to allow reconciliation (e.g., the medication administration record (MAR), proof of use sheets, or declining inventory sheets), including destruction, wastage, return to the pharmacy/manufacturer, or disposal in accordance with applicable state requirements. In the state of South Dakota if the facility does not have a licensed pharmacy, controlled drugs which have been outdated or discontinued must be destroyed in the facility by a pharmacist and a registered nurse.

  • Periodic reconciliation of records of receipt, disposition, and inventory for all controlled medications (monthly or more frequently as defined by facility procedures or when loss is identified). The reconciliation identifies loss or diversion of controlled medications so as to minimize the time between the actual loss or diversion and the time of detection and follow-up to determine the extent of loss. Because diversion can occur at any time, the reconciliation should be done often enough to identify problems. Some state or other federal requirements may specify the frequency of reconciliation. The nursing staff must follow the facility's policy and procedure for frequency of reconciliation.

    • If discrepancies are identified during the reconciliation, the pharmacist and the facility must develop and implement recommendations for resolving the discrepancies.

    • If the systems have not been effective in preventing or identifying diversion or loss, it is important that the pharmacist and the facility review and revise related controls and procedures, as necessary, such as increasing the frequency of monitoring or the amount of detail used to document controlled substances. A facility may have a good system in place with forms that provide space for all of the details needed, but unless the nursing staff consistently completes the forms with all of the information needed and follows the procedure, it is very difficult to have an effective system that will assist the facility in identifying discrepancies.

Note: The pharmacist is not required by these regulations to perform the reconciliation, but rather to evaluate and determine that the facility maintains an account of all controlled medications and completes the reconciliation according to its procedures, consistent with state and federal requirements.

If your facility would like to improve regulatory compliance and quality of care, contact AESS at 605-668-8475 for solutions.


As a former health facilities senior surveyor, Marci worked at the Department of Health Office of Licensure and Certification for eight years. Marci provides Survey Preparedness Consulting designed to create a culture of constant survey preparedness by helping staff understand regulatory requirements, not just comply with them.

Do the math! The facility bottom line improves when resident care continually improves.

Read more Regulations Updates. The Avera Solutions’ Blog contains writings from Marci and other Avera Education & Staffing Solutions staff and consultants.

Marci Pederson, RN, BSN

Marci Pederson, RN, BSN

As a former health facilities senior surveyor, Marci served a variety of health care facilities. Her experience includes nursing education, medical/surgical nursing, psychiatric nursing, infection control, utilization review and quality assurance.