ACP Pharmacy Practice Consultants have observed some pharmacies preparing pre-filled syringes of medications for injection, such as “insulin pre-fills”, on their dispensary counters. Pharmacy professionals are reminded that pre-filled syringes of medications for injection which are dispensed to patients must be prepared in sterile compounding facilities.
Regulatory Framework
Sterility must be maintained during the reconstitution, manipulation, and repackaging (including simple aseptic transfers) of compounded sterile preparations (CSPs) which are dispensed to patients. For pre-filled syringes, this requires a sterile compounding facility. Pharmacies with sterile compounding facilities are required to meet the NAPRA Model Standards for Pharmacy Compounding of Hazardous and/or Non-Hazardous Sterile Preparations. Section 3 of these documents lists different types of CSPs, and includes intramuscular, intravenous, intrathecal, intradermal, and subcutaneous injections.
Section 3 also indicates that pharmacy professionals who do not have the knowledge, training, expertise, facilities, or equipment required to compound sterile products must refer patients to a pharmacy that has the required competencies and facilities to do so.
Collaborate in the care of your patients
As per the NAPRA Model Standards, CSPs must be compounded in a compliant, certified Primary Engineering Control (PEC) or Containment Primary Engineering Control (C-PEC) that maintains ISO Class 5 air quality or better and that is located in an ISO Class 7 clean room or a compliant, certified compounding aseptic isolator (CAI) that meets the criteria specified in section 5.3.3.1 when placed in environments with particle counts exceeding ISO Class 7. If your pharmacy does not meet these requirements, you may not prepare pre-filled syringes of injectable medications to be dispensed to your patients.
If your patients require these syringes, identify other pharmacy professionals in your community who have the necessary competencies and facilities to prepare them. Establish collaborative relationships to transfer care of these patients, or to obtain these CSPs through a Compounding and Repackaging agreement, where applicable.
