Compounded vs. FDA-Approved Peptides: What the Difference Means
The word “peptide” covers both FDA-approved medicines and compounded or unapproved products. This page summarizes what FDA says about the difference. The main source is FDA’s Compounding and the FDA: Questions and Answers.
Compounded drugs are not FDA-approved
FDA states: “Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed.” FDA also notes that compounded drugs are not generics, which are approved under section 505(j).
When FDA says compounding is appropriate
FDA describes compounding for patients who cannot be treated with an FDA-approved medication. One example is a patient allergic to a dye. FDA says compounded drugs “should only be used in patients whose medical needs cannot be met by an FDA-approved drug,” and that poor compounding practices can cause contamination or wrong strength.
503A pharmacies vs. 503B outsourcing facilities
| 503A (state-licensed pharmacy/physician) | 503B (outsourcing facility) | |
|---|---|---|
| Primary oversight | State boards of pharmacy (FDA can do surveillance and for-cause inspections) | FDA, risk-based inspection schedule |
| CGMP requirements | Not subject to CGMP | Subject to CGMP |
| Created by | FD&C Act section 503A | Drug Quality and Security Act (2013) |
Source: FDA Q&A.
Which bulk substances a 503A pharmacy may use is a separate question. See our 503A bulks explainer.
Biologics cannot be compounded
FDA states that biological products “are not eligible for the exemptions for compounded drugs under sections 503A and 503B.”
Buying compounded drugs online
FDA says consumers buying compounded drugs through online pharmacies or telehealth platforms “may not know the identity of the compounder.” FDA encourages consumers to research the pharmacy and to talk to a healthcare provider, and it points to BeSafeRx.
Limits of this summary
This page explains regulatory categories. It is not a recommendation to use any product.