Guidance Documents

This manual is intended to summarize and explain the basic requirements for administering and dispensing (but not prescribing) narcotic controlled substances approved by the Food and Drug Administration (FDA) specifically for use in maintenance or detoxification treatment in a DEA registered NTP under subchapter I (Control and Enforcement) of the CSA and DEA regulations, 21 CFR Parts 1300 to End.

This manual was prepared by the Drug Enforcement Administration (DEA), Diversion Control Division, to assist those persons who handle scheduled listed chemical products and List I and II chemicals in understanding the Federal Controlled Substances Act and its implementing regulations as they pertain to regulated chemicals.

This guidance document addresses how a Drug Addiction Treatment Act of 2000 (DATA)-waived practitioner may request removal of the X Number assigned to the provider’s DEA registration when they no longer intend to administer, dispense or prescribe buprenorphine to treat opioid use disorder and do not need the waiver.

Template letter explaining process and documentation requested for remote quality of service reviews of approved credit counseling agencies

This guidance document addresses issues pertaining to an individual practitioner’s use of their home address as a principal place of business or professional practice and the home address becoming controlled premises subject to unannounced inspections and administrative warrants under existing Drug Enforcement Administration (DEA) regulations

FAQs regarding the Industry Replacement of Tommy Built Tactical Model T36 Receiver.

Question and Answer addressing if a Researcher registrant should complete a DEA Form 222 when participating in double-blind studies in which the exact quantity of schedule I or II controlled substances received is unknown.

Q&A answering whether a physician transport controlled substances and administer controlled substances at the patient’s home residence (the so-called “black bag exception”).

This presentation on fireworks provides an overview of the classification of explosive materials and exemptions under Part 555, storage, identifying appropriate Tables of Distances and determining if a variance to deviate from the regulations might be needed.

Q&A asking if a pharmacy may deliver a prescribed buprenorphine product to a practitioner for direct administration to the patient. This Q&A further explains that a pharmacy may deliver buprenorphine to the registered location of either the prescribing or the administering practitioner, and must be administered by injection or implantation only to the patient named on the prescription within 14 days after the date of receipt of the CS by the practitioner.

This presentation details the process for requesting a variance for deviating from the explosives regulations through use of a quantitative risk assessment software tool known as ‘Institute of Makers of Explosives Safety Analysis for Risk.’

This presentation provides an overview of the FELC’s responsibilities for reviewing and processing all new applications for federal explosives licenses and/or permits as well as renewals, the background check process, and ensuring sufficiency of information received.