Sourcing and Regulatory Policy

InVita sources compounded preparations, as applicable, through appropriately licensed U.S. compounding pharmacies or FDA-registered outsourcing facilities.

We do not purchase or administer products designated “research use only” or “not for human use.”

The appropriate source depends on the specific preparation, its intended use, applicable prescription requirements, availability, and the regulatory pathway under which it is compounded.

Certain patient-specific compounded medications may be obtained through appropriately licensed U.S. compounding pharmacies operating under Section 503A of the Federal Food, Drug, and Cosmetic Act.

Under the federal 503A framework, qualifying compounded medications are generally prepared pursuant to a valid prescription for an identified individual patient and are subject to applicable federal and state requirements.

State boards of pharmacy generally have primary responsibility for day-to-day oversight of state-licensed pharmacies that are not registered with FDA as outsourcing facilities.

Where appropriate, InVita may source preparations from outsourcing facilities registered with the U.S. Food and Drug Administration under Section 503B of the Federal Food, Drug, and Cosmetic Act.

503B outsourcing facilities are subject to current Good Manufacturing Practice (CGMP) requirements, FDA inspection according to a risk-based schedule, adverse-event reporting requirements, and certain product reporting and other federal requirements.

FDA registration as a 503B outsourcing facility does not mean that FDA has approved the facility’s compounded medications or determined that the facility is continuously in compliance with all applicable requirements.

InVita maintains sourcing and product information appropriate to the preparations used in our practice.

Depending on the preparation and supplier, supporting documentation may include information such as:

• supplying pharmacy or outsourcing facility;
• product identification and concentration;
• lot or batch information;
• expiration or beyond-use information;
• prescribing or ordering documentation, where applicable;
• Certificates of Analysis or other quality documentation where available and applicable.

Supporting documentation provided by the supplying pharmacy or outsourcing facility may be made available upon request where appropriate and permitted.

Certificates of Analysis can provide information concerning the identity, specifications, or testing of pharmaceutical ingredients or preparations, depending on the document and supplier.

Federal compounding requirements also include Certificate of Analysis requirements for certain bulk drug substances used in compounding.

Because documentation varies according to the preparation, supplier, and regulatory pathway, InVita does not represent that the same type of Certificate of Analysis or testing documentation exists for every compounded preparation.

A Certificate of Analysis should not be interpreted as FDA approval of a compounded medication.

InVita does not purchase or administer compounds labeled “research use only,” “for research purposes only,” “not for human use,” or otherwise designated by the supplier as unsuitable for administration to patients.

Products used in patient care are sourced through channels appropriate for human medical use.

Compounded medications are not FDA-approved.

Compounded medications have not undergone the same FDA premarket review for safety, effectiveness, and manufacturing quality as FDA-approved drugs.

FDA registration of a 503B outsourcing facility should therefore not be interpreted as FDA approval of the individual compounded medications produced by that facility.

When a compounded medication is considered for a patient, its use is determined based on the patient’s individual circumstances and the professional judgment of the treating healthcare provider.

There is no single sourcing or regulatory pathway applicable to every compounded preparation used at InVita.

A preparation may come from a 503A compounding pharmacy or a 503B outsourcing facility, depending on the product, individual circumstances, availability, prescription requirements, and applicable law.

For this reason, documentation and regulatory requirements may differ from one preparation to another.

We believe patients should be able to ask questions about the products used in their care.

If you would like information about the source of a particular compounded preparation, please ask the InVita team. Where appropriate and available, we can provide or explain relevant sourcing and supporting documentation.