FDA-approved and compounded products are different
FDA-approved medicines undergo agency review for safety, effectiveness and manufacturing quality before approval. Compounded medicines are not FDA-approved, and FDA does not review their safety, effectiveness or quality before they are marketed.
Compounded does not mean generic
An FDA-approved generic must meet agency requirements and receive approval. A compounded drug is not an approved generic and should not be marketed as the same as an FDA-approved brand.
Evidence and claims associated with an approved product cannot automatically be applied to a compounded formulation.
Know exactly what you receive
Confirm the active ingredient, formulation, concentration, dispensing pharmacy and whether the medicine is FDA-approved or compounded. Products sold with misleading labels or from unverified sources may create additional risks.
Contact the pharmacy before use if the medicine, packaging or instructions differ from what was expected.
Dosing and concentration errors
FDA has reported dosing errors involving compounded injectable semaglutide. Confusion among milligrams, milliliters and syringe units can lead to substantial overdoses.
Use only the written instructions for the exact prescription and ask the dispensing pharmacist when the concentration, dose or syringe marking is unclear.
Multi-dose vials require careful handling
Some compounded products may be supplied in vials containing multiple doses. Follow the dispensing pharmacy’s written storage, handling and beyond-use instructions, and ask when the vial must be discarded after first use.
Do not continue using a vial merely because liquid remains inside.
Use product-specific warnings
Contraindications, warnings, missed-dose directions, storage requirements and urgent symptoms differ by medicine. Read the current medication guide or prescribing information supplied with the exact product and contact a licensed clinician about personal risks.
Recognize telehealth and product red flags
Pause when a seller guarantees a prescription, skips meaningful clinical screening, cannot identify the responsible clinician or pharmacy, minimizes product differences, or sends damaged packaging without clear instructions.
Prescription medicines should come through a legitimate clinical evaluation and an appropriately licensed pharmacy.
Report problems and seek appropriate care
Seek emergency care for life-threatening symptoms. Questions about side effects, unexpected product appearance, damaged packaging or dosing should be directed promptly to the prescriber or dispensing pharmacy.
Patients and healthcare professionals can also report adverse events and product-quality problems through the appropriate FDA reporting channels.