Controlled Substances - DEA & MDPH Licenses

Controlled Substances - DEA & MDPH Licenses

Approval, Routing and Designation Form

Instructions: All Principal Investigators who wish to apply for new DEA and MDPH controlled substances licenses (a/k/a “registrations"), or who wish to renew previously issued DEA and MDPH licenses, shall do the following:

Complete this Approval and Routing Form.
Print out and complete the MDPH “Application for Massachusetts Controlled Substances Registration to Use Controlled Substances and Investigational New Drugs in Research in Accordance with the Controlled Substances Act, M.G.L. Chapter 94C” (“MDPH Application”) http://www.mass.gov/Eeohhs2/docs/dph/quality/drugcontrol/app_researcher.rtf

Note (1): An example (sample/model) of an Application, which you can refer for guidance in completing the Application, is available at http://ecommons.med.harvard.edu/ec_res/nt/E42F1AC9-CA54-4107-85A5- 179392E03AD5/CS_-_Model_MDPH_CS_Application_Form.rtf.

Note (2): When completing section 13 of the MDPH Application, please adhere to the following directions:

a) Under “Exact Location”, list the building and room location of each drug storage unit for which Licensee is responsible.

b) Under “Construction of Storage Area”, describe both the type of storage unit (e.g. safe, locking metal cabinet), the method of security of the unit (e.g. bolted to wall, affixed to the floor) and the security of the room in which it is located (e.g. locked room with limited access).

c) Under “Accountability System”, describe very briefly the system for limited access to keys or lock combinations by authorized individuals, and the system for proper completion by CS users of the CS inventory log.

d) List all Authorize Individuals (“AIs”) with authorized (key or combination lock) access to each drug storage unit (Note: List AIs in separate groups, by their separate storage unit location).

Designate an appropriate person as your Controlled Substance Manager and complete and sign, along with that person, the attached “Responsible Licensee Designation of CS Manager” form.
If other PIs in your department (or facility location) are obtaining Controlled Substances under your license, have these PIs appoint an appropriate member of their lab as their Controlled Substances Coordinator, and have that PI and that Coordinator sign the attached the “Responsible PI Designation of CS Coordinator” form.
Submit all of the above to the Department CS Director, for his/her review and approval.
Once the CS Director’s approval is obtained, and the CS Director signs this form below, then

a) Submit your application to MDPH

b) Submit copies of all the above (MDPH Application, this completed and signed Approval and Routing Form, the completed and signed CS Manager Designation Form, any required CS Coordinator Designation Form(s)) to the CS Director, and to ORC.

Apply for and obtain your new or renewal DEA License

(Online or in paper, see http://www.deadiversion.usdoj.gov/online_forms.htm)

Once your MDPH and DEA licenses are obtained, store then in clearly marked file and submit copies of both licenses to your CS Director and ORC.

Controlled Substances - DEA & MDPH Licenses

Approval and Routing Form

Licensee Name: ______

New License Application ⁪ Yes⁪ No

Renewal License Application ⁪ Yes⁪ No

If renewal, any Amendment to Information in last application ⁪ Yes ⁪ No

Department:______

Department Chair:______

Chief Department Administrator:______

Dept. Research Operations Manager:______

Designated Controlled Substances Director for Department

Name: ______

Office Address:______

Phone:______

Fax:______

Email: ______

Licensee’s Designated Controlled Substances Manager: [Note: Licensee and Designated CS Manager must sign and submit the attached “Responsible Licensee Designation of CS Manager”]

Name: ______

Office Address:______

Phone:______

Fax:______

Email: ______

Individual Responsible for Ordering and Receiving Controlled Substances on behalf of Licensee (Must be either Department’s Designated CS Director or Licensee’s Designated CS Manager):

Name: ______

Office Address:______

Phone:______

Fax:______

Email: ______

Other PIs Obtaining Controlled Substances through Licensee [If any]:

______
______
______

Drug Storage Unit Location (s):

Licensee’s Primary Storage Unit

Unit Location (Building/Room): ______

Responsible Licensee: ______

PI/Licensee Designated CS Coordinator/Manager: ______

Manager Phone/Email: ______

Authorized Individuals with Unit Access:1.______

2.______

3.______

Additional Storage Unit #1

Unit Location (Building/Room): ______

Responsible PI: ______

PI Designated CS Coordinator: ______

Coordinator Contact Ph/Email: ______

Authorized Individuals with Unit Access:1.______

2.______

3.______

Additional Storage Unit #2

Unit Location (Building/Room): ______

Responsible PI: ______

PI Designated CS Coordinator: ______

Coordinator Contact Ph/Email: ______

Authorized Individuals with Unit Access:1.______

2.______

3.______

Approval by Department’s

Designated CS Director

I have reviewed the foregoing information, the attached MDPH application, and the other attached forms, with the Licensee and the Licensee’s Designated CS Manager, and find them all to be complete, accurate and in compliance with all applicable regulations and rules.

