VII: TAX-FREE ALCOHOL, PRESCRIPTION BLANK CONTROL, AND CONTROLLED SUBSTANCE
It is the policy of Brigham and Women’s Hospital that all practitioners involved in animal research obtain their own DEA (Drug Enforcement Agency) number and State Registration for use of controlled substances in their laboratory. A researcher is required to obtain a separate registration for each address where he/she is the responsible researcher for a laboratory where animal research is performed. (For example, if a researcher is responsible for two laboratories where animal research is performed and both are located at 75 Francis Street, the researcher may utilize one registration for both laboratories. If, however, one laboratory is located at 75 Francis Street and the other is located at 221 Longwood Avenue, the researcher must obtain two registrations. This policy is intended to prevent drug diversion and ensure researcher accountability of controlled substances according to Federal and State regulations. To facilitate this process, the following steps must be followed for each responsible researcher:
Registration Requirements:
Obtain DEA registration for research use of Controlled Substances
Obtain State registration for research use of Controlled Substances
- Provide BWH Pharmacy with copy of State and DEA registrations. Copies must be provided on a yearly basis upon renewal
- Establish as necessary notarized Power(s) of Attorney. A Power of Attorney should only be granted on a limited, as needed basis. A maximum of two per laboratory is permitted. Any exceptions must be approved by the Director of Pharmacy or the Senior Vice President of Research. The individual to whom the Power of Attorney is given must be an employee (BWH/BWPO/HMS or PHS) or member of the BWH medical staff. The standard BWH Power of Attorney form must be utilized for this purpose and can be obtained at the BWH Pharmacy Website.
Provide BWH Pharmacy with a copy of the notarized Power(s) of Attorney. Power(s) of Attorney must be verified and updated with BWH Pharmacy on a yearly basis.
To obtain controlled substances:
For all controlled substances complete Pharmacy Requisition for Controlled Substances Form (pink form).
For Schedule II controlled substances you must include a completed DEA 222 form.
Submit forms to BWH Pharmacy. Routine requests will be processed and ready for pick-up within 48 hours.
Controlled Substances will not be obtainable until Registration requirements have been met.
• DEA Form 225 – New Application for Manufacturer, Distributor, Researcher, Analytical Laboratory, Importer, Exporter
https://www.deadiversion.usdoj.gov/webforms/app225Login.jsp
The Registration fee is $130 and must be renewed every year.
The certificate of registration must be maintained at the registered location and kept available for official inspection.
If your lab is currently registered with DEA, you will receive a renewal application approximately 45 days before the registration expiration date. The renewal application will be sent to the address listed on the current registration certificate. If the renewal form is not received within 30 days before the expiration date of the current registration, the researcher should contact the DEA registration unit for their state and request a renewal registration form.
Any time a lab moves to a new physical location or the postal address changes at the same location, a new DEA certificate reflecting the new address must be obtained. It is the lab’s responsibility to notify DEA about a change of address before the effective date of the move. A written request for modification of registration should be sent to the DEA Registration Field Office responsible for their state. If the modification is approved, DEA will issue a new certificate of registration and, if requested, new Schedule II order forms (DEA Form-222, Official Order Form). A Renewal Application for Registration (DEA Form-225a) will only be sent to the registered address on file with DEA. It cannot be forwarded.
Official Order Forms (DEA Form-222) can be initially requested by checking "block 3" on the application for new registration (DEA Form-225). These forms are required to order all Schedule II substances.
• Massachusetts Controlled Substances Registration Form
http://www.mass.gov/dph/dcp/pdf/researchapp.pdf
The Registration fee is $150 and must be renewed every year.
Copies of all renewed registrations must be submitted to the Brigham and Women’s Hospital Pharmacy on a yearly basis.
The Pharmacy Requisition for Controlled Substances Form is supplied by Standard Register. Standard Register can be reached at 617-790-0880 or by emailing via Outlook to Standard Register; reference Form #0600951 when ordering. If you need a Pharmacy Requisition immediately, the Pharmacy Requisition Form is also available from Central Pharmacy.
*For CII substance please be sure to make a notation that it is a CII and complete a DEA222 form.
• The completed DEA 222 form must be submitted along with the Pharmacy Controlled Substance Requisition Form. You must keep the Purchaser’s (blue) copy of the 222.
10.5
• Completing Official DEA 222 Forms
When ordering Schedule II substances, you are responsible for filling in the number of packages, the size of the package and the name of the item. Each Official Order Form must be signed and dated by a person authorized to sign a registration application. When the items are received, the receipt must be documented on the purchaser’s copy (copy 3) the actual number of packages received and the date received.
