Regulatory basis
CMS Conditions for Coverage at 42 CFR § 416.48 require pharmaceutical services directed by a designated qualified individual. Joint Commission MM, AAAHC pharmacy chapter, and DEA controlled-substance regulations layer on. ISMP guidance is the operational gold standard.
Program structure
- Designated pharmacist or qualified individual.
- Formulary with P&T committee oversight.
- Storage policy mapped to every location.
- Procurement, receiving, and inventory controls.
- Compounding policy aligned to USP 797.
- Medication reconciliation policy.
- ADR / medication-error reporting through incident reporting .
- Monthly pharmacist medication-storage inspection.
Storage and security
All medications under lock or constant supervision. Refrigerators dedicated to medications. Temperature monitored per shift. Light-sensitive medications shielded. Expired medications quarantined. Patient-care areas free of unattended medications.
Multidose vials
Per CDC injection safety : a multidose vial may be used until manufacturer expiration or 28 days after opening, whichever is earlier. Never in patient treatment areas. Single-dose vials are single-use, period.
Look-alike, sound-alike (LASA)
A LASA list specific to your formulary. Tall-man lettering on labels and screens. Physical separation in storage. Bar-coded scanning. ISMP maintains a frequently updated confused drug names list .
Controlled substances
DEA registration. Schedules II–V tracked by individual unit. Two-person count at every shift change. Discrepancy resolution within 24 hours. Storage per DEA security requirements. Disposal per DEA Diversion Control with witnessed wastage.
USP 797 and USP 800
USP <797> sets standards for compounded sterile preparations. Most ASCs that perform only manufacturer-provided injection draw and immediate-use compounding fall under the immediate-use exception.
USP <800> covers hazardous drug handling. Applies to any ASC handling drugs on the NIOSH list .
Emergency and PRN medications
Crash cart sealed with tamper-evident lock and checked daily. Defibrillator self-test verified. Contents not within 30 days of expiration. Malignant hyperthermia (MH) cart maintained where triggering anesthetics are used. Naloxone, glucagon, and reversal agents in PACU.
FAQ
Does an ASC need a pharmacist?
How long can a multidose vial be used after opening?
Does USP 797 apply to ASCs?
Operationalize this with DocForms
DocForms helps ASCs manage medication-related evidence such as storage checks, controlled-substance counts, temperature logs, multidose-vial controls, LASA review, compounding policies, training, and corrective actions.
Keep requirements linked to the policies, logs, files, tasks, and approvals that prove compliance.
Turn findings into owners, due dates, escalation, and documented closure.
Show a clean evidence trail by requirement, owner, date, and status when surveyors ask.