Skip to main content

FDA Peptide Compounding

Meaning

FDA Peptide Compounding refers to the regulatory position and guidance issued by the U.S. Food and Drug Administration regarding the preparation of custom-made peptide medications by compounding pharmacies. Compounding is typically reserved for patients with specific clinical needs, such as allergies to commercial product excipients, or for drugs unavailable in the required dosage form. The FDA has expressed significant regulatory concerns over the compounding of certain peptides, especially those lacking established clinical evidence or being marketed without appropriate safety oversight, leading to a complex and evolving regulatory environment for these substances.