Apply for a resident outsourcing registration

Learn how to apply for a resident outsourcing registration.

Board of Registration in Pharmacy

The Details of 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.

    Fees for Apply for a resident outsourcing registration

    We accept checks or money orders. Make it payable to the Commonwealth of Massachusetts. All fees are nonrefundable and nontransferable.

    Name Fee Unit
    Outsourcing facility application fee $750 each
    Application for MA controlled substance registration $225 each
    Handling charge for returned checks $23 each

    How to apply Apply for a resident outsourcing registration

    1. Download the Pharmacy Outsourcing Facility Application (DOC)
    2. Fill out the application.
      • Include all required and necessary attachments.
    3. Mail the completed application and all attachments to:

    Board of Registration in Pharmacy
    239 Causeway St.
    Suite 500, 5th Floor
    Boston, MA 02114

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