5 Medication Management Rules Small Practices Cannot Afford to Break (42 CFR § 482.25(a))

(42 CFR § 482.25)

For Medicare-participating hospitals, medication management is a core patient-safety function and a fundamental regulatory obligation under the Conditions of Participation (CoPs). 42 CFR § 482.25 requires hospitals to maintain pharmaceutical services that meet patient needs, minimize medication errors, and ensure drugs and biologicals are controlled, stored, administered, and monitored in accordance with Federal and State law.

Medication-related deficiencies are a frequent focus of CMS surveys because failures in procurement controls, storage, administration, or documentation can directly jeopardize patient safety and expose hospitals to enforcement action. This article outlines five medication management rules hospitals cannot afford to break, explains what surveyors review, and highlights common compliance risks identified during surveys.

Rule 1: Ensure Proper Oversight of Pharmaceutical Services

Under 42 CFR § 482.25(a), hospitals must have pharmaceutical services directed by a registered pharmacist or ensure that drug storage areas operate under competent supervision. A pharmacist, full-time, part-time, or consulting, must be responsible for developing, supervising, and coordinating pharmacy service activities.

Hospitals must demonstrate that:

• Pharmaceutical services are administered in accordance with accepted professional principles

• Oversight responsibilities are clearly assigned and documented

• Adequate personnel are available to support safe medication management

Surveyors often request evidence of pharmacist oversight, including policies, contracts, and documentation of supervisory activities.

Medication storage is one of the most visible survey focus areas. 42 CFR § 482.25(b) requires drugs and biologicals to be controlled and distributed in a manner that protects patient safety.

Key regulatory expectations include:

• All drugs and biologicals kept in secure areas and locked when appropriate

• Schedule II–V controlled substances locked within a secure area

• Access limited to authorized personnel

• Outdated, mislabeled, or unusable drugs removed from patient care areas

Failure to maintain secure storage or remove expired medications frequently results in citations.

Medication administration practices must minimize errors and support traceability. 42 CFR § 482.25(b)(6) requires drug administration errors and adverse drug reactions to be reported promptly to the attending practitioner and, when appropriate, to the hospital’s Quality Assessment and Performance Improvement (QAPI) program.

Surveyors typically assess whether documentation includes:

• Patient identification

• Medication name, dose, route, and time

• Identity of administering personnel

• Evidence of error reporting and follow-up when applicable

Staff interviews are commonly used to validate whether documented processes align with actual practice.

Hospitals must maintain current and accurate records of the receipt and disposition of scheduled drugs under 42 CFR § 482.25(a)(3). Inventory discrepancies, particularly involving controlled substances, raise immediate survey concerns.

Best practices commonly reviewed by surveyors include:

• Regular inventory counts

• Timely reconciliation of discrepancies

• Separate tracking mechanisms for controlled substances

• Clear assignment of responsibility for inventory oversight

Accurate inventory records support both regulatory compliance and internal accountability.

While 42 CFR § 482.25 does not mandate a specific training frequency, hospitals must ensure that personnel involved in medication management are competent to perform their assigned duties. Competency is evaluated through observed practice, documentation accuracy, and staff knowledge during surveys.

Training commonly addresses:

• Safe handling and administration of medications

• Infection control during medication preparation and delivery

• Controlled substance management

• Response to adverse drug reactions

Surveyors evaluate whether training is meaningful, documented, and reflected in day-to-day practice.

Case Example: Medication Management Deficiencies Identified During Survey

During a CMS survey, hospital surveyors identified multiple medication management deficiencies, including unsecured controlled substances, incomplete temperature logs for refrigerated medications, and expired drugs available for use. Staff interviews revealed inconsistent understanding of medication storage and documentation requirements.

The hospital was cited under 42 CFR § 482.25(a) and § 482.25(b) for failure to ensure safe control, storage, and oversight of medications. Corrective actions focused on securing storage areas, reconciling inventory records, reinforcing staff competency, and strengthening pharmacist oversight.

This case illustrates how gaps across multiple medication management elements can result in cumulative survey findings.

Compliance Checklist for Medication Management

• Pharmacist oversight formally documented

• Secure storage for all medications, including controlled substances

• Removal of expired or unusable drugs

• Accurate inventory and reconciliation processes

• Competency-based staff education documented

Hospitals should be able to produce  for each element during a survey.

Sustainable compliance requires more than policies alone. Hospitals that perform well during surveys typically reinforce medication safety through leadership accountability, clear documentation standards, and integration with QAPI activities. Consistent monitoring and timely corrective action demonstrate that medication management is an active, ongoing process rather than a paper exercise.

Medication management under 42 CFR § 482.25 is a critical hospital CoP requirement directly tied to patient safety and survey outcomes. Hospitals must demonstrate effective oversight, secure storage, accurate documentation, inventory control, and staff competency. Clear accountability and consistent monitoring reduce the risk of deficiencies and support safe, reliable medication practices.

1. 42 CFR § 482.25 – Condition of Participation: Pharmaceutical Services

2. CDC Vaccine Storage and Handling Toolkit

3. CMS State Operations Manual – Appendix A: Survey Protocol, Regulations and Interpretive Guidelines for Hospitals