Controlled Substances

There are five established Schedules of controlled substances (21 CFR 1308.11-15; I, II, III, IV, and V, from most stringently controlled to less), where determination is based on potential for abuse, whether there is an accepted medical use for treatment in the United States, and their potential to cause dependence. A list of controlled substances by schedule number is available.

Schedule I drugs have a high potential for abuse, there is no currently accepted medical use in the U.S., and lack of accepted safety for use under medical supervision. Examples include tetrahydrocannabinols and heroin.

Schedule II drugs have a high potential for abuse, there is a currently accepted medical use in the U.S., perhaps with severe restrictions, and abuse may lead to severe psychological or physical dependence. Examples include fentanyl, morphine, pentobarbital, and cocaine.

Schedule III drugs have less potential for abuse than those listed in Schedules I and II, there is a currently accepted medical use in the U.S., and abuse may lead to moderate or low physical dependence or high psychological dependence. Examples include buprenorphine and ketamine.

Schedule IV drugs have low potential for abuse relative to drugs in Schedule III, there is a currently accepted medical use in the U.S., and abuse may lead to limited dependence relative to drugs on Schedule III. Examples include diazepam and midazolam.

Schedule V drugs have low potential for abuse relative drugs in Schedule IV, there is a currently accepted medical use in the U.S., and abuse may lead to limited dependence relative to drugs in Schedule IV.

You will need approval by both the state of Maryland through the Office of Controlled Substances Administration (OCSA) as well as federally through the Diversion Control Division of the Drug Enforcement Agency (DEA).

If you will work only with Schedule II-V substances, you must first register with the OCSA, wait for approval, then register with the DEA using your OCSA number.

If you work with any Schedule I substances, you should first register with the DEA, wait for approval, then register with the OCSA.  

OCSA website: https://health.maryland.gov/ocsa/pages/home.aspx

• You will need to complete the Practitioner – 3 year application: https://health.maryland.gov/ocsa/Pages/CDS-Application.aspx

• You will also need to complete the Researcher Questionnaire:https://health.maryland.gov/ocsa/Pages/CDS-Questionnaire.aspx
• For the fee exempt portion of the state application, please contact Alexandra (Alex) Zouras-Wieneke azouras@umaryland.edu; (410) 706-4439
• Section 4: Mandatory PDMP requirement does not apply to research use, this is for prescribers (but if you’ve already done this as a clinician, you can answer Yes)
• Section 5: “Attestation: A. Have you completed the Mandatory 2-Hour Continuing Education (CE) Course relating to Prescribing or Dispensing of Controlled Substances prior to obtaining a Controlled Substances registration” does not apply to researchers, per the 5th question in the below FAQ, but as above, if you did this anyhow as a clinician then you can answer this. https://health.maryland.gov/ocsa/Documents/CME%20Outreach%20FAQ.pdf

• For the question regarding reverse distributors for disposal, please contact EHS.  

**(update 8/11/21) Since the pandemic, the OCSA is only accepting online applications and that has caused some issues. Another researcher forwarded some very helpful guidance on how to get through the online form:

Question: For a research application, I cannot proceed without entering a PDMP code — how should I respond to the PDMP mandate question?

Answer: In box where you would otherwise type your PDMP code, type “Exempt- Research License”

Question: The only two options in the pull-down menu for attesting to the completion of 2-Hour Continuing Education training are “yes” and “no.” Selecting “no”  prompts you to do the training or you cannot continue with the online application.  Since this is not a requirement for a research license, how should I respond?

Answer: This training is not a requirement for researchers, and therefore will be ignored by reviewers. Respond with “yes” and continue the online application.

Question: The applicant has a PhD but not an MD degree. Online application will not allow you to advance without entering an expiration date for your professional license. Is a professional license a prerequisite to obtain a Researcher license?

Answer: Having a professional license is not a requirement for researchers, and therefore this question also will be ignored by reviewers. Enter any string of numbers and any future date to continue with online application.

Question: The online form is asking for a National Provider Identifier Number. What should I enter?

Answer: For researchers, this is not applicable. Please enter 0. 

Question: How long will it take for review process to get my CDS license approved?

Answer: The website says 10 days but due to COVID-related issues, it will take approximately 3-4 weeks.

DEA website: https://www.deadiversion.usdoj.gov/

• You will need to complete DEA Form 225, which covers Researchers.
• You may or may not be required to submit a researcher questionnaire that asks the same basic questions as the OCSA (but requires that you submit home addresses and SSNs for your authorized users).
• You may or may not be contacted for an in-person inspection prior to approval.
• See the DEA Registration Q&A page for common questions.

