CMS SOM App. A, Tag A-0505

not be available for patient use.

Interpretive Guidelines §482.25(b)(3)

The hospital must have a pharmacy labeling, inspection, and inventory management system that

ensures that outdated, mislabeled, or otherwise unusable drugs and biologicals are not available

for patient use. This would include drugs that are the subject of a manufacturer’s recall.

A drug or biological is outdated after its expiration date, which is set by the manufacturer based

on stability testing under specified conditions as part of the FDA approval process. It should be

noted that a drug or biological may become unusable prior to its expiration date if it has been

subjected to conditions that are inconsistent with the manufacturer’s approved labeling.

A drug or biological is also outdated after its “beyond-use date” (BUD), which may be reached

before the expiration date, but never later. The BUD takes into account the specific conditions

and potential for deterioration and microbial growth that may occur during or after the original

container is opened, while preparing the medication for dispensing and administration, and/or

during the compounding process if it is a compounded medication.

The BUD is to be based on information provided by the manufacturer, whenever such

information is available. The hospital must maintain and implement policies and procedures that

provide clear and consistent direction to pharmacy staff regarding how to determine a BUD

when complete BUD information is not available from the manufacturer. The policies and

procedures must be based on accepted professional principles.

For individual drug containers: each floor stock drug container is expected to be labeled with the

name and strength of the drug, lot and control number equivalent, and expiration date.

Appropriate accessory and cautionary statements are included as well as the expiration date

and/or, if applicable, a BUD. In addition, where applicable, each patient’s individual drug

container is expected to be labeled with the patient’s full name and quantity of the drug

dispensed.

If the unit dose system is utilized, each single unit dose package is expected to be labeled with

the name and strength of the drug, lot and control number equivalent, expiration date and/or, if

applicable, a BUD.

Survey Procedures §482.25(b)(3)

• Spot-check the labels of individual drug containers to verify that they conform to Federal

and State laws, and/or contain the following minimal information:

• Each patient’s individual drug container bears his/her full name, and strength and

quantity of the drug dispensed. Appropriate accessory and cautionary statements are

included as well as the expiration date and/or, if applicable, a BUD;

• Each floor stock container bears the name and strength of the drug, lot and control

number of equivalent, expiration date;

• If the unit dose system is utilized, verify that each single unit dose package bears name

and strength of the drug, lot and control number equivalent, expiration date and/or, if

applicable, a BUD;

• Inspect patient-specific and floor stock medications to identify expired, mislabeled or

unusable medications.