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RESEARCH USE OF CONTROLLED SUBSTANCES:
FREQUENTLY ASKED QUESTIONS

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REGISTRATION AND LICENSING

1. I do not presently hold a State of Michigan researcher license or a DEA researcher registration for controlled substances.  How do I get one?

If you use controlled substances and do not presently hold a State of Michigan license/DEA registration, you must start the application process to obtain both the state license and the federal registration.

See Obtaining a Controlled Substances License and Registration for additional information.

2. Who needs to have a State of Michigan controlled substance research license and DEA controlled substance research registration?

Each Principal Investigator must have a current State of Michigan license and DEA registration for the laboratory location where controlled substances are delivered, stored, and administered.  Refer to the Registration and Licensing Overview for additional information.

21 USC 822

(a)(2) Every person who dispenses, or who proposes to dispense, any controlled substance, shall obtain from the Attorney General a registration issued in accordance with the rules and regulations promulgated by him. The Attorney General shall, by regulation, determine the period of such registrations. In no event, however, shall such registrations be issued for less than one year nor more than three years.

21 CFR 1301.11

(a) Every person who manufactures, distributes, dispenses, imports, or exports any controlled substance or who proposes to engage in the manufacture, distribution, dispensing, importation or exportation of any controlled substance shall obtain a registration unless exempted by law or pursuant to §§1301.22 through 1301.26.

MI 333.7303

(1)  A person who manufactures, distributes, prescribes, or dispenses a controlled substance in this state or who proposes to engage in the manufacture, distribution, prescribing, or dispensing of a controlled substance in this state shall obtain a license issued by the administrator in accordance with the rules.

MI R 338.3132

Rule 32. (1) The following activities are deemed to be independent of each other, shall be conducted under separate licenses, and shall comply with all of the requirements and duties prescribed by law for persons who are licensed to engage in such coincidental activities:

(c) Conducting research and instructional activity with a controlled substance listed in schedule 1 as follows . . .
(d) Conducting research with a controlled substance listed in schedules 2 to 5 . . .

3. What is the difference between a licensee and a registrant?

As used in the associated documents, a licensee is a person who has a current State of Michigan license to use, store and administer controlled substances for research purposes.  A registrant is a person who has a current DEA registration to use, store and administer controlled substances for research purposes.  In Michigan, you must have both a license from the State of Michigan and a registration from the DEA to use, store and administer controlled substances for research purposes.

4. I am a medical practitioner. Can I use the same license/registration for medical and research purposes?

If you are a medical practitioner, it is possible to use the same license for medical and research purposes for Schedule II-V controlled substances and with special approval, Schedule I. However, the location listed on the license and registration must be the same location where both activities take place.  If this is not the case, you will need to obtain a separate research license and registration.

21 USC 823

(f) Separate registration under this part for practitioners engaging in research with controlled substances in schedule II, III, IV, or V, who are already registered under this part in another capacity shall not be required. Registration applications by practitioners wishing to conduct research with controlled substances in schedule I shall be referred to the Secretary, who shall determine the qualifications and competency of each practitioner requesting registration, as well as the merits of the research protocol. . . .

MI 333.7306

(3) A practitioner shall be licensed to dispense or prescribe any controlled substances or to conduct research with controlled substances in schedules 2 to 5 if the practitioner is authorized to dispense, prescribe, or conduct research under the laws of this state. The administrator need not require separate licensure under this article for a practitioner engaging in research with nonnarcotic controlled substances in schedules 2 to 5 if the licensee is licensed under this article in another capacity. A practitioner registered under federal law to conduct research with schedule 1 substances may conduct research with schedule 1 substances in this state upon furnishing the administrator evidence of that federal registration.

21 CFR 1301.13

(e)(iv) Dispensing or instructing (includes Practitioner, Hospital/Clinic, Retail Pharmacy, Online Pharmacy, Central fill pharmacy, Teaching Institution) … May conduct research and instructional activities with those substances for which registration was granted, except that a mid-level practitioner may conduct such research only to the extent expressly authorized under State statute. A pharmacist may manufacture an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in Schedule II–V in a proportion not exceeding 20% of the complete solution, compound or mixture. A retail pharmacy may perform central fill pharmacy activities. An online pharmacy may perform activities of retail pharmacy as well as online pharmacy activities.

5. I conduct research in several different locations on campus.  Do I need a separate State of Michigan license and DEA registration for each location?

The activity associated with the controlled substance must be done at the registered storage location of the drug.  There can only be one storage location for each registration, and ALL materials must be stored at the location on the license and registration.

