Apply for a resident outsourcing registration

What you need for Apply for a resident outsourcing registration

• Name and location of facility
• Name of owner(s)
  • Indicate if individual or partner

If applicable

• Parent company information
• If your company is registered as a 503B Outsourcing Facility by the FDA:
  • Registration number
• Date of most recent FDA inspection
• If your facility had an FDA inspection within the last two years, attach proof of inspection
  • Proof of inspection may include:
    • A copy of the FDA’s Notice of Inspection or Form 483
    • Publication of the inspection date(s) on the FDA website listing 503 B registered outsourcing facilities.
• If your outsourcing facility ever been suspended, revoked or otherwise disciplined:
  • Attach a detailed explanation, along with copy of legal documentation of discipline
• If you also ship controlled drugs
  • Contact information for someone who handles controlled substance distribution records
    • Name
    • Telephone
    • Fax
    • Email address
    • Mailing address
  • Attach a copy of your company’s DEA permit

Controlled substance registration

Resident outsourcing facilities must fill out this attached form on the application.

You will need:

• Registration classification
• Drug schedule
• Current Drug Store Permit Number, if applicable
• Current Wholesale Distributor / Druggist License Number, if applicable
• Payment of controlled substance registration fee

If the applicant is an entity

• A certificate of good standing and legal existence issued by the Secretary of State. You can also submit the equivalent in the state in which the entity was organized or formed.
• A statement of the name and address of each officer, director, or partner of the entity and the position held
• The “doing business as” (DBA) name of the entity
• If the corporation is not publicly owned:
  • The total amount and type of stock issued to each stockholder
  • The names and addresses of said stockholder(s)
• If the outsourcing facility is licensed or registered by another state:
  • Proof of good standing from the licensing or registering authority, issued within three months

Affidavit

You must sign the affidavit on the application and have it witnessed by a Notary Public.