17 Chapter 17: Labelling Compounds

Labelling and Packaging of Non-Sterile Compounded Preparations

Labelling Policy

A standardized policy for the labelling and packaging of compounded non-sterile preparations must be established and adhered to. Labels must comply with the requirements set forth by the respective provincial or territorial pharmacy regulatory authority. Each label must clearly identify all active ingredients along with their respective concentrations. Additionally, the label must include the Beyond-Use Date (BUD), as well as any relevant storage and handling instructions.

For non-sterile preparations compounded on behalf of another pharmacy (where permitted by provincial/territorial regulations), appropriate labelling standards must be maintained. The dispensing pharmacy must retain comprehensive records from the compounding pharmacy, including details such as ingredient names, quantities, lot numbers, and BUD, ensuring accessibility for verification and quality control purposes.

Primary and Auxiliary Labels

In some cases, the standard computer-generated prescription label may not have sufficient space to accommodate all necessary information for the safe use of a compounded preparation. If required details cannot be included on an auxiliary label, a supplemental label should be prepared. This supplementary label is an integral part of the overall labelling system and must ensure that all required information is conveyed effectively.

Together, the primary and auxiliary labels must provide the following details:

• Pharmacy Identification: Name, address, and telephone number of the compounding or dispensing pharmacy, as required by regulatory authorities.
• Drug Information: Active ingredients, their concentrations, dosage form, route of administration, and total quantity prepared.
• Special Precautions: Indications if the product is an irritant or requires special handling.
• Beyond-Use Date (BUD): Clearly stated expiration to ensure product stability and efficacy.
• Regulatory Compliance: All additional information required by provincial/territorial regulations that could not be included on the primary label.
• Administration Instructions: Mode of administration and any specific directions for use.
• Storage Conditions: Essential guidelines for proper storage, such as:
  • “Refrigerate upon receipt — store between 2°C and 8°C. Do not freeze.”
  • “Do not store in the refrigerator door.”
  • “Keep out of reach of children.”
• Disposal Instructions: Any necessary precautions for the disposal or destruction of the compounded preparation.

How to Name a Compound?

• Include name and amount of all APIs
• w/w or w/v, where applicable (eg clindamycin HCL 2%w/v)
• APIs listed in order with highest strength first
• Strength can be expressed in a number of ways.
  • per dosage unit (e.g., progesterone 25 mg capsules)
  • as a percentage of the whole product and dosage form/unit, e.g., clindamycin HCl 2% w/v in ethanol
  • as a ratio (common for semi-solids), e.g., hydrocortisone 2% w/w cream: clotrimaderm 1% w/w cream 2:1
•  Abbreviate dosage forms if needed, e.g., cream = cr, solution = soln, suspension = susp

When packaging a non-sterile compound in a pharmacy setting, several considerations must be addressed to ensure stability, safety, label accuracy, and regulatory compliance. 

1. Appropriate Container Selection

• Compatibility: The container must be chemically compatible with the formulation (e.g., not reactive or adsorptive).
• Protective Properties: Choose containers that protect against:
  • Light (amber bottles or opaque jars for light-sensitive compounds)
  • Moisture (tight-sealing containers for hygroscopic products)
  • Air exposure (minimize oxidation in sensitive preparations)
• Material: Plastic, glass, or metal containers should be selected based on:
  • Stability of ingredients
  • Storage needs (e.g., temperature, protection from contamination)

2. Container Closure Integrity

• Ensure containers are properly sealed to prevent contamination, degradation, or leakage.
• Avoid closures that can leach chemicals or absorb medication (especially with oils, alcohols, or volatile compounds).
• Use tamper-evident seals when needed (especially for external or high-risk preparations).

3. Quantity and Dosage Form Suitability

• Use appropriately sized containers to minimize headspace and evaporation (especially for liquids).
• Use dispensing devices (e.g., oral syringes, spatulas, pump dispensers) when needed to facilitate accurate dosing.
• Avoid transferring from the compounding container to the final dispensing container unless necessary for safety

4. Storage Conditions

• Package in containers that support the required storage conditions (e.g., refrigeration, protection from humidity).
• Provide clear storage instructions to the patient.

5. Safety and Usability for the Patient

• Use child-resistant packaging when required.
• Select packaging that the patient can open and use easily (especially for elderly or those with dexterity issues).
• Consider clarity of dosing (e.g., volume markers on oral syringes, calibrated applicators for topicals).

6. Documentation and Traceability

• Document the container and closure system used in the compounding record.
• Ensure lot numbers of packaging materials are traceable if required for recalls or investigations.

By following these labelling  and package standards, pharmacy professionals can ensure that compounded non-sterile preparations are safely used by patients and properly handled by caregivers or healthcare professionals.