Oregon Pharmacy Law Overview

A designated area in a pharmacy for preparing non-sterile compounds, separate from a sterile workspace if one exists. Only one preparation should be compounded at a time in this area.

A document created for each new compounded preparation, containing details like components, calculations, stability, instructions, and packaging.

A record completed for each compounding event, referencing the MFR and including details like quantities, component information, and quality control.

Use purified or sterile water for compounding; distilled water is acceptable only if it adheres to purified water requirements.

The date after which a compounded preparation should NOT be used, determined by the date of preparation, not the patient's first use.

Standard Operating Procedures (SOP) required in pharmacies or facilities who handle sterile compounds.

Any change from the standard compounding procedure must be documented in writing.

Sterile Compounding Solutions (CSPs) assigned a Beyond Use Date (BUD) of less than 12 hours at room temp or less than 24 hours if refrigerated

CSPs with a BUD of more than 12 hours at room temperature or more than 24 hours if refrigerated, requiring preparation in a clean room suite.

CSPs with extended BUDs (up to 180 days), needing additional preparation requirements.

The primary device in sterile compounding, usually a laminar airflow workstation (LAFW), or compounding aseptic containment isolator (CCACI), sometimes a BSC or CAI, providing ISO class 5 air.

The area surrounding the PEC, maintaining ISO class 7 air quality.

The area before entering the buffer, usually with ISO class 7 or 8 air quality.

Cleaning the PEC must happen daily, before a match, and not longer than 30 minutes when compounding is in progress.

Cleaning of floors and countertops in the buffer and ante areas should be done daily.

Cleaning supplies used in a PEC must be low-lint disposable or dedicated, reusable tools. Sterile water must be used when preparing cleaning solutions.

Detailed records required for CSPs prepared for more than one patient or using nonsterile components.

A record created for all compounded sterile products (CSPs) except for immediate-use products for more than one patient. It may be a prescription, medication order, label, or electronic record providing required information.

Maximum batch size for CSPs requiring sterility testing is 250 final units.

Sterility testing is required for category 3 CSPs. Category 2 CSPs may also require it based on the Beyond Use Date (BUD).

Dispensed CSP labels must clearly indicate that the preparation is compounded.

Factors determining Beyond Use Dates (BUDs) include storage conditions (temperature), compounding method, sterility testing, and storage conditions.

Antimicrobial effectiveness testing isn't required for non-preservative topical ophthalmic CSPs prepared as category 2 or 3 CSPs, for single-patient use, and labeled for discarding after 24 hours (room temp) or 72 hours (refrigerator) post-opening.

Multi-dose CSPs, after being punctured, can only be used for up to 28 days.

Single-dose CSP can be used up to 12 hours when being used to prepare other sterile products

Facility SOP must have procedures for determining recall severity, affected product distribution, patient identification, disposal, and documentation, as well as for investigating the reason for failure.

Personnel handling hazardous drugs (HDs) need restricted access, training, and annual reassessments that cover HD risks and handling procedures. The training must include PPE use, equipment handling, exposure response, spill management, and proper disposal.