Guidance on Labeling and Storage of Drugs and Biologicals

This document is a guide that outlines the requirements for the labeling and storage of drugs and biologicals in Long Term Care Facilities (LTCFs) as specified in F761 of the CMS State Operations Manual Appendix PP. It details the necessary labeling components, including medication name, prescribed dose, strength, expiration date, and resident's name, along with appropriate instructions and precautions. The guide emphasizes the importance of storing all drugs and biologicals in locked compartments under proper temperature controls, with access limited to authorized personnel. It also specifies the storage requirements for controlled substances, highlighting that Schedule II-V medications must be kept in separately locked compartments. The document further discusses compliance cues for surveyors, including potential noncompliance examples and the severity levels associated with labeling and storage failures. Additionally, it provides recommendations for facilities to ensure compliance with federal and state regulations, including the use of consultant pharmacists for internal audits and staff education.