34 Chapter 34: Sourcing Compound Ingredients, Materials, Equipment and Supplies

In the compounding process, the selection and sourcing of high-quality components, materials, equipment, and supplies are essential to ensuring the safety, efficacy, and stability of compounded preparations. The NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations and its associated Guidance Document outline the expectations and best practices for sourcing these critical components. Adherence to these standards guarantees that compounding personnel use only the most reliable and compliant ingredients, tools, and protective measures. In this section, we will review the processes for identifying, sourcing, and maintaining appropriate supplies and equipment, emphasizing the importance of traceability, regulatory compliance, and risk management in maintaining a high standard of compounding practice.

1. Ingredients (Both Active and Inactive):

• Quality:
  • Use ingredients that are pharmacopeial grade (e.g., USP, NF, BP) or approved for pharmaceutical use. (e.g. contains a specified amount of substance between 98-102%)
  • When pharmacopeial-grade ingredients are not available, substances must come with a certificate of analysis to verify their quality, purity, and suitability for compounding.
  • Any drug withdrawn from the market ca not be used/compounded.
• Source
  • Source from Health Canada–licensed suppliers.
  • Bulk ingredients should come from manufacturers that comply with Good Manufacturing Practices (GMP).
• Stability and Compatibility:
  • Confirm chemical and physical stability with other components in the formulation.
  • Check for incompatibilities (e.g., pH, reactivity).
• Storage Conditions:
  • Ensure proper storage (e.g., light protection, refrigeration) per monographs or supplier instructions.
• Expiry Dates:
  • Check expiry dates and assign beyond-use dates (BUDs) based on ingredient data and risk level.
• Records and Documentation:
  • Lot numbers, expiry dates, supplier information, and certificates of analysis must be documented and kept on file to ensure full traceability (per NAPRA, Section 5.1 and GD-5.5.1).
• Other considerations:
  • Cost, availability, compatibility with drug, process, packaging
  • Choice of Salt:
    •  Metronidazole free base is a very unpleasant bitter taste
    •  Metronidazole benzoate is tasteless
      • Benzoate moiety contributes a large percentage of the molecular weight
      • Metronidazole benzoate 400 mg = metronidazole 250 mg
      • 1.6 gram of metronidazole benzoate = 1 gram of metronidazole

2. Packaging and Containers:

• Container Integrity:
  • Use containers that prevent contamination, moisture, and degradation (e.g., tight, light-resistant, child-resistant).

    Remember your dosing device!

  • Containers and closures must be appropriate for the compounded preparation to maintain stability and prevent contamination.
• Compatibility:
  • Ensure materials do not react with the compounded preparation (e.g., avoid plastics that leach chemicals).
  • Must be sourced from suppliers providing containers suitable for pharmaceutical use, ensuring materials do not interact with the compounded product.
• Labelling Space:
  • Ensure enough room for required labels and auxiliary warnings
• Reuse Restrictions:
  • Use single-use containers where required; clean reusable containers appropriately.

    General Considerations (All Categories)

    • Regulatory Compliance:

      • Align with standards from NAPRA, USP <795>, and Health Canada.

    • Documentation:

      • Keep records of supplier certifications, equipment maintenance, and cleaning protocols.

    • Risk Assessment:

      • Select materials and processes based on the risk level (A, B, C) of the compound being prepared.

    • Training:

      • Ensure compounding staff are trained in selecting and using appropriate materials and equipment.

     

     

3. Equipment and Devices:

• Suitability:
  • Equipment must be appropriate for the type and complexity of compounding being performed (e.g., balances, mixers, grinders, etc.).
  • Precision and accuracy must be verifiable, particularly for scales and measurement devices (per NAPRA, Section 5.4.2 and GD-5.4.2.1).
• Calibration and Maintenance:
  • Equipment must be regularly calibrated, maintained, and cleaned according to a documented schedule (Section 5.4.2; maintenance logs required).
  • Must be easy to clean and sanitize between uses; smooth, non-porous surfaces are preferred
• Procurement Sources:
  • Equipment should be obtained from suppliers specializing in pharmaceutical or laboratory-grade devices.
• Dedicated Equipment:
  • Use dedicated or properly cleaned/validated equipment for hazardous or sensitizing compounds.

4. Personal Protective Equipment (PPE):

• Risk of Compounding:
  • PPE (e.g., gloves, gowns, masks) must meet the protective requirements appropriate to the risk level of the compounded preparation (Level A, B, or C).

• Barrier Protection:
  • Use PPE that protects personnel and prevents contamination of the product (e.g., gloves, gowns, masks, hair covers).
• Compliance with Standards:
  • Ensure PPE meets safety and regulatory requirements (e.g., CSA, NIOSH for hazardous materials).
  • PPE suppliers must provide products that comply with occupational health and safety standards (e.g., CSA, NIOSH standards).
• Training:
  • Ensure staff are trained on donning, doffing, and disposal of PPE.

5. Supplies for Cleaning and Decontamination:

• Effectiveness:
  • Use cleaning agents proven to remove residue and disinfect surfaces (e.g., alcohol, quaternary ammonium compounds).
• Residue-Free:
  • Avoid cleaners that leave residues that may contaminate preparations.
• Surface Compatibility:
  • Ensure cleaning products are safe for the surfaces used in compounding areas.
• Safety and Storage:
  • Store cleaning agents safely and label them clearly; use PPE when handling concentrated solutions
• Supplies such as lint-free cloths, approved disinfectants, and cleaning tools must be procured from specialized suppliers.

Additional Notes for Sourcing:

• Supplier Qualification:
  Pharmacies should establish a list of pre-approved suppliers, verified through a qualification process that may include:
  • Reviewing the supplier’s GMP compliance.
  • Checking references or reviews from other healthcare institutions.
  • Confirming appropriate licenses and certifications.
• Ongoing Monitoring:
  Suppliers should be re-evaluated periodically to ensure continued compliance with quality expectations (aligned with NAPRA QA requirements).
• Risk-Based Decision-Making:
  Especially for higher-risk or complex compounding (Level B and Level C), sourcing decisions must consider the risk of contamination or instability introduced by poor-quality components or equipment.

To meet the regulatory and quality standards for non-sterile compounding, it is crucial to source ingredients, materials, equipment, and supplies from reputable suppliers who comply with industry regulations and standards. The use of pharmacopeial-grade ingredients, properly calibrated equipment, and appropriate PPE is vital in minimizing the risk of contamination and ensuring the safety and efficacy of compounded preparations. Documentation of sourcing decisions, including lot numbers, supplier certifications, and certificates of analysis, must be meticulously maintained for traceability. Additionally, a proactive approach to supplier qualification and ongoing monitoring is key to ensuring the continuous compliance and reliability of all components. By following these procedures, pharmacies can mitigate risks, comply with NAPRA standards, and provide safe, high-quality compounded medications for patients.