2 Chapter 2: To Compound or not to Compound?

Before proceeding with non-sterile compounding, pharmacy personnel must determine whether compounding is necessary and appropriate. Compounding should only occur when it is justified by patient-specific needs, clinical appropriateness, and regulatory considerations. This decision aligns with both professional standards and the responsibility to uphold safety, efficacy, and legal compliance in pharmacy practice.

As with all prescriptions, the pharmacist must to a clinical assessment and determine if the prescription is appropriate for the patient.  You must next determine if the product is commercially available or if it needs to be compounded.

If it needs to be compounded, these things need to be considered:

• Is there a formulation record available?
• What is the level of risk to make this compound?
• Do you have the proper space, equipment to make the compound?
• Do you have the ingredients needed to make the compound?
• Is there pharmacy personnel trained and available to make the compound?

If the answer is no to any of these questions, you may need to refer the patient to another pharmacy that could prepare this medication.

Here are some examples that you can use to guide you in your own decision making process:

Example 1: 

Scenario:
A physician writes a prescription for a 5% lidocaine topical gel for a pediatric patient who is allergic to commercial topical anesthetic patches. There is no commercial preparation with only lidocaine and no preservatives.

Questions to Consider:

• Is compounding clinically appropriate? ✅ Yes – due to allergy and need for a specific formulation.

• Is there a formulation record available? ✅ Yes – a PCCA formula is available.

• What is the risk level? ✅ Moderate risk – non-sterile semi-solid with active drug.

• Do we have the space and equipment? ✅ Yes – lab and ointment slab are available.

• Are the ingredients available? ✅ Yes.

• Is trained staff available? ✅ Yes.

Decision: ✅ Proceed with compounding

Example 2:

Scenario:
A prescriber requests a flavored amoxicillin gummy preparation for a child who refuses all liquid antibiotics.

Student Questions to Consider:

• Is compounding clinically appropriate? ✅ Yes – adherence issue with standard forms.

• Is there a formulation record available? ❌ No – no recognized formula in literature or compounding databases.

• What is the risk level? ⚠️ Uncertain – novel dosage form.

• Do we have the space and equipment? ⚠️ Yes, but equipment may not suit gummy prep.

• Are the ingredients available? ✅ Yes.

• Is trained staff available? ✅ Yes.

Decision: ❌ Do not proceed without a validated formulation.
Consider contacting another compounding pharmacy or prescriber.

Example 3: 

Scenario:
A prescription for an oral suspension of spironolactone is received. The pharmacy has no oral liquid compounding tools or space for compounding.

Student Questions to Consider:

• Is compounding clinically appropriate? ✅ Yes – needed for pediatric dosing.

• Is there a formulation record available? ✅ Yes – available in Hospital for Sick Children Compounding Guide.

• What is the risk level? ✅ Simple risk – oral liquid.

• Do we have the space and equipment? ❌ No.

• Are the ingredients available? ✅ Yes.

• Is trained staff available? ✅ Yes.

Decision: ❌ Do not proceed.
Refer the patient to a pharmacy that has appropriate facilities.

Example 4: 

Scenario:
A veterinary prescription requests a metronidazole 10 mg/mL oral suspension for a dog. The active ingredient is not in stock.

Student Questions to Consider:

• Is compounding clinically appropriate? ✅ Yes – no suitable veterinary commercial preparation.

• Is there a formulation record available? ✅ Yes – veterinary compounding references.

• What is the risk level? ✅ Simple risk.

• Do we have the space and equipment? ✅ Yes.

• Are the ingredients available? ❌ No.

• Is trained staff available? ✅ Yes.

Decision: ❌ Do not proceed.
Order ingredients if time allows or refer the client