Dear Dr Jay Bouldin, BSc, MSc, MBBS/MD, PHD'22,
We acknowledge receipt of your outsourcing facility registration information submitted via FDA's Electronic Registration System dated 01/22/2022 for your facility SUD Facility Optimization, LLC .
Please be aware that section 503B of the Federal Food, Drug, and Cosmetic Act (FD&c Act) defines an outsourcing facility, in part, as a facility that is engaged in the compounding of sterile drugs (section 503B(d)(4)).
FDA has issued a guidance, For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act, see
to help clarify which products are eligible for the exemptions under section 503B and which are not, and we recommend you review this guidance and section 503B of the FD&c Act before you proceed with the registration process.
We will promptly issue an invoice to you for the establishment (registration) fee that must be paid under sections 503B and 744K of the FD&c Act before your facility can be considered a registered outsourcing facility. Once an invoice is issued, if an entity does not pay the full invoiced amount within fifteen calendar days, FDA will consider the submission of registration information to have been withdrawn and adjust the invoice to reflect that no fees are due. However, FDA has determined that once an entity pays the full establishment fee pursuant to sections 503B and 744K of the FD&c Act, it will not be refunded, even if an entity that has registered as an outsourcing facility subsequently withdraws its registration as an outsourcing facility.
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