• To order additional DEA 222 forms:
Official Order Forms may be ordered by calling the DEA Headquarters Registration Unit toll free at 1-800-882-9539 or the nearest DEA Registration Field Office. The forms will be mailed within 10 working days. Official order forms may also be obtained by submitting a completed requisition form, DEA Form 222a, to DEA, Registration Unit, PO Box 28083, Washington, DC 20038-8083. There is no charge for Official Order Forms
https://www.deadiversion.usdoj.gov/webforms/orderFormsRequest.jsp
Any registrant may authorize one or more individuals, whether or not they are located at the registered location, to obtain and execute Official Order Forms by granting a power of attorney to each such individual. The power of attorney must be signed by the same person who signed the most recent application for registration or renewal registration, as well as the individual being authorized to obtain and execute Official Order Forms. The power of attorney may be revoked at any time by the person who signed the power of attorney. The power of attorney should be filed with executed Official Order Forms as a readily retrievable record. The power of attorney is not submitted to DEA.
Power of attorney must be limited and granted on an as needed basis. A maximum of two per laboratory is permitted unless prior approval is obtained from the Director of Pharmacy or the Senior Vice President of Research. The individual to whom the Power of Attorney is given must be an employee (BWH/BWPO/HMS or PHS) or be a member of the BWH Medical Staff. The standard BWH Power of Attorney form must be utilized for this purpose and can be obtained at the BWH Pharmacy Website.
Power of Attorney must be notarized and a copy must be provided to BWH Pharmacy. Power of Attorney must be verified and updated with BWH Pharmacy on a yearly basis.
Record keeping Requirements
Researchers are responsible for maintaining an ongoing perpetual inventory, which documents all controlled substances received, dispensed, or wasted. Researchers must also maintain complete and accurate records for purchases, or returns to a vendor. All records of controlled substances must be maintained for two years. This record keeping system allows a controlled substance to be tracked from the time it is manufactured to the time it is dispensed to the ultimate user.
All records concerning controlled substances must be maintained for at least two years for inspection and copying by duly authorized DEA officials.
All inventories are subject to immediate inspection by the Vice President of Research Administration, the Director of the BWH Pharmacy Department, the Massachusetts Department of Public health, and the Drug Enforcement Administration.
The Code of Federal Regulations (CFR) also requires that all inventories be maintained at the registered location in a readily retrievable manner for at least two years for copying and inspection. After the two-year period has expired, records must be maintained in a retrievable location for seven years.
Records that Must be Maintained
- Official Order Forms (DEA Form-222).
- Power of Attorney authorization to sign Order Forms.
- Receipts and invoices for Schedule III, IV, and V controlled substances.
- All inventory records of controlled substances, including the initial and perpetual inventories.
- Records of controlled substances distributed or dispensed.
- Report of Theft or Loss (DEA Form-106).
- Inventory of Drugs Surrendered for Disposal (DEA Form-41).
- DEA registration certificate.
- MA DPH registration certificate.
Inventory Requirements
When issued a DEA registration, a registrant must take an initial inventory, which is an actual physical count of all controlled substances in their possession. If there are no stocks of controlled substances on hand, the registrant should make a record showing a zero inventory. There is no requirement to submit a copy of the inventory to the DEA.
The Code of Federal Regulations (CFR) requires that the inventory include:
1. The inventory date.
2. The time the inventory is taken (i.e., opening or close of business).
3. The drug name.
4. The drug strength.
5. The drug form (e.g., tablet, capsule, etc.).
6. The number of units/volume.
7. The total quantity.
DEA recommends that the inventory record include:
1. The name, address and DEA registration number of the registrant.
2. The signature of the person or persons responsible for taking the inventory.
Following the initial inventory, the registrant is required to keep a perpetual inventory, which requires the same information as the initial inventory (see list above) of all controlled substances on hand. There is no requirement to submit a copy of the inventory to DEA.
The Brigham and Women’s Hospital requires a complete physical inventory of all controlled substances a minimum of once per month. The term physical inventory means a complete and accurate accounting of all of controlled substances in the possession of the registrant as determined by an actual physical count.
Inventory Count Discrepancies:
Any suspected discrepancy or deviation in inventories must be investigated and resolved by the registrant. BWH Pharmacy will assist in the resolution if requested. If a resolution is not achieved by the registrant, any discrepancy or loss of a controlled substance must be reported immediately by the registrant to the Senior Vice President of Research, BWH Security, and the Director of the BWH Pharmacy Department. Once reported, the loss will be investigated by the Senior Vice President and Director of BWH Pharmacy to resolve the discrepancy or to identify root causes of the loss. A follow-up summary will be provided detailing further steps. If the controlled substances cannot be located or accounted for, the Director of the BWH Pharmacy will notify the registrant whether the registrant must file a report with the Massachusetts Department of Public Health (“Drug Incident Report” located at www.mass.gov/dph), and the Drug Enforcement Administration (DEA form –106). DEA and Massachusetts DPH forms must be completed and submitted by the registrant. Copies of the DPH and DEA loss forms must be sent to the BWH Pharmacy, Risk Management, and the Senior Vice President of Research.
