Regulatory · Also: 503A pharmacy

503A compounding

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

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

Also known as: 503A pharmacy

Section 503A of the federal law covers traditional compounding, in which a licensed pharmacy prepares a medication for an individual patient’s prescription. These preparations are not FDA-approved.

503A facilities are overseen primarily by state boards of pharmacy and are not required to follow the manufacturing standards that apply to 503B outsourcing facilities.

Related terms

503B outsourcing facility

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

Compounded medication

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

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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