Laboratories in separate locations that receive, store, or administer controlled substances at those locations must acquire a separate State of Michigan controlled substance license and DEA registration for each location.

Materials may be checked out of the storage location for immediate use in a research protocol and then any remaining material returned to the storage location by the end of the day.  Each step of this process must be documented and the materials must be secured at all times.

21 USC 822

(e) A separate registration shall be required at ach principal place of business or professional practice where the applicant manufactures, distributes, or dispenses controlled substances or list I chemicals.

21 CFR 1301.12

(a) As separate registration is required for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, imported, exported, or dispensed by a person.

MI 333.7303

(5) A separate license is required at each principal place of business or professional practice where the applicant manufactures, distributes, prescribes, or dispenses controlled substances.

MI R 338.3132

(2) A separate license is required for each principal place of business or professional practice.  A principal place of business or a professional practice is the physical location where controlled substances   are manufactured, grown, cultivated, processed, or by other means produced or prepared, distributed, stored, or dispensed by a licensee.

(3) If a principal place of business or professional practice consists of multiple locations, then each location shall obtain a separate controlled substance license if controlled substances are received, stored, administered, or dispensed at that location.

6. What fees are associated with getting and maintaining my State of Michigan License and DEA Registration?

State of Michigan Fees:

  • Fingerprinting/Background Check- $62.75 (one time)
  • Application Fee- $85 (annually)

Federal Fees:

  • Application Fee- $244 (annually- increase in price as of April 16, 2012)
    However, employees of the university qualify for the fee exemption.  The department chair qualifies as a certifying official for this purpose.

7. Do I qualify for the fee exemption on the DEA registration application (DEA Form 225, Section 6)?

Yes. Employees of the university qualify for the fee exemption.  DEA Form 225, Section 6, requires the signature of a “certifying official (other than the applicant).”  The department chair qualifies as a “certifying official” for this purpose.

21 CFR 1301.21

(a) The Administrator shall exempt from payment of an application fee for registration or reregistration:

(1) Any hospital or other institution which is operated by an agency of the United States . . ., of any State or any political subdivision or agency thereof.

8. Can I charge the State of Michigan fingerprinting and application fees to a grant or contract?

Maybe. The fee for the State of Michigan license may be charged to the grant or contract only if you can show that there is direct benefit to the research project funded by the grant or contract. If obtaining the State of Michigan license will benefit other projects (funded or non-funded), the charge must be appropriately prorated. 

There is no requirement to charge this cost to the grant or contract. If you have questions about charging the cost to a grant, contact the MSU Contract and Grant Administration (355-5040).

9. MSU Police has the ability to do fingerprinting.  Can I get my fingerprinting for the State of Michigan background check done there?

No.  You must use one of the vendors listed on the State of Michigan license application.

10. How long does registration last? When do I need to renew my State of Michigan license and DEA registration?

Both the State of Michigan license and the DEA registration must be renewed annually.

21 U.S.C. 822

(a)(2) The Attorney General shall, by regulation, determine the period of such registrations. In no event, however, shall such registrations be issued for less than one year nor for more than three years.

21CFR 1301.13

(b) Any person who is registered may apply to be reregistered not more than 60 days before the expiration date of his/her registration . . .

(c) At the time a . . . researcher  . . . is first registered, that business activity shall be assigned to one of twelve groups, which shall correspond to the months of the year. The expiration date of the registrations of all registrants within any group will be the last date of the month designated for that group.

MI 333.7303

(1) A person who has been issued a controlled substances license by the administrator under this article and a license under article 15 [occupations] shall renew the controlled substances license concurrently with the renewal of the license issued under article 15, and for an equal number of years.

11. How do I know when I have been approved and can begin using controlled substances?

The State of Michigan will issue you a license number and the DEA will issue you a registration number once you have been approved.  You will need the DEA registration number to order controlled substances.

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AUTHORIZED USE

1. Can I assign controlled substance related duties to my laboratory employees?

The licensee/registrant may delegate responsibility to others by designating them as authorized agents when certain conditions are met. The licensee/registrant must document each activity that has been delegated to each authorized agent.  This documentation must be updated as necessary.

For additional information regarding authorized agents refer to the overview on authorized use.

21 USC 822

(c)   The following persons shall not be required to register and may lawfully possess any controlled substance or list I chemical under this subchapter:

(1)      An agent or employee of any registered manufacturer, distributor, or dispenser of any controlled substance or list I chemical if such agent or employee is acting in the usual course of his business or employment.

