This Standard Operating Procedure (SOP) outlines the responsibilities and expectations of NuBalance Health’s clinical staff and administration when establishing and managing partnerships with licensed pharmacies, including compounding pharmacies. The goal is to ensure that all pharmaceutical services provided to patients meet clinical, legal, and ethical standards in accordance with:

• HIPAA (Health Insurance Portability and Accountability Act)

• FDA regulations

• State pharmacy boards

• Telemedicine prescribing laws

• USP (United States Pharmacopeia) standards for compounding

• Professional clinical obligations to patient safety

2. Scope

This SOP applies to all NuBalance Health clinics, telehealth providers, medical directors, prescribing physicians, nurse practitioners, and administrative personnel who:

• Refer patients to partner pharmacies

• Communicate with pharmacy staff

• Coordinate prescription fulfillment

• Maintain relationships with compounding labs

• Store or distribute pharmaceutical samples or inventory

It includes all medication-related services, including but not limited to hormone therapy, peptide therapy, nutritional injections, and controlled or non-controlled medications.

3. Definitions

• Partner Pharmacy: A licensed pharmacy that has entered into a formal or informal agreement to dispense prescriptions on behalf of NuBalance Health’s providers.

• Compounding Pharmacy: A pharmacy that prepares customized medications per individual prescriptions.

• SOP: Standard Operating Procedure.

• Prescriber: A licensed clinician (MD, DO, NP, PA) authorized to prescribe medications.

• BAA: Business Associate Agreement (when handling PHI)

4. Roles and Responsibilities

A.Clinical Director

• Approves and monitors pharmacy partnerships

• Conducts due diligence on pharmacy licensure and compliance

• Ensures SOP adherence by clinical teams

B. Medical Providers

• Prescribe only to pharmacies that meet NuBalance standards

• Maintain documentation of clinical justifications for prescriptions

• Confirm patient consent for medication delivery

C. Pharmacy Liaison (if designated)

• Acts as point of contact between NuBalance and the pharmacy

• Handles escalations, supply issues, and patient concerns

• Tracks prescription turnaround time and fulfillment rates

D. Compliance Officer

• Reviews pharmacy compliance with federal/state law

• Ensures BAA is signed and HIPAA guidelines are followed

• Coordinates audits or inspections if necessary

5. Pharmacy Selection Criteria

Pharmacies partnered with NuBalance Health must:

Hold active state licensure in the states where patients reside

Have FDA registration or follow USP <795>/<797>/<800> if compounding

Provide certificates of liability insurance

Employ licensed pharmacists and certified pharmacy technicians

Use HIPAA-compliant communication methods

Agree to a Business Associate Agreement (if handling PHI)

Have capacity to fill and ship prescriptions within 24–72 hours

6. Prescription Workflow Process

Step 1: Provider Evaluation

• Provider completes a clinical evaluation of the patient.

• Documentation includes diagnosis, lab results (if applicable), and medication justification.

Step 2: Patient Consent

• Patient receives a treatment plan that includes:

  • Medication name and dosage

  • Expected side effects

  • Chosen pharmacy (or option to choose their own)

  • Shipping or pickup instructions

Step 3: Prescription Submission

• Prescription is sent electronically or via secure fax to the pharmacy.

• All orders must include:

  • Patient identifiers

  • Diagnosis code (ICD-10)

  • Prescriber signature

  • Dosing instructions and refills

• Clinic notes are sent if required by state law.

Step 4: Pharmacy Fulfillment

• Pharmacy verifies prescription accuracy and patient information.

• Pharmacy prepares, fills, and ships medication within approved timeframe.

• Tracking information is provided to the clinic and/or patient.

Step 5: Follow-Up and Documentation

• Provider or staff follows up with the patient within 3–7 days to confirm receipt.

• Adverse events, patient satisfaction, and refill status are documented.

• Any pharmacy performance issues are reported to the Pharmacy Liaison.

7. Patient Choice Policy

NuBalance Health acknowledges every patient’s legal right to use a pharmacy of their choosing. Patients may:

• Request to use an alternative pharmacy

• Receive a printed or electronic prescription to submit independently

• Revoke their initial pharmacy preference at any time

No patient shall be forced, misled, or coerced into using a specific pharmacy.

8. Compounding Pharmacy Compliance

When using a compounding pharmacy, NuBalance Health must verify that:

• The pharmacy compounds in accordance with USP <795>, <797>, or <800>, depending on the substance

• The pharmacy has state authorization for non-sterile/sterile compounding

• Medications are not being compounded solely for resale (violates 503A regulation)

• The pharmacy is not distributing unapproved drug substances or non-compliant bioidentical hormone therapy (BHT) without appropriate justification

9. Communication & Recordkeeping

• All communications with partner pharmacies must be documented in the EHR or CRM.

• Prescription receipts, tracking logs, and confirmation calls should be logged.

• Clinics should maintain a secure log of:

  • Prescriptions sent

  • Medications ordered

  • Shipments tracked

  • Reported delays or issues

10. Confidentiality and HIPAA Compliance

• Clinics must never email, fax, or text PHI to a pharmacy without proper encryption.

• All prescription-related PHI must be shared only with authorized pharmacy staff.

• If a breach occurs (e.g., PHI faxed to the wrong pharmacy), it must be reported to the Privacy Officer immediately.

11. Review and Oversight

• Pharmacy partnerships must be reviewed semi-annually by the Clinical Director and Compliance Officer.

• Complaints or performance concerns should be addressed within 7 days.

• Pharmacies with repeated compliance failures will be removed from the preferred partner list.

12. Auditing

• NuBalance Health reserves the right to audit any partner pharmacy’s records related to prescriptions filled on its behalf.

• Pharmacies must maintain a log of compounded or dispensed medications for a minimum of 5 years or as required by state law.

13. SOP Violations

Failure to follow this SOP may result in:

• Disciplinary action against staff or providers

• Termination of the pharmacy relationship

• Regulatory reporting if a violation involves fraud, misconduct, or patient harm

14. Contact for Pharmacy Partnership Oversight

Pharmacy Compliance Liaison

NuBalance Health Compliance Division

lacey@nubalance.health

678-313-5106