When Compound Medication is Required for a Patient
Compound medications should be prescribed only when no FDA-approved medication can meet the patient's specific medical needs, and the benefits clearly outweigh the risks of using a non-FDA-approved product. 1, 2
Primary Indications for Compounding
Compounding is medically justified in the following specific situations:
- Unavailable commercial formulations: When a patient requires a specific dose, strength, or route of administration that is not commercially available 3, 1
- Allergy or intolerance to inactive ingredients: When a patient has documented allergies to preservatives, dyes, or other excipients in FDA-approved formulations and requires reformulation without these components 1, 4
- Rare disease treatment: When there is no authorized on-label or off-label treatment available for patients with rare diseases, and evidence in medical/pharmaceutical literature supports the compounded formulation 3
- Pediatric dosing requirements: When children need precise doses or alternative formulations (e.g., liquid instead of tablet) not available commercially 5
- Discontinued medications: When a previously FDA-approved medication has been discontinued but remains medically necessary for the patient 3, 4
Critical Safety Requirements Before Prescribing
Before prescribing any compounded medication, verify:
- No FDA-approved alternative exists that could meet the patient's needs through standard dosing, formulation changes, or therapeutic substitution 1, 2
- Evidence-based support: Medical and/or pharmaceutical literature supports the specific compounded formulation being prescribed 3
- Pharmacy certification: The compounding pharmacy uses validated standard operating procedures and is appropriately certified 3
- Quality assurance: All ingredients are accompanied by certificates of analysis, and full production records are maintained for traceability 3
Important Clinical Caveats
Compounding should never be used for economic reasons alone (e.g., creating cheaper versions of brand-name drugs when generics or brand products are commercially available), as this violates FDA guidance and exposes both prescriber and patient to unnecessary risk 2, 4
Prescribers assume significant liability when prescribing compounded medications, as malpractice claims can be brought against both the pharmacy and the prescribing physician if patient harm occurs 2
Contamination and concentration errors are the two primary safety concerns with compounded medications, with contamination errors affecting larger numbers of patients (particularly with parenteral formulations) and concentration errors disproportionately harming individual patients, especially children 5
Documentation Requirements
When compounding is medically necessary, document:
- Specific medical justification: Why no FDA-approved product can be used 2
- Patient-specific factors: Allergies, dosing requirements, or rare disease diagnosis necessitating compounding 3, 1
- Informed consent discussion: Risks of using non-FDA-approved products versus benefits 2
- Pharmacy verification: Confirmation that the compounding pharmacy meets quality standards 3