"Application for Distributor License and Controlled Substances Registration" - Rhode Island

This "Application for Distributor License and Controlled Substances Registration" is a part of the paperwork released by the Rhode Island Department of Health specifically for Rhode Island residents.

The latest fillable version of the document was released on December 10, 2012 and can be downloaded through the link below or found through the department's forms library.

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Download "Application for Distributor License and Controlled Substances Registration" - Rhode Island

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*** Submit This Cover Page With Application ***
***FOR OFFICE USE ONLY***
Receipt #:
ID#:
Issue Date:
License #
DIS
CDIS
Rhode Island
Board of Pharmacy
Room 205
3 Capitol Hill
Providence, RI 02908-5097
Instructions and Application For
Distributor License
and
Controlled Substances Registration
Wholesaler
New Application
Manufacturer
Controlled Substances Registration
Change of Location (License # _________ )
Change in Ownership (License # _________ )
Applicant - Print Pharmacy/Facility Name
Phone: (401) 222-2837
TTY/TDD: (800) 745-5555
Fax: (401) 222-2158
Revised 12/10/2012 jcp
*** Submit This Cover Page With Application ***
***FOR OFFICE USE ONLY***
Receipt #:
ID#:
Issue Date:
License #
DIS
CDIS
Rhode Island
Board of Pharmacy
Room 205
3 Capitol Hill
Providence, RI 02908-5097
Instructions and Application For
Distributor License
and
Controlled Substances Registration
Wholesaler
New Application
Manufacturer
Controlled Substances Registration
Change of Location (License # _________ )
Change in Ownership (License # _________ )
Applicant - Print Pharmacy/Facility Name
Phone: (401) 222-2837
TTY/TDD: (800) 745-5555
Fax: (401) 222-2158
Revised 12/10/2012 jcp
***Detach Page - Do Not Submit With Application ***
GENERAL INFORMATION
Enclosures
The following materials and information should be enclosed within this application packet:
Application Process Overview........................................................................................................... 4
Instructions for Completing Application..............................................................................................6
Application Materials
Application.............................................................................................................................. 7-10
Application Checklist.............................................................................................................. 11
Licensure Requirements
Wholesaler
• In State - Application Fee of $220.00 (add $100.00 for Controlled Substances Registration for a total
of $320.00) Check or money order only (NOTE: All application fees are non-refundable)
• Out-Of-State - Application Fee of $340.00 (add $100.00 for Controlled Substances Registration for a
total of $440.00) Check or money order only (NOTE: All application fees are non-refundable)
• Federal Drug Enforcement Administration (DEA) Registration (if applicable)
• Licensure in state in which located (for Out-of-State Wholesalers)
Manufacturer
• In State - Application Fee of $220.00 (add $100.00 for Controlled Substances Registration for a total
of $320.00) Check or money order only (NOTE: All application fees are non-refundable)
• Out-Of-State - Application Fee of $340.00 (add $100.00 for Controlled Substances Registration for a
total of $440.00) Check or money order only (NOTE: All application fees are non-refundable)
• Federal Registration of Establishment/Facility
• Federal Drug Enforcement Administration (DEA) Registration (if applicable)
• Licensure in state in which located (for Out-of-State Manufacturers)
Every wholesale distributor and/or manufacturer, wherever located, who engages in wholesale distribution into,
out of, or within this state, must be registered licensed by the Board in accordance with the laws and
regulations of this state, before engaging in wholesale distribution of prescription drugs. Where operations are
conducted at more than one location by a single wholesale distributor, each such location distributing into the
state shall be registered licensed by the Board. Each board of pharmacy in the state(s) in which the applicant
holds a registration or license shall submit to the Department in this state a statement confirming the applicant
holds a current license in good standing in said state.
A “Wholesaler” is a person who buys drugs or devices for resale and distribution to corporations, individuals,
or entities other than consumers. A “Wholesale Distributor” is anyone engaged in the wholesale distribution of
drugs, including, but not limited to, manufacturers, repackers, own-label distributors, private-label distributors,
jobbers, brokers, warehouses, including manufacturers’ and distributors’ warehouses, chain drug warehouses,
and wholesale drug warehouses, independent wholesale drug traders, and retail pharmacies that conduct
wholesale distribution.
“Manufacturer” means anyone who is engaged in manufacturing, preparing, propagating, compounding,
processing, packaging, repackaging, or labeling of a prescription drug or poisons. “Manufacturing” means the
production, preparation, propagation, conversion or processing of a drug or device, either directly or indirectly,
by extraction from substances of natural origin or independently by means of chemical or biological synthesis,
and includes any packaging or repackaging of the substances or labeling or relabeling of its container, and the
promotion and marketing of such drugs and devices. Manufacturing also includes the preparation and
promotion of commercially available products from bulk compounds for resale by pharmacists, practitioners,
or other persons.
Rhode Island Board of Pharmacy - Page 2
***Detach Page - Do Not Submit With Application ***
GENERAL INFORMATION (CONTINUED)
Wholesale drug distributors and/or manufacturers that deal in controlled substances shall register with the
Department of Health, and with the Drug Enforcement Administration (DEA), and shall comply with all
applicable state, local and DEA regulations.
“Wholesale distribution” means distribution of prescription drugs to person other than a consumer or patient,
but does not include:
• intracompany sales;
• the purchase or other acquisition by a hospital or other health care entity that is a member of a group
purchasing organization of a drug for its own use from the group purchasing organization or from other
hospitals or health care entities that are members of such organizations;
