Ordering Guidelines for Research Chemicals and Controlled Substances

To obtain research chemicals and controlled substances from the NIDA DSP, all research investigators will need to prepare a Request Package. A Request Package should include the following items: 1. A cover letter including: Name, phone number and e-mail address of Research Investigator (and consignee, if applicable), Provide a current and complete address that would allow shipment by a suitable carrier such as Federal Express (FedEx) (i.e. street address, building name or number, room number, city and state) – This address should coincide with the address on the DEA order form. For radio-labeled drugs or chemical substances, indicate the address to which such materials will be shipped. In case the shipping address is different from the researcher’s address, a current copy of the radioactive materials license must be submitted. If applicable, NIH grant number of project and name and contact information of project’s NIDA/NIH Program Officer. If a non-grantee, no information on Program Officer and grant number is required. Name(s) and quantity of compounds or other substances being requested, The total radioactivity (preferred units of measurement, mg per vial, etc.) If multiple studies/tasks are planned, combine projected needs into a single order rather than placing several separate requests in a short time interval. The request should generally be limited to four items or drugs/compounds per order to avoid delay. Avoid drug abbreviations, and include specifications such as (+), (‑), (dl), base, or salt, as appropriate. Please visit the NIDA Drug Supply Catalog (PDF, 4.9MB) (this document is not fully accessible, for help viewing this content, please contact Rik Kline(link sends email) at 301-827-5243), for drug supply information. 2. The Research Investigator’s curriculum vitae (CV). 3. A detailed research protocol clearly indicating: The specific aims and goals of proposed study (preferably the study abstract) The number of experiments and experimental subjects The dosages or concentration of drugs Calculate required amount of drugs or chemical substances for your project and submit your request well in advance of your planned experiments or tasks, or 6‑8 weeks prior to depletion of stock on hand for ongoing studies/tasks. Justification of quantities of drug(s) requested. If the request is related to a previously submitted protocol, provide a reference to this protocol and a brief statement of progress along with references to resulting publications. 4. Statement of commitment that NIDA will be acknowledged in research publications using the NIDA Drug Supply Program. 5. A completed DEA Order Form-222 for Schedule I-II controlled substances. DEA Form-222 is not necessary for drugs in Schedules III‑V, but a valid registration for the appropriate schedule is required. Under the third column of DEA Form-222 (Size of Package), list quantities as bulk weight. Radio-labeled compounds must be listed by weight and NOT by units of activity. 6. A copy of current DEA registration, Form DEA-223 for controlled substances. It is the Research Investigator’s responsibility to keep his/her registration current and to verify the drug code for requested drug. Investigators who request a Schedule I drug and/or Etorphine HCl or Diprenorphine must provide DEA documentation under which the requested drug is covered under their current DEA registration. Avoid drug abbreviations, and include specifications such as (+), (‑), (dl), base, or salt, as appropriate. 7. For radioactive compounds, a copy of Nuclear Regulatory Commission license. For more information, please visit the Nuclear Regulatory Commission licensing website. 8. For clinical research projects involving human subjects Investigational New Drug (IND) number and a copy of approved IND letter from the FDA. For more information, please visit the FDA IND Application website. A copy of your Institutional Review Board (IRB) approval letter , A copy of your Data Safety and Monitoring Plan, Proof of registration with clinicaltrials.gov (NCT #) A copy of the study consent form(s) 9. For basic (non-human) research projects A copy of the document demonstrating that the research is approved by the Animal Care & Use Committee and that adequate care in conducting animal research will be exercised (if applicable). For more information, please visit the Animal Care & Use Committee Animal Study Proposal website. 10. For ongoing research projects (This includes research previously supported by the NIH prior to request) Reference information1 pertaining the previous protocol / FDA approval to the previous protocol A brief statement of progress (500 words or less) A list of any relevant publications.

Leave a Reply

Your email address will not be published. Required fields are marked *

Open chat