503A / 503B context

Compounded does not mean FDA approved.

Compounding law, shortage policy, clinical evidence, and product quality are separate questions. This page highlights records for substances FDA currently identifies as presenting significant safety concerns or insufficient information.

Read the current FDA source

Approval

FDA has not reviewed a compounded drug for safety, effectiveness, or manufacturing quality before marketing.

Eligibility

Whether a substance may be compounded is a legal and policy question that can change independently from clinical evidence.

Product risk

Identity, potency, sterility, endotoxin, aggregation, and peptide-related impurities can materially affect risk.

FDA SAFETY-RISK LIST

Inspect each entity record.

Recovery / Synthetic peptide

BPC-157

Not FDA approved; FDA identifies important compounding safety and characterization concerns.

Human evidence 1/53 sources

Immune / Inflammation / Peptide fragment

KPV

No FDA-approved drug product; FDA reports no identified human exposure data for compounded KPV products and insufficient safety information.

Human evidence 1/53 sources

Longevity / Mitochondrial-derived peptide

MOTS-c

Not FDA approved; FDA reports no identified human exposure data for drug products containing MOTS-c.

Human evidence 1/53 sources

Growth Hormone / Synthetic peptide

Ipamorelin

No FDA-approved drug product; FDA identifies significant safety and characterization concerns for compounding.

Human evidence 2/52 sources

Immune / Inflammation / Native peptide

LL-37

No FDA-approved LL-37 drug product; FDA reports insufficient human safety information for compounded LL-37 products.

Human evidence 1/53 sources

Weight & Metabolism / Peptide fragment

AOD-9604

No FDA-approved AOD-9604 drug product; FDA identifies limited safety information and potential concerns for compounded use.

Human evidence 2/53 sources

Cognition / Peptide analog

Semax

No FDA-approved Semax drug product; FDA identifies immunogenicity and peptide-impurity concerns for compounded Semax products.

Human evidence 2/53 sources

Cognition / Peptide analog

Selank

No FDA-approved Selank drug product; FDA identifies immunogenicity and peptide-impurity concerns for compounded Selank acetate products.

Human evidence 2/53 sources

Other / Melanocortin receptor agonist

Melanotan II

No FDA-approved Melanotan II drug product; FDA identifies safety and immunogenicity concerns and has warned about illegal marketing.

Human evidence 1/53 sources