Apply for an outsourcing registration

The instructions on how to apply as an FDA 503B outsourcing facility, both resident and non-resident, can be found here.

Board of Registration in Pharmacy

The Details of Apply for an outsourcing registration

What you need for Apply for an outsourcing registration

  • Proof of FDA inspection within the last 2 years; may include a copy of the FDA’s Notice of Inspection, Form 483, or publication of the inspection date(s) on the FDA website listing 503B registered outsourcing facilities.
  • Copy of DEA Registration Certificate, if applicable.

Fees for Apply for an outsourcing registration

Name Fee Unit
Outsourcing facility application – non-resident $750 each
Outsourcing application and controlled substance registration – resident $975 each
Handling charge for returned checks $23 each

How to apply Apply for an outsourcing registration

Go to the Health Professions Licensing Portal  and create an account, or log into your existing account. If this is your first time using this new portal, please visit Health Professions Licensing System User Guide.

Contact for Apply for an outsourcing registration

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