21 USC 802

(3) The term “agent” means an authorized person who acts on behalf of or at the discretion of a manufacturer, distributor, or dispenser; except that such term does not include a common or contract carrier, public warehouseman, or employee of the carrier, public warehouseman, or employee of the carrier or warehouseman, when acting in the usual and lawful course of the carrier’s or warehouseman’s business.

MI 333.7303

(3) The following persons need not be licensed and may lawfully possess controlled substances or prescription forms under this article:

(a) An agent or employee of a licensed manufacturer, distributor, prescriber, or dispenser of a controlled substance if acting in the usual course of the agent's or employee's business or employment.

21 CFR 1301.22 (a)

(a) The requirement of registration is waived for any agent or employee of a person who is registered to engage in any group of independent activities, if such agent or employee is acting in the usual course of his/her business or employment.

2. What is the difference between a registrant/licensee and an authorized agent?

In practical terms, an authorized agent is an employee of the registrant/licensee who performs controlled substance related duties under the direction of the registrant/licensee.  An authorized agent cannot purchase controlled substances for the registrant/licensee. Only the DEA registration holder may order and sign a DEA Form 222 for Schedule I or II controlled substances. A power of Attorney may not be used. Although the CFR (1305.05) allows for Power of Attorney, this authority is not granted under Michigan law.

MI 333.7331

(1) Only a practitioner who holds a license under this article to prescribe or dispense controlled substances may purchase from a licensed manufacturer or distributor a schedule 1 or 2 controlled substance. The authority granted under this subsection to purchase a schedule 1 or 2 controlled substance is not assignable or transferable.

(2) A purchase of a schedule 1 or 2 controlled substance under subsection (1) shall be made only pursuant to an order form which is in compliance with federal law.

3. Can authorized agents administer controlled substances to a research subject?

Yes, authorized agents can administer controlled substances to a research subject if the licensee/registrant has delegated that responsibility to them and that delegation of responsibility has been put in writing.

4. How do I make someone an authorized agent?

Individuals in each laboratory using controlled substances must:

  • Be fully identified
  • Complete Controlled Substance Awareness training
  • Acknowledge understanding of the responsibilities associated with the handling of controlled substances
  • Sign a screening statement

A log of all authorized agents in your laboratory with access to controlled substances should be maintained. Documentation must also be kept regarding the specific controlled substance-related duties that have been delegated to each authorized agent.

Authorized User Questionnaire
Authorized Agent Log

For additional information regarding authorized agents refer to the overview on authorized use.

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RECORDS AND INVENTORIES

1. What types of records do I have to keep?

The following records must be maintained and readily available:

  • State of Michigan controlled substance license
  • DEA Certificate of Registration
  • Authorized agent screening statement(s)
  • Acquisition and ordering invoices
    • Signed and dated supplier invoices or packing slips
  • DEA Form 222s
    • Used, voided and unused Form 222s
  • Inventory records
    • Initial inventory
    • Annual inventory – State of Michigan
    • Biennial inventory – DEA
    • General inventory
  • Usage and administration records
    • Multiple dose usage log
    • Diluted drug solution log
  • Transfer records of controlled substances transferred between registrants
  • Disposal records- DEA Form 41
  • DEA Form 106- Report of Loss or Theft

See the Records and Inventories Overview for additional information.

2. Do I have to use specific forms for inventories and usage/administration logs?

No, you do not need to use specific forms for recording inventories or for your usage and administration logs.  You must however, have specific information captured in the forms, so we have supplied some sample forms that you can use as is, or modify for your own use.

Initial Inventory Form
Annual Inventory Form
General Inventory Form
Multiple Dose Usage Form
Diluted Solution Usage Form

3. How long do I need to keep records for?

It is recommended that you keep all records for a period of five years from the date of the record.

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ORDERING

1. How do I purchase controlled substances?

Controlled substances must be ordered using the Principal Investigator’s DEA registration number.  You must use pharmaceutical grade materials, if they will be used for animal research. Refer to the Ordering Overview and Helpful Tips for Purchasing Controlled Substances for additional information.

2. I am a medical practitioner.  Can I write a prescription and get it filled at a pharmacy to obtain controlled substances for research purposes?

A practitioner cannot write a prescription to obtain controlled substances to be stored or dispensed at their laboratory location.

21 CFR 1300.01 (b) (35)

The term prescription means an order for medication which is dispensed to or for an ultimate user but does not include an order for medication which is dispensed for immediate administration to the ultimate user. (e.g., an order to dispense a drug to a bed patient for immediate administration in a hospital is not a prescription.)

21 CFR 1306.04 (b)

(b) A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients.

MI 333.7333

(7) A prescribing practitioner shall not use a prescription form for a purpose other than prescribing.