10.8 Storage Requirements:
General: Regulations of the Department of Public Health require every registrant to provide effective physical security controls against theft and diversion of controlled substances. Access to all controlled substances must be restricted to duly authorized personnel. In order to reduce the likelihood of diversion and enable timely identification of potential problems, strict accountability of controlled substances in Schedules II-V must be maintained and an effective level of accountability for those controlled substances in Schedule VI. BWH requires all research labs to store controlled substances in a double locked, permanently affixed cabinet, or in a single locked, permanently affixed cabinet that is stored in a locked room or closet.
10.9 Transport of Controlled Substances
Controlled substances may be picked up and transported only by: (1) the responsible researcher who has obtained the appropriate federal and state registration; (2) the employee or medical staff member to whom a Power of Attorney has been given provided the Power of Attorney is on file with the BWH Pharmacy Department; or (3) a Massachusetts licensed BWH/BWPO/HMS/PHS employee or Massachusetts licensed BWH medical staff member who has been authorized by the responsible researcher to do so.
Pick-up requires Customer Copy (yellow) of the Pharmacy Requisition for Controlled Substances Form as well as the Purchaser’s (blue) copy of the 222 for Schedule II substances.
Proper BWH picture identification must be shown.
• DEA
BOSTON FIELD DIVISION
(617) 557-2200; 1-888-272-5174; (617) 557-2126 (Fax)
BOSTON
JFK Federal Building
15 New Sudbury Street
Room E-400
Boston, MA 02203• Massachusetts Department of Public Health Drug Control Program
305 South Street, 2nd Floor
Jamaica Plain, MA 02130
(617) 983-6700 - Telephone
(617) 524-8062 - Fax
Email: dcp.dph@state.ma.us
Grant Carrow, Director• BWH Pharmacy
Purchasing: Karen Kelley or Tom Burke
(617) 732-7155
Angela Triggs or John Fanikos
(617) 732-7153
References:
Office of diversion
Control
http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/index.htm
Department of Public
Health
http://www.mass.gov/dph
Appendix I
Appendix II
Frequently Asked Questions
Controlled Substances for Animal Research
Q. I already have a DEA license. Why do I need to have one for my research lab?
A. This is a requirement of the Mass Department of Public Health. It ensures that the researcher is solely responsible for the use and control of Controlled Substances and that the BWH cannot be held liable for misuse or diversion.
Q. Will the BWH Pharmacy provide adequate support, training and updated information for the transition?
A. A step by step manual has been created and will be available on the BWH pharmacy website: http://www.bwhpikenotes.org/PatientCareServices/Pharmacy/pharmacyMain.asp
Additional assistance may be obtained by contacting Angela Triggs, RPh., Pharmacy.
Q. Will the BWH allow sufficient transition time for this new policy such that the continuation of my animal experiments will not be compromised?
A. The pharmacy will continue to provide Controlled Substances to research labs in the current capacity through July 1, 2006.
Q. Where do I obtain Controlled Substances for my research?
A. The purchase of all controlled substances for animal research will be done through BWH Pharmacy by the researcher.
Q. Can any member of the research staff order controlled substances?
A. Only staff members who have a DEA and State Registration on file with BWH Pharmacy or a proper executed Power of Attorney form may order Controlled substances.
Q. How do I obtain DEA order forms required for ordering Schedule II substances?
A. Official Order Forms can be initially requested by checking "block 3" on the application for new registration (DEA Form-224). There is no charge. Once a registrant has received Official Order Forms (DEA Form-222), a separate requisition form (DEA Form-222a) will be mailed to the registrant to request additional Official Order Forms. The registrant may also request Official Order Forms by calling either the DEA Headquarters Registration Unit (toll free: 1-800-882-9539) or the nearest DEA Registration Field Office
Q. Can any member of the research staff pick-up and transport controlled substances?
A. Only staff members who are authorized to order Controlled Substances or MA licensed personnel may pick up and transport Controlled Substances. Proper BWH picture identification must be shown.
Q. How long must records of Controlled Substance procurement and utilization be kept?
A. All documentation must be kept at the registered location and readily retrievable for 2 years. After 2 years, storage is required for an additional 7 years.
Q. How do I obtain a double locked cabinet?