1. Running logs kept on loose-leaf paper, binder, or easily modified notebook.

   EHS strongly recommends the use of dedicated, bound notebooks, as loose-leaf, spiral-bound, perforated, or solely digital records can lead to lost records, retroactive recordkeeping, and replaced records. All written documentation must be written in indelible ink.

   When moving records to a bound notebook, there is no need to re-create records that were once on loose-leaf. Transfer over the last relevant data (if you are mid-bottle, move that information over, but you don’t need to move over bottles that were used previously) and continue in the bound notebook for the future. Keep all old records in case of inspection for at least two years from the date of last entry.

2. Log is incomplete, incorrect, does not have enough information, or cannot be followed.

   A running log should be readily understandable, so that upon inspection it is clear what was used and what is remaining in the lab stocks.

   EHS does not provide a required template, as different labs may require different recordkeeping practices that fit within the space of a particular notebook.

   Recommended columns include:

   Date

   Container ID

   Amount used

   Amount remaining

   Admin’d to (#animals)

   Admin by (initials or signature)

   Name of the substance can be another column, or appear as a page header, along with concentration.

   All bottles must either come to 0 (zero) in the log, be found in the inventory, or be accompanied by a note that indicates disposal. If there is a small amount remaining but it is irretrievable for the purposes of the experiment, make a note rather than leave a listing of 50ul that can no longer be found in inventory. It is strongly recommended that any additions to stock (through purchases) or deletions from stock (for example, disposals) be kept in the log as well, whether it is maintained on a separate page, or appears as a note in the running log by chronological order.
   
   
3. Containers do not have unique identifiers.

   Each container should have a unique identifier, which is also used in the log. If a package contains 5 bottles of 1 ml each, they should be identified, for example, as 12-1, 12-2, 12-3, 12-4, and 12-5. Each 1ml container in this example must be tracked, rather than treating the whole package as 5ml.

4. No inventory, only a running log.

   A running log notes what is used when; it is used in day-to-day operations. An inventory is a biennial (every two years) list of every controlled substance, in every formulation, whether stock or working, expired, unexpired, or scheduled for disposal, under a registrant’s control on a given date. Registrants are expected to keep both a running log AND a biennial inventory of controlled substances.

5. Expired controlled substances - must contact EHS/Simone for disposal.

   An Excel disposal sheet must be submitted to EHS, which will review and forward on to the reverse distributor. This is not a quick process, so the sooner a sheet is submitted, the better.

6. Controlled substances not properly secured and stored.

   CDS must always be stored and secured as approved on DEA and OCSA registrations, double locked in a safe or cabinet of substantial construction. If CDS are being actively used, they must be under the direct control of the registrant or an authorized user.

7. Empty containers being stored.

   Some labs keep their empty containers just in case they are needed for disposal. If the container is empty, or as empty as can be reasonably expected, through necessary practices, the registrant or authorized user must deface the original label (so the content is no longer identifiable), triple-rinse the container if possible, then throw away the container. Pouring unwanted CDS down the drain or into general hazardous waste containers is not a necessary practice, so this is NOT an accepted means of disposal. This should only be used for containers that are actually empty.

8. Non-CDS stored with CDS.

   CDS must be kept stored separately from non-CDS. There is an item in the regulations where Schedule III, IV, and, V substances may be stored with non-CDS, but only with prior written permission from a DEA Special Agent in Charge. Without that written permission, the expectation is that non-CDS are kept separately. 

9. CDS is used or shared inappropriately. IACUC approval is not the same as DEA/OCSA approval to use controlled substances.

   Investigators are not “allowed to use controlled substances” because they have IACUC approval. In a similar vein, investigators may not share controlled substances with other PIs “that are on their IACUC protocol.”

10. Medical registration is used for research use inappropriately. A research-specific registration is required for research using controlled substances.

    Registrants may not conduct research using controlled substances using a medical/practitioner registration. A medical registration is intended for prescription, administration, or direct dispensation at the listed place of business and does not allow for authorization of subordinate personnel to handle materials obtained under the license at the registrant’s research laboratory. If a clinician prescribes CDS during medical practice and conducts research using CDS, then they must have a research registration with the DEA and with the OCSA as well as a medical registration with the DEA and OCSA.

11. Thefts or losses must be reported to the DEA, OCSA, UMB Police, and EHS.

    If you are unsure if the theft or loss has been reported or if you have any information of these activities, reach out to EHS at 410-706-7055.