Controlled Substances

Tufts EHS is primarily involved with the disposal of controlled substances.

Tufts University requires that all individuals conducting activities with DEA controlled substances be registered with the DEA and comply with state and federal regulations regarding the acquisition, storage, use and disposal of those substances.

To apply for a DEA license please see:
http://www.deadiversion.usdoj.gov/drugreg/index.html

To apply for a license with the Massachusetts Department of Public Health please see:
http://www.mass.gov/eohhs/gov/departments/dph/programs/hcq/drug-control/mcsr/application-for-controlled-substances-registration.html

DEA license holders at Tufts University are required to comply with DEA and MADPH regulations.  They are summarized below:

Purchasing:
Please see Tufts University’s purchasing department procedures at:
http://finance.tufts.edu/purchasing/10-purchasing-controlled-substances/

Storage:
As indicated in the Controlled Substances Security Manual, security requirements may vary according to the number of employees with access to controlled substances, the location of the registrant (high or low crime area), availability of an effective alarm system, the quantity of controlled substances on hand, and any prior history of theft or diversion.  Minimum standards require that controlled substances be stored in a securely locked cabinet of “substantial construction.” Although the locked cabinet construction is not specifically defined, the intent of the regulation is to ensure that controlled substances are adequately safeguarded.

Inventory and Dispensing Record-keeping:
Each registrant is required to take an initial inventory of controlled substances (at the initial registration) and biennially thereafter. Records must be retained for two years. Records for Schedules I-III drugs must include the name of the substance, the size of the finished form in metric weight or volume (or if not in finished form, the quantity of the substance to the nearest metric unit of weight), and the number of units or volume in finished form.

Reporting Losses:
Any losses must be reported. If there is a theft or significant loss of any controlled substances, registrants must notify their DEA field offices and the designated agent of the Commonwealth. Registrants must retain these reports for a period of two years following the date of the theft or significant loss.

Disposal:
According to the DEA Practitioners’ Manual “a practitioner may dispose out-of-date, damaged, or otherwise unusable or unwanted controlled substances, including samples, by transferring them to a registrant (reverse distributor) who is authorized to receive such materials. The practitioner must maintain copies of the records documenting the transfer and disposal of controlled substances for a period of two years. Tufts has contracted with Veolia, a reverse distributor to collect expired or unused controlled substances, prepare the DEA Form 222, and remove, transport and incinerate them.  Tufts EHS contracts with Veolia to do quarterly pick-ups of controlled substances.  Please contact EHS at x63615, to schedule a pick-up.

DEA Controlled Substances Security Manual:
http://www.deadiversion.usdoj.gov/pubs/manuals/sec/index.html

DEA Practitioner’s Manual:
http://www.deadiversion.usdoj.gov/pubs/manuals/pract/index.html

http://www.deadiversion.usdoj.gov/pubs/manuals/pract/pract_manual012508.pdf

Massachusetts Department of Public Health (MDPH):
http://www.mass.gov/eohhs/gov/departments/dph/programs/hcq/drug-control/

In addition to DEA and MDPH regulations on controlled substances researchers must comply with Tufts Institutional Animal Care and Use Committee (IACUC) policies and procedures. The IACUC performs routine inspections which includes controlled substance storage and control and seeks compliance with the Guide for the Care and Use of Laboratory Animals: Eighth Edition.

http://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-Use-of-Laboratory-Animals.pdf

For more information on IACUC policies and procedures, please contact Tufts Office of the Vice Provost for Research.

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