______

CS Director Signature

Name: ______

Date: ______

Controlled Substances Compliance

Department Chair Designation of Department CS Director

As Department Chair, I understand my general responsibility for helping ensure that faculty and other researchers in my department who utilize controlled substances in their research understand their roles and responsibilities with respect to the acquisition, storage, use, accounting and disposal of controlled substances, all which are governed by federal and state law and Harvard University and Harvard Medical School policies.

I am aware of the requirements of the Harvard University Researcher’s Guide for Use of Controlled Substances (“the Guide”) and the “HMS Supplement” to that Guide, both of which are available at the Office of Research Compliance Website at http://medapps.med.harvard.edu/orc/controlledsubstances.html.

To assist the department, and its researchers, in better understanding their obligations relating to controlled substances, and to better ensure our department’s compliance with applicable regulations and policies in this area, I am appointing the following individual as the Department’s Controlled Substances Director and charging that individual with the responsibility for serving as our CS operations and compliance expert, educating all appropriate members of all the CS-utilizing labs in the Department on CS compliance issues, and carrying out the specific tasks described in the above mentioned Guide and HMS Supplement.

Name of Designated CS Director: ______

______

Chair Signature

Chair Name:

Date:

The above named Controlled Substances Director accepts this designation and acknowledges his/her responsibility for carrying out the functions and obligations relating to that role, as described above and in the Harvard University Researcher’s Guide for Use of Controlled Substances and the HMS Supplemental Guide.

______

CS Director Signature

Name:

Date:

Controlled Substances Compliance

Responsible Licensee Designation of CS Manager

As an HMS faculty member holding DEA and MDPH licenses to use controlled substances in research (“Licensee”), I understand my responsibility for ensuring that I, and other researchers and technicians in my department who obtain and use controlled substances under my license, understand our roles and responsibilities and meet all of our regulatory obligations with respect to the acquisition, storage, use, accounting and disposal of controlled substances, all which are governed by federal and state law and Harvard University and Harvard Medical School policies.

To better ensure compliance with all applicable regulations and policy requirements, and to help all researchers and technicians in my lab who utilize controlled substances in our research activities (as well as all other researchers in my department who obtain and use controlled substances under my license) better understand their duties and responsibilities relating to controlled substances, I am appointing the following individual as my Controlled Substances Manager and charging that individual with the responsibility for serving as our CS operations and compliance expert, educating all appropriate members of my lab and other labs on CS compliance issues, and carrying out the specific tasks described in the above mentioned Guide and HMS Supplement.

Name of Designated CS Manager: ______

______

Licensee Signature

Licensee Name:

Date:

The above named Controlled Substances manager accepts this designation and acknowledges his/her responsibility for carrying out the functions and obligations relating to that role, as described above and in the University Researcher’s Guide for Use of Controlled Substances and the HMS Supplemental Guide.

______

CS Manager Signature

Name:

Date:

Controlled Substances Compliance

Responsible PI Designation of CS Coordinator

As an HMS faculty member and Principal Investigator who, in my research, utilizes controlled substances obtained under DEA and MDPH licenses issued to another HMS faculty member in my department (or in my facility location), I understand my responsibility for ensuring that I, and other researchers and technicians in my lab who also utilize controlled substances in research protocols for which I am responsible, understand our roles and responsibilities and meet all of our regulatory obligations with respect to the acquisition, storage, use, accounting and disposal of controlled substances, all which are governed by federal and state law and Harvard University and Harvard Medical School policies.

To better ensure compliance with all applicable regulations and policy requirements, and to help all researchers and technicians in my lab who utilize controlled substances in our research activities better understand their duties and responsibilities relating to controlled substances, I am appointing the following individual as my Controlled Substances Coordinator and charging that individual with the responsibility for serving as our lab’s CS operations and compliance expert, educating all appropriate members of the lab on CS compliance issues, and carrying out the specific tasks described in the above mentioned Guide and HMS Supplement.

Name of Designated CS Coordinator: ______

______

PI Signature

PI Name:

Date:

The above named Controlled Substances Coordinator accepts this designation and acknowledges his/her responsibility for carrying out the functions and obligations relating to that role, as described above and in the Harvard University Researcher’s Guide for Use of Controlled Substances and the HMS Supplemental Guide.

______

CS Coordinator Signature

Name:

Date: