Guidelines for Compounding Preparations - Effective September 1, 2006
The Working Group to Examine Pharmacy Compounding based these guidelines on the following performance indicators for pharmacists fulfilling this role:
The Guidelines for Compounding Preparations are not meant to supersede the Standards of Practice but to enhance the area of addressing compounding.
1. Have accurate knowledge and expertise to compound preparations;
The key elements of good compounding include qualified and trained personnel, adequate premises and space, appropriate compounding procedures and instructions, suitable equipment, labels and containers, and accurate documentation.
2. Confirm the need for a compounded product;
3. Maintain access to contemporary equipment;
4. Use of quality ingredients;
5. Appropriate labeling;
6. Suitable containers for each unique product;
7. Safe and acceptable storage; and
8. Documentation to ensure accurate checking, duplicating and tracing.
9. Adherence with health, safety and environmental practice
Extemporaneous preparation of products that:
1. Are considered to be within the professional practice of pharmacy, regulated by provincial regulatory authorities in accordance with guidelines and standards that ensure the quality and safety of pharmaceuticals;
Preparation of products:
2. Are prepared pursuant to:
a. Or in anticipation of, a prescription with an established pharmacist-patient/ patient’s agent-prescriber relationship and;
3. Do not circumvent a regulatory process or patent laws; and
b. A consultation between the pharmacist and the patient and/or patient’s agent in which the pharmacist uses their knowledge and expertise within federal and provincial regulations;
4. Provide a customized therapeutic solution to improve patient care.
1. Are subject to the Food and Drug Act and Regulations, Good Manufacturing Practice guidelines, and inspection by Health Canada;
2. Require a Drug Identification Number (DIN); and
3. Are produced by a manufacturer independently of a prescription or consultation between a pharmacist and the patient and/or his/her agent.
3.1 Pharmacists that compound or delegate compounding activities to technical staff should have the knowledge and skills to be responsible for the preparation of the product.
3.2 Pharmacists shall use their professional judgment when deciding whether they have the expertise to compound a specific product and should be aware of good compounding principles.
3.3 Pharmacists unable to compound a drug product for the patient should refer the patient to a pharmacist with the ability to prepare the product.
3.4 The pharmacist shall gather sufficient information to make knowledgeable decisions regarding the formulation and process of the compounding. Formulations should be accessed from a reputable source. If no formulation is available, a formula shall be completed using the pharmacist’s knowledge in pharmacology, chemistry, and therapeutics.
3.5 The pharmacist shall:
a. Assist patients requiring a compounded item;
b. Counsel individuals on the appropriate use of the compounded product;
c. Determine whether the product shall be compounded in a sterile manner;
d. Ensure the quality and accuracy of the ingredients;
e. Calculate required quantities, dilutions, percentages or other pharmaceutical calculations as required;
f. Be knowledgeable of the purpose of each ingredient in the compound;
g. Recognize the potential for incompatibilities;
h. Determine the equipment needed to compound the product;
i. Prepare the product in a logical, safe and pharmaceutically elegant manner ensuring the safety of personnel; and
j. Document the required information to maintain accurate records.
4.1 The compounding area shall be clean, sanitary, orderly and of sufficient space to perform the compounding activity involved.
4.2 Premises shall permit effective cleaning of all surfaces. Surfaces include floors with no carpets.
4.3 Premises shall prevent contamination of medication and the inadvertent addition of extraneous material to the medication.
5.1 Equipment used for compounding shall:
a. Be situated in an area conducive to the practice of compounding;
5.2 Equipment used in the compounding process shall be calibrated on a regularly scheduled basis and documentation showing proof of calibration and servicing shall be maintained in the pharmacy records.
b. Be easily and routinely cleaned to minimize the potential for contamination;
c. Be suitable for the preparation of the desired compound; and
d. Be kept clean, dry and protected from contamination during storage to prevent the addition of extraneous materials.
6.1 The pharmacy shall have available a written sanitation program to include cleaning requirements for the premises and equipment as well as the safe disposal of consumables pursuant to prevailing environmental guidelines.
6.2 Written procedures detailing the minimum requirements for health and hygienic behaviour of individuals performing compounding activities shall be addressed in a policy manual. This shall include, but not be limited to:
a. Suitable dress (e.g. gowns, masks, gloves, footwear);
b. Hand washing; and
c. Open sores.
7. Quality Control Requirements
7.1.1 The pharmacist shall be able to distinguish materials that require specialized
handling and storage and demonstrate safe handling techniques such as, but not limited to:
a. Measuring or triturating in an appropriate environment;
7.1.2 The pharmacist shall ensure the quality of the ingredients by using products with a standard designation or equivalent pharmacopoeia standard such as:
b. Donning the appropriate apparel; and
c. Ensuring that personnel handling the ingredients do so in a safe manner.
a. BP (British Pharmacopoeia), USP (United States Pharmacopoeia), NF (National Formulary), CF (Canadian Formulary), PhI (Pharmacopoeia Italy), PhF (Pharmacopoeia France), or PhEur (Pharmacopoeia European) standard of quality;
7.1.3 Ingredients shall be selected based on but not limited to knowledge to the nature of the substance considering:
b. A valid lot number and expiry date (if available). If expiry is not available, a date of receipt shall be recorded on the raw material; and
c. A Certificate of Analysis (C of A) for Raw Materials that is maintained in the records.
7.2 Record Keeping
7.2.1 Written compounding records must be available to enable the pharmacist to check all compounded medication to ensure that all compounded products can be:
c. Patient’s allergies;
d. Intended use; and
e. Route of Administration.
f. Any other properties which may affect the finished product
a. Replicated in formulation and production; and
7.2.2 Information documented on each compounding record shall include, but not be limited to:
b. Tracked in the event of a recall or adverse event.
a. Name, lot number and expiry of raw material if available;
7.2.3 Deviations from written preparation process shall be avoided. If deviations occur, the pharmacist shall describe the deviation and the rationale.
7.2.4 A yield and reconciliation shall be carried out on each compounded medication.
7.2.5 At all times during the compounding process materials shall be labeled to prevent confusion.
7.2.6 Records of complaints from patients and adverse events regarding compounded medications shall be maintained for a minimum of two years. Consideration should be given to investigation as to cause as well as appropriate measures to be taken to prevent recurrence.
7.2.7 All records shall be maintained as per Standards of Practice
b. Quantity required and quantity actually weighed;
c. Date of preparation and expiry;
d. Initials of compounder and/or pharmacist responsible for the preparation and checking;
e. Written formula used; and
f. Any other documentation required by the provincial regulatory authority.
8.1 Product labels shall follow all federal and provincial requirements.
8.2 Labels of compounded products shall include, but not be limited to:
a. List of active ingredients;
8.3 Individually packaged medications (such as lollipops) shall be individually labeled with the name of the compound, lot number and estimated expiry date, then put in a larger container with a prescription label for dispensing.
b. Concentration of the active ingredient;
c. Lot number if applicable, of the compounded product;
d. Estimated expiry date and/or best before date of the compound based on available references; and
e. Storage instruction as needed.
9.1 The packaging shall be appropriate for the stability of the product and proper patient use.
10. Storage and Transportation
10.1 Raw material shall be stored and transported in a manner that prevents the alteration to the potency, purity and physical characteristics of the raw material.
10.2 Transportation of the compounded product shall be appropriate to the nature of the product.
10.3 Special transportation instructions of the compounded product should be relayed to the patient or patient’s agent.
11. Sterile Compounding
11.1 Pharmacists engaging in sterile compounding shall be knowledgeable and trained in this area.
11.2 Standards for the operation of clean rooms and the preparation of sterile products shall be established and documented in accordance with a recognized source (e.g. USP, Canadian Society of Hospital Pharmacists, OCP’s Sterile Compounding, A Guide for Community Pharmacists).
11.3 Sterility testing shall be done according to a standard (e.g. USP) and the product assigned an estimated expiry date.
12. Veterinary Medicine
12.1 Compounding of medications indicated for veterinary use shall follow the same guiding principles as found in this document and the Standards of Practice.
12.2 All products for veterinary use shall, in addition to compliance with labelling requirements for human products, be labeled “For Veterinary Use Only”.
12.3 If the intended use of the compound is “For Office Use” it shall be labeled as such, include storage requirements as well as an expiry date.
12.4 Pharmacists dispensing products intended for administration to food producing animals shall be aware of relevant sections of pertinent legislation specific to that population.
12.4.1 Withdrawal times shall be added to the label as assigned by the veterinarian ordering the product.
12.5 Drugs should not be compounded in order to be sold to third parties who will in turn sell/deliver to patients outside of their defined pharmacist-patient-prescriber relationship.