• the sale, purchase or trade of a drug of an offer to sell, purchase, or trade a drug by a charitable organization
to a non-profit affiliate of the organization to the extent otherwise permitted by law;
• the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug among hospitals or other
health care entities that are under common control. For purposes of this section, “common control” means
the power to direct or cause the direction of the management and policies of a person or an organization,
whether by ownership of stock, voting rights, by contract or otherwise;
• the sale, purchase or trade of a drug or an offer to sell, purchase, or trade a drug for emergency medical
reasons. For purposes of this section, “emergency medical reasons” includes transfers of prescription drugs
by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage;
• the sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug
pursuant to a prescription.
• the lawful distribution of drug samples by manufacturers’ representatives or distributors’ representatives.
• the sale, purchase, or trade of blood and blood components intended for transfusion.
Where operations are conducted at more than one location by a single wholesale distributor, each such location
distributing into the state shall be licensed by the Board. Each board of pharmacy in the state(s) in which the
applicant holds a registration or license shall submit to the Department in this state a statement confirming the
applicant holds a current license in good standing in said state.
Rules and Regulations
To obtain the Rules and Regulations for your profession visit the A-Z list on the Topics & Programs page at the
following web site. From the list click on the letter for your profession.
http://www.health.ri.gov/atoz/
Rhode Island Board of Pharmacy - Page 3
***Detach Page - Do Not Submit With Application ***
APPLICATION PROCESS OVERVIEW
The licensure process in the State of Rhode Island is conducted by the Rhode Island Department of Health
(HEALTH), Office of Health Professions Regulation, and the Rhode Island Board of Pharmacy (BOARD).
Application Process
This application is to be used for a new license as a drug distributor (out-of-state wholesaler or
manufacturer),and to apply for a new license due to a change in ownership or location. A license will be
issued to a person,owner, corporation, or other legal entity, hereinafter called the “Licensee”. The license shall
entitle the owner to operate such facility at the location specified and shall not be transferred. When there is a
change in ownership, operation and/or location, the license immediately becomes void and shall be delivered
by the licensee to the BOARD. It is the duty of the owner to immediately notify the BOARD of any proposed
change of location or ownership, and to file the required application prior to the change. Changes in any
information required bythis section shall be submitted to the Department within fifteen (15) days of change.
“Change of ownership” means:
a. In the case of a pharmacy, manufacturer or wholesaler which is a partnership which results in a new
partner acquiring a controlling interest in the partnership;
b. In the case of a pharmacy, manufacturer or wholesaler which is a sole proprietorship, the transfer of
the title and property to another person;
c. In the case of a pharmacy, manufacturer or wholesaler which is a corporation:
i. A sale, lease exchange, or other disposition of all, or substantially all of the property and
assets of the corporation; or
ii. A merger of the corporation into another corporation; or
iii. The consolidation of two or more corporations, resulting in the creation of a new corporation; or
iv. In the case of a pharmacy, manufacturer or wholesaler which is a business corporation, any
transfer of corporate stock which results in a new person acquiring a controlling interest in
the corporation; or
v. In the case of a pharmacy, manufacturer or wholesaler which is a nonbusiness corporation,
any change in membership which results in a new person acquiring a controlling vote in the
corporation.
All items listed on the “checklist” (page 11) must be submitted for an application to be considered complete. All
applications are considered valid for six months from the day they are received at HEALTH. If you do not
complete the application process and obtain a license within those six months, a new application and fee must
be submitted.
If the applicant has had criminal or disciplinary history in Rhode Island or another state, it may take an
additional two or three months for all pertinent documentation to be received, and a decision to be made
regarding the issuance of a license. This is an estimate of the amount of time that is required to become
licensed. The entire process may take more or less time than estimated.
Licenses will be issued within five working days following the Board’s approval of the completed application.
Wall permits are mailed approximately two weeks from the date of issuance, and are mailed to the address
furnished in the application. It is the applicant’s responsibility to notify the BOARD, in writing, if there are
changes during the interim, or at any time after the license is issued.
Rhode Island Board of Pharmacy - Page 4
***Detach Page - Do Not Submit With Application ***
APPLICATION PROCESS OVERVIEW
(continued)
HEALTH will not, for any reason, accelerate processing of one applicant at the expense of other applicants.
Once completed, the application will be reviewed, and will be contacted by the BOARD if further information is
required. Be advised, the applicant may be required to appear for an interview.
NOTE:
Licensure application materials are public records as mandated by Rhode Island law and may be made
available to the public, unless otherwise prohibited by State or Federal Law.
The license will expire on September 30th (regardless of the date issued), and a form will be mailed to renew
the pharmacy license for the period October1st through September 30th. It is the licensee’s responsibility to
maintain an active license. If a renewal is not received, the licensee is to contact the BOARD to follow-up on
the status of the renewal:
https://healthri.mylicense.com/Verification/
Please continue to review the remaining portions of this application packet for instructions and other materials
necessary to complete the Board application. If you have any questions about this application process, or
would like to check on the status of your BOARD application, please contact the BOARD at (401) 222-2837.
Rhode Island Board of Pharmacy - Page 5
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