Pharmacy Providers

1. Overview

Livozo is a technology platform. We are not a pharmacy. When a clinician at {{PC_NAME}}writes a prescription, that prescription is sent to an independently owned and operated pharmacy that is licensed in your state. The pharmacy — not Livozo and not the clinician — is responsible for the preparation, labeling, and shipping of your medication, and for compliance with state and federal pharmacy laws.

2. Licensing and accreditation

Pharmacies we work with hold, at minimum:

• An active license from the state board of pharmacy in their resident state.
• Non-resident pharmacy licenses in every state to which they dispense, as required.
• Where applicable, accreditation by LegitScript or the Pharmacy Compounding Accreditation Board (PCAB), a service of ACHC.
• For sterile compounding pharmacies, compliance with United States Pharmacopeia (USP) chapters <795>, <797>, and (where hazardous drugs are involved) <800>.

3. Compounding standards

Pharmacies we work with represent that they follow USP chapters that govern non-sterile and sterile compounding, that they maintain documented standard operating procedures, and that they conduct routine environmental and product testing where required by USP, state law, or FDA regulation.

4. 503A vs 503B

Federal law recognizes two categories of compounding pharmacies, each authorized under a different section of the Federal Food, Drug, and Cosmetic Act (FDCA):

• Section 503A pharmacies compound medications for an identified individual patient pursuant to a valid prescription. They are regulated primarily by state boards of pharmacy. Products are not FDA-approved.
• Section 503B outsourcing facilities are registered with FDA and may compound batches in advance of receiving a prescription, subject to current good manufacturing practice (cGMP) and other requirements. Products are not FDA-approved.

We do not publicly name our pharmacy partners on this page because doing so creates competitive, operational, and litigation risk. We will identify the dispensing pharmacy on your prescription label and on shipping confirmations.

5. Certificate of Analysis

For compounded sterile products, you may request a Certificate of Analysis (COA) for your lot from the dispensing pharmacy. Email [email protected] with your order number and we will route the request.

6. Recalls and adverse events

If a pharmacy partner issues a recall or quality alert that affects medication we have routed to you, we will notify you by email and SMS at the address and number on file. To report a side effect or suspected product defect:

• Contact your Livozo clinician through the Platform or call [email protected].
• Report serious adverse events to the FDA MedWatch program at fda.gov/medwatch or by calling 1-800-FDA-1088.

7. Questions

Email [email protected] with any pharmacy question, or read the Compounded Medication page for the full disclosure on non-FDA-approved compounded medications.