Quality compounding

Compounded medications are prescription preparations created by a licensed pharmacist to meet the specific needs of an individual patient when commercially available products are not appropriate or available.

Compounded medications are prepared pursuant to a valid patient-specific prescription and are not FDA-approved products.

Licensed health care providers with prescriptive authority may prescribe compounded medications for their patient in accordance with applicable state and federal regulations. Prescriptions must be issued by a provider acting within the scope of their professional license and scope of practice.

Prescriptions should be submitted through the provider’s electronic prescribing system (eRx) by selecting our pharmacy within the prescribing platform.

• Prescriptions must include:
• Patient full name and date of birth
• Prescriber name, credentials, NPI number, and signature (when required)
• Medication or compounded formulation
• Strength and dosage form
• Directions for use
• Quantity to dispense.
• Number of refills (if applicable)
• Date written.
• Clinical rationale indicating why the patient requires a compounded preparation that cannot be met by a
• commercially available product.
• Patient allergies or relevant clinical information (when applicable)

Under federal compounding regulations, pharmacies operating under Section 503A of the Federal Food, Drug, And Cosmetic Act generally compound medication only when there is a clinical need for a patient specific preparation that cannot be met by an FDA-approved product.

Out pharmacy compounds sterile preparations in accordance with USP <797> standards and applicable state board of pharmacy regulations.
Quality systems include:

• Environmental monitoring of sterile compounding areas
• Sterility and endotoxin testing when applicable
• Qualified cleanroom facilities
• Standardized compounding procedures
• Ongoing quality assurance and continuous quality improvement programs.

No. Compounded medications are not FDA approved products. They are prepared by licensed pharmacists in accordance with federal and state compounding regulations to meet the needs of individual patients.

Storage requirements vary depending on the formulation. Most sterile injectable preparations require refrigerated storage (typically 2°C to 8°C / 36°F to 46°F) unless otherwise specified on the prescription label. Providers and patients should follow the storage instructions provided with each medication.

Medications are shipped using packaging designed to maintain product integrity during transit. Temperature-controlled packaging is used when required based on product storage conditions.

If a prescription requires clarification or changes, our pharmacy team will contact the prescriber’s office. Updated prescriptions may be submitted electronically or provided verbally to a licensed pharmacist, in accordance with applicable state regulations.

In most cases, prescriptions cannot be transferred to our pharmacy. Compounded medications are prepared based on specific formulations and requirements that may differ between pharmacies.

Additionally, prescriptions written for commercially available brand-name medications cannot be filled as compounded preparations unless the prescriber issues a new prescription specifying the compounded medication.

Providers who wish to have a prescription filled by our pharmacy should submit a new prescription directly to our pharmacy.

Yes. Our pharmacists are available to discuss formulation options, administration considerations, stability information, and other pharmacy-related questions to support patient care.