Controlled Substances/Controlled Dangerous Substances (CDS)

Authorized user- A Johns Hopkins faculty member, staff, or student working under the direction or authorization of a Registrant to have access to, use, manage, or otherwise interact with controlled substances for research, held in a Registered Location under the responsibility of that Registrant. Authorized users must be explicitly listed under the Registrant’s profile with the DEA and the OCSA. Inclusion on other institutional protocols (such as Institutional Animal Care and Use Committee IACUC protocols) does not constitute authorization to share controlled substances. 

Controlled Substance or Controlled Dangerous Substance (CS or CDS)- Any substance listed in the Controlled Substances Act (see list in alphabetical order) These may include opiates, hallucinogenic substances, depressants, stimulants, and cannabinols. They are divided into five (5) Schedules based on an assessment of currently accepted medical use in treatment, its relative abuse potential, and likelihood of causing dependence.  

Registrant- A person employed by Johns Hopkins, registered federally with the DEA and in Maryland under the OCSA, to acquire, store, manufacture, use, and/or disposal of Controlled Substances.

DEA Researcher’s Manual (2022) 

DEA Registration (contact)- new applications and renewals 

OCSA Registration (contact)- online application and researcher questionnaire 

COMAR 10.19.03.03 Registration, Registration Certificate and 21 CFR 1301 Registration

All purchase and use of CDS for research must be conducted under appropriate registration. In the state of Maryland, this requires registration through the US DOJ DEA Diversion Control Division as well as through the Maryland Department of Health Office of Controlled Substances Administration (OCSA). 

Registrants may not conduct research activities using controlled substances using a medical/Practitioner registration.  DEA Practitioner registrations for physicians, dentists, veterinarians, and other health care professionals permit the practitioner to “distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research,” generally understood to be related to their clinical practice.  A separate registration is required for each separate place of business, professional practice, or location for which registration is required.   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. 

In June of 2022, the DEA released a Researcher’s Manual: An Informational Outline of the Controlled Substances Act PDF, which offers some clarification of situations that may not occur in clinical practice. 

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 and choose the appropriate Researcher option: https://health.maryland.gov/ocsa/Pages/CDS-Application.aspx 

• You will also need to complete the Researcher Questionnaire and upload it during the application process: https://health.maryland.gov/ocsa/Pages/CDS-Questionnaire.aspx 

• The online form may not allow you to move forward without entering a professional license number.
  •   If you are a clinician, you may enter your professional license number.  
  • If you are applying solely as a researcher, enter any string of numbers and a future date to continue with the online application.  

• The online form may ask for a National Provider Identifier number; this is not applicable to researchers. Please enter 0. 

• Section 4: Mandatory PDMP requirement does not apply to research use, this is for prescribers.
  •  If you are a clinician and have completed the PDMP, answer Yes and fill in your code 
  • If you are not a clinician and you are applying solely for research, enter “Exempt- Research License” 

• 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
  •  As of early 2024, the form does not allow you to continue if you answer “no.” Answer “yes” to continue the form; it will be ignored by reviewers.  

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

• OCSA registration numbers are valid for 3 years.  

• The OCSA registration application process can take several weeks to several months; plan accordingly before starting any new work.  

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

• You will need to complete DEA Form 225, under the Researcher option. 

• 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. 

• Applications for Schedule I registrations must be accompanied by a research protocol (21 CFR 1301.18 and 21 CFR 1301.32). 

• DEA registration numbers are valid for 1 year, however it is important to note that research applicants are placed into twelve groups based on the first letter of your last name. Your first registration may be valid for as short as 3 months, or as long as 14 months.  

See the DEA Registration Q&A page for common questions. 

21 CFR 1304.04

Each Registrant must keep complete and accurate records for all controlled substances, from ordering to disposal. Records should be kept by the Registrant for at least two years from the date the record was made, on-site, and be made readily available for inspection. Records should include (exerpted from the DEA Researcher’s Manual, Section V): 

• Executed official order forms (DEA Form 222) or the electronic equivalent.  

• Unexecuted official order forms (DEA Form 222).  

• Power of Attorney authorization to sign order forms, if applicable.  

• Receipts and/or invoices for schedules III, IV, and V controlled substances.  

• Records of controlled substances distributed (i.e., sales to other Registrants, returns to vendors, distributions to reverse distributors).  

• Records of dispensing (dispensing log).  

• All inventory records of controlled substances, including the initial and biennial inventories, dated as of beginning or close of business.  

• Reports of Theft or Significant Loss (DEA Form 106), if applicable.  

• Inventory of Drugs Surrendered for Disposal (DEA Form 41), if applicable. 

The DEA requires that an initial inventory be taken on the date he or she first engages in activity with CDS. After this date, at a minimum, a biennial inventory (every two years, within two years of the previous inventory) should be taken. Note that an inventory consists of a count of all controlled substances on hand on a given day. The inventory should include a separate listing for each kind of substance or preparation, the number of packages, total content of packages, with individual amounts in containers if not full. 

A running log of activities should also be kept to document when, where, and for what purpose the substance was used, but is not the same as an inventory. It is best practice to uniquely identify containers in multi-pack packages, particularly if they contain multiple doses. The running log and inventory should specify the amount remaining in each container by their unique identifier. These records must be kept for both stock and working solutions. 

Inventories and records for Schedule I and II drugs must be kept separate from Schedule III-V. 

HSE strongly recommends that dedicated, bound notebooks be used for running logs and inventories, as looseleaf or binder documentation can lead to lost records, retroactive recordkeeping, and replaced records. Any written documentation must be written in indelible ink. 

21 CFR 1301.90

Per the DEA regulation, it is assumed that the following questions will become a part of an employer’s comprehensive employee screening program:

Question. Within the past five years, have you been convicted of a felony, or within the past two years, of any misdemeanor or are you presently formally charged with committing a criminal offense? (Do not include any traffic violations, juvenile offenses or military convictions, except by general court-martial.) If the answer is yes, furnish details of conviction, offense, location, date, and sentence. 

Question. In the past three years, have you ever knowingly used any narcotics, amphetamines, or barbiturates, other than those prescribed to you by a physician? If the answer is yes, furnish details. 

A research Registrant may grant access to Authorized Users to have access to, use, manage, or otherwise interact with controlled substances for research, held in a Registered Location under the responsibility and direction of that Registrant. It is important that the Registrant discloses all authorized users to the OCSA and the DEA and documents their screening process. 

All registrants and authorized users must complete and maintain required training certification. Registrants should consider creation of a training program for controlled substances recordkeeping, storage, and usage, specific to their unique situation. All training should be documented and records of training retained for a minimum of 2 years.

Anyone having knowledge or reasonable suspicion of Inventory irregularities or diversion, theft, or loss of CDS has an obligation to report such information to Johns Hopkins Public Safety, HSE, and the Registrant (if the Registrant is not the person reporting). The Registrant shall notify the DEA Field Division Office below of any theft or significant diversion or loss of any Controlled Substances upon discovery of the theft, loss, or diversion using DEA Form 106.  

DEA District Field Office 

200 St. Paul Plaza, Suite 2222 
Baltimore, MD 21202 
410-962-4800