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Apply for a resident outsourcing registration

Learn how to apply for a resident outsourcing registration.

Board of Registration in Pharmacy

The Details

What you need

  • 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

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

Fees

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

  1. Download the Pharmacy Outsourcing Facility Application.
  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

Downloads

Contact

Address

239 Causeway St., 5th Floor, Suite 500, Boston, MA 02114

Phone

Fax

(617) 973-0980

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