Regulatory
Bulk Substance
An active ingredient used by a compounding pharmacy to prepare a custom medication.
Definition
Under Section 503A, compounding pharmacies may only use bulk substances that are on the FDA's approved list or are the subject of an FDA-approved drug. The FDA maintains nomination and review lists for candidate bulk substances.
Related terms
- Compounding PharmacyA pharmacy that prepares customized medications not commercially available.
- 503A PharmacyA pharmacy registered under Section 503A of the FDCA to compound patient-specific prescriptions.
- FDA Compounding Category 2FDA designation for bulk substances that cannot be used in compounded drugs due to safety concerns.
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