Approved, generic
or compounded?

FDA-approved brand-name and generic medicines.

Approval applies to a particular product and its labeling. Generic medicines go through an FDA approval pathway; the FDA distinguishes approved generics from compounded preparations. A brand reference can help identify a medicine, but the product name, strength, formulation and route still matter.

Compounded preparations.

The FDA explains that compounded medicines are not FDA-approved and do not undergo its premarket review for safety, effectiveness and quality. Compounding can meet a particular patient need when an approved medicine is not medically appropriate.

A mixture containing an approved ingredient is not automatically an approved finished product. Ask whether the proposed preparation is approved or compounded, and why that particular product is being considered for you.

An approved product and an approved use are separate questions.

The FDA describes off-label use as using an approved drug in a way that differs from its approved labeling. That can concern the condition, dose or route. It does not mean the FDA has approved that particular use.

Ask your clinician to explain the intended use and the information supporting the decision. This guide is not a recommendation for a specific treatment.

How PEPT-I-DO organizes its directory.

Our directory focuses on FDA-approved products and their specified indications. It does not list research-only peptides or unapproved compounded blends as treatment options. A directory listing does not confirm availability, eligibility or a prescription.