906 Pharmaceutical Compounding

Purpose

To ensure the Principal Investigator (PI) and all research team members assisting with the conduct of clinical research at the Ohio University Heritage College of Osteopathic Medicine’s Clinical and Translational Research Unit (CTRU) are informed about their obligations and responsibilities as they pertain to Good Clinical Practices (GCP), the investigational plan, applicable regulations, and institutional policies.

This Standard Operating Procedure (SOP) describes the training and procedures needed to safely compound low risk, immediate use sterile preparations for the purposes of administration to human subjects. Attachment templates include:

A: Sterile Compounding Hand Hygiene and Garbing Assessment, B: Sterile Compounding Gloved Fingertip Assessment, C: Sterile Compounding Media- Fill Testing Assessment

Responsibilities

The CTRU is responsible for developing, implementing, and maintaining SOPs. Creating new or revising an existing SOP is determined by changes to federal regulation, guidelines, institutional policies, or procedures. All applicable documents will be provided to departments and research teams conducting human subject research.

Definitions

Primary Engineering Control: A device or room that provides an ISO Class 5 environment for the exposure of critical sites when compounding sterile preparations. Such devices include, but may not be limited to, laminar airflow workbenches (LAFWs), biological safety cabinets (BSCs), compounding aseptic isolators (CAIs), and compounding aseptic containment isolators (CACIs)

Direct Compounding Area: A critical area within the ISO Class 5 primary engineering control (PEC) where critical sites are exposed to unidirectional HEPA-filtered air, also known as first air.

Procedures

1. Initial Training

• Critical Point Sterile Compounding or equivalent is required for individuals preparing low risk immediate use sterile compounds under Ohio Rule 4729:7-3-04, Sterile Non-Hazardous Drugs Compounded by a Prescriber.

2. Performing Compounding

• Use of a primary engineering control is recommended.
  • When used, primary engineering controls shall be operated continuously during compounding activity. When the blower is turned off it shall be turned on at least 30 minutes prior to sterile compounding activities.
  • The primary engineering control shall be cleaned with appropriate antiseptic spray prior to and after each use.
  • Traffic in the Direct Compounding Area will be minimized and controlled.
  • All supply items will be arranged in the Direct Compounding Area to reduce clutter and provide maximum efficiency and order for the flow of work.
• Aseptic technique is required.
  • Hand hygiene, including thoroughly washing hands, removal of jewelry, and wearing sterile gloves is required.
  • All procedures will be performed in a manner designed to minimize the risk of touch contamination. Gloves will be disinfected with adequate frequency with an approved disinfectant such as sterile 70% isopropyl alcohol.
  • All rubber stoppers of vials and bottles and the necks of ampules shall be disinfected by wiping with sterile 70% isopropyl alcohol and waiting for at least 10 seconds before they are used to prepare CSPs. Syringes, needles, etc., used for compounding are required to be sterile, medical grade, and within expiration date.
• After the preparation of every Compounded Sterile Preparation, the contents of the container will be thoroughly mixed and then inspected for the presence of particulate matter, evidence of incompatibility, or other defects. If particulate matter or other evidence of defects is present, the CSP will be disposed of.
• CSPs must be administered within six hours of compounding.
• CSPs must be labeled with 1) the name and quantity of each ingredient, 2) the before use date and time prepared, and 3) the initials of the preparer.
• Documentation of compounding activities and oversight by the IRB approved study physician or CTRU Medical Director is required.
  • Documentation must minimally include:
    • The amount(s) of each product used in the final sterile preparation
    • The time the product was compounded
    • The time the product was administered to the participant
    • A statement confirming appropriate aseptic technique was used
    • The signature of the CTRU Medical Director or study physician confirming their oversight of the process, including that the correct dose was compounded and administered to the participant.

References: None

Attachments: A: Sterile Compounding Hand Hygiene and Garbing Assessment, 
B: Sterile Compounding Gloved Fingertip Assessment, C: Sterile Compounding Media- Fill Testing Assessment

Appendices: None

Approver: CTRU Medical Director,
Sarah Adkins PharmD, BCACP
Director, CTRU and Clinical Partnerships

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