What is a FDA 503B?

What is a FDA 503B?

Section 503B(d) defines an outsourcing facility, in part, as “a facility at one geographic location or address.” FDA interprets “facility,” as used in this section, to mean a business or other entity under one management, direct or indirect, engaged in the compounding of human drug products.

Do compounding pharmacies have to register with the FDA?

To register as an outsourcing facility, a compounder must use the electronic registration system unless granted a waiver. See FDA’s final guidance, Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act for more information.

Are compounded drugs safe?

Compounded drugs can serve an important medical need for patients, but they do not have the same safety, quality, and effectiveness assurances as approved drugs. Unnecessary use of compounded drugs unnecessarily exposes patients to potentially serious health risks.

Can a pharmacy be both 503A and 503B?

503A compounding complies with USP <797> standards and focuses on customized patient-specific compounding dispensed only with a prescription….It takes both to meet your compounding needs.

503A 503B
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Are compounded drugs new drugs?

Although compounded drugs are considered new drugs, it would not be practicable for pharmacies to obtain FDA approval for each drug compounded for an individual patient. Thus, compounded drugs are not evaluated by FDA prior to marketing for safety, effectiveness, or quality.