MI 333.17708

(2) "Prescriber" means a licensed dentist, a licensed doctor of medicine, a licensed doctor of osteopathic medicine and surgery, a licensed doctor of podiatric medicine and surgery, a licensed optometrist certified under part 174 to administer and prescribe therapeutic pharmaceutical agents, a licensed veterinarian, or another licensed health professional acting under the delegation and using, recording, or otherwise indicating the name of the delegating licensed doctor of medicine or licensed doctor of osteopathic medicine and surgery.

3. Who can order controlled substances?

Only the DEA registration holder may order and sign a DEA Form 222 for Schedule I or II controlled substances.  A power of Attorney may not be used.  Although, the CFR (1305.05) allows for Power of Attorney this authority is not granted under Michigan law.

MI 333.7331

(1) Only a practitioner who holds a license under this article to prescribe or dispense controlled substances may purchase from a licensed manufacturer or distributor a schedule 1 or 2 controlled substance. The authority granted under this subsection to purchase a schedule 1 or 2 controlled substance is not assignable or transferable.

(2) A purchase of a schedule 1 or 2 controlled substance under subsection (1) shall be made only pursuant to an order form which is in compliance with federal law.

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SECURITY

1. What are the requirements for storing and securing controlled substances?

At a minimum, controlled substances in Schedule II-V must be stored in a securely locked, substantially constructed cabinet.  There are additional requirements for Schedule I controlled substances.  Refer to the Security Overview  and the DEA publication: Controlled Substances Security Manual: A Security Outline Of The Controlled Substances Act of 1970 for additional information.

21 CFR 1301.75

(a) Controlled substances listed in Schedule I shall be stored in a securely locked, substantially constructed cabinet.
(b) Controlled substances listed in Schedules II, III, IV, and V shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies and institutional practitioners may disperse such substances throughout the stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of the controlled substances.
(c) This section shall also apply to nonpractitioners authorized to conduct research or chemical analysis under another registration.
(d) Carfentanil etorphine hydrochloride and diprenorphine shall be stored in a safe or steel cabinet equivalent to a U.S. Government Class V security container.

MI R. 338.3143

Rule 43. (1) A controlled substance that is listed in schedule 1 of R. 333.3111 to R. 338.3114a shall be stored in a securely locked, substantially constructed cabinet that is anchored to a wall or the floor.

Rule 43. (2) A controlled substance that is listed in schedules 2, 3, 4, and 5 of R. 338.3116 to R. 338.3126 shall be stored in a securely locked, substantially constructed cabinet, room, or cart.

2. Who can have access to the controlled substances in my laboratory?

Only authorized agents can have access to controlled substances in your laboratory.  Access includes, but is not limited to receiving packages, conducting inventories, having access to the keys for the storage unit, etc. Refer to the Authorized Use Overview for additional information on authorized agents.

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OTHER

1. How do I get rid of controlled substances that are out of date or that I no longer need?

Contact EHS to dispose of controlled substances via a DEA approved method. All controlled substances must be kept secure until an appropriate disposal method can be arranged. Refer to the Disposal Overview for additional information.

2. What penalties are associated with controlled substance violations?

The State of Michigan and DEA can impose administrative, civil, and criminal actions against a controlled substance licensee and DEA registrant for noncompliance and/or theft or loss associated with storage, administration, recordkeeping, etc. of controlled substances.

Michigan State University has a University Policy on a Drug Free Workplace. “Any employee involved in the unlawful use, sale, manufacturing, dispensing, or possession of controlled substances . . .will be subject to disciplinary action up to and including dismissal and referral for prosecution.” http://www.hr.msu.edu/documents/uwidepolproc/drugfreeworkplace.htm

3. I no longer need a controlled substance license and registration.  What do I need to do?

If you no longer need a State of Michigan controlled substance license and DEA registration you need to do the following:

  • Cancel your DEA registration and State of Michigan license.
  • Send any remaining DEA Form 222s to the Detroit DEA office.
  • Notify EHS that you will no longer be using controlled substances for research.
  • IMPORTANT: Contact EHS for disposal of your current inventory of materials or arrange for a transfer of the materials to another researcher with a license/registration.  It is the responsibility of the licensee/registrant to make arrangements for any remaining inventory before cancelling a license/registration. 

4. What federal and state requirements govern the use of controlled substances in research at MSU?

These requirements include but are not limited to:

5. If I have questions about use of controlled substances in research, who at MSU should I contact?

Amber Bitters
Environmental Health and Safety
164 Giltner Hall
432-5262
bitters1@msu.edu
www.ehs.msu.edu

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