Contact for 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.
- Proof of inspection may include:
- 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
- Contact information for someone who handles controlled substance distribution records
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
- Download the Pharmacy Outsourcing Facility Application (DOC)
- Fill out the application.
- Include all required and necessary attachments.
- Mail the completed application and all attachments to:
Board of Registration in Pharmacy
239 Causeway St.
Suite 500, 5th Floor
Boston, MA 02114