Pharmacy Compounding and Lab Study Material
Types of Compounding
Non-sterile compounding:
Preparing oral solutions, suspensions, topical creams, ointments, etc.Sterile compounding:
Preparing injections, ophthalmics, and IV admixtures under aseptic conditions.Simple vs. Moderate vs. Complex compounding:
- Simple: Following USP monographs or established formulations.
- Moderate: Requires special calculations or procedures.
- Complex: Requires special training, facilities, equipment, or procedures.
This section explains the different ways medications can be custom-prepared in a pharmacy. Compounding involves creating personalized medications for patients when commercial products are not suitable. It includes non-sterile compounding, such as creams, ointments, and oral liquids, and sterile compounding, which involves injections and IV solutions prepared in sterile environments.
The types of compounding are also categorized by complexity: simple (based on standard formulas), moderate (requires some calculation or special procedure), and complex (involves advanced equipment or safety considerations). Understanding these distinctions is essential for proper handling, safety, and compliance with regulations.
The types of compounding are also categorized by complexity: simple (based on standard formulas), moderate (requires some calculation or special procedure), and complex (involves advanced equipment or safety considerations). Understanding these distinctions is essential for proper handling, safety, and compliance with regulations.
USP Chapters
USP Chapters, outlines the official standards for pharmacy compounding set by the United States Pharmacopeia (USP).USP <795> – Non-sterile compounding.
USP <795> governs non-sterile compounding, such as creams, ointments, and oral suspensions.USP <797> – Sterile compounding.
USP <797> covers sterile compounding, ensuring aseptic preparation of injections and ophthalmic solutions.USP <800> – Handling hazardous drugs (includes compounding safety).
USP <800> addresses the safe handling of hazardous drugs to protect staff and patients, focusing on containment strategies, PPE, and facility requirements.
These chapters define proper procedures, environment controls, personnel training, documentation, and beyond-use dating. Understanding these helps ensure compounded medications are safe, effective, and meet regulatory standards for patient care and workplace safety.
Personal Protective Equipment (PPE)
- Gloves, gowns, hair covers, masks, shoe covers. The Personal Protective Equipment (PPE) section explains the essential clothing and gear pharmacy staff must wear during compounding to prevent contamination and ensure safety. This includes gloves, gowns, hair and beard covers, masks, and shoe covers.
- Sterile compounding requires additional aseptic gear like sterile gloves and goggles. For sterile compounding, sterile gloves and face shields or goggles may be required. PPE protects both the compounded preparation and the technician from exposure to hazardous substances, especially when handling cytotoxic or dangerous drugs as outlined in USP <800>.
Cleanroom and Equipment Standards
- Laminar airflow workbench (LAFW): For sterile prep.
- Compounding aseptic isolator (CAI): Closed system for sterile compounding.
- Beyond-use dating (BUD): Per USP guidelines, not manufacturer’s expiration date.
- Cleaning and sanitizing procedures: Regularly scheduled and documented.
In this section we discuss the sterile environment and tools required for safe compounding, especially sterile preparations. This section covers the use of laminar airflow workbenches (LAFWs) and compounding aseptic isolators (CAIs), which provide contamination-free zones. Cleanrooms must meet strict air quality standards, with regular cleaning, sanitization, and airflow monitoring. Technicians must follow aseptic techniques to maintain sterility, and all equipment must be regularly inspected and maintained to ensure safety and compliance with USP <797> guidelines.
Ingredient Handling and Documentation
- SDS (Safety Data Sheets): For all chemicals used.
- Master Formulation Record: “Recipe” of a compounded medication.
- Compounding Record (or log): Actual preparation details, lot numbers, initials, etc.
Ingredient Handling and Documentation, emphasizes the importance of safely managing all components used in compounding. Pharmacy technicians must refer to Safety Data Sheets (SDS) for hazard information, use only approved and quality-checked ingredients, and ensure proper storage.
Every compound must have a Master Formulation Record detailing the recipe and a Compounding Record documenting the actual preparation—tracking lot numbers, quantities, dates, and the technician’s initials to ensure traceability and compliance with regulations.
Every compound must have a Master Formulation Record detailing the recipe and a Compounding Record documenting the actual preparation—tracking lot numbers, quantities, dates, and the technician’s initials to ensure traceability and compliance with regulations.
Safety and Hazardous Drug Handling (USP <800>)
- Negative pressure rooms for hazardous drug compounding.
- Special disposal procedures (e.g., chemo waste bins).
- Importance of containment primary and secondary engineering controls (C-PEC and C-SEC).
This section covers USP <800>, which outlines the safe handling of hazardous drugs in healthcare settings to protect personnel, patients, and the environment. It emphasizes the use of negative pressure rooms, closed-system transfer devices (CSTDs), and personal protective equipment (PPE). It mandates containment primary and secondary engineering controls (C-PEC and C-SEC) and proper disposal procedures for hazardous waste. The section also includes staff training, spill control, and regular cleaning protocols to reduce exposure risks.
Packaging, Labeling, and Storage
- Proper containers (light-resistant, tight-sealing, etc.).
- Required labeling: drug name, strength, BUD, storage instructions, route of administration, compounding personnel initials.
The Packaging, Labeling, and Storage section in compounding emphasizes using appropriate containers that protect the medication from light, moisture, or air as required (e.g., amber vials for light-sensitive drugs). Labels must include the drug name, strength, dosage form, beyond-use date (BUD), storage instructions, route of administration, and compounding personnel initials.
Proper storage conditions—such as refrigeration or room temperature must be followed to maintain stability, efficacy, and safety of the compounded product. Compliance ensures accurate dispensing and patient safety.
Proper storage conditions—such as refrigeration or room temperature must be followed to maintain stability, efficacy, and safety of the compounded product. Compliance ensures accurate dispensing and patient safety.
Quality Assurance (QA) and Quality Control (QC)
- Checking for proper technique, cleanliness, stability, and potency.
- Double-checking ingredients and processes to prevent contamination or error.
Quality Assurance (QA) and Quality Control (QC) in compounding ensure that medications are prepared safely, consistently, and accurately. QA refers to the overall process and systems in place to prevent errors, such as training, procedures, and environmental monitoring. QC focuses on checking the final product for accuracy, clarity, and contamination. Together, they help maintain high standards in compounding by identifying and correcting issues before they affect patient safety or medication efficacy.
Documentation Requirements
- Batch records, training records, cleaning logs, environmental monitoring logs.
- Importance of record-keeping for legal and safety compliance.
The Documentation part refers to the essential records kept during the compounding process to ensure accuracy, traceability, and compliance with regulations. This includes batch compounding records, master formulation records, equipment cleaning logs, ingredient lot numbers, and personnel training documentation.
Proper documentation helps identify errors, supports quality assurance, and is required for legal and safety audits. It ensures accountability by tracking who prepared, verified, and cleaned during each step of compounding.
Proper documentation helps identify errors, supports quality assurance, and is required for legal and safety audits. It ensures accountability by tracking who prepared, verified, and cleaned during each step of compounding.
