Medication · Also: compounding pharmacy, compounded drug

Compounded medication

A medication custom-prepared by a pharmacy that is not an FDA-approved manufactured product.

A medication custom-prepared by a pharmacy that is not an FDA-approved manufactured product.

Also known as: compounding pharmacy, compounded drug

A compounded medication is prepared by a pharmacy to meet an individual need, for example when a patient cannot use a commercially available form. Compounded drugs are not FDA-approved and are not tested for safety and effectiveness the way manufactured drugs are.

Compounding is regulated under FDA sections 503A and 503B, which set different oversight standards.

Related terms

503A compounding

Traditional pharmacy compounding of medications for individual patient prescriptions under FDA section 503A.

503B outsourcing facility

An FDA-registered compounding facility that follows current good manufacturing practice under section 503B.

Bioidentical hormones

Hormones chemically identical to those the body produces; some are FDA-approved, some are compounded.

Off-label use

Prescribing an FDA-approved drug for a use, dose, or group not specified in its labeling.

Source

FDA: Human Drug Compounding

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