BOP Program Statement 6360.03 § 15

All drugs will be labeled adequately, including the addition of accessory or cautionary statements

and the expiration date, if appropriate.

Discontinued and outdated drugs and containers with worn, illegible, or missing labels will be

returned to the pharmacy for proper disposition.

Each institution will establish a High-Risk Medication Program. The Institute for Safe

Medication Practices defines high risk medications as those that bear a heightened risk of causing

significant patient harm when they are used in error. Through local P&T, institutions will identify

6360.03 5/7/2026 PROPERTY OF US GOVERNMENT 21

medications used locally that are potentially high risk and implement mitigation strategies to

reduce risk of error.

Look Alike/Sound Alike medications and High-Risk medications will be updated at each local

P&T meeting for staff to reference in their daily operations.

The HSD participates in adverse reaction reporting programs sponsored by the FDA of the

Department of Health and Human Services (DHHS).

 Adverse drug reactions will be reported using the system defined by the Bureau Chief

Pharmacist.

 Institutions may also choose to report adverse drug reactions through MedWatch: The FDA

Safety Information and Adverse Event Reporting Program on the FDA’s website.

 Drug product defects will be reported in accordance with the FDA drug product problem

reporting program.

Medication Non-Adherence. Institution supplements will include procedures for timely

notification of non-adherence. Such notification will be made to the CD and other relevant staff.